Lecture by J Ralph Blanchfield MBE
1. Introduction
Hello Everyone. At the time of writing (mid-October 2008) this Lecture is due to be on-line for two weeks during November. I recommend that you use the first week to study and assimilate the material in the Lecture itself and the material in the on-line references; and then carry out your Assignment (described in Section 14) in the following week. Assignments should be sent in as soon as possible thereafter.
I have also provided this Module also as a .pdf file so that, it you wish you can print it out to read while not at your computer.
This is such a fast moving subject that this module has to be substantially updated from one semester to the next. Although I have delayed sending this version of the module to Mary Anne until the last minute so that I could keep updating it until then, undoubtedly in the few weeks that elapse before it goes on-line for you, there will be further significant developments. If so I'll post them on the Discussion page. But I encourage you to post there any new developments that you spot.
At the time of writing this module, the internal links and the links to on-line references were operative; but, occasionally it may happen that the transfer of the module to ANGEL may result in links not working properly. If an external link does not work by clicking on it, try copying and pasting the URL into your browser. Also, URLs do sometimes change, so if you try to access an external link and it does not work by either method, please notify Mary Anne (with copy to me) and we'll try to sort out the problem.
While mentioning URLs, may I offer a word of caution. Nowadays we take it for granted that with a mouse click or two we can easily acquire valuable knowledge from the Web. Sometimes however that very fact leads us to forget that "all is not gold that glisters" -- and that some easily acquired URLs are wolves in sheep's clothing -- vested interest axe-grinding, junk science masquerading as science-based information, or speculation presented as though it is established fact. Remember, anyone can create a Website and put whatever they like on it. In one sense that is great, but in another sense it is dangerous and means we need to exercise our critical faculties to separate the wheat from the chaff.
As in previous semesters, I have avoided pointing students to Websites which serve and promote commercial or ideological vested interests, either from a pro-GM or an anti-GM perspective. Moreover, such is the exponential growth in the volume of more trustworthy GM-related URLs, even since the Fall 2007 version of this module, that it would take you forever to visit them all, let alone find time to read them. So I am listing what I consider to be the most trustworthy, reliably science-based and useful URLs.
In order to understand the laws and regulations relating to GM foods in the European Union (EU), one needs to have some knowledge of the EU legislative structure, how it has evolved and and how it works, and some background about GM, how it is carried out, what its potential benefits are, the concerns (whether real or speculative) to which it gives rise and the issues which the EU GM-related legislation is intended to address.
The first several sections of this Lecture are therefore intended to provide summary outlines of that knowledge and background.
Course students who consider themselves adequately familiar with one or more of these topics may skip the relevant sections and
Return to the Index of Contents to select their starting points, though even they may find that the outlines are useful reminders.On a personal note may I add that although I have extensive experience of communicating on-line and helping to draft IFST Information (formerly called "Position") Statements and putting them on the IFST Web site, I am not an academic lecturer by profession and experience; and although this Lecture is now my eighteenth experience of contributing to this virtual on-line distance-learning study course, it continues to be a learning experience for me, too. I have been helped and encouraged by feedback from students involved in the previous seventeen occasions. When in due course you return your assignments I would welcome inclusion of brief feedback on how useful (or otherwise) you found this Lecture.
2. Background to EU legislative structure
Most matters relating the European Union may be found by using links on the EU Web site
http://europa.eu.int/index-en.htmIn simplified summary, at present food legislation is formed by recommendations from the DG Consumer Policy and Consumer Health of the Commission (based on advice from EFSA) to a succession of meetings of the officials from Member States, where, ideally, differences in approach are resolved, but in practice these meetings often involve "horse trading" and compromises, and are the main reason why the process is sometimes lengthy; thence to the European Parliament for a "first reading"; thence to the Council of Ministers: and finally a second reading in the European Parliament before returning the final version to the Council of Ministers. During this period, drafts (and often a succession of drafts) are widely circulated within their respective countries by the national government departments for public consultation.
The main forms of legislation, including food legislation, are EU Directives and EU Regulations. When adopted, the full text of the Directive or Regulation is published in that day's "L" issue of the Official Bulletin of the European Communities (quoted in references as "OJ L" followed by volume number date and page(s). Food-related texts are accessible to authenticated subscribers on-line at
http://europa.eu.int/eur-lex/en/lif/reg/en_register_152030.html
The measures in a Directive must, within a limited time from the date of its adoption, be given legal effect by national legislation in each Member State. In contrast, a Regulation takes immediate force in all Member States. Although national legislation is not necessary to bring a Regulation into force, it is customary for national legislations to mirror it, providing for national enforcement machinery and penalties for non-compliance.
3. Background to GM
Food biotechnology is the application of biological techniques to food crops, animals and microorganisms 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.
Although the transfer of genes by selective breeding has been practised by mankind for around 10,000 years, a relatively more recent (i.e. starting about 25 years ago) application of biotechnology to food is known as 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 microorganisms.
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 microorganisms such as yogurt cultures and yeasts, to produce domesticated variants better suited to the needs of humans. What most people think of as "traditional breeding" are selective breeding methods based on the transfer of unknown numbers and kinds of genes between individuals of the same species.
However, what many do not know is that, before the advent of GM technology, 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! There are numerous examples within 'conventional' plant breeding of successive techniques being developed that have blurred species boundaries.
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 intentionally to move genes between different species. This property makes the technique revolutionary in terms of the potential benefits that it may bring but it has also caused concern regarding issues of safety, ethics, consumer choice and environmental impact.
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.
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."
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:
The use of antibiotic marker genes has, however, been a source of concern, and other methods have become 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.
However, in August 2005 Menetawab and Stewart at University of Tennessee reported that
Selectable markers of bacterial origin such as the neomycin phosphotransferase type II gene, which can confer kanamycin resistance to transgenic plants, represent an invaluable tool for plant engineering. However, since all currently used antibiotic-resistance genes are of bacterial origin, there have been concerns about horizontal gene transfer from transgenic plants back to bacteria, which may result in antibiotic resistance. Here we characterize a plant gene, Atwbc19, the gene that encodes an Arabidopsis thaliana ATP binding cassette (ABC) transporter and confers antibiotic resistance to transgenic plants. The mechanism of resistance is novel, and the levels of resistance achieved are comparable to those attained through expression of bacterial antibiotic-resistance genes in transgenic tobacco using the CaMV 35S promoter. Because ABC transporters are endogenous to plants, the use of Atwbc19 as a selectable marker in transgenic plants may provide a practical alternative to current bacterial marker genes in terms of the risk for horizontal transfer of resistance genes.
4. What are the potential benefits of GM?
For the development of improved food materials, GM has the following advantages over traditional selective breeding:
These advantages, in turn, lead to a number of actual and potential benefits, especially in the longer-term, for the consumer, industry, agriculture and the environment:
At present, however, commercially grown GM crops are "first generation" and the present situation is reported in the ISAAA Report issued 13 February 2008,"Biotech Crops Experience Remarkable Dozen Years of Double-Digit Growth". .
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 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.htmlISAAA 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 3 October 2008, but there are also links to previous issues.
http://www.isaaa.org/kc/cropbiotechupdate/online/default.asp?Date=10/3/2008
GM has huge potential for mankind in medicine, agriculture and food. In food, the real benefits are not the early instances that have been appearing so far, but 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". I know of no reputable scientist who has made such a claim. 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. The Nuffield Council on Bioethics, in its May 1999 Report on "Genetically modified crops: the ethical and social issues", (see Section 5c of this module) not only adopted this position, but referred to it as a compelling moral imperative. It also stressed that this is something that should not be left to commercially-oriented R&D, but must be progressed by governments and international agencies.
We should not expect the present "first generation" of GM crops to contribute significantly to all that but we need a more farsighted recognition of the potential of future GM to provide ability to grow crops in inhospitable environments ( drought, saline soil, aluminium-rich soil, extremes of temperature);crops with enhanced nutrition attributes (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 crops that aid the farmer to produce greater output with lesser input of energy, labour and resources.
That is not to say that they do not contribute some of those advantages at present. An ounce of practical experience is worth a ton of assertion. In the Fall 2003 semester one of the students on this course, Abigail ("Abby") Smith, wrote in her assignment for this module:
"The (GM) seed is comparable in price to the conventional equivalent. Farmers in the USA have seen the benefits of growing these crops and will pay the extra money to be able to reap their benefits. I am from a midsize cash crop farm in the USA where the only soybeans we plant are Round-up Ready and in certain situations we plant Bt Corn. We have experienced increased yields and reductions in the amount of herbicides we use and tillage we have to perform. For us this has meant higher income, less work and more profit. When farmers experience benefits from planting a crop they are more likely to keep using that product. ".The Institute of Food Science & Technology, in its Information Statement on GM, states
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.
But do carefully observe the phrase beginning "provided that".
5. What are the concerns about GM?
Many concerns about GM have been aired, some of them genuine, based on hazard analysis and risk assessment; some speculative and without scientific basis (often presented as though they were evidence-based); and some which are urban myths.
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?") &emdash; 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. We can be thankful that it was eventually legalised and over the last seven 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 skillful 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.
The relationship involving these three activities in 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 scrutinised to ensure that there is a broad scientific consensus that it is based on some hard scientific evidence.
Moreover, what is frequently overlooked &emdash; and always overlooked by the opponents of a development &emdash; is that PP should be applied not only to that development but to all alternative courses of action, including that of doing nothing.
The foregoing account of risk analysis and the precautionary principle has appeared in this module for many previous semesters. In September 2007 it was formally embodied in the Scientific Information Bulletin on that topic issued by the International Union of Food Science and Technology (IUFoST)
http://www.iufost.org/Issues/IUF.SIB.Safety,Risk.P.P.pdf
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 that is the touchstone of sincerity and objectivity for us all.
How do we go about it? My contribution on behalf of the Institute of Food Science & Technology (IFST) to the OECD on-line Forum for the Paris Biotechnology Consultation on 22 November 1999, explained how. This constructive approach is to prevent hazards giving rise to risks. The established methodology for that, used by those responsible for safety in food production and distribution, is a systematic one called Hazard Analysis Critical Control Point (HACCP).
Those students working in food technology in industry will be very familiar with HACCP. For any who are not, in brief, you study the specific system concerned and identify the hazards. You then establish "critical control points" where you operate controls (measures and limits to prevent hazards causing risks, and monitoring to ensure that the controls are working effectively). A food technologist or engineer designing a new system or re-designing an existing one, first uses the HACCP approach to design it so as to avoid as far as possible "built-in" hazards, and then applies HACCP to the resulting system.
So, instead of identifying possible hazards and crying "look at these scary dangers" (the passive "victim" approach), society should require the case-by-case application of the food safety HACCP approach to GM.
The further development of GM technology holds out such indispensable prospects for humanity's future that any other approach would be indefensible.
For those who wish to explore the HACCP methodology further, some useful on-line and print references are included at the end of this Lecture.
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)]
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://www.royalsociety.org/displaypagedoc.asp?id=6591 (Note this is a very large file with a huge "front page" graphic, and takes a long time to download -- but it is worth it!).
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.
Their "bottom line" conclusions were as follows:
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 then Agriculture Under Secretary Bill Hawks said: 'This new unit will ensure USDA is at the forefront in developing appropriate regulatory policies to address today's biotechnology issues and challenges.' The creation of BRS provides APHIS and its cadre of biotechnology experts with an opportunity to review its leadership position in the agriculture biotechnology field and speak to its stakeholders with one voice. The new program will focus on regulation of biotechnology, risk assessments and permitting. BRS will also work with foreign governments to help create compatible biotechnology standards and will follow industrial trends and forecast scientific advancement to better regulate the biotechnology industry. This reorganization will also better position USDA to address the recommendations provided by the National Academy of Sciences in its February 2002 report 'Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation.' While the NAS report recognizes the strengths in APHIS' biotechnology regulatory process, it also provides recommendations to enhance this system to make it more effective. APHIS' new biotechnology unit will enable the department to take a more comprehensive approach to regulating genetically modified organisms such as transgenic arthropods and transgenic animals. APHIS will be reassigning 25 staff members to this new unit and focusing approximately $4 million on the effort ..."
The World Health Organization has issued http://www.who.int/foodsafety/publications/biotech/20questions/en/">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.
(a) Safety
To produce food by any new technology, including gene technology, there must be appropriate safeguards to protect human health and animal health. Most countries in the Western hemisphere started developing regulatory controls long before any GM foods became available to consumers. These controls were developed, not because of identified safety problems but because of a lack of previous experience of GM foods. Although many of the early concerns regarding the safety of GM foods have not materialised, the precautionary approach remains, 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 way, 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 involve, but, importantly, are not limited to, the concept of substantial equivalence. This concept was developed in the late 1980s by several national regulators, was refined and given international recognition by OECD in 1993 and further refined in the FAO/WHO Consultation of Experts in 1996 with particular reference to foods produced by modern biotechnology. It 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 concept holds 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 categoriesWhere 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.
At this point it should be mentioned that the EU Commission has introduced stricter interpretation rules which result in some differences between EU and FDA in their respective applications of substantial equivalence (see Section 8).
An understanding of substantial equivalence is key to understanding the basis of GM regulatory controls. This brief outline needs to be supplemented by studying the text of the Report of the Joint FAO/WHO Consultation on Biotechnology and Food Safety
http://www.fao.org/es/ESN/food/pdf/biotechnology.pdfThe 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.
On 28 September 2006, it was announced that a Michigan State University scientist has developed the first animal model to test whether genetically engineered foods could cause human allergic reactions. Venu Gangur, MSU Assistant Professor of food science and human nutrition, has received a $447,000 grant from the US Environmental Protection Agency to validate the test ... The Food and Agriculture Organization within the World Health Organization has a structured approach to determining whether genetically engineered foods cause allergies, according to Gangur, who also is a faculty member in the National Food Safety and Toxicology Center. 'But it has a major flaw. A critical question in that process asks, 'Does the protein cause an allergic reaction in animals?' The problem is that there has been no good animal model available to test this.' Gangur and students in his lab have developed a mouse model – the first of its kind – to test the allergy-causing potential of genetically engineered foods. He'll use the EPA grant to examine whether the model works on a variety of proteins. If successfully validated, the testing could be available commercially in about five years ... Robert Tempelman, MSU Professor of Animal Science and statistics and probability, is the project's co-investigator. Gale Strasburg, chairperson of the MSU Department of Food Science and Human Nutrition; and Jim Pestka and Maurice Bennink, MSU Professors of Food Science and Human Nutrition, also are participating in the project .
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 http://www.bma.org.uk/ap.nsf/Content/GMFoods/$file/GM.pdf
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."
On 6 January 2005, CORDIS (Community Research and Development Information Service), the EU's official online information platform for scientific research, issued a News Release, "EU project publishes conclusions and recommendations on GM foods," which states in part that " ... the European Commission funded a thematic network on the safety assessment of genetically modified food crops, the ENTRANSFOOD project ... Funded under the Fifth Framework Programme (FP5), ENTRANSFOOD sought to identify prerequisites for introducing agricultural biotechnology products in a way that is largely acceptable to European society ... the consortium ... consists of 65 partners from 13 different European countries, including representatives from academia, regulatory agencies, food manufacturers, retailers and consumer groups ... The project found that existing test methods for safety assessment of genetically modified organisms (GMOs) are efficient and ensure that GM foods that have passed the test are as safe and nutritious as plant-derived foods ... ENTRANSFOOD also noted that process-based labelling of all foods containing GM crops is a necessity in order to dispel the fears of EU citizens, but recognised that difficulties are unavoidable in implementing the EU's labelling requirements ... On the subject of detection of unintended effects and gene transfer, ENTRANSFOOD emphasised that there is no indication that unintended effects are more likely to occur in GM foods or that there is any inherent risk in the transfer of DNA between organisms, since DNA is not toxic ... ENTRANSFOOD recommended the creation of an evaluation and discussion platform combining a range of diverse perspectives on new food technology to formalise public engagement and consultation in the GM debate ..." - The complete text of the CORDIS news release is at
http://cordis.europa.eu/fetch?CALLER=EN_NEWS&ACTION=D&DOC=1&CAT=NEWS&QUERY=1173302230405&RCN=23144
Information about the ENTRANSFOOD project is at http://www.entransfood.com
The European Food Safety Authority is working closely with Member States on GMO risk assessment. At a meeting organised by EFSA, more than 60 GMO experts from national regulatory risk assessment bodies from across the European Union discussed best scientific approaches to evaluate the safety of GMOs at national and European level.
EFSA is pro-actively working to keep at the forefront of risk assessment methodologies and approaches to GMOs and is working with Member States to draw on the best scientific minds in Europe on these issues.
Scientists from the European food safety watchdog, including a number from its GMO Panel, and the national experts nominated by the national food safety agencies met in November 2007 to examine EFSA’s risk assessment procedures and its Guidance Documents. EFSA subjects each individual GMO application to rigorous review carried out according to internationally agreed guidelines.
Most experts agreed at the meeting on the general approach on risk assessment methodologies and approaches to GMOs. EFSA is building on the exchange of views to continue to strengthen its risk assessment approach and will take a number of recommendations to the Advisory Forum for further discussion.
One key issue addressed at the meeting was the Environmental Risk Assessment of GM plants intended for cultivation in Europe. Several experts asked EFSA to develop guidance further, particularly concerning field trials, regional specificity and potential effects on non-target organisms. EFSA will pursue its work in this area in co-operation with Member States and in light of a question recently received from the European Commission (DG Environment) on Environmental Risk Assessment.
The use of statistics in GMO risk assessments, to estimate biological differences between a GM plant and its conventional counterpart, was discussed in detail. EFSA has a working group looking at new statistical methods that could help further advance harmonisation in risk assessment. The majority of Member State experts agreed that statistics had an important role to play in GMO risk assessment but emphasised that biological relevance should drive the dynamics of the risk assessment rather than statistical significance.
On animal feeding trials, the majority of Member State experts was satisfied with present EFSA risk assessment guidance which requires a 90-day feeding trial study whenever evidence indicates significant differences in the GM plant which requires further investigation . However, one Member State expert asked for animal feeding trials to be conducted as a matter of routine. EFSA’s GMO Panel has adopted a Report on animal feeding trials which will be published in a peer-reviewed scientific journal over the coming months.
It is worth mentioning here four supposed safety concerns which have been given wide publicity but which are in fact urban myths. These are the L-tryptophan story; the brazil nut allergen story; the events surrounding Arpad Pusztai and his potato experiment; and the alleged dangers of feeding livestock with GM feed.
The accounts which follow shed interesting sidelights on supposed safety concerns but are not essential for this course. Students who do not have the time or inclination to read them, may skip to the next Section.
The L-tryptophan story
A frequently repeated account, quoted as established fact in a key debate about GM in the UK House of Commons in February 1999, 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 were 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 UK 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."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.
"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."
The alleged dangers of feeding livestock with GM feed
Activist campaigners, especially in Europe, have been trying to scare the public about the supposed dangers of consuming meat or poultry (or milk from cows or eggs from poultry) fed with GM feed.
On 23 September 2005, the Canadian Food Inspection Agency, Science Branch, Office of Biotechnology. updated information on its website, entitled "Genetically Engineered Livestock Feeds Derived from Plants: Assessment and Safety," which addresses questions such as " … Can GE livestock feed affect human food or health? … Do GE feed ingredients affect animal health and productivity? … Does eating products from livestock that consume GE feed (for example, such as milk, meat, and eggs) affect human health? … Do GE ingredients approved for livestock feed get into human food? … What is livestock feed and how is it regulated? … What are novel feeds? … What is a novel trait? … Who determines whether novel feeds are safe? … How are novel feeds assessed? … How do we know that a gene in a novel feed doesn’t pose a risk to animal or human health? … What if a gene did survive intact? …" - The document concludes with the following statement " … The World Health Organization (WHO) and other international organizations have stated that the consumption of DNA from any source -- including plants improved through biotechnology -- is safe and does not pose a risk to human health. This conclusion is based on the long history of safe consumption of DNA. The CFIA and Health Canada continue to work together to assess the safety of livestock feeds for animals, people, and the environment ..."
http://www.inspection.gc.ca/english/sci/biotech/gen/feebete.shtml
(b) Environmental
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 public information has been seized on by organised gangs of terrorist activists who invade and destroy the trials.
The EU objective has been to protect health and the environment when
Data required other than for higher plants:
Data required for GM higher plants:
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.
However, the relevance of environmental data obtained from small field trials to large-scale sowing on several million acres of land has been questioned.
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. There is also concern that traits such as herbicide resistance may spread to wild "relative" weeds (at present the only GM crops that have wild "relatives" are canola and squash) and that the problem of insect resistance may be aggravated. It has been suggested that the adoption of insect-resistant crops by farmers worldwide may lead to the extinction of certain insect species (e.g. Lepidoptera) thereby reducing the biodiversity of the planet. Environmental regulation is difficult to enforce when there are no clear standards against which the performance of a product can be measured (e.g. how many birds, butterflies and wild flowers should there be on a farm and to what extent can their numbers be affected before the environment is harmed?).
Concern has been expressed about the potential risk of GM crops hybridizing (i.e. sharing their genes) with wild closely related species and thereby creating herbicide resistant weeds. This has certainly happened with conventional crops but there is no evidence of it having occurred with GM crops. According to Rick Roush, director of the University of California Statewide Integrated Pest Management Program, reviewing the book "Dangerous Liaisons: When Cultivated Plants Mate with their Wild Relatives" by Norman C. Ellstrand Nature (Book Review) 427, 395 - 396; Jan. 29 2004) :"Ellstrand provides an introductory section for readers who are not population geneticists, before detailing hybridization between domesticated plants and their wild relatives, and then presenting his interpretation of these observations.
Despite his effort to provide this broad context for hybridization between crops and wild plants, and its consequences, I suspect that most readers will focus on chapter 7, where Ellstrand contrasts his views with an opening quote from the Israeli plant scientist Jonny Gressel: "Most crops have no interbreeding relatives in most of the world." Ellstrand reviewed the data for the world's 25 most widely planted crops, summarized their interbreeding with wild plants in a single table, and showed that 22 of them do hybridize with wild relatives somewhere in the world. I suspect that this table will be the most widely referenced in the book, and wish that a few of the distributions were more precisely stated. For example, cotton, beans and potatoes are listed with a "multicontinental" distribution of hybridization; more precisely this refers to Latin America (and, for cotton, some islands in the Caribbean and Pacific).
But what about Gressel's proposition, especially in the context of GM crops? Using statistics from the database of the Food and Agriculture Organization of the United Nations, cited by Ellstrand http://fao.apps.org, I checked on the dominant GM crops. At least 87% of the world's soybean crop, and 95% of the world's maize and cotton, are grown in countries for which Ellstrand lists no hybridization — and even for those countries with hybridization, such as China for soybeans, wild relatives are found in only some areas. Many of the other crops are complicated to tabulate, but Gressel seems to be correct that most crops are not interbreeding locally with wild relatives.
This still leaves the possibility that serious problems could arise in the few areas of the world where hybridization can occur. This currently seems possible for GM canola in Canada and the United States, and for transgenic maize that is probably growing illegally in Mexico (but has apparently escaped documentation in the refereed literature). But even after reading this book, I haven't seen any evidence of harm to human health or to the environment (including weediness) from such hybridization. Where are the super-weeds that were predicted to occur from the exchange of transgenes with wild relatives?
In contrast to the lack of evidence for deleterious effects of gene flow from GM crops, there is evidence that conventional agriculture has adversely affected wild plants through genetic swamping of their populations, and that wild plants have generated weediness in crop--weed hybrids. As noted by Ellstrand, "problems associated with hybridization between conventional crops and their wild relatives received scant attention until potential gene-flow problems were described for transgenic crops".
For example, hybridization with cultivated rice has been implicated in the near-extinction of an endemic Taiwanese wild rice. Hybridization of maize with its ancestor teosinte may be contributing to the extinction of teosinte populations. Indigenous cotton in the Galapagos Islands could be at risk of extinction or replacement as a result of hybridization with cultivated cotton. Ellstrand cites similar evidence for at least another nine species. He also documents in great detail the history of sugar beets in Europe, where hybrids between cultivated beets and their progenitors, the sea beets, have caused major weed problems."
However, the problem of gene flow, whether from GM to non-GM (or vive versa) or from hybridization of conventional crops with wild relatives looks like being due to be solved by -- genetic modification! The February 2004 issue of The Scientist contained a report by Ivan Oransky as follows (courtesy of Henry Daniell):
Self-Containment for GM PlantsGenetically engineered plants pose several major environmental concerns, according to Henry Daniell, a professor of molecular biology and microbiology at the University of Central Florida. When foreign genes are introduced into the nuclear genome, they end up in pollen, posing the risk of transfer to other species. And sometimes, expression levels are low.
Daniell and colleagues have come up with what he says is a solution: chloroplast genetic engineering. The method--the recipient of several patents, most recently US #6,680,426--offers two benefits, says Daniell. First, like mitochondria, chloroplast genes are maternal and therefore not passed through pollen. And because each cell has 10,000 copies of the chloroplast genome, expression levels are generally high. "This is absolutely a beautiful system," he says.
The transgene construct is designed to minimize disruption of the chloroplast genome. The gene to be inserted is put under the control of chloroplast regulatory signals so that errant transgenes won't express in the nucleus, Daniell says. Those that do hit their mark in the chloroplasts integrate via homologous recombination into a non-coding spacer region, where, Daniell says, "they won't disrupt anything else." Gene delivery is achieved via a biolisitic "gene gun."
From there, it's typical transgenic manipulation--selection of cells that have modified chloroplasts, followed by testing the construct's maternal inheritance. Daniell has founded a company, Chlorogen, to license the method.
The US National Academies of Science, National Research Council on January 20 2004 issued a report about a study of methods of preventing GM plants from mating or spreading novel genes to other species, entitled "Biological Confinement of Genetically Engineered Organisms".
http://www.america.gov/st/washfile-english/2004/January/20040122180302FJrelluF0.8825647.htmlIn the UK, English Nature (which at the time was the Government's statutory adviser on wildlife and natural features) monitored developments which may affect wildlife and advised on how any damaging effects might be avoided. Its environmental concerns about GM crops were among those which led the UK Government to approve the holding of the UK Farm Scale Evaluations (FSEs) of GM crops and to delay commercial introduction of genetically modified herbicide tolerant (GMHT) and insect resistant (IR) crops until research was completed and the results assimilated.
In 1998, four genetically modified crops had cleared most of the regulatory hurdles before commercial growing could be allowed in the UK. While these crops had been assessed as safe in terms of human health and direct impacts upon the environment, there had been insufficient research to determine whether there might be any significant effects on farmland wildlife resulting from the way that the crops would be managed. The FSEs of these GMHT crops were established to bridge this important gap in our knowledge.
The results of three FSEs were issued on 16 October 2003. The presentations, by the authors, of the eight rigorously peer-reviewed research papers on the three spring-sown FSEs, between them constituting a huge, rigorously designed, rigorously conducted, epoch-making GM research project costing nearly six million pounds sterling. In their presentations the authors were at pains to point out that their findings did not relate to the fact that the GM herbicide tolerant (GMHT) crops were GM, but to the differing herbicides and herbicide management systems that accompanied the GM crops and the conventional crop controls respectively.
The eight research papers present the FSE findings for those spring sown crops (namely beet, maize and spring oilseed rape – the FSE trials results of winter-sown oilseed rape were not published until May 2005). The researchers analysed the effect of each crop and accompanying herbicide and herbicide management system on the plants and animals living in the vicinity. About 60 fields in different parts of the UK where these crops were normally grown, each were sown with beet, maize and spring oilseed rape. Each field was split, one half being sown with a conventional variety managed according to the farmer's normal practice, the other half being sown with a GMHT variety, with weeds controlled by a broad-spectrum herbicide (glufosinate-ammonium in maize and spring oilseed rape, and glyphosate in beet). There was stringent auditing of the farmers' adherence to the protocols. Comparisons in biodiversity were made by looking at the levels of weeds and invertebrates, such as beetles, butterflies and bees, in both the fields and the field margins immediately surrounding them. The results revealed significant differences in the effect on biodiversity when managing GMHT crops as compared to conventional varieties.
Predictably, activists of one sort or another, and the media, have been interpreting the results to fit in with their respective preconceived positions. For the scientist, the outcomes point to the importance of weeds and of soil seed-banks in sustaining farmland wild life. It has been axiomatic that with the present generation of GMHT crops the purpose was to get rid of weeds as thoroughly and effectively as possible with the minimum of labour and tillage and with minimum application (in quantity and frequency) of a relatively environmentally-friendly broad-spectrum herbicide. Purely from a farmland wild live aspect, it could be argued that in two of the three crops (beet and spring oilseed rape) the herbicides performed their function too well. These results seem to suggest that there is a case for organizing the provision of sufficient weeds to maintain the farmland wild life.
Put another way, a rational society wishing to take advantage of the agricultural benefits that each of these GMHT crop systems can provide would recognize the need for a trade-off, to establish for each crop and herbicide management system a point of equilibrium where the benefits can accrue alongside the sustaining of the farmland "natural communities". Whilst the findings cannot answer all the questions resulting from the intense public interest and debate on the future of genetic modification in agriculture in the UK, they do provide a valuable model for the assessment of technological change. The FSEs also demonstrate that it is possible to design experiments at an adequate scale to help forecast the potential environmental impacts of new technologies and practices in agriculture - something that has never been done before.
On 13 January 2004 ACRE gave its verdict on the FSEs. The Committee noted that in the cases of beet and spring-sown oilseed rape FSEs, evidence showed that insect species and weeds declined in the trial areas, endangering birds that fed on them. However, it supported the growing of GM maize, saying it was better for the environment than conventional farming. It also suggested the other crops might be grown in future if measures were taken to protect wildlife.
Although the UK Government subsequently approved in principle the growing of the GM maize for animal feed, the approval was heavily hedged around with onerous conditions (including a four years repeat of the FSE trial but with a non-atrazine control). The company concerned (Bayer CropScience) regarded it as totally impracticable and “economically non-viable” and withdrew.
On 1 July 2004 it was announced that Syngenta, the last big biotechnology company working on GM crops in Britain, was to close its research facility in the UK and transfer its efforts to the United States.
Professor Chris Pollock, the ACRE chairman, said: 'ACRE operates on a case by case basis. It does not seek to give approval for GM as a blanket technology or disapproval for it.' The modified maize in question - T25 - was created by German biotech firm Bayer to resist a specific weed killer. Before farmers can use T25, it needs Government approval and has to be registered on the national seed list. The weed killer also needs official clearance. Jules Pretty, ACRE's deputy chairman, said: 'The decision could come reasonably quickly. It could come in time for this coming spring. It doesn't really matter if the decision is this week or next week or February.' ACRE added that farmers planting the new maize would have to meet strict conditions, including monitoring the effect on the environment and on the animals which eat it. Farms would also have to match conditions in the FSE.
Note that permission to grow GM crops commercially in the UK would not necessarily mean that they will in fact be grown. Given the retailers' perception of the attitude of consumers, are they are likely anyway to change from their present position of not wanting GM ingredients in their products? And are manufacturers likely to revert to using GM ingredients?
A report on 27 September 2003 ominously threatened that a new organisation called Greengloves, promoted by Greenpeace, Friends of the Earth and other organisations, will sign up people pledged to uproot any GM crops. Current policy is that the locations must be publicised in detail, making it easy to identify and vandalise.
Most GM crop trials carried out over the past few years have been sabotaged, not only those of Bayer. Other companies have pulled out. Now Bayer, the last to continue with them, has decided to call it a day. The current 'brain drain' of UK agricultural scientists to the US and Canada is now only likely to intensify.
On 19 January 2005, May M et al published a paper "Management of genetically modified herbicide-tolerant sugar beet for spring and autumn: environmental benefit" by researchers with Broom's Barn Research Station, Higham, Bury St Edmunds, Suffolk IP28 6NP, UK, published in the January 2005 issue of the Proceedings of the Royal Society.
"When used in genetically modified herbicide-tolerant (GMHT) crops, glyphosate provides great flexibility to manipulate weed populations with consequences for invertebrates and higher trophic levels, for example birds.
A range of timings of band and overall spray treatments of glyphosate to GMHT sugar beet were compared with a conventional weed control programme in four field trials over 2 years. Single overall sprays applied between 200 and 250 accumulated day degrees (above a base air temperature of 3°C; °Cd) and band applied treatments applied at 10% or 20% ground cover within the crop rows generally gave significantly greater weed biomass and seed rain than conventional treatments, while later band sprays (more than 650 °Cd) reduced seed return. Two overall sprays of glyphosate produced low weed biomass and generally lowest seed return of all treatments but tended to give some of the highest yields.
However, the early overall sprays (200-250 °Cd) and band sprays gave as good or better yields than the conventional and were generally equivalent to the two overall-spray programme. Viable seeds in the soil after the experiment were generally higher following the early overall (200-250 °Cd) and the band spray treatments than following the conventional.
The results show that altered management of GMHT sugar beet can provide alternative scenarios to those of the recent Farm Scale Evaluation trials. Without yield loss they can enhance weed seed banks and autumn bird food availability compared with conventional management, or provide early season benefits to invertebrates and nesting birds, depending on the system chosen.
Conventional weed control does not have the flexibility to enable these scenarios that benefit both agriculture and environment, although there may be some options for increasing weed seed return in autumn."
In an accompanying 19 January 2005 News Release, titled "New GM Crop Management Systems Give Wildlife Benefits," the authors suggest that by the new crop management approaches they have demonstrated wildlife benefits In spring, the authors have improved timing of herbicide application to maximise both crop yields and the benefits from leaving weeds between crop rows. Maximising yields removes barriers to farmer up-take. However, autumn environmental benefits are more important, as autumn weeds provide seeds for bird food and for recharging weed seedbanks. The paper demonstrates a system that gives maximum crop yield AND increased weed seed availability (up to 16 fold), compared to previous GM or conventional management systems tested in the government's recent Farm Scale Evaluation trials.
The news release is at http://www.rothamsted.bbsrc.ac.uk/broom/PressReleases.phpSOCIO-ECONOMIC ASPECTS
In June 2008, Brookes G and Barfoot P (PG Economics Ltd UK) issued a report “GM crops: global socio-economic and environmental impacts 1996-2006”.
This comprehensive study presents the findings of research into the global socio-economic and environmental impact of GM crops in the eleven years since they were first commercially planted on a significant area. It focuses on the farm level economic effects, the environmental impact resulting from changes in the use of insecticides and herbicides, and the contribution towards reducing greenhouse gas (GHG) emissions.
http://www.pgeconomics.co.uk/pdf/globalimpactstudyjune2008PGEconomics.pdf
Much of the vocal antagonism to GM expressed by its opponents appears to consist of ideological antipathy to large companies engaged in GM and to the socio-economic system which allows large companies to exist and thrive. This is, however, not specific to GM, for similar antipathy by the same groups is expressed about large companies engaged in other products and activities. A great deal has been said and written to the effect that the existence of GM seeds somehow denies the farmer the ability to practice in the traditional way -- as though farmers cannot choose whether to use GM seed or stick with non-GM.
One manifestation of this concern has been about the potential for misuse of the so-called terminator genes which prevent seeds from germinating. Although patents exist for terminator technology, it is not available commercially. There are fears that large corporations might use such genes in all their GM crops to prevent farmers from storing seed and that plants that produce barren seed could make life more difficult for poor farmers in the developing world. However, farmers would only buy these seeds if they found an overall advantage in doing so; otherwise they could continue to grow conventional cultivars and save the seed in the traditional way. Furthermore, some fear that if cross-pollination occurs, GM plants with terminator genes could transfer their sterility to other plants grown nearby. However, on the positive side, terminator technology could ensure that GM plants do not themselves become weeds.
Concerns have been expressed over the supposed problem of patents held by biotechnology companies preventing the use of beneficial GM crops in developing countries. Leaving aside the strange contradiction that these concerns are expressed in many cases by the same people who deny that there are GM benefits and leaving aside too that many of the original patents are already expiring, the fact is that today, over eleven million resource-poor farmers in South Africa, China, India, the Philippines and elsewhere already happily grow nearly one-third of the world’s total GM hectarage because they have higher yields, require fewer inputs and raise income.
The classic case is GM vitamin A rich golden rice developed by Ingo Potrykus (referred to earlier) and his colleague Peter Beyer. Here the research has involved the use of over 70 patents owned by biotechnology companies from whom they had to obtain permission before they could begin testing the golden rice in field trials. What the critics fail to mention, however, is that those patent holders granted Potrykus and Beyer exemptions for Golden Rice; and moreover have agreed to provide free licences for use by poor farmers in developing countries.
At the 12th World Congress of Food Science and Technology in Chicago in July 2003, Potrykus stated, in the course of a comprehensive presentation, that obtaining those exemptions was time-consuming, but the main reason why golden rice and other GM nutrient-enhanced crops have not yet begun to help resource-poor farmers is not patents but "regulatory obstacles based on undue paranoia." He has even argued that "those who oppose GM technologies for political advantage or self-interest [should be] held responsible for the unnecessary suffering of millions of people with vitamin A deficiency," which golden rice could help address.
His most up-to-date presentation (April 2004) is at http://tinyurl.co.uk/mkmx
.A wider matter, however, involves the general question of patents in relation to GM, and, more particularly whether genes can or should be patentable. By analogy with computer language, the procedure of inserting a gene into an organism is not just "cut-and-paste" but "cut- copy (billions of times over)-and-paste". The laboratory-generated copies by that procedure are in every way exact copies of the copied original, but are not the original. Precise details of patent law vary from country to country, but in principle, patents are intended to protect inventions and give the inventor monopoly for a limited time to benefit from the invention. Whether it is the original gene or DNA fragment, or a lab-generated exact copy, these are not "inventions" and ought not to be patentable. A gene is a pre-existing thing, and identification of a gene and its function is a "discovery" rather than an "invention". However, an invention is often a novel combination of pre-existing things, and it is not those things but the combination of them which may be accepted as an invention and therefore patentable. Generally, patent law requires novelty and also that the novelty and its claimed benefits would not be obvious to those "skilled in the art". If these principles are valid, then someone inventing a novel combination involving a gene can patent the combination, but cannot use patent law to prevent someone else from using that gene for other purposes (or even patenting a different combination involving that gene).
Usage of herbicides and pesticides - An important environmental benefit claimed for the existing GM crops has been reduced usage of pesticides in the case of Bt corn and Bt cotton, and reduced use of herbicide in the case of GMHT crops. The main source of information on whether this has been achieved are data from practice in the USA, collected by USDA.
The main herbicide used on GM soya is glyphosate. Contrary to the widely held misconception, this is not a relatively new herbicide developed for GM crops. On the contrary it has been in use for getting on for 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 to genetically modify soya so that it was not killed by, but resistant to, glyphosate. To many people's surprise, over nearly 30 years of extensive use of glyphosate, weeds had not become resistant to it -- but in anticipation that they might, other new broad-spectrum herbicides had been researched and developed.
At this point it is relevant to refer to a report http://www.biotech-info.net/technical_paper_6.pdf by Charles Benbrook (a well-known pro-organic and anti-GM activist) who accepts the reduction of pesticide use in the case of Bt crops but uses USDA figures and his own assumptions to demonstrate an increase between 2001 and 2003 in the US use of herbicide on GM herbicide tolerant crops. Benbrook's use of the USDA figures and his assumptions have been challenged (for example by Wayne Parrott of University of Georgia). Those interested in pursuing the topic in detail should check out the actual USDA-ERS’s study at http://www.ers.usda.gov/publications/aer810/. The section on “Adoption and Pesticide Use” is the most relevant to the topic.
Nevertheless Abby Smith (a student in the Fall 2003 semester who comes from a cash crop farm growing GM soya), mentioned in Section 4 above) also wrote
"Recently, in the US there has been a few cases of weeds becoming resistant to glyphosate (Marestail is one of the weeds). The research has shown that it is because the glyphosate is being used several consecutive years on the same piece of land (i.e. when the farmer plants two to three years of Round-up Ready crops) .........I believe that we will see more cases of weeds becoming resistant to glyphosate (round-up) and other herbicides. This may require regulation on how GM crops are planted ........ 'rules' might be made for RR crops that specify how many consecutive years they can be planted, to help prevent further resistance."
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
On 8 August 2007, after months of negotiations, the German minister for agriculture, Horst Seehofer, agreed on new rules for the cultivation of genetically modified crops with his coalition partners from the CDU and SPD. The cabinet agreed to the amendments to the genetic engineering legislation today. As Seehofer told the press at the end of July, fields of GM and conventional maize must in future be separated by a distance of at least 150 metres. If organic maize is grown in the vicinity, the minimum distance will be double. Other controversial points, such as the liability provisions and the public site register remain largely unaltered. A relaxation of the "GM-free" labelling rules for food are to follow.
http://www.gmo-safety.eu/en/news/579.docu.html(c) Ethical
Mankind has been manipulating nature from the very start of agriculture. Moreover, nature itself carries out random GM through accidental mutation. All present-day food plants (and animals) are GM, most by traditional or accidental methods. For this reason we cannot really talk about non-GM foods - perhaps we should speak of traditionalGM to distinguish it from newGM. Whichever method is used, the same risk analysis and risk assessment should be (and is) carried out. As regards within-species GM there is no fundamental difference between traditional GM and modern except that the latter is more precise, more capable of providing desired characteristics unaccompanied by disadvantageous ones, and more rapid.
Trans-species GM, however, produces results that could not be achieved by traditional methods, and this can give rise to perceived religious dietary concerns or fears of cannibalism or aesthetic concerns or worries about "interfering with nature" or even of "playing God" .
The officially appointed UK Committee on the Ethics of Genetic Modification and Food Use, chaired by the Rev. John Polkinghorne, carried out a wide public consultation and issued a report in September 1993 on all of the moral and ethical issues involved. This was accepted by the UK Government and welcomed by the Institute of Food Science & Technology. The Committee found that the concerns were misconceptions rather than of real substance, arising from lack of knowledge, outside the scientific community, of just what was involved.
The Committee pointed out that because any gene extracted from one species for copying into another, is not itself inserted but is copied in the laboratory and diluted millions of times before a single gene is transferred, the chance that the original gene would be found are much less than the chance of recovering a particular drop of water from all the oceans of the world. If this were widely understood fears of cannibalism or of contravening religious food taboos would be seen to be unwarranted. Unfortunately, this fact does not make good media copy, whereas sensational stories do.
The Polkinghorne Committee's conclusions were:Because what is transferred to the "host" is not the DNA direct from the donor but a laboratory copy of it (in familiar terms, it is cut-copy (billions of times over)-and-paste rather than cut-and-paste) the perceived concerns are mistaken, but no less real for that.
As a matter of interest that not many people realise, we are in fact all cannibals - everyone is continuously shedding skin cells, which of course contain their DNA. We are all ingesting the DNA of people around us, or who, for example, have previously been in the same room or public transport.
It is noticeable that when "ethical aspects" of GM are raised it is mostly in terms of ethical objections. However, two major reports have included addressing the ethical and social imperatives involved in making the potential benefits of GM available to improve the present and future food supply, especially in developing countries.
A most thorough and balanced study of the ethics, environmental impacts and social aspects of GM was carried out in 1998 under the auspices of the Nuffield Foundation. The Nuffield Council on Bioethics carried out a widespread public consultation using a questionnaire posing the ethical, environmental and social issues and issued a comprehensive report on its conclusions and recommendations, "Genetically modified crops: the ethical and social issues".
http://www.nuffieldbioethics.org/go/browseablepublications/gmcrops/report_234.html
In June 2003 the Nuffield Council on Bioethics issued for public consultation a Discussion Paper GM Draft Paper.pdf on the use of GM in developing countries. This evoked a response from the Institute of Food Science & TechnologyIFSTNuff.pdf
Following the consultation, on 28 December 2003 the Nuffield Council on Bioethics issued its Report http://www.nuffieldbioethics.org/fileLibrary/pdf/gm_crops_paper_final001.pdf (described as a "Follow-up Discussion Paper") on "The use of genetically modified crops in developing countries".
Both Nuffield Council Reports are very lengthy documents, but for those interested in gaining awareness of these issues, they will repay careful study.
(d) Socio-economic
Much of the vocal antagonism to GM expressed by its opponents appears to consist of ideological antipathy to large companies engaged in GM and to the socio-economic system which allows large companies to exist and thrive. This is, however, not specific to GM, for similar antipathy by the same groups is expressed about large companies engaged in other products and activities. A great deal has been said and written to the effect that the existence of GM seeds somehow denies the farmer the ability to practice in the traditional way -- as though farmers cannot choose whether to use GM seed or stick with non-GM.
One manifestation of this concern has been about the potential for misuse of the so-called terminator genes which prevent seeds from germinating. Although patents exist for terminator technology, it is not yet available commercially. There are fears that large corporations might use such genes in all their GM crops to prevent farmers from storing seed and that plants that produce barren seed could make life more difficult for poor farmers in the developing world. However, farmers would only buy these seeds if they found an overall advantage in doing so (cf Abigail Smith.quoted earlier) ; otherwise they could continue to grow conventional cultivars and save the seed in the traditional way. Furthermore, some fear that if cross-pollination occurs, GM plants with terminator genes could transfer their sterility to other plants grown nearby. However, on the positive side, terminator technology could ensure that GM plants do not themselves become weeds.
Many crocodlie tears have been shed over the supposed problem of patents held by biotechnology companies preventing the use of beneficial GM crops in developing countries. Leaving aside the strange contradiction that these tears are shed in many cases by the same people who deny that there are GM benefits (!) and leaving aside too that many of the original patents are already expiring, the fact is that today, over 5 million resource-poor farmers in South Africa, China, India, the Philippines and elsewhere already happily grow nearly one-third of the world’s total GM hectarage because they have higher yields, require fewer inputs and raise income.
The classic case is GM vitamin A rich golden rice developed by Ingo Potrykus (referred to earlier) and his colleague Peter Beyer . Here the research has involved the use of over 70 patents owned by biotechnology companies. from whom they had to obtain permission before they could begin testing the golden rice in field trials. What the critics fail to mention, however, is that those patent holders granted Potrykus and Beyer exemptions for Golden Rice; and moreover have agreed to provide free licences for use by poor farmers in developing countries.
At the 12th World Congress of Food Science and Technology in Chicago in July 2003, I heard Potrykus himself say, in the course of a comprehensive presentation, that obtaining those exemptions was time-consuming, but the main reason why golden rice and other GM nutrient enhanced crops crops have not yet begun to help resource-poor farmers is not patents but "regulatory obstacles based on undue paranoia." He has even argued that "those who oppose GM technologies for political advantage or self-interest [should be] held responsible for the unnecessary suffering of millions of people with vitamin A deficiency," which golden rice could help address. Here is a Potrykus presentation potrykus[2].ppt given at a conference at Tufts University in November 2001. As far as I know his World Congress presentation is not available on-line, but is the full text http://www.agbioworld.org/biotech_info/articles/potrykus.html of the paper he gave in April 2004 along similar lines.
A wider matter, however, involves the general question of patents in relation to GM, and, more particularly whether genes can or should be patentable. By analogy with computer language, the procedure of inserting a gene into an organism is not just "cut-and-paste" but "cut- copy (billions of times over)-and-paste". The laboratory-generated copies by that procedure are in every way exact copies of the copied original, but are not the original. Precise details of patent law vary from country to country, but in principle, patents are intended to protect inventions and give the inventor monopoly for a limited time to benefit from the invention. Whether it is the original gene or DNA fragment, or a lab-generated exact copy, these are not "inventions" and ought not to be patentable. A gene is a pre-existing thing, and identification of a gene and its function is a "discovery" rather than an "invention". However, an invention is often a novel combination of pre-existing things, and it is not those things but the combination of them which may be accepted as an invention and therefore patentable. Generally, patent law requires novelty and also that the novelty and its claimed benefits would not be obvious to those "skilled in the art". If these principles are valid, then someone inventing a novel combination involving a gene can patent the combination, but cannot use patent law to prevent someone else from using that gene for other purposes (or even patenting a different combination involving that gene).
(e) Information
Information (and particularly label information) about the GM status of foods or ingredients is a topic with polarised views that do not lend themselves to an intermediate position. On the one hand, it is argued that if a food or ingredient has been approved as "safe", the method of production is irrelevant and need not be stated. On the other hand, it is argued that provision of that information is necessary for informed consumer choice, including the consumer who wishes to choose GM, and the consumer who wishes to avoid GM for whatever reason – even an irrational reason or whim.
As will be seen in Sections 7 and 8, the EU Commission adopts the latter position while the US FDA adopts the former.
6. Potential benefits versus concerns
There are two ways of dealing with 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 birth of her first seven children ("not natural, not proved safe, not sufficient testing, 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. We can be thankful that it was eventually legalised and over the last several 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.
One might usefully remember the old adage "Don't throw out the baby with the bath-water".7. Factors affecting EU approach to regulating GM
In the EU, the general legislative approach throughout its existence has been that if anything can conceivably be regulated, regulate it. So it had built a comprehensive system and machinery for considering and approving (or otherwise) applications for approval of specific lines of GMOs, and for controlling the release of GMOs into the environment. Likewise, it adopted from the outset the principle of informed consumer choice, which has led to increasingly comprehensive measures, initially voluntary and then by more and more stringent legislation, to provide distinctive labelling of GM foods. In this, as in other aspects, the nature and extent of the regulatory provisions has been influenced by the governments of the Member States, reflecting a public opinion in turn influenced by activist campaigning. However, there may be signs that, despite continued intensity of anti-GM activism, a more rational public opinion may be developing. Across the EU, this is reflected in the most recent EuroBarometer on attitudes of EU consumers about the environment issued in March 2008 which had a specific question about GMOs and found that 20% of EU citizens picked out the use of GMOs in farming as a concern from a list of environmental issues, down from 24% in 2004. When unprompted, GM ranks low on the list of EU consumer concerns relative to other environmental issues. However, when prompted by a specific question, 58% said they were personally opposed to the use of GM).
http://ec.europa.eu/public_opinion/archives/ebs/ebs_295_en.pdf
In the UK, the annual Food Standards Agency consumer survey on all food issues showing a decrease since 2006 in concern over many food safety issues including additives (35% down from 38%), food poisoning (36% down from 42%), GM foods (20% down from 25%); by recent media articles and editorials and by the recent statement by the UK Environment Minister Phil Woolas to media about the need to look at GM technology positively in context of global food shortage.
7. Differences in the US approach In contrast, in the USA the Food and Drug Administration (FDA) has, despite increasing pressure, refused to require distinctive labelling of GM materials, on the grounds that it has determined that they are substantially equivalent to the non-GM versions; and that being so, their method of production is irrelevant. The most comprehensive analysis of the approach and reasoning underlying the US position is given in the Expert Panel Report on the Biotechnology of Foods issued by the Institute of Food Technologists (IFT). The full text is available at http://www.ift.org/cms/?pid=1000380
The absence of distinctive labelling in USA has had a consequence that most US consumers have not had the presence of GM foods or ingredients drawn to their attention (although over the past few years this situation has been gradually changing). Most of those that have been aware of it, have evidently been reassured by approval on the part of both FDA and EPA. This has in turn has been one of the factors making US consumers much less susceptible (
so far) than European consumers to the kind of activist campaign that has dramatically affected public opinion in the EU and especially in the UK.A survey by the Pew Initiative on biotechnology and GM foods revealed that Americans’ knowledge of GM foods remains low and their opinions about its safety is just as divided as it was two years ago. The survey also shows that knowing FDA reviewed and approved a GM product can increase public confidence and that public support for GM products decreases as uses of the technology shift from plants to animals.
Using data from a similar survey released by the Pew Initiative in March 2001, the survey was able to compare awareness levels over a two-year period and draw two major conclusions: Americans’ knowledge about GM foods remains low, even as GM technology is increasingly applied to agriculture; and opposition to GM foods has softened somewhat in the last two years but opinions about safety remain split. The survey also probed topics rarely explored in widely-available opinion polls about agricultural biotechnology, including how Americans feel about the way GM products are regulated in the US and the application of genetic engineering technology to animals. Key findings indicate that Americans oppose a ban on GM foods, but are strongly supportive of a regulatory process that directly involves the FDA. It was also determined that Americans are far more comfortable with genetic modifications to plants than animals, and are particularly supportive of genetic modifications that improve health. The nationwide survey, conducted August 5-10, 2003 by The Mellman Group and Public Opinion Strategies, consisted of telephone interviews of 1,000 American consumers. The margin of error for this survey is +/- 3.1%. The margin of error is higher for subgroups. Data from a similar survey, released by the Pew Initiative in March 2001, was used for tracking purposes. The full report is at http://pewagbiotech.org/research/2003update/
In September 2007, the International Food Information Council (IFIC) commissioned Cogent Research to conduct the 12th in a series (1997-2007) of quantitative assessments of U.S. adult consumer attitudes toward food biotechnology during July 2007. The survey had a sample size of 1,000 and the data were weighted on age and education to be nationally representative. The survey found that consumer familiarity and overall impression of food biotechnology remains little changed from a year ago in the United States, amidst major concern over food safety. There was little change in the American public's perception of food biotechnology, and those who have an opinion are twice as likely to have favourable - as opposed to unfavourable - impressions. The national survey represents the 12th time IFIC has commissioned a survey on public attitudes about food biotechnology since 1997.
Overall confidence in the food supply remained at a high level with 69 percent of Americans indicating they were "very" or "somewhat" confident in the food supply compared to 72 percent last year. However, the number of Americans selecting "very confident" decreased from 21 percent in 2006 to 15 percent this year.
25 percent cited no particular food safety concern. Of the three-quarters of respondents who listed a specific food safety concern, disease and contamination topped the list at 38 percent; however, the biggest increase was in the "source" category, where concern about country of origin caused this category to rise from 6 percent of those citing a specific concern with the food supply in 2006 to 20 percent this year. Handling and preparation decreased as a food safety concern, cited by 26 percent of those citing a specific concern this year, dropping nine percent from last year's survey.
While the public's overall favorable impression of plant biotechnology remained little changed in the past year, favorable impressions of animal biotechnology increased from 19 percent in 2006 to 24 percent this year. Nearly half of Americans (46 percent) said they were "somewhat" or "very" likely to buy meat, milk and eggs from cloned animals if the Food and Drug Administration (FDA) determined they were safe. When the phrase "from cloned animals" was replaced with "from animals enhanced through genetic engineering" the number of Americans who were "very" or "somewhat" likely to buy these food products jumped to 61 percent. Both of these figures show an increase from the 2006 survey.
Increased awareness of potential positive impacts of animal biotechnology continues to correlate with increased support among consumers. Two-thirds of consumers (66 percent) said they had a positive impression of animal biotechnology when informed that "animal biotechnology can improve the quality and safety of food," up from 59 percent in 2006. More than half of Americans (53 percent) reacted positively to the statement "animal biotechnology can increase farm efficiency," up from 36 percent in 2005 and 47 percent in 2006.
Satisfaction with current information on food labels remained high in 2007. Only 16 percent of consumers mentioned information they felt was missing, with less than one percent specifically mentioning biotechnology.
FDA requires special labeling only when the use of biotechnology introduces an allergen, or when it substantially changes the food's nutritional content. Well over half of those polled (61 percent) "strongly" or "somewhat" support the FDA labeling requirements for food produced using biotechnology, while 24 percent were "neutral" which was unchanged from last year's survey.
This year, IFIC included questions about "sustainability" in the food biotechnology survey for the first time. Although Americans use a variety of terms to describe "sustainability," 83 percent equate the term to "long-lasting" or "self-sufficiency." Close to three-quarters of Americans (70 percent), however, say they have heard "nothing" about sustainable food production. When sustainability was defined as a method to "operate in a manner which does not jeopardize the availability of resources for future generations," 63 percent of Americans said they thought it was important. In a question where consumers were asked to rank 5 factors related to growing crops in a sustainable way, the factor ranked number one was "increasing the production of food staples in the world, thereby reducing world hunger", with "reducing the amount of pesticides needed to produce food" coming in second. Other eco-friendly factors like rainforest conservation and reducing green house gas emissions ranked lower.
http://ific.org/newsroom/releases/biotechresearchrelease2007.cfm
Another major difference is that, in the definition of substantial equivalence, still used in many countries including the USA and Canada, the presence of degraded novel DNA or protein does not preclude a GM food from being considered substantially equivalent to a conventional food. However, in the EU, the concept of substantial equivalence was redefined in December 1997. Only highly processed foods derived from GM crops, such as highly refined oil, white sugar and starch hydrolysates, are considered substantially equivalent to their conventional counterparts on the grounds that neither DNA nor protein would be expected to be present following the processing that these foods receive. All other ingredients derived from GM crops, such as flour and protein extracts, require a full safety evaluation as they may contain novel DNA and/or protein, in either intact or degraded form. Thus, lecithin from GM soyabean, used extensively as an emulsifier in many processed foods, would be considered substantially equivalent to conventional lecithin in North America but not in the UK and the rest of the EU.
9. Factors affecting public opinion in the EU and the USA
The "engineering" of European public opinion and the role of distinctive labelling
Public opinion on GM in the EU, and particularly the UK, changed dramatically between January and May 1999. This did not just happen. It was "engineered" -- skillfully planned by a consortium of "fundamentalist" anti-GM organizations, and brilliantly organized and executed. The plan was first spotted on one of the complex networks of listservs operated by those groups - and for those who monitor those listservs it is a real eye-opener how effectively they use the internet not merely to exchange information but to plot and plan activities such as intimidating manufacturing companies and retailers. marches, demonstrations, rioting, uprooting of experimental plants, destruction of property. The plan to focus on Europe was hatched at a meeting hosted by the Green Parties, with the participation of "the usual suspects", in St Louis, Missouri, in July 1998. It was planned to be launched in January 1999 to coincide with the World Summit on the Environment in Columbia.
Reasons that are often quoted for the turn-around of European and especially UK public opinion, are in fact not the reasons for the turn-around, but are the underlying factors that made the public susceptible to being manipulated by an intensive propaganda campaign. Some observers, mainly in USA, blame EU protectionism and a not-very-well-hidden trade barrier. Well, of course every Government wants to protect its own industry and will ingeniously find ways of creating trade barriers if it can, and no doubt the EU Member States' Governments are no different in that respect. However, the EU Commission expresses an opposite concern. In a 30-page strategy paper entitled 'Life Sciences and Biotechnology: A Strategy for Europe.'', issued as a consultative document in September 2001, it stated that the EU is in serious danger of lagging behind the US in biotechnology industries because public concern over biotechnology was holding back its evolution in the EU. "Uncertainty about societal acceptance had stifled our competitive position, weakened our research capability and could limit our policy options in the longer term.".
As a result of the consultation the EU Commission issued the final strategy document and published it in the Official Journal of the European Communities, C55/3 dated 2 March 2002, on-line at
http://europa.eu.int/eur-lex/pri/en/oj/dat/2002/c_055/c_05520020302en00030032.pdf
I suggest that the real driving force is something quite different -- that the Commission, the European Parliament, and European retailers and manufacturers are all highly sensitive to what is perceived as an extremely strong anti-GM attitude by European consumers, who frankly "don't gave a damn" about protectionism, any more than do the anti-GM activist organizations that deliberately and skillfully engineered and publicly exaggerate that consumer attitude. Moreover, the Green Parties now have strong political influence in some Member States and in the European Parliament.
The main factors that made the public susceptible to being influenced by anti-GM activities were :
None of the factors changed significantly between January and May 1999 yet public attitude was dramatically changed.
The plan, capitalizing on the above factors, effectively utilized the Internet, and was amplified by the media, highlighting problems and uncertainties, some real, some pure speculation, some spin-doctored and some just urban myths, combined with vandalizing of experimental crop trials and with intimidation and threats to companies and major retailers (picketing, organized bombarding of companies and named individuals therein with letters and phone calls, activists in white "space suit" simulated protective clothing invading supermarket aisles). The purpose was to get GM legally banned; and if that failed, the fall-back aim was so to scare the public and intimidate industry that the result would be the virtual equivalent of a ban.
In these circumstances is hardly surprising that by mid-1999 the UK public became turned against GM, and that, reacting to their customers views and "pressure" from these organisations,, major retailers and manufacturers decided to exclude GM foods and ingredients.
The first to succumb was Sainsbury (actually Iceland announced prohibition of GM much earlier, but not as a result of this propaganda - the then chairman of Iceland was personally anti-GM). Other major supermarket groups quickly followed Sainsbury, and each tried to outdo the others in advertising that they were "squeakier-clean" than the others.
It is difficult to blame them. Even apart from the threats and intimidation, their Boards had a responsibility to look at their respective bottom lines, provided that food safety was not thereby compromised. At the time I said that if I owned a grocery store on which my livelihood depended, I would, however reluctantly, have had to do the same.
Nevertheless, when these major retailers, followed by major manufacturers like Unilever and Nestle, made their announcements, headlined by the media, that gave a further message to the public that GM foods and ingredients were "bad".
In a much larger, more representative and more recent study of consumer opinion on GM, more than 35,000 respondents were asked whether the benefits of GM crops (with respect to reduced pesticide use) were greater than the risks. Over two thirds of respondents from USA, Colombia, Cuba, Dominican Republic, China, India, Indonesia and Thailand believed the benefits outweighed the risks, while less than one third of respondents from France, Greece, Italy, Spain and Japan did so. The USA led the industrialised countries in support for biotechnology. Overall, people in developing countries were supportive of GM crops (Hoban 2004, "Public Attitudes towards Agricultural Biotechnology. ESA Working Paper No. 04-09. FAO, Rome, Italy, May 2004. ftp://ftp.fao.org/docrep/fao/007/ae064e/ae064e00.pdf ).Where does distinctive labelling fit into this picture? The attitude of the EU and its Member States (and indeed of IFST) to distinctive labelling has been that the principle of informed consumer choice (i.e. that a consumer is given on the label sufficient information on which to take a decision, for whatever reason, on whether or not to purchase that product) takes precedence over the valid arguments used by FDA (and IFT) to justify the lack of need for distinctive labelling.
However, note the paradox - distinctive labelling made the mass of consumers aware that they had been consuming GM foods, bringing neophopia into play and helping to make the public susceptible to the anti-GM propaganda campaign. So distinctive labelling, introduced in pursuance of informed consumer choice, has substantially contributed in Europe to destruction of such choice, as it is now virtually impossible to purchase a GM food.
Anti-GM campaigning within the USA has continued. Since mid-1999,a coalition of extreme groups has been carrying out targeting of consumers, intimidation of manufacturers, and vandalising of experimental crop trials in the USA. The process was heavily intensified, as a result of a meeting of the top planners of the "usual suspects", at Blue Mountain Lake, New Jersey. and has been widened by a large number of national and local groups, many masquerading under the cloak of "environmental protection".
Among companies heavily targeted in during recent years have been Kraft, Starbucks and Trader Joe.
Here,an example of "environmental protection" GM module.ppt (two pages), by the self-styled "Earth Liberation Front", was setting fire to Catherine Ives's Agricultural Biotechnology Sustainability Project laboratory and office on the Michigan State University Campus on New Year's Day 2000. In 2001 similar acts of terrorist firebombing were perpetrated at Oregon, and the Center for Urban Horticulture at Washington University, destroying the office and laboratory of Prof Toby Bradshaw, presumably because of his basic research into the genetics of fast-growing hybrid poplars, but also destroying many irreplaceable books, historical documents and photographs belonging to the faculty, staff, students and volunteers who worked there for the past 20 years, and severely damaging research efforts aimed at conserving endangered plant species, ecological restoration of wetlands, creating environmentally sound urban landscapes and gardens, and discovering the patterns of plant regeneration after the eruption of Mount St. Helens, as well as outreach programs such as vegetable gardening classes for low-income families.
Two subsequent (January 2002) similar outrages were the fire-bombing of a construction site of the University of Minnesota's new Microbial and Plant Genomics Research Center and the adjacent crop research facility, and the sabotaging of a biotechnology Park in Fairfield, Maine.
In the USA it is taking, and will take, much longer to engineer consumer hostility to GM than the five months that sufficed in Europe. Why? Because, in the continuing absence of mandatory distinctive labelling, the majority of US consumers are not aware of eating GM foods, and most of those who are aware are also aware that FDA, USDA and EPA have okayed them. This explains why the anti-GM coalition is focusing so heavily on demands for mandatory distinctive labelling in USA, and have been orchestrating town meetings in many towns to demand mandatory distinctive labelling.
It is highly instructive to read the frank Q & A statement of the "strategy" of the (US) Campaign to Label Genetically Engineered Foods ("Leading a national grassroots campaign to convince Congress to label genetically engineered foods").
Q. Why does The Campaign support labeling but not an outright ban on genetically engineered foods?
A." In fact, The Campaign has joined other environmental groups in calling upon the United States government to place a moratorium on genetically engineered foods until their safety can be assured.
But our main focus is on pushing legislation through Congress to label genetically engineered foods. We have several strategic reasons for this approach.
When the European Union passed mandatory labeling legislation in 1998, European businesses had two options: They could either continue to use genetically engineered ingredients and put labels on their products, or they could purchase non-genetically engineered ingredients and forego having to put labels on their foods.
Practically every company decided to purchase non-genetically engineered ingredients. It became good PR to jump on the non-GE bandwagon. In other words, labeling had nearly the same effect as a ban. We expect the same thing to happen in the U.S. Most companies will purchase non-GE ingredients to avoid the labeling requirement. They know most consumers do not want to buy products that contain genetically engineered ingredients.
It would be nearly impossible to get Congress to pass legislation this year that would ban genetically engineered foods altogether. Indeed, we realize it will be quite a challenge to pass labeling legislation, but already a significant number of Congress members have signed on as co-sponsors. Perhaps in another two or three years there will be enough opposition to genetically engineered foods to ban them, but not this year."
10. Detection and analysis of GM materials
Effective regulatory control over GMOs is crucially dependent on the existence of reliable analytical methodology for detection and identification of specific genes, and for quantification where, for example, a threshold limit is set. Until the mid-1990s, in the absence of reliable analytical methods it was impossible to determine whether a food or food ingredient had been genetically modified. More recently, however, new methods have been developed based on the polymerase chain reaction (PCR) – a method for several-million-fold amplification in vitro of specific DNA sequences known as nucleotides or "primers". Compared with the millions of bases in the DNA in an organism, and 100 bases in an average gene, it has been discovered that primers as short as 21-24 bases in length can act as a unique "fingerprint" for a gene.
PCR-based assays involve the following three basic steps:
Detailed knowledge of analytical methods is not necessary for the course but information is given here for those who are interested.
Within the framework of the development of EU legislation on GMOs in food and food ingredients, the Health and Consumer Protection Directorate General of the European Commission in December 1998 commissioned two studies on the development of qualitative as well as quantitative methods for the detection of GMOs in food, after an open call for tender procedure (Official Journal S 122 of 27 June 1998, p.34) to two leading institutions in the field of analytical methods:
The World Health Organization on 1 August 2003 announced the availability of a guidance manual which is " ... used in the training courses organized jointly by the Joint Research Centre (JRC) of the European Commission and WHO/Europe, [which] provides the theoretical and practical information on methodologies and protocols followed during the courses. It covers a wide variety of techniques for GMOs detection, identification, characterization and quantification, and includes key background theoretical information for working in the field of GMO detection ..." Details are available at <http://www.euro.who.int/foodsafety/Assistance/20030728_1
The course is intended to teach molecular detection techniques to laboratory personnel with a good level of analytical knowledge, but with no or little expertise in this specific domain. The Course Manual, entitled "The analysis of food samples for the presence of genetically modified organisms", edited by M. Querci, M. Jermini and G. Van Den Eede, has now been made available on-line.
In March 2004 the European Committee for Standardization (CEN) issued European Standard EN ISO 21572 :2004 "Methods for detection of Genetically modified organisms and derived products - Protein based methods".
EU Commission Regulation (EC) No1981/2006 sets out detailed rules for implementation of Article 32 of Regulation EC (No) 1829/2003 regarding the Community Reference Laboratory (CRL) for GMOs. It sets out requirements for national laboratories that can engage on such work and lists national reference laboratories that may assist the CRL in testing and validating methods of delection.
11. EU Directives and Regulations concerning GM
Relevant regulatory information has been given under various headings in the foregoing text, but for convenience is collected under this heading, and presented in a way which shows the historical development of the legislation.
Relevant regulatory information has been given under various headings in the foregoing text, but for convenience is collected under this heading.
Releases in the Environment
Under Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms [OJ L 117, 8 May 1990, p 15; amended by Commission Directive 94/15/EC (OJ L103, 2214/94, p.20) and Commission Directive 97/35/EC (OJ L169, 27/6/97, p 72)] up to 29 October 2001, under the procedure set out in Directive 90/220/EEC and using the current risk assessment methodology, 18 GMOs had been authorised in the EU. Two genetically modified plants, a variety of soya and a variety of maize were authorised for use in food. From October 1998 until the present no further authorisations were granted under Directive 90/220/EEC and as of 29 October 2001, 12 applications for authorisation were pending. The moratorium continued but (unless blocked by some Member States) was due to be lifted following the adoption of the new Directives. Directive 2001/18/EC provides for the deliberate release into the environment of genetically modified organisms and repealed Directive 90/220/EEC. It requires that introduction of GMOs into the environment should be carried out according to the step by step principle. This means that the containment of GMOs is reduced and the scale of release increased gradually, step by step, but only if evaluation of the earlier steps in terms of protection of human health and the environment indicates that the next step can be taken.
Annexes to the Directive contain full details of the extensive information that must be submitted in support of any application.
Containment
EU Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms [OJ L117, 8 May 1990, pp 1-14], as amended by Council Directive 98/81/EC of 26/10/98 (OJ L330, 5 December 1998, p13).
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0081:EN:HTML
http://ec.europa.eu/environment/biotechnology/pdf/dir98_81.pdf
This Directive, which provides the circumstances and conditions under which
GMOs (including fermentation organisms) require consent for contained use, is administered in the UK by the Department of the Environment and implemented in the UK by:
Placing on the Market and Labelling
Prior to May 1997, labelling of GM foods in many countries, including the UK, was not explicitly mandatory. Nevertheless, some food manufacturers and retailers labelled GM foods on a voluntary basis (e.g. the Co-op's vegetarian cheese prepared using GM chymosin and Sainsbury's and Safeway's GM tomato puree) to allow consumers to exercise choice and to gain consumer confidence. Labelling guidelines were developed by a number of bodies including the independent Food Advisory Committee in 1993 (revised in 1996) and the Institute of Grocery Distribution in 1997. These guidelines took into account the need for labelling of novel foods which contain material (e.g. allergens) which may have implications for the health of some sections of the population (e.g. infants or the elderly) as well as those which contain "ethically sensitive genes". The latter include foods that contain copy genes originally derived from humans or from animals which are the subject of religious dietary restrictions (e.g. pig genes for Muslims) or any animal genes for vegetarians. Much of the provision on ethically sensitive genes has been based on the findings of the UK Polkinghorne Committee, which reported on the ethics of genetic modification in 1993.
On 15 May 1997, the EU Novel Foods Regulation (258/97) was made, controlling the placing on the market and the labelling of GM foods or foods obtained from GMOs mandatory in the European Union if, on the basis of a scientific assessment, they were judged not to be substantially equivalent to an existing food (for a definition of substantial equivalence, see section above on "Safety and regulation of GM foods"). Article 8 of the Novel Foods Regulation requires foods and food ingredients containing or consisting of GMOs and foods and food ingredients produced from (but not containing) GMOs to be labelled so as to inform consumers of any characteristic or property that makes the food or food ingredient different from an equivalent, existing food or food ingredient. Not only must the modified characteristic or property be identified, the method by which it was obtained must be indicated. The regulation allowed voluntary labelling to indicate the absence of any genetic material.
On 15 May 1997, the EU Novel Foods Regulation (258/97) were made, controlling the placing on the market and the labelling of GM foods or foods obtained from GMOs mandatory in the European Union if, on the basis of a scientific assessment, they were judged not to be substantially equivalent to an existing food (for a definition of substantial equivalence, see section above on "Safety and regulation of GM foods").Over the next three years there followed a succession of increasingly stringent measures, enforcement of which were carried out by Member States' authorities.
From July 2000 discussions and work proceeded in the Commission, the Council of Ministers and the European Parliament, to provide a new comprehensive and stringent regulatory regime, replacing the previous piecemeal measures covered in the various pieces of legislation. This would cover traceability of GMOs throughout the chain from farm to table, and labelling of GMOs and products produced from GMOs and regulating GM food and feed.
'Traceability' here means the ability to trace and follow a food, feed, food-producing animal or substance, through all stages from rearing or growing of primary products, through production, manufacture and distribution up to and including its sale or supply to the final consumer; and in the case of a food containing a GMO, or a food, food ingredient, additive, or flavouring derived from a GMO, an unique code identifier following it from "farm to fork", and provision to the authorities of information facilitating the detection and identification of a particular GM product including lodging of a sample of the GMO or its genetic material.
Of course traceability is highly important for all aspects of product food safety. But for any scheme that needs an effective system for authorization of specific GMOs, and labelling distinction between GM and non-GM products, not only analysis but also traceability is a must. However, this was the first time that a proposal had been made to establish mandatory traceability measures. Moreover, it would seem that the new approach placed emphasis on traceability of heritage rather than relying solely on analysis.
These proposals went through a long period of gestation and debate, but finally emerged from their second reading in the European Parliament in June 2003. The new legislation was given final approval by the Council of Ministers on 22 July 2003, published in the Official Journal of the European Union on 22 September 2003 and designated
These mean that GM crops have to be kept separate from conventional crops and put strict limits on the accidental mixing of the two. The rules allow for no more than 0.9% accidental mixing of GM in non-GM shipments to the EU. All products containing more than 0.9% GMOs have to be distinctively labelled as genetically modified. Genetically modified material will also have to be traced at all stages of production. In the UK, the Food Standards Agency carried out consultations on the enforcement and penalties in the UK of these two EU Regulations, and on draft Guidance Notes http://www.food.gov.uk/multimedia/pdfs/gmconsultnotes.pdf, although, as FSA points out, this is draft informal guidance for application of both Regulations in the UK and cannot modify the Regulations themselves.
Several countries in the EU had said they would keep the unofficial moratorium in place until the new legislation regarding labelling and traceability was introduced. Member States were divided in several votes since December 2003, which under EU rules sent the decision ultimately to the EU Commission.
On 2 October 2003 the EU Commission issued "Questions and Answers about GMOs in seeds," which provides answers to the following questions: What is the EU seeds legislation? Is there separate legislation on GM seeds? Why is there a need to set thresholds for GM-impurities in conventional seeds? What thresholds for GM-presence in conventional seeds will the Commission propose? What is the aim of such thresholds, what is the relationship between the seed thresholds and the labelling thresholds for food and feed products? What kind of GMOs will benefit from the thresholds proposed? and Will these thresholds be important for the co-existence of genetically modified crops with conventional and organic farming? It can be found at http://europa.eu.int/comm/food/plant/gmplants/index_en.htm
On 12 May 2004 the Commission decided to lift the 6-year-old unofficial moratorium by approving imports of an insect-resistant Bt11 strain of sweet corn for human consumption from Swiss-based Syngenta. This GM corn would only be imported and not grown in the EU, although an application for cultivation is pending. Any sold – whether canned or fresh - would have to be labelled in accordance with the new Directives. David Byrne, EU Commissioner for Health and Consumer Protection, said the GM corn was approved after "the most rigorous pre-marketing assessment in the world”. "It has been scientifically assessed as being as safe as any conventional maize. Food safety is therefore not an issue, it is a question of consumer choice. Labelling provides consumers with the information they need to make up their own mind. They are therefore free to choose what they want to buy." Events showed, however, that in the prevailing engendered climate of European consumer fears, importers and retailers in the EU Member States considered it too commercially risky to offer consumers that choice. The report of the 36th Session of the Codex Committee on Food Labelling (CCFL), that took place from 28 April to 2 May 2008 in Ottawa, Canada, is now available. Agenda Item 5, on "Labelling of foods and food ingredients obtained through certain techniques of genetic modification/genetic engineering", is covered in paragraphs 75-93 of the report. http://www.codexalimentarius.net/web/archives.jsp?lang=en On 6 January 2005, CORDIS (Community Research and Development Information Service), the EU's official online information platform for scientific research, issued a News Release, "EU project publishes conclusions and recommendations on GM foods," which states in part that " ... the European Commission funded a thematic network on the safety assessment of genetically modified food crops, the ENTRANSFOOD project ... Funded under the Fifth Framework Programme (FP5), ENTRANSFOOD sought to identify prerequisites for introducing agricultural biotechnology products in a way that is largely acceptable to European society ... the consortium ... consists of 65 partners from 13 different European countries, including representatives from academia, regulatory agencies, food manufacturers, retailers and consumer groups ... The project found that existing test methods for safety assessment of genetically modified organisms (GMOs) are efficient and ensure that GM foods that have passed the test are as safe and nutritious as plant-derived foods ... ENTRANSFOOD also noted that process-based labelling of all foods containing GM crops is a necessity in order to dispel the fears of EU citizens, but recognised that difficulties are unavoidable in implementing the EU's labelling requirements ... On the subject of detection of unintended effects and gene transfer, ENTRANSFOOD emphasised that there is no indication that unintended effects are more likely to occur in GM foods or that there is any inherent risk in the transfer of DNA between organisms, since DNA is not toxic ... ENTRANSFOOD recommended the creation of an evaluation and discussion platform combining a range of diverse perspectives on new food technology to formalise public engagement and consultation in the GM debate ..." - The complete text of the CORDIS news release is at http://cordis.europa.eu/fetch?CALLER=EN_NEWS&ACTION=D&DOC=1&CAT=NEWS&QUERY=1173302230405&RCN=23144The scope of application for the labelling of GMOs would not include products derived from animals fed with GM feed (eggs, milk and meat).
The proposals went through a long period of gestation and debate, but finally emerged from their second reading in the European Parliament in June 2003. The new legislation was given final approval by the Council of Ministers on 22 July 2003, and resulted in:
Operators had to comply with the new rules on labelling within 6 months after the date of publication. The rules allow for no more than 0.9% accidental mixing of GM in non-GM shipments to the EU. All products containing more than 0.9% GMOs will have to be distinctively labelled as genetically modified. Genetically modified material will also have to be traced at all stages of production.
The EU Commission is now carrying out its scheduled review re the implementation of these Regulations by industry, and to assess whether any aspect of the legislation requires clarification.
The new laws also allow EU Member States to take “appropriate measures” to ensure GM crops planted in the EU do not cross-pollinate with conventional crops. However, on 26 January 2004, EU Agriculture Commissioner Franz Fischler warned delegates at a conference on organic farming that food which is completely free of GMOs is a thing of the past. When it comes to setting acceptable thresholds for the levels of GMOs in organic and conventional products, the Commissioner said that Europe must take guidance from scientists, rather than politicians. 'We have been banished from paradise. The idea of a zero per cent threshold was no doubt possible in the Garden of Eden, but not in the real world,' said Dr Fischler. Then on 23 February 2004 a report was issued by the (US) Union of Concerned Scientists entitled "Gone to Seed: Transgenic Contaminants in the Traditional Seed Supply". It described tests carried out in USA on supposedly unmodified corn, soy and canola seeds, all purchased commercially. Of 18 seed varieties tested, 16 seemed to contain some GM elements. On 27 February 2004 the 87 member states of the Cartagena Protocol on Biosafety, which entered into force in September 2003, adopted documentation requirements and other procedures for promoting the safety of international trade in GMOs http://www.biodiv.org/doc/press/2004/pr-2004-02-27-bs-en.pdf
The new legislation did not, however, stop the US from going ahead with its WTO case against the EU. Although favouring the lifting of the moratorium, the US considered such stringent labelling laws unworkable and in practice as trade barriers.
On 7 February 2006 the preliminary confidential verdict of the World Trade Organisation (WTO) over genetically modified foods and crops was sent to the EU and the three WTO member countries that brought the trade complaint - Argentina, Canada and USA.
Then on 28 September 2006 the WTO issued the 1000 pages of reports of the panel that had examined complaints by the United States, Canada and Argentina, respectively, against “European Communities — Measures affecting the approval and marketing of biotech products” (DS291, DS292 and DS293).
.These can be found at
http://www.wto.org/english/news_e/news06_e/291r_e.htm
The WTO Panel's 21 pages report on its Recommendations and Conclusions can be found at
http://www.wto.org/english/tratop_e/dispu_e/291r_conc_e.pdf
The main conclusions of the panel of WTO judges, were as follows
The de facto EU moratorium, which operated between 1998 and 2004, has been lifted, since when 10 GM products have been authorised, according to the European Commission. More than 30 applications are being examined.
A great deal of heated argument has developed on both sides, but having watched the historical developments from "a grandstand seat" it is my opinion that the "villain of the piece" is neither the EU Commission nor the US Bush Administration, but the skillfully executed plan of the anti-GM ideologists. In targeting Europe, not only were they attacking the easiest target, but they were successfully instigating a situation that would deny the European market to US farmers, and also that would make some developing countries in Africa frightened to embrace the much-needed benefits of GM for fear of losing European export markets.
On 6 February 2006, the EU Commission issued its latest updated Questions-and-Answers fact sheet on the regulation of GMOs in the EU, It can be found at
http://europa.eu.int/rapid/pressReleasesAction.do?reference=MEMO/06/58&format=HTML&aged=0&language=EN&guiLanguage=en
On 2 October 2003 the EU Commission issued "Questions and Answers about GMOs in seeds," which provides answers to the
following questions: What is the EU seeds legislation? Is there separate
legislation on GM seeds? Why is there a need to set thresholds for
GM-impurities in conventional seeds? What thresholds for GM-presence in
conventional seeds will the Commission propose? What is the aim of such
thresholds, what is the relationship between the seed thresholds and the
labelling thresholds for food and feed products? What kind of GMOs will
benefit from the thresholds proposed? and Will these thresholds be
important for the co-existence of genetically modified crops with
conventional and organic farming? It can be found at
http://europa.eu.int/comm/food/plant/gmplants/index_en.htm
USDA Foreign Agricultural Service has a large number of GAIN Reports from FAS overseas Attaches regarding the biotechnology situation in individual countries. These are contained in a database accessed at
http://www.fas.usda.gov/scriptsw/attacherep/default.asp.
To read these FAS Attaché Reports, search by date and choose “Biotechnology” under “All Commodities” and “All Countries” under “Countries” or choose a specific country or countries.
12. On-line References
The following are useful references, some of which are also given in the module text:
Advisory Committee on Novel Foods and Processes (ACNFP) (UK) Annual Reports 1989-2006,
http://www.food.gov.uk/science/ouradvisors/novelfood/acnfpannualreports/
Animal and Plant Health Inspection Service of the U.S. Department of Agriculture (APHIS-USDA), Biotechnology Regulatory Services,
http://www.aphis.usda.gov/biotechnology/index.shtml
Bennett, P M et al, "An assessment of the risks associated with the use of antibiotic resistance genes in genetically modified plants”: report of the Working Party of the British Society for Antimicrobial Chemotherapy
http://www.agbiotechnet.com/news/Database/jac.oupjournals.org/
BioCassava Project. Anon (2008). “Fortified Cassava Could Provide A Day's Nutrition In A Single Meal”. Science Daily, June 30 2008.
http://www.sciencedaily.com/releases/2008/06/080630102737.htm
Brookes G and Barfoot P (2008) Report “Global impact of biotech crops: socio-economic and environmental effects 1996-2006”, PG Economics Ltd UK (118pp).
Department of Food, Environment and Rural Affairs (UK) http://www.defra.gov.uk
Center for Science in the Public Interest: “Genetically Engineered Foods: Are They Safe?” http://www.cspinet.org/nah/11_01/
Codex Committee on Food Labelling (CCFL) (2008). Report of the 36th Session, 28 April to 2 May 2008 in Ottawa, Canada. Agenda Item 5, on "Labelling of foods and food ingredients obtained through certain techniques of genetic modification/genetic engineering", paragraphs 75-93.
http://www.codexalimentarius.net/web/archives.jsp?lang=en
European Food Safety Authority Website http://www.efsa.eu.int
European Food Safety Authority (EFSA) Scientific advice on the use of antibiotic resistance marker genes in genetically modified plants http://www.efsa.eu.int/press_room/press_release/386_en.html
EuroBarometer (2008). “Attitudes of European citizens towards the environment”. http://ec.europa.eu/public_opinion/archives/ebs/ebs_295_en.pdf
European Food Safety Authority (2008). “Statement on the fate of recombinant DNA or proteins in the meat, milk or eggs of animals fed with GM feed”.
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178623095798.htm
European Food Safety Authority (2008). "EFSA works with Member States on best approaches to GMO risk assessment". http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178682961414.htm
European Food Safety Authority (July 2008). “EFSA GMO Risk Assessment FAQs”
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_EFSAGMORiskFAQs.htm
European Union DG Consumer Policy and Consumer Health Protection ("Sanco") Web site http://europa.eu.int/comm/food/index_en.html
Question and Answers on the regulation of GMOs in the EU http://europa.eu.int/comm/food/food/biotechnology/gmfood/qanda_en.pdf
European Union: Questions and Answers on the European Food Safety Authority
http://europa.eu.int/rapid/pressReleasesAction.do?reference=MEMO/06/58&format=HTML&aged=0&language=EN&guiLanguage=en
European Union: European Food Safety Agency Website http://www.efsa.eu.int
European Union: Question and Answers on the regulation of GMOs in the EU.
http://europa.eu.int/comm/food/food/biotechnology/gmfood/qanda_en.pdf
European Union (2000) European Commission "Communication on the Precautionary Principle".
European Union: Consultation on "Life Sciences and Biotechnology: A Strategic Vision".
http://europa.eu.int/comm/dgs/health_consumer/library/press/press298_en.pdf
European Union: Questions and Answers on the European Food Safety Authority.
http://europa.eu.int/comm/dgs/health_consumer/library/press/press135_en.pdf
European Union: Novel Foods -- Lists of applications and notifications for approval may be found at http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm
European Union:CORDIS (Community Research and Development Information Service) News Release on the report of the ENTRANSFOOD project, "EU project publishes conclusions and recommendations on GM foods," issued 6 January 2005.
http://dbs.cordis.lu/cgi-bin/srchidadb?CALLER=NHP_EN_NEWS&ACTION=D&SESSION=&RCN=EN_RCN_ID:23144
European Union. Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms. http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_368/l_36820061223en00990109.pdf
European Union (August 2007). Comments on Codex Circular Letter CL 2007/17-FBT: Proposed Draft Annex to the Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants on Low-level Presence of Recombinant-DNA Plant Materials.
http://ec.europa.eu/food/fs/ifsi/eupositions/tffbt/archives/tfbt_2007-17_en.pdf
Foodfuture: Food and Biotechnology, Food and Drink Federation (UK)
http://www.foodfuture.org.uk
Food and Agriculture Organisation (FAO). Report of Joint FAO/WHO Consultation on Biotechnology and Food Safety http://www.fao.org/ag/agn/food/pdf/biotechnology.pdf
Food and Agriculture Organisation (FAO). Annual Report “The State of Food Insecurity in the World, 2006”.
ftp://ftp.fao.org/docrep/fao/009/a0750e/a0750e00.pdf
Food and Agriculture Organisation (FAO) (2001). "Agricultural biotechnology for developing countries - results of an electronic forum". FAO Research and Technology Paper No. 8. Contains the Background and Summary Documents from Conferences 1-6. Available, in English, Spanish and Chinese, at www.fao.org/DOCREP/004/Y2729E/Y2729E00.HTM
Food and Agriculture Organisation (FAO)(2003). "Principles for the Risk Analysis of Foods Derived from Modern Biotechnology". CAC/GL (2003). ftp://ftp.fao.org/es/esn/food/princ_gmfoods_en.pdf
Food and Agriculture Organisation (FAO)(2003). "Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. CAC/GL, 2003" ftp://ftp.fao.org/es/esn/food/guide_plants_en.pdf
Food and Agriculture Organisation (FAO)(2003)"Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms". CAC/GL, 2003. tp://ftp.fao.org/es/esn/food/guide_mos_en.pdf
Food and Agriculture Organisation (FAO). (2006). "The role of biotechnology in exploring and protecting agricultural genetic resources". Containing the Background and Summary Document from Conference 13, plus papers from a workshop held as part of the build up to the conference - available at www.fao.org/docrep/009/a0399e/a0399e00.htm
Food and Agriculture Organisation (FAO) (2007). FAO Research and Technology Paper 11, "Results from the FAO Biotechnology Forum: Background and dialogue on selected issues", by J. Ruane and A. Sonnino. The 152-page book can also be freely downloaded from the web at ftp://ftp.fao.org/docrep/fao/009/a0744e/a0744e00.pdf
Food & Agriculture Organisation (FAO) (2007) . FAO annotated list, updated in December 2007 of on-line documents, including 180 web links to a wide range of articles, books, meeting reports, proceedings and studies published by FAO, or prepared in collaboration with FAO, over the last 10 years concerning biotechnology in food and agriculture. http://www.fao.org/biotech/doc.asp
Food Standards Agency (UK). Consumer Survey 2007.
http://www.food.gov.uk/science/socsci/surveys/foodsafety-nutrition-diet/eighthcas2007
Institute of Food Science & Technology (IFST). http://www.ifst.org
James, C (2008). ISAAA Brief 37-2007: Global Status of Commercialized Biotech/GM Crops: 2007.
Mentewab, A and Stewart, C N, (2005)
"Overexpression of an Arabidopsis thaliana ABC transporter confers kanamycin resistance to transgenic plants", Nature Biotechnology 23, 1177 - 1180 Published online: 21 August 2005.May, M at al (2005). "Management of genetically modified herbicide-tolerant sugar beet for
spring and autumn environmental benefit", Royal Society Proceedings: Biological Sciences
272 (1558).
http://www.journals.royalsoc.ac.uk/app/home/contribution.asp?
New Zealand Institute of Crop Research (2008). "International magazine announces New Zealand “tearless onion” breakthrough"
Nuffield Council on Bioethics (1999). Report "Genetically modified crops: the ethical and social issues".
http://www.nuffieldbioethics.org/go/ourwork/gmcrops/introduction
Nuffield Council on Bioethics (2003). "The Use of Genetically Modified Crops in Developing Countries". . http://www.nuffieldbioethics.org/go/ourwork/gmcrops/publication_313.html
OECD. 2000 "GM Food Safety - Facts, Uncertainties and Assessment.
http://www.oecd.org/dataoecd/34/30/2097312.pdf
PEW Initiative on Food and Biotechnology. Public Sentiment About Genetically Modified Food.
http://www.pewagbiotech.org
Rea, P A (2005) "A Farewell to Bacterial ARMs?", Nature Biotechnology 23, 1085 - 1087
The Royal Society
http://www.royalsoc.ac.uk
Royal Society Statements:
Links at http://royalsociety.org/document.asp?id=1170Feb 1998: Genetically Modified Plants for Food Use;
March 1999: The Regulation of Biotechnology in the UK;
April 1999: Scientific Advice on GM Foods: A Response to the inquiry by the House of Commons Science and Technology Committee;
April 1999: GMOs and the Environment: A Response to the inquiry by the House of Commons Environmental Audit Committee.
Links at http://www.royalsoc.ac.uk/policy/rep_fr.htm
UK House of Commons, Select Committee on Science and Technology http://www.publications.parliament.uk/pa/cm199899/cmselect/cmsctech/286/9030801.htm http://www.parliament.the-stationery-office.co.uk/pa/cm199899/cmselect/cmsctech/286/9030801.htm; and
http://www.publications.parliament.uk/pa/cm199899/cmselect/cmsctech/286/28602.htmUSDA Agricultural Research Service. 2005 GAIN Report "Twenty EU Regions Defend Right to Ban Biotech Production".
http://www.fas.usda.gov/gainfiles/200502/146118774.doc
USDA Foreign Agricultural Service. 2005 GAIN Report "FAO and Biotechnology"
http://www.fas.usda.gov/gainfiles/200601/146176552.doc
USDA Foreign Agricultural Service has a large number of GAIN Reports from FAS overseas Attaches regarding the biotechnology situation in individual countries. These are contained in a database accessed at
http://www.fas.usda.gov/scriptsw/attacherep/default.asp.
To read these FAS Attaché Reports, search by date and choose “Biotechnology” under “All Commodities” and “All Countries” under “Countries” or choose a specific country or countries.
US National Research Council. 2004"Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects".
http://www.iom.edu/report.asp?id=21496
World Health Organisation (WHO): 20 QUESTIONS ON GENETICALLY MODIFIED (GM) FOODS http://www.who.int/fsf/Documents/20_Questions/q&a.pdf
The Canadian Food Inspection Agency 's Food Safety Enhancement Program Web page of links at http://www.inspection.gc.ca/english/index/fssae.shtml
The Canadian Food Inspection Agency, Science Branch, Office of Biotechnology (2005) "Genetically Engineered Livestock Feeds Derived from Plants: Assessment and Safety"
http://www.inspection.gc.ca/english/sci/biotech/gen/feebete.shtmlHazard Analysis and Critical Control Point Principles
(US) Food Safety and Inspection Service of USDA
http://www.fsis.usda.gov/OA/background/keyhaccp.htm
13. Further Printed Information
Advisory Committee on Novel Foods and Processes (ACNFP). 1989-2001. Annual Reports. Available from ACNFP Secretariat, Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH, UK. (See also On-line References)
Advisory Committee on Releases into the Environment (ACRE). 1993-present. Annual Reports. Available from DEFRA, Nobel House, 17 Smith Square, London SW1P 3JR, UK (See also On-line References)
Advisory Committee on Releases into the Environment (ACRE). 1993-present. Annual Reports. Available from DEFRA, Nobel House, 17 Smith Square, London SW1P 3JR, UK (See also On-line References)
Astwood, J.D. et al. 1996. Stability of food allergens to digestion in vitro. Nature Biotechnology 14, 1269-1273.
Committee on the Ethics of Genetic Modification and Food Use (The "Polkinghorne Committee"). 1993. Report. Available from HMSO, P.O. Box 276, London SW8 5DT.
Food Advisory Committee (FAC). 1990-present. Annual Reports and Guidelines for the Labelling of Foods Produced using Genetic Modification. 1994. Available from FAC Secretariat, Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH, UK. (See also On-line References)
Committee on the Ethics of Genetic Modification and Food Use (The "Polkinghorne Committee"). 1993. Report. Available from HMSO, P.O. Box 276, London SW8 5DT.
European Committee for Standardization (CEN): European Standard EN ISO 21572 :2004 “Methods for detection of Genetically modified organisms and derived products – Protein based methods”
Food Labelling (Amendment) Regulations 1999. S.I. 1999/747 (UK)
Foodsense. Genetic Modification and Food. Leaflet available from Defra, London SE99 7TT.
Food and Drink Federation. 1995, 1997. Food for our Future and Modern Biotechnology - Towards Greater Understanding. Colour brochures available from the FDF, 6 Catherine Street, London WC2B 5JJ.
Herian, A.M. et al. 1990. Identification of soybean allergens by immunoblotting in sera from soy-allergic adults. International Archives of Allergy Applications and Immunology 92, 193-198.
Institute of Food Science and Technology (IFST). 1996. Guide to Food Biotechnology. Available from IFST, 5 Cambridge Court, 210 Shepherd's Bush Road, London W6 7NJ, UK.
Institute of Grocery Distribution. 1996, 1997. Biotechnology Factfile. Available from IGD, Grange Lane, Letchmore Heath, Watford, Herts., WD2 8DQ.
Novel Foods and Novel Food Ingredients Regulations 1997. S.I. 1997/1335 (UK).Nordlee, J.A. et al. 1995. Identification of Brazil-nut allergen in transgenic soybeans. New England Journal of Medicine 334, 688-692.
Nuffield Foundation on Bioethics (1999). Report "Genetically modified crops: the ethical and social issues" (also available on http://www.nuffieldbioethics.org/go/browseablepublications/gmcrops/report_234.html ).
Regulation (EC) No. 258/97 of the European Parliament and the Council of 25 January 1997 concerning Novel Foods and Novel Food Ingredients, Official Journal of the European Communities No L 43, 14 February 1997.
Thompson, J (2003) Chapter 3 in Report on "Genetically Modified Foods for Human Health and Nutrition: The Scientific Basis for Benefit/Risk Assessment"; a Monograph resulting from an ICSU sponsored workshop in 2002 (in press).
UK National Consensus Conference on Plant Biotechnology. 1994. Final Report. Available from The Science Museum, London SW7 2DD, UK.
The Codex Alimentarius Commission revised 3 basic texts on food hygiene in
1997; officially published in Volume 1B of the Codex Alimentarius and have
been republished in a compact format: 15 x 21 cm,
58 pages, ISBN 92-5-104021-4 Contents:
May be obtained through the worldwide Sales Agents, see http://www.fao.org/ or Publication-sales@fao.org(cost around $7).
Selected HACCP references
A Simple Guide to Understanding and Applying the Hazard Analysis Critical Control Point Concept. ILSI Europe, 1997. http://www.ilsi.org/pubs/ilsihace.pdf
HACCP: A Practical Guide (2nd Edn). Technical Manual No. 38, Campden and Chorleywood Food Research Association (1997)
HACCP: A Practical Approach, Mortimore, S.E. and Wallace, C. Aspen, 1994. (A small but exceptionally valuable book. The authors also have published a vast HACCP training manual that costs the earth).
How to HACCP. 2nd Edn. Dillon, M. and Griffith, C. MD Associates, 1996.
HACCP in Meat, Poultry and Fish Processing (Advances in Meat Research, Volume 10). Eds. Pearson, A.R. and Dutson, T.R. Blackie, 1995.
HACCP: An Integrated Approach to Assuring the Microbiological Safety of Meat and Poultry. Sheridan, J.D., Buchanan, R.L. and Montville, T.J., 1996.
IFST's Food and Drink -- Good Manufacturing Practice: A Guide to its Responsible Management (5th Edition) (January 2007). It costs 90 pounds sterling and if you visit www.ifst.org/ you will find out how to order it.
14. Case Study – Your Assignment
Part I. Compare (i.e. highlight similarities) and contrast (i.e. highlight differences) in the GM-affecting regulatory and other factors (including factors influencing public attitude) in the EU and USA respectively.
Part II. Discuss possible alternative scenarios that might develop in the EU and the USA respectively, in the short-term (i.e. 2 years) and longer-term (i.e. say 10 years), and indicate, with reasons, which short-term scenario and which long-term scenario you think is the likeliest to occur in EU and in USA respectively.