Table of Contents

  • Risk Analysis encompasses the relevant steps for handling food risks by differentiating the scientific level of Risk Assessment, the political level of Risk Management and the communicative level of Risk Communication. The Codex Alimentarius Commission has developed guidelines for optimizing Risk Analysis by separating all levels functionally and especially by splitting Risk Assessment from Management. This divorce is stressed to ensure the neutral basis for derivating independent, and objective management strategies. Additionally to these guidelines, the actual relevance of an independent Risk Assessment and a neutral ...

  • Biotechnology is a revolutionary technology. It offers humanity the power to change the characteristics of living organisms by transferring the genetic information from one organism, across species boundaries, into another organism. These solutions continue the tradition of selection and improvement of cultivated crops and livestock developed over the centuries. However, biotechnology identifies desirable traits more quickly and accurately than conventional plant and livestock breeding and allows gene transfers impossible with traditional breeding. The use of biotechnology in sectors such as agriculture and medicine has produced a growing number of genetically modified organisms (GMOs) and products derived from them. Changing the characteristics of organisms may provide benefits to society, including new drugs and enhanced plant varieties and food. However, biotechnology does not come without risks and uncertainty. Its potential effects on the environment, human health and food security are being actively debated at the national and international levels. Countries’ positions depend ...

  • The drafting of the new regulations on genetically modified organisms (GMOs) in the European Union (EU) has been a difficult and controversial task. EU regulators have been faced with the challenge of creating rules that address the possible risks to health and the environment from GMOs, in the face of scientific uncertainty regarding these risks. They have also had to ensure that the new rules will give consumers confidence in the safety of those GMOs that are approved for use in the EU. This is part of a general effort to address the erosion of consumer confidence in the EU regulatory system following several recent food-safety crises. As the European Commissioner for Health and Consumer Protection, ...

  • This paper was presented orally, but was unfortunately not available at the time of publication.

  • Genetically modified (GM) crops were introduced commercially in 1996. Since that time the adoption of GM crops has continuously increased till a worldwide cultivated area of approximately 60 million hectares nowadays. Currently, cultivated GM crops carry traits that are predominantly of agronomic importance, e.g. herbicide and or insect resistance. Examples are soybeans, canola, cotton, maize, sugar beet and potatoes. Several GM crops have been modified with traits that affect the functional and quality properties of the final product. Examples are long-ripening tomatoes with favorable post-harvest texture characteristics for processing into tomato paste, soybeans high in oleic acid and canola high in lauric acid. Moreover in the ...

  • This paper focus on the relevant EU provisions on patentability of plants and other related aspects such as questions raised by the Rio Convention on biological diversity. The aim of this paper is however not to deal with other controversial issues currently being discussed within the EU relating rather to the patentability of elements of the Human body (i.e. scope conferred to inventions related to human DNA sequences and patentability of Human Stem Cells and cell lines derived from them). The introductory remarks will illustrate the long and thorough discussions which led to the adoption by the Council and the European Parliament of the directive 98/441 on the legal protection of ...

  • With the application of biotechnology in agriculture - the green biotechnology - in Europe we find ourselves in a turbulent phase between the already more structured application of the red biotechnology (medicine) and the low profile application of the white biotechnology (industrial use of genetically modified micro-organisms). In economic terms this turbulent phase can be characterized as a million dollar/Euro World Trade Organisation WTO conflict. In terms of governance it can be characterized as controversies about facts and controversies about values. The application of this technology in agriculture has forced the European governments into a learning by doing policy cycle both at the national level and in the European Union but also in Codex Alimentarius and the United Nations Environment Programme. In general the way out of policy controversies is creating a culture of consultation and dialogue about the ...

  • The United States has a long history of encouraging innovations requiring intellectual property protection and also of analyzing and managing risks associated with those innovations. Although the history of genetic engineering is relatively recent — just over 30 years—the approach taken by the US is to adapt existing legal and regulatory frameworks to encompass biotechnological innovations. Most other jurisdictions, in contrast, decided to develop new regulatory structures exclusively for biotechnological innovations. As well, the approach of the US is to evaluate the risks associated with the tangible product of biotechnology, while most other nations attempt to evaluate the risks associated with ...

  • One of the central questions in the development of international biotechnology policy is whether persons have the same concepts of benefit and risk between countries, and how these views influence the policy. The first part of this paper presents analysis of comments on the benefits, risks and moral acceptability of biotechnology in Japan as viewed from different sectors of society. Two samples were obtained from mail response surveys in the year 2000, from the general public (N=297) and scientists (N=370), and one from the general public in 2003 (N=377). Comparison was made for a series of four questions on utility, risk, moral acceptability and overall encouragement, for applications of technology. The questions requested both agreement with a 5-point self-indicated scale, and the reasons behind these attitudes through open comments. The most acceptable of the applications were medicines ...

  • This contribution surveys some perspectives of developing countries in addressing policy and practical challenges associated with the regulation of genetically modified organisms (GMOs). It would be inaccurate, of course, to seek to portray developing countries as a homogenous group with regard to their priorities and concerns relating to modern biotechnology and biosafety; as in other countries, a diversity of interests and perspectives within and among developing countries gives rise to a tension in policy debates on appropriate GMO regulation. With that limitation in mind, this contribution focuses on a limited set of considerations related to the elaboration and implementation of the Cartagena Protocol on Biosafety. It surveys the main concerns and positions of developing countries in the negotiation of the Protocol and the extent to which those concerns were reflected in the Protocol as adopted. Specific areas addressed include the scope of the Protocol and its advance informed agreement procedure, the ...

  • Related to food safety aspects, the concept of substantial equivalence is a guiding tool for the assessment, developed by OECD and further elaborated by FAO/WHO. One of the safety concerns regarding GM crops pertains to the potential of unintended effects caused by processes of transgene insertion (DNA rearrangements) or from metabolic effects of novel gene product(s). Unintended effects are phenotypic, response or compositional effects which go beyond that of the original genetic modification and which might impact primarily on health. Unintended effects occur in both GM and non-GM crops; however, GM crops are better characterised. Conventional ‘targeted’ analytical approaches and animal feeding trials with whole foods may reveal unintended effects only by chance or if anticipated. Therefore, it is a scientific challenge to develop new methodology that allow for a ‘holistic’ simultaneous screening of potential alterations in the physiology of the GM crop at different biological integration levels. The present tendency is to include metabolomics (parallel analysis of a range of primary and secondary ...

  • The introduction to modern agricultural practice of genetically modified plants (GMPs) has raised a series of questions and concerns that have been debated within the political and scientific communities in recent years (20).1 Although biological products could offer great potential benefits to agriculture, such as the reduced use of pesticides and fertilizers, there are many uncertainties about the risks of the introduction of transgenic plants into the open environment and the ecological impact of engineered genes. This is based on the hypothesis that if the genetic alteration is transferred to other organisms, in particular microbial recipients, it could be disseminated into the natural habitat, with unpredictable ...

  • European agriculture is characterised by a small-scale structure and by a high share of organic farmers. Traditional production systems are also preferred in conventional agriculture. The EU Regulation for organic farming no. 2092/91 forbids strictly the use of GMOs. Farmers, ecologists as well as consumers in Europe have quite a critical attitude towards genetic techniques, as they are seen as not necessary and dangerous in certain areas. In Europe, except Spain, there are no GMOs cultivated commercially. There are no long-term studies about the effects of GMOs on ecosystems. In addition, the problems of coexistence, measures to avoid contamination, liability, costs and others, have not been solved yet. On the basis of the studies published up to now, a co-existence of organic, GMO-free and GMO agriculture is not possible. Therefore, in spite of an enormous pressure on the part of the WTO and the USA, the ...

  • Six examples of innovations with modern biotechnology are discussed in terms of their effects on industrial economic value creation, environmental performance and on the effects on people’s lifestyles and working conditions. The examples span a period of 3 decades. Gradually increasing levies on end-ofpipe pollution and societal pressure for cleaner processes, technology development and the need to compete on a global market for food, feed and pharmaceutical ingredients all four resulted in new and innovative solutions. We conclude that industry can and will indeed respond to environmental concerns by developing cleaner technology and will come with innovative products and processes. However these developments need sufficient time and sometimes support from national and local governments before ...

  • COPA represents the farmers of the European Union as they are organised in several farmers’ organisations in the member states. COGECA is the representative body for the farmers’ co-operatives in the member states. The two bodies have their secretariat in Brussels and organise many Committee that deal with agricultural issues. One of them is the Committee for ‘Biotechnology, bio-energy and agricultural resources’ that was established during the mid eighties of the last century. This naming of the Committee clearly indicates that biotechnology is interpreted as potentially instrumental to agriculture and processing industries in ...

  • The U.S. farmer’s perspective on biotechnology is well summarized up by two simple statistics: 1) Since the introduction of Roundup Ready soybeans in 1996, plantings have grown to 75% of the U.S. soybean crop. 2) Biotechnology enhanced corn varieties are now planted on 34% of U.S. corn acres. This rather rapid rate of adoption of new technology is driven primarily by a desire to produce more efficiently, by increasing yield per acre or reducing pest control costs. American farmers generally cite these two factors, along with a reduced introduction of pesticides into the environment, as benefits of GMO crops. Increased yield, however, is considered to be a benefit for some, and a cost for others. Those who ...

  • This paper was presented orally, but was unfortunately not available at the time of publication.

  • The media faces numerous challenges in attempting to inform the public about real hazards and dangers in this world without causing mass hysteria. These challenges include the audience that is targeted, selection of appropriate language, and finding a balance between points of view. Other challenges that face the media include identifying the stories that genuinely require attention and recognising those based on hype or false claims. Reporters are under a number of pressures from the media itself and this can lead to conflicts between the hysteria driving viewpoint and the more objective position. We must all be aware that bad news sells, ...

  • B. Le Gallic highlighted certain definition issues. He expressed surprise about the range of terms and concepts used (e.g. GMO, LMO, GMPs, Conventionally Modified Organism, GMO-free, etc.) and pointed out that this may increase difficulties in achieving a clear and transparent discussion on GMOs. In particular he noted the difference between US and EU approaches, namely: product (US) vs. process (EU) as well as the related distinction between LMOs and GMOs, the first of which seems to exclude processed product from the analysis (e.g. milk, eggs or meat from animal fed on GMOs; cheese using GM enzymes). He concluded that while products may be similar (following the principle of “substantial equivalence”), it may nevertheless be important for the consumer to have access to information on the ...