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PubMedDate not supplied

[Revocation of authorizations on GMO under the precautionary principle (with special attention to the Justice Tribunal of the European Communities].

During the last decade, the european institutions have done a great effort in order to introduce the precautionary principle, applicable to the management of serious and uncertain risks. Under the protection of the precautionary principle, european authorities and authorities of the member states have partially modified, suspended or revoked authorizations relative to genetically modified organisms. Is it rightful this use of the precautionary principle? This is the matter that the European Communities Justice Court has faced when the affected companies have lodge their appeals against this decisions.

European Union↗

PubMed2005

Globalisation, environmental harm, and progress: the role of consensus and liability.

Two conditions are stated that must be fulfilled to make sure that the negative effects of environmental pollution and risks stemming from the spread of free markets and technology do not outweigh the beneficial effects of this development. (1) For all activities, all those who may experience the negative effects of the activities must have given their consent to the activities and the conditions under which they are performed. (2) Those who engage in activities without this consent must be held to unlimited and unconditional liability for the negative effects that the activities may cause for those who did not give their consent. These conditions are necessary principles for the responsible management of environmental harm and risks. If the conditions are not satisfied, then the belief that the global spread of free markets and technology is beneficial for all, or does not harm anyone, cannot be justified. Neither of the conditions is fulfilled at present. This is illustrated using examples drawn from international legislation regarding liability for oil transportation, energy production, genetically modified organisms and chemicals in the environment. Directions for improving existing liability legislation are identified. The relationship between the conditions and the precautionary principle is explained.

Commerce↗

PubMed2005

Improving the biosafety of cell sorting by adaptation of a cell sorting system to a biosafety cabinet.

BACKGROUND: The jet-in-air cell sorters currently available are not very suitable for sorting potentially biohazardous material under optimal conditions because they do not protect operators and samples as recommended in the guidelines for safe biotechnology. To solve this problem we have adapted a cell sorting system to a special biosafety cabinet that satisfies the requirements for class II cabinets. With aid of this unit, sorting can be performed in conformance with the recommendations for biosafety level 2. METHODS: After integrating a modified fluorescence-activated cell sorter (FACS) Vantage into a special biosafety cabinet, we investigated the influence of the laminar air flow (LAF) inside the cabinet on side stream stability and the analytical precision of the cell sorter. In addition to the routine electronic counting of microparticles, we carried out tests on the containment of aerosols, using T4 bacteriophage as indicators, to demonstrate the efficiency of the biosafety cabinet for sorting experiments performed under biosafety level 2 conditions. RESULTS: The experiments showed that LAF, which is necessary to build up sterile conditions in a biosafety cabinet, does not influence the conditions for side stream stability or the analytical precision of the FACS Vantage cell sorting system. In addition, tests performed to assess aerosol containment during operation of the special biosafety cabinet demonstrated that the cabinet-integrated FACS Vantage unit (CIF) satisfies the conditions for class II cabinets. In the context of gene transfer experiments, the CIF facility was used to sort hematopoietic progenitor cells under biosafety level 2 conditions. CONCLUSIONS: The newly designed biosafety cabinet offers a practical modality for improving biosafety for operators and samples during cell sorting procedures. It can thus also be used for sorting experiments with genetically modified organisms in conformance with current biosafety regulations and guidelines.

Aerosols↗

PubMed2002

Exploitation of genetically modified inoculants for industrial ecology applications.

The major growth seen in the biotechnology industry in recent decades has largely been driven by the exploitation of genetic engineering techniques. The initial benefits have been predominantly in the biomedical area, with products such as vaccines and hormones that have received broad public approval. In the environmental biotechnology and industrial ecology sectors, biotechnology has the potential to make significant advances through the use of genetically modified (GM) microbial inoculants that can reduce agri-chemical usage or remediate polluted environments. Although many GM inoculants have been developed and tested under laboratory conditions, commercial exploitation has lagged behind. Here, we review scientific and regulatory requirements that must be satisfied as part of that exploitation process. Particular attention is paid to new European Union (EU) regulations (Directives) that govern the testing and release of genetically modified organisms and microbial plant protection inoculants in the EU. With regard to the release of GM inoculants, the impact of the inoculant and the fate of modified genes are important concerns. Long term monitoring of release sites is necessary to address these issues. Data are reported from the monitoring of a site 6 years after release of GM Sinorhizobium meliloti strains. It was found that despite the absence of a host plant, the GM strains persisted in the soil for at least 6 years. Horizontal transfer and microevolution of a GM plasmid between S. meliloti strains was also observed. These data illustrate the importance of assessing the long-term persistence of GM inoculants.

Biotechnology↗

PubMed2003

Challenges when transferring technology from Lactococcus laboratory strains to industrial strains.

Many genetically modified Lactococcus strains have been constructed in research laboratories around the world. Most of these have originated from laboratory strains and therefore there are several barriers to using them in an industrial setting. Laboratory strains are often plasmid-free and consequently Lac- and Prt-, rendering them unable to grow in milk. Many of the commonly used techniques have been optimised for laboratory strains and their application to industrial strains may require a great deal of effort. Often genetically modified organisms produced in the laboratory do not fit the published definition of 'food-grade' (Johansen, 1999, Encyclopedia of Food Microbiology, Academic Press, London, pp. 917-921) and a great deal of effort is required to eliminate undesirable DNA sequences. As a consequence, it is often necessary to recreate the strains in industrial backgrounds before the innovations described in the scientific literature can be applied to the real-world dairy industry.

Biotechnology↗

PubMed2005

Biosafety evaluation of recombinant live oral bacterial vaccines in the context of European regulation.

Live bacterial vaccines represent a highly valid preventive strategy in the fight against infectious disease. However, the road from research to market is peppered with hurdles, one of which is the requirement for high biosafety characteristics, which the candidate vaccine has to display. In Europe, the European Agency for the evaluation of medicinal products (EMEA) is the relevant authority regulating the licensure of genetically engineered vaccines. For this purpose, the agency may rely on several directives and guidelines defined in the past 15 years. As for live vaccines containing genetically modified organisms (GMOs) susceptible to be released into the environment, Directive 2001/18/EC determines the framework and principles of an environmental risk assessment (ERA) process, the results of which constitute an important section of the vaccine registration package submitted to registration authorities. In this article, we address the implications of current European regulations for the approval of live oral bacterial vaccines with emphasis on the assessment of potential risks associated with environmental release. Biosafety aspects of already registered and some promising live bacterial vaccine strains will be briefly discussed.

Bacterial Vaccines↗

PubMed2002

The impact of biotechnology on agricultural worker safety and health.

Biotechnology applications such as the use and production of genetically modified organisms (GMOs) have been widely promoted, adopted, and employed by agricultural producers throughout the world. Yet, little research exists that examines the implications of agricultural biotechnology on the health and safety of workers involved in agricultural production and processing. Regulatory frameworks do exist to examine key issues related to food safety and environmental protection in GMO applications. However, based on the lack of research and regulatory oversight, it would appear that the potential impact on the safety and health of workers is of limited interest. This article examines some of the known worker health and safety implications related to the use and production of GMOs using the host, agent, and environment framework. The characteristics of employers, workers, inputs, production practices, and socio-economic environments in which future agricultural workers perform various tasks is likely to change based on the research summarized here.

Agricultural Workers' Diseases↗

PubMed2005

Invited review: methods for the screening, isolation, and characterization of exopolysaccharides produced by lactic acid bacteria.

The ability to produce exopolysaccharides (EPS) is widespread among lactic acid bacteria (LAB), although the physiological role of these molecules has not been clearly established yet. Some EPS confer on LAB a "ropy" character that can be detected in cultures that form long strands when extended with an inoculation loop. When EPS are produced in situ during milk fermentation they can act as natural biothickeners, giving the product a suitable consistency, improving viscosity, and reducing syneresis. In addition, some of these EPS may have beneficial effects on human health. The increasing demand by consumers of novel dairy products requires a better understanding of the effect of EPS on existing products and, at the same time, the search for new EPS-producing strains with desirable properties. The use of genetically modified organisms capable of producing high levels of EPS or newly designed biopolymers is still very limited. Therefore, exploration of the biodiversity of wild LAB strains from natural ecological environments is currently the most suitable approach to search for the desired EPS-phenotype. The screening of ropy strains and the isolation and characterization of EPS responsible for this characteristic have led to the application over the past years of a wide variety of techniques. This review summarizes the available information on methods and procedures used for research on this topic. The information provided deals with methods for screening of EPS-producing LAB, detection of the ropy phenotype, and the physicochemical and structural characterization of these molecules, including parameters related to their viscosifying properties. To our knowledge, this is the first compilation of methods available for the study of EPS produced by LAB.

Dairy Products↗

PubMed2001

Democracy and the governance of uncertainty. The case of agricultural gene technologies.

The use of genetically modified organisms (GMOs) in agriculture and food production is the object of an intense and divisive debate. Drawing on a study on the public perception of agricultural gene technologies carried out in five European countries, the article deals with the policy aspects of the issue, and more precisely on the relation between institutions, experts and the public in a context of deep uncertainty. A theoretical framework is developed and compared with the study findings, suggesting that issues like the GMOs one represent a strong case for a more participatory policy-making. My conclusions suggest a style of governance based on the principles of deliberative democracy, as a suitable approach to the confrontation of different viewpoints and forms of knowledge. This appears to be the best way to improve the overall quality of policy-making: in this I include its legitimacy, the degree of public trust, and also the actual quality of its products. Strengthening the role of the public sphere seems more effective than simply increasing direct decision-making by the populace, and it offers an alternative to the 'elitist' solutions to the crisis of representative democracy.

Agriculture↗

PubMed2005

Stretched peer-review on unexpected results (GMOs).

Science is the basis for governance of risk from genetically modified organisms (GMO), and it is also a primary source of legitimacy for policy decision. However, recently the publication of unexpected results has caused controversies and challenged the way in which science should be performed, be published in scientific journals, and how preliminary results should be communicated. These studies have subsequently, after being accepted for publication within the peer-review process of leading scientific journals, been thoroughly re-examined by many actors active within the GMO debate and thereby drawn extensive media coverage. The publicized charges that the research involved does not constitute significant evidence or represent bad science have in fact deflected attention away from the important questions related to ecological and health risks raised by the research. In this paper, I will argue that unexpected findings may represent "early warnings." Although early warnings may not represent reality, such reports are necessary to inform other scientists and regulators, and should be followed up by further research to reveal the validity of the warnings. Furthermore, science that embraces robust, participatory and transparent approaches will be imperative in the future to reduce the present controversy surrounding GMO use and release.

Environmental Health↗

PubMed2005

Food and values: an examination of values underlying attitudes toward genetically modified- and organically grown food products.

This study addresses which specific values play a role in predicting participants' attitudes toward genetically modified food (GMF) and organically grown food (OGF). The first central question is whether the attitudes towards GMF and OGF are influenced by specific values and beliefs. The second central question is whether the attitudes towards GMF and OGF are related to each other, and whether the specific values underlying these two attitudes are also related to each other. A total of 100 participants responded to the Schwartz Value Survey and two questionnaires about GMF and organically grown food. When respondents scored high on the value power (dominance, submission), they rated GMF positively and OGF more negatively. Respondents who rated the value universalism (welfare for all people and protection of nature) high, rated OGF as positive. Furthermore, the relationship between attitudes and values was mediated by beliefs. These findings imply a meaningful relationship between specific values, beliefs, and these food-related attitudes, and suggest that values might play a role in explaining attitudes toward GMF and OGF products.

Adolescent↗

PubMedDate not supplied

Databases on biotechnology and biosafety of GMOs.

Due to the involvement of scientific, industrial, commercial and public sectors of society, the complexity of the issues concerning the safety of genetically modified organisms (GMOs) for the environment, agriculture, and human and animal health calls for a wide coverage of information. Accordingly, development of the field of biotechnology, along with concerns related to the fate of released GMOs, has led to a rapid development of tools for disseminating such information. As a result, there is a growing number of databases aimed at collecting and storing information related to GMOs. Most of the sites deal with information on environmental releases, field trials, transgenes and related sequences, regulations and legislation, risk assessment documents, and literature. Databases are mainly established and managed by scientific, national or international authorities, and are addressed towards scientists, government officials, policy makers, consumers, farmers, environmental groups and civil society representatives. This complexity can lead to an overlapping of information. The purpose of the present review is to analyse the relevant databases currently available on the web, providing comments on their vastly different information and on the structure of the sites pertaining to different users. A preliminary overview on the development of these sites during the last decade, at both the national and international level, is also provided.

Argentina↗

PubMedDate not supplied

Making the EU "risk window" transparent: the normative foundations of the environmental risk assessment of GMOs.

In Europe, there seems to be widespread, morally based scepticism about the use of GMOs in food production. In response to this scepticism, the revised EU directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms stresses the importance of respecting ethical principles recognized in the Member States. However, the directive fails to reflect the critical role of value judgements in scientific risk assessment and any subsequent approval procedure. In this paper we argue that it is important to make all ethically relevant assumptions involved in the approval procedure transparent and thus available for public scrutiny. Mapping the value judgements that are made in an environmental risk assessment and approval procedure, we describe the political liberal nature of the EU legislation. We then look more closely at the prescriptions for environmental risk assessment and approval of GMOs outlined in the directive. An environmental risk assessment views the world through a "risk window" that only makes visible that which has been predefined as a relevant risk. The importance of the value judgements that define the risk window consists in limiting the information the risk assessment can provide. In the penultimate section of the paper, the significance of the risk window is demonstrated through a case study of the approval of glyphosate resistant fodder beets (Beta vulgaris L. ssp. vulgaris) in Denmark.

Animal Feed↗

PubMed2004

Evaluation of the potential allergenicity of the enzyme microbial transglutaminase using the 2001 FAO/WHO Decision Tree.

All novel proteins must be assessed for their potential allergenicity before they are introduced into the food market. One method to achieve this is the 2001 FAO/WHO Decision Tree recommended for evaluation of proteins from genetically modified organisms (GMOs). It was the aim of this study to investigate the allergenicity of microbial transglutaminase (m-TG) from Streptoverticillium mobaraense. Amino acid sequence similarity to known allergens, pepsin resistance, and detection of protein binding to specific serum immunoglobulin E (IgE) (RAST) have been evaluated as recommended by the decision tree. Allergenicity in the source material was thought unlikely, since no IgE-mediated allergy to any bacteria has been reported. m-TG is fully degraded after 5 min of pepsin treatment. A database search showed that the enzyme has no homology with known allergens, down to a match of six contiguous amino acids, which meets the requirements of the decision tree. However, there is a match at the five contiguous amino acid level to the major codfish allergen Gad c1. The potential cross reactivity between m-TG and Gad c1 was investigated in RAST using sera from 25 documented cod-allergic patients and an extract of raw codfish. No binding between patient IgE and m-TG was observed. It can be concluded that no safety concerns with regard to the allergenic potential of m-TG were identified.

Animals↗

PubMed2005