Genetic modified organisms

The majority of industrial research describes classical approaches to yield improvement (49). However, there has been some work using genetically modified organisms. In the case of these recombinant organisms, the carotenoid biosynthetic gene cluster has been expressed in noncarotegenic species such as E. coli (50) and S. cerevisiae (51). 

Recently a biosensor as new airalytical tool for GMO (genetic modified organism) detection has been reported. 

SI 1992/3280 The Genetically Modified Organisms (Deliberate Release) Regulations... 

EEC Directive on the deliberate release into the environment of genetically modified organisms... 

Contained use of genetically modified organisms Drug misuse at work - A guide for employers Dangerous substances on site notification and warning signs Solvents and you... 

L 29 A guide to the Genetically Modified Organisms (Contained Use) Regulations 1992, as amended m 1996... 

There are a number of other regulations/directives that you will need to consult, as appropriate. These address topics such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), the conduct of clinical trials, variations to authorised drugs, and the use of genetically modified organisms. A list of the most relevant directives is shown in Table 1.5. 

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC... 

The Competent Authorities are allowed a maximum of 60 days to review the data, or 90 days in the case of trials involving medicinal products for gene therapy, somatic cell therapy (including xenogeneic cell therapy), and all medicinal products containing genetically modified organisms. Such trials require written authorisation from the Competent Authority as distinct from other types of product where the authorities may just notify the sponsor of the acceptability (no-objection) of the application. If issues are raised, the sponsor may amend the application once, with a consequent extension to the allowed review period. 

Animals may not be moved for 14 days after administration of the experimental product, and records on the disposition of trial animals must be retained for 2 years. Bio-security issues will be of particular concern to the environmental impact assessment where trials involve live organisms or genetically modified organisms, either in vaccine challenge studies or as experimental products. 

Part V contains amendments to the Radioactive Substances Act 1960, Part VI controls the use, import, containment or release of genetically modified organisms to the environment, and Part VII provided for the reorganization of the Nature Conservancy Council and Countryside Commission. 

On the GM debate and biosafety research, a review of results performed under the European Commission supervision ( EC-sponsored Research on Safety of Genetically Modified Organisms , edited by C. Kessler and I. Economidis) is available also online at the EU-website http //europa.eu.int/ comm/research/quality-of-life/gmo/. An update on current research in food safety, nutrition and food-related disease might be found in the websites of the World Health Organization, http //www.who.int/fsf/GMfood/index.htm, and of the UK Food Standards Agency, http //www.foodstandards.gov.uk/. 

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