Biosafety

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Biosafety refers to all of the measures, policies and procedures necessary to minimize the potential risk for the environment and the human health resulting from modern biotechnology.
The Convention on Biological Diversity (CBD) clearly recognizes that modern biotechnology is a relevant tool to the conservation and sustainable use of biological diversity (see art. 16.1 and art. 19.1-2); on the other hand, the CBD seeks to ensure the development of appropriate procedures to improve biotechnology safety in order to reduce any potential threat to biological diversity, taking also into account risks to human health.
The Cartagena Protocol on Biosafety is intended to ensure an adequate level of protection in the field of the safe transfer, handling and use of living genetically modified organisms resulting from modern biotechnology, in order to ensure the conservation and sustainable use of biological diversity and no risks to human health.
The European Union (EU) and its Member States have adopted regulatory instruments (Directive 2001/18/EC and Regulation(EC) no.1829/2003) to provide high levels of safety for the environment and the human and animal health. In the EU genetically modified organisms (GMOs) may be authorized only after a rigorous evaluation process regarding their safety to ensure that any possible consequence, unintended or undesirable, either directly or indirectly on the environment and human and animal health, is detected and avoided, through an "case by case" assessment, taking into account the risk/benefit ratio.

Modern biotechnologies
The modern biotechnology uses molecular biology techniques to produce living modified organisms (LMOs) and thus organisms showing a genome altered for DNA sequence modification or for the introduction of DNA material (transgene) deriving from a different organism. The way of action of the modern biotechnology mimics what normally is observed in natural evolution mediated by phenomena known as mutation and gene flow among organisms, as a consequence of adaptation to the changing conditions of the Earth.

The role and the use of modern biotechnology in medicine, industry, agriculture and environment fields are gaining increasing importance.
In medicine, biotechnology is involved in the development of new pharmaceuticals, vaccines, genetic therapies and in the improvement of the diagnosis of hereditary diseases and knowledge of the human genome.

In the industry (chemical, pharmaceutical or food industry) genetically modified microorganisms are largely used for the improvement of production processes of antibodies, vitamins, amino acids, enzymes, sugars, drinks, acids, solvents, soaps, glues, oils, plastics etc.

The application of biotechnology to the agriculture has led to the development and subsequent commercialization of genetically modified (GM) plants with improved nutritive qualities, productivity, herbicide tolerance and resistance to adverse factors, both biotic (pathogens, parasites) and abiotic (salinity, drought). The development of the agro-biotechnology started with the production of GM plants able to tolerate herbicides and to show resistance to the most important parasites and adverse environmental factors (1st generation of LMOs) and then went on with the production of “functional foods” represented by genetically modified plants with improved nutritional properties (2nd generation of LMOs).

Even if GM plants show many advantages, their cultivation in open fields is still largely discussed because of the potential risks which could derive from the transgene transfer to wild plant species or to other organisms, from the potential toxicity and from the unlikely development of allergies and intolerances in humans and animals.

Nowadays the prospective for the application of biotechnology in environment field is thought for the solution of many problems: pollution control and toxic waste elimination; metal recovery from mining waste; uses of renewable energy sources, in particular for lignocellulose; generation of new chemical raw materials and energy sources, like ethanol, methane and hydrogen.

Moreover future applications of the biotechnology could be addressed to the zootechnical field to obtain improvements of farm animal productivity and thus improved foods with the respect to quality and absence of pathogen organisms.

In the light of what reported above it is evident that the biotechnology covers a broad range of application fields with enormous potentialities and that its success is dependent also from the solutions to the important ethic, social, economic and environmental questions that are linked to the risk assessment of LMOs on human, animal and environmental health.

More details can be found in the section Publications.

The protection of biotechnological inventions is guaranteed at communitary level by Directive 98/44/EC on the legal protection of the  biotechnological inventions.

Italy has adopted the directive with Law decree of the 10th January 2006, n. 3, then converted in Law n. 78 of the 26th February 2006.

 

For the sake of completeness, we also briefly introduce regulations on the contained use of Genetically Modified Microorganisms (GMMs).
GMM refers to any microbiological entity, cellular or non-cellular (including viruses, viroids, animal and plant cells in culture) whose genetic material has been modified with either recombinant nucleic acid, techniques for direct introduction of genetic material or techniques of cell fusion or hybridization, however, with a recombination or crossover process that does not occur in nature.

Legislative Decree of 12 April 2001 n. 206 establish the measures for the contained use of genetically modified microorganisms, to protect human health and the environment.
The Ministry of Health is the National Competent Authority for GMMs.
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