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The Cartagena Protocol on biosafety, established under The Convention of Biological Diversity, aims at protecting biological diversity from potential risks
that may be posed by living modified organisms (LMO) resulting from modern biotechnology.
The Protocol's main features include procedures for transboundary movement of LMOs that are to be intentionally introduced into the environment (advance informed agreement (AIA) procedure), and for LMOs that are intended to be used directly as food or feed or for processing (LMOs-FFP). The Party of import makes its decisions in accordance with scientifically sound risk assessment. The Protocol sets out principles and methodologies on how to conduct a risk assessment.
Parties to the Protocol must also ensure that LMOs subject to intentional transboundary movement are handled, packaged and transported under conditions of safety and are accompanied by appropriate documentation.
To facilitate its implementation, the Protocol establishes a Biosafety Clearing-House (BCH) to exchange information, and contains a number of important provisions including capacity-building, financial mechanism, compliance procedures and public awareness and participation.
The Protocol makes reference to the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development.
Adopted by the Parties to the Convention on Biological Diversity in January 2000, the Cartagena Protocol on biosafety entered into force on September 11, 2003, after its ratification by 50 different States.

More:
On the text of the Convention on Biological Diversity
On the Biosafety Clearing House
Frequently Asked questions on theCartagena protocol

A precautionary approach challenges us to prevent harm before it occurs. It holds that where there is scientific evidence that an activity threatens wildlife, the environment or human health, protective measures should be taken even in the absence of full scientific certainty.
The principle 15 of the Rio Declaration on Environment and Development says: " In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation".
This approach has been proposed in relation to some, already existing, global environmental damages, as the damage of the ozone layer among others. So far, the precautionary principle has been embraced particularly by the Cartagena Protocol on Biosafety.

The genetically modified micro-organisms (GMMs) are being used widely both for research purposes, intended to bring human health benefits and by industry to produce enzymes, food additives and drugs (insulin, antibiotics). The work with such GMMs is done in so called "contained conditions", which encompasses basically laboratories and fermenters in fabrics.
According to the EU Directive 90/219, ammended by 98/81, the contained use of GMMs is subject to regulation in order to prevent their potential accidental escape into environment and thus to guarantee the protection of human and environment. For experiments in the laboratory or for industrial use, micro-organisms are grown in controlled systems according to the degree of hazard represented by an accidental release of these micro-organisms.
The GM micro-organisms used for industrial purposes are normally not pathogenic and their growth is optimized for the conditions of laboratory production. An accidental release would not represent a health hazard. Such micro-organisms will probably have no or very limited survival chances outside the laboratory or outside the industrial fermentation containers. Even so, the use of GM micro-organisms has to be notified to (if no risk is known) or permitted by competent authorities. All accidents have also to be notified with the description of all protection and decontamination measures taken.
For example, the intended release of non-pathogenic GM micro-organisms designed to decontaminate a site is submitted to the same stringent authorisation and control procedures as the field release of GM plants.
The intentional release of genetically modified hazardous or pathogenic micro-organisms for bio-terrorist or military purposes is officially banned worldwide under the international convention on biological warfare.
More at:
European legislation on the contained use of GM micro-organisms
Articles on biological warfare and on the new technologies which could be used for military purposes

As in any other activity, it is impossible to achieve 100% control and 100% safety. The control of biotechnology is both a national and an international issue. It is based on complex legislation and implemented by the local competent authorities. Most countries have laws to regulate the developments of biotechnology according to internationally accepted guidelines. Nevertheless, the general feeling with the control of biotechnology is that the legislation in place is often behind the pace of the scientific and industrial developments.

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The regulation of modern biotechnology, especially genetic engineering, is both a national and an international issue. It is based on complex legislation and implemented by the local competent authorities. Most countries have legislative frameworks in place thatregulate the developments of modern biotechnology according to internationally accepted guidelines. Some countries have developed new laws on GMOs and other have adapted their existing legislative framework to cover the issues of genetic engineering.

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The first releases of transgenic plants into the environment took place in the eighties, so that they have already about 25 years of history, to a total surface of about 400 million ha. The cultivation of transgenic plants is submitted to prior authorisation and considered safe. Up to now, there is no evidence or proof for any adventitious harm on the environment or human and animal health.
However, the long-term risks of genetic engineering, in particular the indirect or delayed longterm risk caused by the growing of transgenic crops, are still a matter of debate. Data are now accumulating on the possible impacts, if any, of transgenic crops on the environment.
The purpose of a well-designed systematic monitoring, as foreseen in the European directives on the growing and market of a transgenic crop, is to collect data and set the basis for a science-based assessment of the uncertainties and risks (if any) associated with the products of genetic engineering applied to agriculture. The periodic reports of monitoring legitimise the decisions on the removal of unjustified safety measures when risk can be excluded, or, on their reinforcement, if the occurrence of a putative new risk has been identified. They may also justify a decision for further monitoring.

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Note: the multi-langual FAQs on biotechnology, food, medicine, safety and ethics have been provided by the ECOD-BIO project (www.ecod-bio.org).