Regulation Deliberate Release Regulations

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

At the time of writing, it is reported that NIH-RAC will withdraw from the role of regulating deliberate-release experiments. 

The novel interest here was that the field tests proposed would have involved the first deliberate release of genetically engineered bacteria. In the United States, the National Institutes of Health (NIH) already had established a Recombinant Advisory Committee (RAC) to consider the hazards of accidental release it was natural that RAC should assume responsibility for regulating the new class of experiments. The RAC guidelines show that the accidental release of engineered syringae is not considered a serious problem, since the construction of such strains is permitted under low levels of physical containment. The key difference between accidental and deliberate release is in the number of organisms likely to be introduced into the environment thus the main question was whether... 

Regulatory requirements that have not been addressed in detail concern the potential ecological impact of organisms proposed for release in the environment. Any organism may have a detrimental impact when introduced into a new environment. Therefore, for the sake of defensible and consistent regulation (18), any organism, regardless of the process used to produce it, shouTd be evaluated as carefully as is possible before deliberate release. 

The legal basis of the Deliberate Release Directive (DRD) is Article 100a of the Treaty of Rome, which is concerned with the adoption of measures for approximating law, regulation or administrative actions of Member... 

The 1986 Act effectively banned the deliberate release of GMOs, but in 1989 the Minister of the Environment, with the specific authority of the Danish Parliament, agree to permit two small-scale trials with modified plants. In the same year, an amendment to the 1986 Act was passed to permit large-scale research to be regulated by notification only. 

Release of a GMO in the waste stream could be construed to be a deliberate release although it falls within the remit of the contained use regulations. Nevertheless, information from studies on deliberate releases of GMOs could be usefully deployed for contained use operations. The IBP is seeking to collate relevant information for risk assessment purposes. The Royal Commission on Environmental Protection adapted the HAZOP technique as a practical and systematic technique to consider, assess and control possible risks from GMO release to the environment. The technique, termed GENHAZ, has also been tested by the IBP for contained use assessments. We developed an integrated approach to assess the operational aspects of the plant and equipment (as described in section 11.4.5) and the environmental aspects of possible GMO releases. We concluded that a more rigorous environmental risk assessment could be developed than had hitherto been provided by companies. 

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