Methodology for operational management of releases from bioindustrial plants - identification, audit, change

Five Danish bioindustrial pilot plants applying genetic engineering have been evaluated with regard to the identification of gaseous or liquid releases containing living genetically modified organisms. The objective was to identify escape paths, to evaluate spill detection measures and to recommend additional safety measures. A key point was the strong involvement of the competent authorities in the planning and performance of the analyses, which were carried out in structured group sessions in which the company staff, the competent authorities and risk analysis experts participated. Each safety analysis comprised five stages: (1) Presentation of the plant configuration; (2) An identification of possible escape paths and preconditions for liquid and gaseous releases; (3) An evaluation of incident causes and spill detection mechanisms; (4) Recommendations concerning additional measures to improve safety; (5) Preparation of a safety report. The approach will make it easier to prepare safety documentation for new activities and to carry out safety audits.