About EBSA19 - Course K - How to decide - the border between contained use or deliberate release?

Course description:

Did you ever ponder whether an activity with genetically modified organisms (GMO) would fulfil the requirements for contained use or whether you had to submit an authorisation application for deliberate release? On paper, the regulatory requirements and the distinction between contained use and deliberate release of GMO seems to be straight forward. In practice, there can be quite some uncertainty for which situations ‘contained use’ applies. A combination of biological, organisational and physical containment measures can either avoid or minimize the release of GMO into the environment. Under which setting and for which GMOs is ‘minimize’ sufficient with respect to the protection of people and the environment? Under which circumstances would an extended environmental risk assessment be necessary because, even though not deliberate, a minimal release of GMO cannot be avoided?

The workshop is suitable for all interested and involved in risk management of activities related to genetically modified organisms which might be slightly different from the usual contained use setting such as laboratories or production facilities and, foremost, for biosafety professionals facing new challenges regarding biocontainment related to, for instance, clinical trials or research with gm plants and animals in special settings.

The workshop will cover these aspects by discussing case studies, taking into account both the characteristics of the GMOs, the risks related to the activities, the safety measures taken and the context of regulatory requirements. Participants are asked to bring their own cases for discussion. Active participation in the discussion is expected.

The biosafety professional shall be able to:

• understand the risks for the environment associated with work involving biological material;
• evaluate the suitability of measures to prevent or minimize the escape of biological material into the environment;
• design suitable monitoring strategies to evaluate prevention measures;
• distinguish between contained use and deliberate release regulatory requirements and their implication.

CWA16335:2011 Biosafety professional competence references:

This competence is relevant to task B.21 (Environmental safety) of Annex B of CWA16335:2011 Biosafety Professional Competence and can be fulfilled by training specification C2.1.2.5, biorisk assessment and management, and C2.1.2.6, environmental safety. The course draws on CWA 15793:2011 Biorisk Management, specifically on section 4.3.1 on risk planning for hazard identification, risk assessment and risk control.
 

Instructor:
Ursula Jenal