43RD GENERAL SESSION OF THE EuFMD
ROME 17-18 APRIL 2019
Item 12. Report of the Special Committee Biorisk Management; Minimum Standards for laboratory containment of foot-and-mouth disease virus and training planned Proposed revision: Appendix 20 Presentation: Appendix 21 The Chair of the Special Committee for Biorisk Management (SCBRM), Kirsten Tjørnehøj (National Veterinary Institute, Lindholm, Denmark) summarized the main issues addressed to the Special Committee, and the background to the Minimum Biorisk Management Standard (MBRMS). The SCBRM (Special Committee on BioRisk Management) had met on two occasions organised by EuFMD and additional meetings organized by the Chair on the side of international biosafety working groups meetings. It had been an intense work with three rounds of consultation (Biorisk officers, CVOs of member states and a final round at the General Session in April). The initial consultation had directly involved almost all of the European laboratories handling FMDV, both at Tier D level (containment facilities including vaccine production) and Tier C (handling FMDV only under specific circumstances, usually emergency settings).The final of these was with the EuFMD MS. The MBRMS: Defines the roles, duties and responsibilities of the management and of Biorisk officers, defines expected biorisk, risk assessment(RA) and hazard identification responsibilities, Has 70 specific points covering management, personnel, training, biosecurity, facility design, handling of live FMDV, air, waste, effluent and materials, biological materials across barriers and shipment, commissioning and decommissioning. The SCBRM was formed in 2017 at the General Session to ensure there is a competent Committee for the regular reviewed and to manage any questions which could arise. The review process on this occasion probably exceeded 300 hours of technical input by the SCBRM members. The main consultation to yield detailed responses was that of initial draft circulated to the Biorisk officers of European Tier C and D facilities. Over 140 comments /proposals for revision had been received and considered by the SCBRM. The response rate to the consultation was high, with 26 of the 37 facilities providing feedback and all but 3 of the Tier D laboratories:
The final consultation (to CVOs) had yielded only one proposal for change, which can be taken to indicate the revision process had dealt with the earlier comments to a sufficient degree. The SCBRM considered the proposed updating to thorough and there are no significant changes posing any additional risks that need to be understood by the CVOs. The changes in the MBRMS do not impose significant additional burdens on BROs of the facilities. She brought to attention issues to be addressed by the Committee in future, -Continued development of the MBRMS, including Tiers A and B -Training in Biorisk management -Annex/database of accepted inactivation/disinfection methods
43rd General Session of the EuFMD:: 17-18 April 2019 : :Rome - Italy
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