Appendix 2 Minimum standards for bio-security for laboratories undertaking serology with blood samples from areas not considered free from foot-and-mouth disease The following is a supplement to “Security Standards for FMD laboratories” adapted by the EUFMD General Session in 19931 Introduction The following Minimum standards for bio-security for laboratories undertaking serology including for foot-and-mouth disease during an FMD emergency or during FMD surveillance after an outbreak only apply to the testing of blood samples from holdings without clinical signs by laboratory tests based on FMDV antigens where virus infectivity has been inactivated by documented procedures2, or those produced by techniques which do not require live FMD virus Blood sampling is often combined with surveillance and staff taking samples may also examine the mouth of possibly infected animals, which may increase the risk of a surface contamination of packing material. This risk, as well as the risk of leakage during transport has to be mitigated by appropriate provisions. The risk of FMD occurring as a result of sero-diagnostic activities within laboratories is associated with escape of virus following receipt of blood samples from viraemic animals. While the likelihood of virus being present in samples originating from holdings without clinical signs during an FMD epidemic generally is moderate to low, it is almost impossible to predict due to the dynamic nature of an epidemic. However, the maximum virus titres in blood of viraemic animals is about 10 000 to 100 000 fold lower then in vesicular material. Risk categories for blood samples Blood samples coming from holdings with clinical signs indicating the possible presence of FMD are considered FMD sample risk category 3. They must be examined in laboratories meeting the “Security Standards for FMD laboratories” adapted by the EUFMD General Session in 1993. Blood samples originating in an area that is not considered free of FMD, but coming from holdings without clinical signs indicating the possible presence of FMD are considered FMD sample risk category 2. They must be examined in laboratories meeting the “Minimum standards for bio-security for laboratories undertaking serology for foot-and-mouth disease”. Blood samples originating in an area considered free of FMD coming from holdings without clinical signs indicating the possible presence of FMD are considered FMD sample risk category 1. They can be examined in any laboratory. Minimum Requirements 1. 2. 3. 4. 5.
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Personnel A disease security officer (DSO) and deputy (DDSO) must be designated, and one or both present on-site at all periods in which samples are being received, and contactable at all periods when sero-diagnostic activities are ongoing. The DSO/DDSO must have sufficient experience and technical training to enable assessment of FMD risk and risk management procedures. There must be a designated restricted area or areas with controls in place to limit human access Personnel must be authorised to enter the restricted area by the DSO/DDSO Authorised personnel working in the restricted area must be trained in disease security and evidence of the training recorded. Where facilities for the inactivation of waste from the restricted area are located outside of this area, also staff working with such waste must be th
Appendix 6 (ii), Report of the 30 Session of the European Commission for the Control of Foot-and-Mouth th Disease, Rome, Italy, 27-30 April, 1993. Online version: http://www.fao.org/ag/againfo/commissions/docs/SecurityStandards.pdf
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