The four-tier classification system
Due to the different objectives and nature of work on FMD performed at each laboratory, and the subsequent large differences in containment requirements depending on whether infectious FMDV is handled, the 2013 version of the MBRMS introduced four Tiers for laboratories dependent on their involvement with FMD.
Currently, the 4-Tier system is implemented as follows:
Tier A: General diagnostic laboratories in FMD endemic countries.
Tier B: Laboratories working with infectious FMDV, including for the purpose of vaccine development and production, in FMD endemic countries.
Tier C: Laboratories undertaking diagnostic investigations for FMD without handling infectious FMDV in FMD-free countries, including both national reference laboratories without permit to work with infectious FMDV and FMD Contingency Laboratories.
- Category I: national reference laboratories without a permit to work with infectious FMDV but maintaining a continually alert FMD biorisk management system including trained and vigilant biorisk officer and laboratory staff.
- Category II: FMD contingency laboratories limited to performing FMD diagnostic tests on no risk or very low risk samples or not performing FMD diagnostics except in the framework of an FMD emergency.
Tier D: International FMD reference and national laboratories working with infectious FMDV, including for the purpose of vaccine development and production, in FMD-free countries.
The MBRMS standards apply to and must be implemented in EU Tier C and D laboratories (including animal facilities). For Tiers A and B, implementation of the MBRMS is not required, however they may be used for instructive purposes, assisting in the improvement of biocontainment operations.
The EuFMD may develop biorisk management guidelines specific to Tiers A/B facilities in the future for information and education purposes.