New Biological Agents Regulations and Code of Practice 2020
The Safety, Health and Welfare at Work (Biological Agents) (Amendment) Regulations 2020 (SI No. 539 of 2020) amend the Safety, Health and Welfare at Work (Biological Agents) Regulations 2013 (SI No. 572 of 2013) to give effect to:
- Commission Directive (EU) 2019/1833 of 24 October 2019
- relating to general worker safety from exposure to biological agents
- Commission Directive (EU) 2020/739 of 3 June 2020
- relating specifically to SARS-CoV-2, the causative agent of COVID-19
both of which amend Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work. A minor change to schedule 1 of the 2013 Regulations is made by deleting the following activity: “3. Work in biotechnology, including the production of pharmaceutical products.” Moreover, regulation 16(c) of the 2013 Regulations is amended by deleting subparagraph (i).
Accompanying these amendments is the publication of the 2020 Biological Agents Code of Practice, which entered into force on the 24th of November 2020. The Code of Practice contains the list of classified biological agents in Schedule 1 to the Safety, Health and Welfare at Work (Biological Agents) Regulations 2013 (SI No. 572 of 2013). The minimum containment measures for the specific containment levels for laboratories, rooms for laboratory animals and human and animal isolation facilities are given in Schedule 2 while Schedule 3 details those for industrial processes. In addition, dispensations from minimum containment measures for laboratories and animal rooms are detailed in Schedule 4, which has been updated to include nomenclature changes and a special dispensation for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of the disease COVID-19. This special dispensation is primarily in order to ensure sufficient testing capacity and continuity of testing.
The following are the relevant dispensations from containment measures pertaining to working involving severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2):
- Non-propagative diagnostic laboratory work (for example sequencing, nucleic acid amplification test [NAAT]), involving SARS-CoV-2 subject to written risk assessment, can be conducted at a facility using procedures equivalent to at least containment level 2. Heightened control measures may be required based on the written risk assessment. Initial sample processing (before virus inactivation) must take place in a validated safety cabinet.
- Research or development work using non-propagative laboratory work techniques may be carried out at minimum of containment level 2 subject to written risk assessment and heightened control measures where required.
- Handling of materials with high concentrations of the live virus or large volumes of infectious materials must be carried out at containment level 3.
- Propagative work (for example, virus culture, isolation or neutralisation assays) involving SARS-CoV-2 must be conducted in a containment level 3 laboratory with air pressure negative to atmosphere.
Reporting Occupational Exposure to COVID-19
The explicit inclusion of SARs-COV-2 in the Code of Practice introduces a reporting obligation under Regulation 12 of the 2013 Regulations. Cases of COVID-19 disease, or death, in employees resulting from confirmed occupational exposure in connection with the carrying on of work with the coronavirus (SARs-CoV-2) are reportable. Occupational exposure to SARs-CoV-2 may arise from deliberate work with the virus, for example, working in a research laboratory. Alternatively, workplace exposure to SARs-CoV-2 may also occur incidentally from other specific work activities with the virus, for example, working with a COVID-19 patient, handling infected waste or carrying out diagnostic testing for COVID-19 in a laboratory.