The BioIndustry Association (BIA) and the UK Home Office wish to remind individuals of the legal obligations for laboratories holding certain pathogens (including viruses and bacteria) and toxins, as set out in the Anti-Terrorism Crime and Security Act (ATCSA) 2001.
Please share this information with the relevant person in your organisation.
Part 7 of the ATCSA regulation provides controls for sites such as universities, hospitals, science research laboratories, and businesses/SMEs to obtain, store and work with dangerous pathogens and toxins listed under Schedule 5 of the Act. Under Section 59 of this legislation, sites have a legal obligation to notify the Home Office of their intention to work with any Schedule 5 substances prior to obtaining them. The legislation also mandates that sites must comply with the security standards guided by the National Counter Terrorism Security Office prior to any substances being obtained.
The below links provide further information on the ATCSA 2001 including any potential exemptions that may apply to exclude a site from the legislative requirements. The final link sets out what substances are included in Schedule 5 of the ATCSA 2001.
Anti-terrorism, Crime and Security Act 2001 (legislation.gov.uk) – Part 7
Anti-terrorism, Crime and Security Act 2001 (legislation.gov.uk) – Schedule 5.
The Security of Pathogens and Toxins (Exceptions to Dangerous Substances) Regulations 2002 (legislation.gov.uk) – Regulations 1, 2 and 3.
If your site is holding any of the substances listed in Schedule 5 of the ATCSA 2001, which include viruses, bacteria, and toxins, and your site has not notified the Home Office as required under Section 59 of the legislation, the Home Office request that you do so. Ahead of notifying the Home Office, you should consider if the work you undertake in relation to these substances meets any of the exemptions explained in the above links.
Notifying the Home Office
In order to notify the Home Office as required under Section 59, or confirm your compliance, please contact
PathogenAndToxins@homeoffice.gov.uk to request a Section 59 notification form. The Home Office will then contact your site to explain the next steps to ensure compliance with the legislation as soon as possible. A local Counter Terrorism Security Advisor will work with your site to implement the appropriate security measures to ensure the secure storage and usage of dangerous biological substances.
The Home Office’s duty is to ensure the security of biological substances as quickly and effectively as possible and any potential investigation in relation to any past failure to notify would be a matter for local police. Storage and usage of Schedule 5 substances without prior notification with the Home Office is a criminal offence.
If you have any questions relating to this notice, please contact
PathogensAndToxins@homeoffice.gov.uk.
Sites are also responsible for organising the safe and secure transportation of Schedule 5 substance when moving substances within the UK. Sites should refer to the relevant legislation (ADR 1.10, and regulations 5, 7 & 8 of
The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009) and ensure they are compliant with the necessary regulations. For queries on the transportation of dangerous goods, please contact
landsecurity@dft.gov.uk. Please note, Part 7 of the Anti-terrorism Crime and Security Act 2001 does not cover the transportation of Schedule 5 substances.
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Information correct at time of writing.