Regulation of biological agents

Biological agents, including micro-organisms and genetically modified materials, are regulated by the following legislation:

• Control of Substances Hazardous to Health Regulations (COSHH) 2002 as amended
  • employers must follow to protect all employees, visitors, members of the public from substances hazardous to health that are present in the workplace. This also covers biological agents and naturally forming microorganisms. 
• Genetically Modified Organisms (Contained Use) Regulations (2014)
  • Covers all Genetically Modified Material handled in a contained workplace such as specialist laboratories, BSUs and greenhouses.
• Genetically Modified Organisms (Deliberate Release) Regulations (2002)
  • Covers Genetically Modified Material that is purposely released to the environment e.g. growing genetically modified plants in a field or clinical trials where GMM is shed from the body and can enter the environment such as sewage water treatment works.
• Animal Health Act 1981
  • Covers the protection of welfare, safety and health of animals
• Specified Animal Pathogen Order (2008)
  • Covers a specified list of animal pathogens which can potentially impact farming in the UK e.g. foot and mouth disease, anthrax etc. 
• Anti-terrorism, Crime and Security Act (2001) & Anti-terrorism, Crime and Security Act (Modification) Order 2007 (ACSAMO) - Schedule 5
  • Covers microorganism and toxins that can be used for dual purpose e.g. for research which can benefit society or potentially can be used for malicious intent e.g. terrorism. When research uses the pathogens or toxins listed in Schedule 5 of the Act, the Home Office and Counter Terrorism and Security Advisers (CTSA) must be informed to ensure that the security of the biological agents meets best practice.
• Human Tissue Act
  • Covers ethics and consent for sourcing human tissues and bodily fluids or materials

All activities including research using biological agents require risk assessments documenting, the hazards, risk of exposure to biological agents which could be harmful to human health and how these will be controlled to mitigate the risks. Work with biological agents may also require permissions and or licenses from a governing agency before work can start. The legislation listed above is regulated and enforced by various governing agencies:

• HSE
• Department for Environment, Food and Rural Affairs (DEFRA)
• Home Office
• Human Tissue Authority (HTA)

The HSE uses a variety of methods to ensure compliance with regulations, including:

• announced inspections by a specialist team of inspectors
• unannounced or short-notice visits following notification under RIDDOR or injury, illness or dangerous occurrence relating to work involving biological agents
• lab visits by Field Operations Directive (FOD)
• oversight of all Hazard Group 2 and 3 and Class 2 and 3 work through the notification system

During an announced inspection, a full review of paperwork will be conducted to demonstrate that:

• the required levels of containments are being met
• training is being completed
• all incidents are reported
• any recommendations, requests or actions by the HSE from previous visits, whether verbal or in writing, have been actioned and are still being implemented

Inspections are risk-based, however, UCL would expect at least one department each year to be inspected, and all departments to be inspected at least every 5 years.

For Hazard Group 2 and 3 and Class 2 and 3 work, following notification, the HSE will have a set time depending on the notification type to ask for further information, at which point, work can either begin or they will send a consent letter. Please see the pages referring to working with different biological agents for the details of the notifications, time scales and if a consent letter is required.

The CTSA will carry out an annual inspection of UCL looking at all locations which hold substances notifiable under Schedule 5 of the ACSAMO and as directed by the Home Office. They are only looking at the security arrangements for the safe storage of these holdings. This will include the specific site security plan and the procedure for access to the holdings.

To ensure that you and your department have all the support you require, please contact the Biological and Chemical Safety Team within Safety Services if the HSE contact you.

The Biological and Chemical Safety Team will provide:

• advice and guidance on if you need to notify the HSE or another regulatory authority, and which form to use
• administrative support to ensure the paperwork is complete and accurate to minimise delays
• a single point of contact, which is accessible during all working hours
• coordination of RIDDOR notifications
• liaison with the HSE for both announced and unannounced visits to provide access to people and UCL-wide documents