Notification and Licensing of Work with Biological Agents and Hazards

COSHH requires HSE to be notified of premises and certain higher risk activities in advance of commencement of the work. Hazard group 3 and 4 biological agents and hazards and the hazard group 2 agents and hazards Bordetella pertussis, Corynebacterium diphtheriae and Neisseria meningitidis activities have to be notified in advance to the HSE on an individual basis and specific consent obtained to carry out the work. HSE produces a CBA1 notification form to provide the information and request consent for the activity. A copy of the biological COSHH risk assessment for the work has to be provided as part of the notification. HSE will send acknowledgement of the notification and there are then various notification periods before work can start depending on the particular activity and whether that hazard group of work has been done at the premises previously. HSE examines notifications and may request additional information, impose conditions and time limits to consents and revoke or vary them. HSE does not charge any fees for processing COSHH notifications. Work may not start until HSE has given written consent. HSE must also be notified of any subsequent significant changes in activities or new information which may have a bearing on the biological COSHH risk assessment. HSE must be informed of any changes to processes, procedures or agents that are of importance to health and safety and which render the original notification invalid. You can modify a biological COSHH risk assessment which has been notified under COSHH but you must first reassess the risks of the project and make the appropriate changes to the biological COSHH risk assessment. If the modification is within the scope of the original notified project and there is no significant increase in the risks of the work, then you only need to make the changes to the risk assessment and obtain the relevant approval and no further action is required. If the modification is within the scope of the original notified project but will significantly increase the risks of the work, then you must not carry out the work until consent for these changes has been obtained from the HSE. This will require making changes to the biological COSHH risk assessment and sending the modified risk assessment and an updated CBA1 form to the HSE. Note that you cannot change the scope of the original notified project. If the modification is outside the scope of the original notified project, whether or not it changes the risks, then you must not carry out the work until consent has been obtained from the HSE. This will require a new request for consent for this project to the HSE. This will require a separate new biological COSHH risk assessment and CBA1 form. HSE must be notified when the project has ceased and all of the biological agents and hazards have been destroyed. Information submitted to HSE as part of a notification is placed on the public register on the HSE website. However in certain circumstances it is possible to claim confidentiality and exemption from public disclosure for some information but any claim has to be fully justified against stringent criteria and is subject to agreement by HSE. Notifications do not have to be made if the activity has already been notified under the Genetically Modified Organisms (Contained Use) Regulations.

Many animal and plant pathogens and pests are covered by specific animal and plant health and environmental laws and in certain cases require licences from the Scottish Government, DEFRA or related agencies for possession, use, consignment, importation and exportation. The Scottish Government and DEFRA specify specific containment and control conditions for licensed pathogens and pests. The COSHH, SAPO and other relevant animal or plant health or environmental classifications are not complementary and the requirements are very different for the containment and control of human and animal pathogens, plant pathogens and pests. Compliance with one does not absolve managers, principal investigators and their workers from responsibilities under the other and in all cases where there is any discrepancy between COSHH, SAPO or other relevant requirements then you must comply with all of the requirements for containment and control although the higher control requirements must be the minimum standard which must be followed.

HSE is the licencing authority and regulator for the Specified Animal Pathogens Order (SAPO). HSE issues SAPO licences, provides advice to duty holders, carries out inspections and enforces the law in relation to SAPO. Work with SAPO controlled pathogens requires a licence which is obtained from HSE and this will involve completion of a licence application and submission of a biological COSHH risk assessment and or GM risk assessment as part of the application process. HSE may carry out inspections as part of the application process depending on the pathogens and nature of the work. HSE will approve suitable licence applications.

Managers and principal investigators must keep a list of workers exposed to hazard group 3 or 4 agents, including details of the type of work involved, the agents to which they have been exposed and records of exposures, accidents or incidents. There is an exemption to this requirement if the risk assessment indicates the activity does not involve a deliberate intention to work with or use the agent or that there is no significant health risk to exposed workers. The list must be kept for at least 40 years from the last known exposure. HSE must be notified of any accident involving a significant and unintended release of biological agents and hazards which present an immediate or delayed hazard to either human health and safety or the environment. This requirement is in addition to any notification requirements under Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR). The HSE notification must provide information on the circumstances of the incident, identity and quantity of biological agents and hazards concerned information necessary to assess the risk and any measures taken to deal with the accident. Note that all incident reports should be made to the Safety and Environmental Protection Service which makes RIDDOR and other reports to HSE.