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Biological Safety in the Department of Physics 1. Types of Work Conducted Work in the Department of Physics is currently undertaken at Containment Levels 1 and 2 (algae, bacteria and mammalian cells in tissue culture), as well as at derogated CL3 (Plasmodium falciparum). We are also a GM centre notified to HSE and house pathogens classed under the Approved List (ACDP). Some members of the laboratory work with laboratory animals elsewhere in the University; we therefore follow the University policy with regard to occupational health surveillance for Laboratory Animal Allergy. 2. Notification of Biological Work 2.1. We do not currently perform any experiments that fall under ATCSA, SAPO, HTA or have any samples that require consideration under the polio virus eradication guidelines. If a new investigator wishes to conduct experiments that fall under this legislation, they should contact the Departmental Safety Officer and Departmental Biological Safety Officer in the first instance. See below to find out your experiment classes under the stated legislation. 2.2. Anyone wishing to undertake biological work, either as a new project or as part of ongoing work, should contact: Saba Alai (Departmental Safety Officer) Sarah Bohndiek (Biological Safety Officer) Fiona Morgan (PoM Acting Biological Laboratory Manager) 3. Guidance and Information 3.1. Those wishing to know more about the facilities and process for access should consult: http://www.bss.phy.cam.ac.uk/facilities/cellculture http://www.bss.phy.cam.ac.uk/facilities/POMAccess 3.2. Key documents defining containment levels and important legislative guidance related to biological work undertaken in the Department of Physics can be found below: HSE Biosafety guidance (webpages) Approved List of Biological Agents (Advisory Committee on Dangerous Pathogens) The Biological Agents and Genetically Modified Organisms (Contained Use) Regulations 2014 – HSE Guidance The Biological Agents and Genetically Modified Organisms (Contained Use) Regulations 2014 – Schedules The SACGM Compendium of Guidance – Part 3: Containment and control of activities involving genetically modified microorganisms Containment measures for use of microorganisms - plants Containment measures for use of microorganisms 3.3. Example risk assessments that can be used as a starting point for basic cell culture work are available on the Department of Physics Website. Dept of Physics – BSS Policy/Procedure | Issue 2 | Issue date: October 2015 Page 1 of 4 4. Reference / Terminology 4.1. Anti-Terrorism Crime and Security Act (ATCSA) Laboratories have a duty to ensure that the storage and use of dangerous pathogens and toxins listed within Schedule 5 of the Act are as secure as reasonably practicable. In broad terms, the laborators are required to: register their holdings under Schedule 5 of the act with the Home Office; inform the police of security measures in place; ensure Schedule 5 substances and premises they are stored in are secure; and access is controlled. 4.2. Advisory Committee on Dangerous Pathogens (ACDP) The Approved List of biological agents and associated guidance are produced by the Advisory Committee on Dangerous Pathogens (ACDP) at the request of the HSE. The Control of Substances Hazardous to Health Regulations 2002 (COSHH) make reference to the ‘approved classification’ of a biological agent, as approved by HSE. The Approved List is therefore relevant for risk assessment of your work. For a link see 3.2 above. 4.3. Genetically Modified Organisms (GMOs) Regulations aim to prevent harm to human health that arises from contained use involving genetically modified (GM) organisms, that is, micro-organisms (bacteria, fungi, viruses, cell and tissue cultures), animals (multi-cellular and higher) and plants. GM means any alteration of the genetic material of an organism (DNA or RNA) that does not occur naturally. 5. Requirements of work with GMOs in Department of Physics 5.1. Before working with GMOs, ensure you have in place: GM registration form completed and sent to BSO Risk assessment and GMO form notified to Biological Safety Sub-Committee (will consider these in light of regulations), who must decide whether the work can commence, then record and retain associated paperwork. Class 1 risk assessments may be advised from the committee alone Class 2 or higher assessments may require advice from external experts Adherence to appropriate containment and control measures Informing a competent authority (BSO or deputy) when: Work is planned RA and GMO forms completed Work starts Accidents happen Work changes (new RA or GMO forms) Work finishes Requirements also apply to synthetic biology applications. Inserting the synthetic material is what makes it ‘contained use’ not the incorporation into DNA synthesis. 5.2. Contained use is permitted and defined by physical, chemical or biological barriers. Such use is classified into one of four classes, based on the risk presented to human health. Class 1 signifies no or negligible risk, Class 2 is low risk, Class 3 is moderate risk and Class 4 is high risk. This is derived from the outcome of the risk assessment. Full details can be found in the Guidance on Regulations: http://www.hse.gov.uk/pubns/priced/l29.pdf http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/ Dept of Physics – BSS Policy/Procedure | Issue 2 | Issue date: October 2015 Page 2 of 4 6. Hazard Group (HG) Definitions Group 1 Group 2 Group 3 Group 4 Unlikely to cause human disease Can cause human disease and may be a hazard to employees; it is unlikely to spread to the community and there is usually effective prophylaxis or treatment available Can cause severe human disease and may be a serious hazard to employees; it may spread to the community, but there is usually effective prophylaxis or treatment available Causes severe human disease and is a serious hazard to employees; it is likely to spread to the community and there is usually no effective prophylaxis or treatment available. 6.1. The relationship to containment levels of handling is direct, i.e. Hazard Group 2 biological agents should be handled at Containment Level 2. 6.2. Note: Certain HG3 biological agents (including Plasmodium falciparum) have been identified within the list of Community Classifications as presenting a limited risk of infection for works as they are not normally infectious by the airborne route. It may not be necessary to use all CL3 measures in this case, but this does not imply that the work can be carried out at CL2. It simply allows certain physical containment requirements (aimed at controlling airborne infection) to be dispensed with. All other aspects of the work, in particular supervision and training, should reflect the high stands of CL3. This type of work is known as Derogated CL3. 7. Human Tissue Act The Act regulates activities concerning the removal, storage, use and disposal of human tissue. Consent is the fundamental principle of the legislation and underpins the lawful removal, storage and use of body parts, organs and tissue. The premises must be licensed for work regulated by the act. Further information can be found at https://www.hta.gov.uk/sites/default/files/Code_of_practice_9_-_Research.pdf 8. Laboratory Animal Allergy While you are working with animals Occupational Health will regularly monitor your health. This will be at the start of your work and at 6, 12 weeks later. Thereafter an annual questionnaire will be issued. If you think you may have symptoms of an animal allergy, you must report them to Occupational Health immediately, for a confidential assessment to be made. 9. Polio (Eradication) Poliomyelitis (polio) is a highly infectious viral disease that mainly affects young children. The virus is transmitted person to person spread through the faecal-oral route or by common vehicle. The polio eradication and endgame strategic plan 2013-2018 is a comprehensive long-term strategy that addresses what is needed to deliver a polio-free world. See http://www.polioeradication.org/Resourcelibrary/Strategyandwork.aspx. Dept of Physics – BSS Policy/Procedure | Issue 2 | Issue date: October 2015 Page 3 of 4 10. Specified Animal Pathogen Order (SAPO) 11. These are infectious agents, such as viruses, bacteria and parasites. Their use is controlled under SAPO and separate application to the HSE must be made to work with these agents. A full list can be found at http://www.legislation.gov.uk/uksi/2008/944/schedule/1/made 12. SAPO work will never by permitted in the department and if it is considered essential for a research project, an alternative solution, such as using a lab in a department already set up for SAPO work, must be considered. Dept of Physics – BSS Policy/Procedure | Issue 2 | Issue date: October 2015 Page 4 of 4