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/ Biological agents eBulletin

Welcome to the HSEBiological AgentseBulletin

Welcome to the fifth edition of the Biological Agents eBulletin. The purpose of which is to provide an update on developments relevant to the health and safety regulation of biological agents. /

1. New regulatory approach for specified animal pathogens

New arrangements for the licensing, inspection and enforcement in relation to the Specified Animal Pathogens Orders 2008, 2009 (SAPO) came into effect on the 1 April 2015. In addition to the transfer of licensing responsibilities to HSE, these new arrangements mean that HSE is the single regulator and single point of contact for contained uses involving biological agents. The new SAPO licences and associated guidance align more closely with requirements of other containment regimes (ie Genetically Modified Organisms (Contained Use) Regulations 2014 (GMO(CU)) and Control of Substances Hazardous to Health Regulations 2002 (COSHH)), which means there is a common regulatory approach to contained uses involving biological agents.
New SAPO webpages were launched on the 1 April 2015 on the HSE website. The webpages include information on:
· the new arrangements, including how to apply for a new licence;
· transition from an existing to a new licence; and
· new animal pathogens guidance entitled Guidance for licence holders on the containment and control of specified animal pathogens (HSG280) published on 30 April 2015 and is available to download free of charge from the HSE website.
If you have a query relating to SAPO, please visit these new SAPO webpages in the first instance and if further information is required, please direct your enquiry to HSE at .

2. Application of inward airflow and HEPA filtration (extract air) for specific non-airborne biological agents

GMO(CU) introduced, amongst a number of changes, a risk based approach to the application of inward airflow and HEPA filtration (for extract air) at containment level (CL) 3. These control measures are intended to prevent the dispersal of airborne biological agents beyond the confines of the laboratory. Where the risk assessment for the activity concludes that there is no risk of airborne transmission, these specific measures may not be required.
This approach is consistent with the requirements of COSHH. Although, the containment tables in Schedule 3 of COSHH indicate that inward airflow and HEPA filtration (for extract air) are required at CL3, these requirements can be adjusted through reference to the Approved List classification. The classification identifies certain biological agents (denoted by an asterix), that are not normally infectious to humans via the airborne route (eg blood-borne viruses) and provides guidelines on circumstances where these measures may not be required. Similar to GMO(CU), their application is subject to the outcome of a local risk assessment.
It is recognised that the new approach is not consistent with that set out in Biological agents: Managing the risks in laboratories and healthcare premises. While the guidance recognises that not all containment measures are required for diagnostic activities involving non-airborne hazard group (HG) 3 biological agents, it specifically states that full CL3 is required where the work involves the intentional use of HG3 biological agents (ie concentration or propagation). HSE is in the process of revising this guidance and will remove this inconsistency. In the interim period, the requirement for inward airflow and HEPA filtration (for extract air) for activities involving such biological agents (denoted by an asterix on the Approved List), whether genetically modified or not, should be determined by a local risk assessment. While the specific physical containment measures can be dispensed with, the other procedural/management measures normally required at CL3 (above those required at CL2) must still be in place.

3. Revision of Part 3 of the 'SACGM Compendium of Guidance' for contained use of genetically modified organisms

The introduction of the new GMO(CU) 2014 regulations has necessitated changes to be made to the SACGM Compendium of Guidance (‘the Compendium’), which was published in 2007 to cover all work with genetically modified organisms in containment. Whilst an update to Part 2 (risk assessment) is warranted to take account of new technologies and techniques, the most pressing part of the Compendium for revision is Part 3, which relates to the containment requirements for genetically modified microorganisms. HSE intends to take a phased approach to the revision of the Compendium, with the objective of completing a revision of Part 3 by the end of September 2015.
HSE, with contributions from the Scientific Advisory Committee for Genetic Modification (SACGM(CU)), has commenced drafting a revised Part 3 and this will be posted to HSE’s Microbiological Hazards Web Community in June 2015. Those interested can provide feedback on the draft guidance.
If you are not a member of the Community and wish to see the draft guidance, you can request an invitation to join by emailing HSE at . There are in the region of 100 members, who are provided with regular updates on a number of microbiological safety related matters and have the opportunity to start discussions on such matters.

4. Synthetic biology – new report on positive and negative impacts on biodiversity

A new report CBD Technical Series No.82 - Synthetic Biology published on 20 April 2015, from the Secretariat of the Convention on Biological Diversity (CBD) discusses the potential for synthetic biology to have both positive and negative impacts on biodiversity and looks at gaps and overlaps with other existing regulatory regimes.
The report, developed on a review of the literature and on the basis of information and views submitted by Parties to the CBD and other stakeholders through a peer review process, aims to support the emerging international debate on synthetic biology. In addition to considering potential impacts on biodiversity, the report considers how adequately existing regulations, including risk assessment and international regulatory regimes cover the components, organisms and products of synthetic biology.
Free guidance covering a wide range of biological agents and biosafety health and safety topicsis availableonHSE's website.
This bulletin provides a sample of the wide range of information that can be found under ‘What’s New' on HSE’s website.
Please feel free to use this information and pass it on, using your own networks. / /

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