/ Biological agents eBulletin
Welcome to the 7th HSEBiological AgentseBulletin
Welcome to the seventh edition of the Biological Agents eBulletin. This provides an update on developments in the health and safety regulation of biological agents including a strategy for health and safety in GB, revision of the Approved List of Biological Agents and consultations on guidance revision. /1. Help Britain work well
Great Britain’s health and safety record is the envy of much of the world. Central to this is protecting people by managing risk in a proportionate and effective way, supporting innovation and increasing productivity. The challenge is to improve even further on this impressive record. The key points raised in theHelp Great Britain work well strategy(launched at the beginning of March 2016) are:- Great Britain has a health and safety record to be proud of
- Six new priority themes will help Great Britain to work well
- Everyone in the health and safety system should play their part
2. Revised version of the Approved List of Biological Agents
Following advice from the Advisory Committee for Dangerous Pathogens (ACDP), HSE has revised the Third Edition of the Approved List of Biological Agents. The Approved List classifies biological agents hazardous to humans into hazard groups (HG). The revisions to the Approved List are limited to a re-classification of zika virus (reclassified from HG3 to HG2), inclusion of Middle East Respiratory Syndrome coronavirus (HG3) and a new classification for type 2 poliovirus (HG3). When the type 2 component is withdrawn from the trivalent poliovirus vaccine, attenuated strains of type 2 poliovirus will also be classified as HG3. Types 1 and 3 polio virus will remain as HG2. From6 April 2016, the revised version of the Third Edition of the Approved List of Biological Agents can be downloaded from the HSE website.3. Revision of Part 3 of the Scientific Advisory Committee for Genetic Modification (SACGM) Compendium of Guidance
The SACGM Compendium of Guidance is being revised in a phased manner. The revised Part 3 of the Compendium, which relates to the containment requirements for genetically modified microorganisms, is now available for review and comment via HSE’s microbiological hazards on-line community. Those interested are welcome to provide feedback on the drafted guidance via a feedback form. Please complete this and return it to by close of play on Monday 2 May 2016.If you are not a member of the Community, you can request an invitation to join by emailing HSE at .
4. Revision of ACDP guidance on ‘deliberate work’ with biological agents
The new guidelines “Management and operation of microbiological containment laboratories” will replace ACDP's 2001 publication “The management, design and operation of microbiological containment laboratories” and the 2005 publication “Biological agents: managing the risks in laboratories and healthcare premises” except Part 2 “Working in Healthcare” which will remain as a standalone document.This new publication is intended to provide the benchmark standards for laboratory (deliberate use) work at containments levels 2 and 3 including relevant links to requirements of Specified Animal Pathogens Order(s) and Genetically Modified Organisms (Contained Use) Regulations. In addition to containment standards, the guidance will cover fumigation; sealability; spillage procedures; microbiological safety cabinets and waste management. It is envisaged that in future this “core document” will be supplemented by electronically linked topic-specific guidance.
The new guidance will be ready for consultation from 2 May 2016 for six weeks via HSE’s microbiological hazards on-line community, with anticipated publication in2016.
5. Interesting articles relating to regulation of biological agents
a) The Dutch National Institute for Public Health and the Environment (RIVM) has published apolicy report on ‘gene drive’. The report describes gene drive as a genetic trait that is built into the DNA of an organism in such a way that it is passed on to all its offspring, instead of only to some of the offspring. This trait is passed down through the generations. This trait can spread quickly and permanently through an entire population, especially when organisms reproduce rapidly. The report recommends changes to the authorisation process for such work in the Netherlands.b) In February 2016, Minister for Life Sciences George Freeman MP launched the UK Synthetic Biology Strategic Plan 2016 — "Biodesign for the Bioeconomy" at Imperial College London, estimated to be worth £30 billion to the UK economy by 2030. Synthetic biology involves designing and adapting biological systems to deliver new solutions to key challenges across the bioeconomy including global health and clean energy production. The Strategic Plan 2016 focuses on five themes: Accelerating industrialisation and commercialisation; Maximising the capability of the innovation pipeline; Building an expert workforce; Developing a supportive business environment; and Building value from national and international partnerships.
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.
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