Select Committee on Innovation, Universities, Science and Skills Written Evidence

Memorandum 4

Submission from the Institute of Safety in Technology and Research

  The opportunity to participate in the discussion concerning this important topic is welcomed by the Institute of Safety in Technology and Research (ISTR).

  The ISTR is a professional association of in safety professionals from the whole spectrum of public, government and commercial research and high technology organisations with similar research and technological interests. The organisation was formed in 1982.

  The members, currently 250, come from across research organisations but are mostly universities and are highly qualified and have a huge body of experience.

  Its aims are to further the advancement of safety skills and knowledge among its membership; the maintenance of the professional standards; the preservation and enhancement through representation to bodies of influence; the promotion of communication and exchange of information; the maintenance of dialogue with other professional bodies in areas of related interest.

  With the increased activity in bioscience and biotechnology within members' workplaces, a Bio sub-group has been established within ISTR. There are three regional groups meeting several times a year and one major symposia on a current topic.

  The Institute runs skills workshops, and three open symposia each year. Recent subjects of symposia have included: Animal facilities, Benefits of improving health & safety; The GMO regulations 2000; Laboratory containment; Student placements; Off site working; Biological safety, Improving Health and Safety, Managing contractors, Legislation update, Transport safety, Laboratory design, Biosafety auditing, Novel technologies, physical agents..

  In addition to the meetings there is web based information, discussion forum, award programme for outstanding performance, membership directory, twice yearly publication and a new accreditation scheme. The Institute and its members interact on a regular basis with regulators especially NATSCO and HSE.

  This document brings together the comments of a component of the research community comprised of professional safety practitioners working in the areas of cutting edge biological research in UK universities, government laboratories, commercial biopharm industry, hospitals and charities.

  There is an active UK biosafety/biosecurity community which liaises with regulators and others in the related biological areas such as animal containment and welfare, occupational diseases, gene-therapy, technology and product manufacturers. Also engaging with other countries and international GOs/NGOs to exchange and share experiences.

  In Europe and beyond there are a number of initiatives on improving biosafety bio-risk and biosecurity (WHO, EU, CEN, EBSA).

  Laboratory Standard

  Review of EU Arrangements for Biosafety




    —    Education:

    —  Regulators,

    —  Specialist Biosafety Advisors,

    —  Researchers and undergraduates, and

    —  Architects and engineers in containment.

    —    Implementation of existing regulation evenly.

    —    Learning from European and World Experiences.

    —    Co-ordination of funding of containment facilities including infrastructure.

Who we are

  Institute of Safety in Technology and Research; has members represent professional safety practitioners in the field of high technology research in universities and other research organisations. We are the only national forum for biosafety and biosecurity in the UK and as such represent the experts in biosafety and biosecurity for the United Kingdom. In addition many of our members are active in European activities to promote better bio controls and uniformity of standards


The current capacity for research on dangerous pathogenic material in the UK and the capability to conduct research on the causative agents of disease that may emerge at a future time

  The UK has a comprehensive range of university, governmental and private laboratories researching into health, medical, animal, plant and immunology and diagnosis and detection systems for dangerous pathogens. The community works closely at a scientific level and is well regarded around the world. However, source of funding is wide ranging and disparate. The lack of co-ordinated research is lacking. This leads to overlap and duplication. The capacity exists within the scientist's expertise and facilities, as long as the funding can be made available. Many funders appear to be unwilling to acknowledge that running the sorts of containment facilites which are required is an expensive business, however, and seem unwilling to contribute towards the necessary overhead costs.

  Further there are organizations with little experience of pathogens and genetic modification engaging in new fields with little prior experience. The ability for regulators to respond quickly to emerging infections which the UK plays a significant part in national response is questionable as illustrated with participation in global outbreak while addressing local outbreaks.

The state of biological containment facilities in the UK

  A recent survey (HSE) of the highest containment level 4 laboratories in the UK identified 10 facilities. The procedures for human pathogen-related work generally are satisfactory. The issues related to animal pathogen work are more complex The majority are old or ageing. There has been a lack of coherent strategy for UK contained research leading to "silo" operation and varying standards and levels of investment in infrastructure or maintenance. Grant based research often covers research and some refurbishment and thus does not address basic of secure services and ongoing costs. These laboratories have been very expensive. Note US experience of "explosion" of new facilities with no confirmed on going funds or ability to provide sufficient trained staff.

  The number of containment laboratories in UK has grown as interest in dangerous pathogen research has grown. The skills and training has not matched this as experience staff have drifted away. Understanding of containment construction and a caucus of engineering knowledge has added to diverse engineering standards and lack of UK based specialist containment architects and engineers.

Laboratory inspection regimes and the rationale and practicalities of the licensing system

  Some institutes are frequently inspected (HSE, DEFRA, EA, CPA, MHRA) and high operational standards are expected. Other laboratories, perhaps those not normally associated with biology are less scrutinized. This has resulted in severe differences in operational standards related to biosecurity. The field of biosafety/biosecurity requires broad experience current inspectors of HSE or DEFRA do not have sufficient range of experience. The context of the work is very important. Why are diagnostic standards lower than in research, it is the nature of the risk to workers, the community and the environment.

  Frequent and non risk based legislation and elevated inspection expectation discredits risk based controls.

  Many parts of the world have laboratory certification. This variously involves local authority or national highly commercial schemes. Varying levels of federal regulation often sets the acceptance criteria. The burden not only to administer such schemes but also prepare for certification is highly time consuming taking researchers away from project time, adds time to project start sometimes by years and thus cost and delay. The value and benefit of any licensing should be considered in relation to risk from unregulated work and advantages of bureaucratic oversight.

  The process of lab notification has worked well in the UK. Licences for working with certain most dangerous agents has to date been adequate. Additional and conflicting list of agents can dilute the emphasis on "most dangerous" cf Schedule 5. It may seem attractive to raise standards across the board but risk based controls and restriction that is proportionate without affecting the "health" of UK science and global public health.

Biosafety training provision for staff working in containment facilities

  In many parts of the world biosafety and biosecurity are included in undergraduate and masters programmes in biological subjects. This is rare in the UK. Principle investigators are required to ensure that researchers are competent including in safe working. This is difficult where their own experience/training is limited. There are few courses and mostly offered in house thus perpetuate current practice.

  Disiplines outside biology and health (structural and electronic engineers) are increasingly using biological agents with no basic knowledge. It is essential to ensure adequate controls are maintained is the role of the "biological safety officer" also referred to as biosafety specialist. Currently there is no regulatory description of the role or knowledge require. The ISTR has been developing an accrediation programme for training providers developing foundation and professinal level courses in biosafety/biosecurity topics. Further the scheme which is ISTR funded develops and recognises personal development as a specialist and will increase the number and quality of providers. The quality and standing of advice to employers on the complex range of safety and regulatory matters from enforcers and specialists needs shoring up with well desigend training programmes.

  This would place biosafety specialists on a par with radiological, pharmacy and medical laboratory specialists accreditation.

The maintenance and recording practices surrounding the storage and transportation of dangerous pathogens

  Historically research laboratories accumulate collections of biological agents and the accuracy of the accounting is variable. There is a valid argument to consolidate master stocks into fewer appropriate holdings where security and inventory control is maintained.

  The provenance of holdings is scientifically important and proper accountability is essential for valid result reporting. The conditions under which agents are held also vary due to diverse locations and underinvestment. Appreciation of the "value" of biological material is not well understood or well resourced.

  The recently revised transport of dangerous goods regulations (IATA/ADR) including pathogens has a generally high compliance where there is understanding.

Measures implemented when pathogenic material cannot be accounted for

  Key to the control of the most dangerous pathogens is proper accounting and a foil to that is a loss response system. It is therefore part of good general management of dangerous pathogens that procedures to readily identify loss, detect theft or misappropriation and to intervene and thus require education as well. ISTR is well placed to assist in developing training in biosecurity risk evaluation and controls.

The role of universities in overseeing security clearance for research students working with dangerous pathogens

  The success of research is collaboration between institutes nationally and internationally, exchange of students and research to ensure best brains and the advancement of scientific knowledge. To exclude such transit would have a profound and disproportionate impact on UK science. There is no consistent UK procedure for undertaking identity and background checks. For those individual wishing to conceal affiliation this may not be adequate. Any system must be easy, swift and at modest cost. Systems operated in US (CFR 49) have been hampering programmes, added cost and considerable delay.


  There is considerable misunderstanding and use of some of the related terminology in the fields of biosafety, and biosecurity. It is essential that common internationally applied terms are used or referenced.

  The ISTR would welcome funding stream to assist in developing training for undergraduate, principle investigators and specialists in biosafety, bio security and bio containment.

  The ISTR would welcome interaction with policy makers and participation in developing control measures with policy makers and regulators.

  The ISTR would welcome support to participate in European initiatives to ensure UK interests are properly represented cf CEN workshops require funding matching before EU funds are available. Also participants must self fund to participate in meeting held in various locations in Europe, thus travel budgeting has to be found. ISTR is a voluntary organization and has limited funds from membership fees only.

  ISTR suggests development of training programmes for researchers, regulators and containment construction specialists in physical and personnel security in relation to the handling and holding dangerous pathogens.

January 2008

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