Bio-safety issues came to the fore last year following the release of the foot-and-mouth virus in Surrey. The incidence of infection from hazardous biological agents is relatively low but, with the number of escapes of such agents on the increase, Gary Burns explores the problem and explains what is being done to address it.
Work with biological agents, or materials that contain, or may contain them, is carried out in laboratories and manufacturing plants in a wide range of organisations — from hospitals and clinics in the public and private health-care sectors, to university departments in medicine and the life sciences, pharmaceutical and biotechnology companies, and various government agencies. The type of work includes routine diagnostic activities, research and development, and large-scale manufacture of such products as vaccines.
The accidental release of the foot-and-mouth virus from facilities at Pirbright in the UK last summer led to an outbreak of the disease in Surrey, with serious financial consequences for the livestock trade in Great Britain. The subsequent investigations — one led by the Health and Safety Executive and the other by Professor Brian Spratt — revealed serious shortcomings in both management practices and in the current regulatory framework for animal pathogens.
Sir Bill Callaghan, former chair of the Health and Safety Commission, was requested by the Government to chair a review of the regulatory framework, and his report,1 published on 13 December last year, included recommendations for major reforms. Secretary of State Hilary Benn said at the time he fully accepted all the recommendations, which include a move to a single regulatory framework for human and animal pathogens.
Focusing on human infections, data published by the HSE indicate that in 2006, 1576 cases of occupational infection were reported. A figure of this order of magnitude has been reported every year for several years, and the HSE considers that these annual estimates probably substantially underestimate the true incidence of occupational infections in Britain. While the availability of this data does not specifically indicate the numbers of those cases that are associated with laboratory-acquired infections, this can be deduced to be a very small proportion of the total.
This conclusion is supported by a number of surveys specifically addressing this issue. Walker and Campbell,2 for example, identified only nine cases in a survey of UK clinical laboratories covering 1994 and 1995. The authors acknowledge that periodic studies of this type are not adequate for comprehensive monitoring and, despite the low reported incidence, there is a long history of laboratory-acquired infections associated with such work,3,4 and there is a wide range of individual case reports available.
Over the years, many control measures have been developed to reduce the risk of accidental exposure. These include specific laboratory design and construction features, specialised equipment for containment and decontamination purposes, appropriate procedures and practices, and personal protective equipment. Despite the general high standards indicated by the low incidence of infection, there is room for improvement since unintentional exposure of persons and the environment continues to take place.
An escalating problem?
Dangerous occurrences reported under RIDDOR involving escape or release of hazardous biological agents have gone up in the last five years (see Table 1). This is interesting given the increasing awareness of risks and control measures in the bioscience community, but it may be a reflection of an increased volume of activity and/or better reporting.
The aforementioned Pirbright escape is a good example of harm to the environment but there are many relatively recent examples of harm to human health following laboratory exposure. These include two laboratory-acquired cases of Severe Acute Respiratory Syndrome (SARS) infection in late 2003 — first in Singapore, and then in Taiwan — and infection of three researchers at Boston University in the USA in 2004 following exposure to the bacterium Francisella tularensis, which can cause tularaemia, another potentially lethal disease.
Also in the USA, biodefence research at A&M University in Austin, Texas was suspended by the Centers for Disease Control and Prevention (CDC) in June 2007 following the university’s failure to report illnesses and infection in the wake of earlier accidental laboratory exposures. The subsequent investigation by CDC revealed a number of failures in biosafety and biosecurity management at the university. In February this year, A&M agreed to pay a fine of US$1,000,000 to resume the relevant research programmes.
In addition to the risk of accidental exposure, the circulation of the “anthrax letters” in the wake of the September 11 attacks in New York, and events since then, have provoked serious concerns about the potential for intentional use of pathogens and biological toxins by terrorist organisations. While the use of such materials in warfare or terrorism has a long history, the infections caused by the anthrax-contaminated letters prompted the introduction of specific legislation to restrict and control the acquisition, storage, and use of pathogens and toxins seen to be of particular risk in this context.
Legislation was introduced first in the United States and was followed soon after by similar legislation in the UK, in the form of the Anti-terrorism, Crime and Security Act 2001. The focus of the initial legislation in the UK was on agents that are harmful to humans, but in recognition of the severe economic consequences of deliberate dissemination of animal pathogens the list in Schedule 5 to the Act was revised to include a number of animal pathogens, even before the escape from Pirbright last summer.
Rapid response
The recent breaches of biosafety and biosecurity described above have caused widespread concern. The European Commission published a Green Paper on biopreparedness in July last year, which covers both prevention and protection issues. In the USA, a Congressional hearing was held in October, while in the UK in December, the Parliamentary Innovation Universities, Science and Skills Committee announced an inquiry into biosecurity in UK research laboratories.
Various projects have recently been completed, or are underway, which should help underpin high standards of both biosafety and biosecurity. February this year saw the publication of international biosafety and biosecurity standard, CWA 15793:2008. The standard was developed using the CEN Workshop Agreement procedure, with the majority of funding provided by the European Commission under its European Programme for Critical Infrastructure Protection.
The standard, which is compatible with the ISO 9001:2000 (quality), ISO 14001:2004 (environmental), and OHSAS 18001:2007 (occupational health and safety) management systems standards, sets out the requirements of a management system to enable organisations to effectively identify, monitor, and control laboratory biosafety and biosecurity aspects of their activities.
Competence is key
One of the requirements in CWA 15793 is the designation of a competent individual, or individuals to provide advice and guidance on biorisk management issues. This mirrors the general legal requirement in the Management of Health and Safety at Work Regulations 1999 (as amended), which states that competent persons must be appointed by employers to assist in undertaking the measures needed to comply with relevant statutory provisions. In those regulations, competency is defined to include qualifications, training, and experience, but there is no specification as to exactly what those should comprise.
In the USA, the American Biological Safety Association5 (ABSA) not only organises relevant training courses and workshops but also administers a voluntary scheme for certification and registration of biosafety professionals. Certification as a biological safety professional is available via an examination, developed by members of ABSA and administered by the USA National Registry of Microbiologists (NRM). Application requirements for the examination include submission of transcripts, references and work history. Upon successful completion of the NRM examination, individuals can apply to ABSA for the designation of Certified Biological Safety Professional (CBSP). Maintenance of CBSP status is dependent on suitable demonstration of continuing professional development analogous to the procedure applied by IOSH for chartered members.
Also in the USA, the National Biosafety and Biocontainment Training Program (NBBTP), a partnership between the Division of Occupational Health and Safety (DOHS) and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institute of Health in Bethesda, Maryland also provides training and certification for biosafety professionals.
In Europe the situation is complex, with competency schemes varying from country to country. The variability extends to the legal status of training and examination, as well as their scope — in some countries, there are requirements for persons advising on matters related only to genetically modified organisms (GMOs), while in others, requirements apply to both GMOs and naturally-occurring pathogens. The European Biosafety Association is currently working on proposals for a broadly-based European competency standard that will address work with both GMOs and naturally-occurring pathogens.
There is currently no UK statutory requirement for setting standards of competence for biosafety professionals. However, it is recognised that the global move in this direction is building up pressure to establish standards that will support the UK’s goal-setting approach, while matching the more prescriptive requirements of other nations.
An initiative to develop such standards has come from the professionals themselves and, in 2005, the membership of the Institute of Safety and Technology in Research (see panel) set up a working group to examine the feasibility of ISTR becoming an accrediting body.
Following an initial feasibility study it was agreed that the scheme should be developed to operate at two levels: a Foundation Level, appropriate for individuals with limited biosafety responsibilities and experience, who need to comprehend and apply the essential concepts in executing the day-to-day tasks of advising on, monitoring, and enforcing safety standards within their organisation; and a Biosafety Professional Level, for those for whom biosafety management, including the development and implementation of policy and strategy within their organisation, is their main or sole role.
While it is not intended that the scheme will be a statutory requirement, it is being developed with the support of specialist inspectors from the Health and Safety Executive’s Biological Agents Unit.
Certification at the Foundation Level will require candidates to successfully complete a formal training course, with defined objectives and learning outcomes, which is expected to require approximately 40 hours of contact time. To ensure consistency in standards, ISTR will accredit course providers, which are anticipated to include academic institutions and other training organisations in the private sector. Certification of individuals at the Biosafety Professional Level will be based on portfolio development measured against a set of agreed criteria, covering both compulsory and optional topics.
Conclusion
The role of the competent safety advisor is essential in raising awareness, implementing the law, raising standards and ensuring safe working. This is no less true in the world of biology, where generally the risks are well controlled but the threat of infectious disease is ever present. There are clear benefits to both employers and biosafety professionals in establishing a UK scheme that will identify the knowledge and skills required by those professionals, and provide not only a mechanism to improve the quality and availability of training but also evidence that individuals have achieved defined standards of competency.
References
1 FMD: Investigations and reviews into the outbreak
2 Walker, D and Campbell, D (1999): ‘A survey of infections in United Kingdom Laboratories 1994-1995′, in J Clin Pathol; 52:415-418
3 Sulkin, SE and Pike, RM (1951): ‘Survey of laboratory-acquired infections’, in American Journal of Public Health, 41 (7) 769-81
4 Collins, CH and Kennedy, DA (1999): Laboratory-acquired Infections: History, incidence, causes and preventions, ISBN 0 7506 4023 5, Butterworth-Heinemann
5 The American Biological Safety Association website
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