Biorisk – a global issue
The management of biosafety and biosecurity (collectively know as biorisk) have become a vital global issue, especially in light of the laboratory-acquired cases of SARS in Singapore, Taiwan and China in 2004.
This is particularly true for operators of biological containment laboratories handling dangerous bacteria and viruses, such as anthrax, ebola and avain flu.
Over the past six years, DNV has worked with a number of internationally recognized institutes and companies in conducting audits and risk assessments of their biocontainment facilities. This work has covered laboratories from biosafety level 2 to 4, and have included, The Swedish National Institute for Infectious Disease, The World Health Organisation, The European Commission and Eijkman Institute, the leading national laboratory in Indonesia.
Not without risk
According to Dr Stephen McAdam, Biorisk Programme Director in DNV Research and Innovation many facilities conduct research, diagnostic and production activities on many organisms of serious potential threat to humans and animals, and are designed to ensure that the risk of worker exposure and release of materials to the community or environment is minimized. However, the work of such facilities is not without risk and there have been several cases of laboratory acquired infections in recent years.
“A feature of these cases is that often there is a failure of the safety management system, as opposed to deficiencies in the facility and equipment employed,” Dr McAdam points out and adds, ‘It is also our experience that in this field a great deal of emphasis is placed on the design and construction of the facility itself, but rather less attention can sometimes be paid to how the facility will be run and the staff deemed competent with regard to biosafety and biosecurity.
“This can be partly due to the difficulty in finding experienced personnel available in this field, but also a lack of the necessary structures and frameworks around which facilities can build adequate biorisk management systems. Such problems exist in Europe and North America, but can be particularly severe in developing countries,” he adds.
International project
DNV recently managed an international project to develop the Laboratory Biorisk Management Standard, (CWA 15793:2008) which has a scope to set requirements necessary to control risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities.
The standard is performance-based and sets out requirements for and places responsibility on organisations to demonstrate that appropriate and validated risk reduction procedures have been established and implemented. The standard is based on a traditional management systems approach. The organisation’s ability to deal with the hazards associated with biological agents and toxins is hence improved through the identification, understanding and managing a system of interrelated and relevant processes.
Efforts to address this global issue gathered momentum in June this year when a regional seminar for South East Asia on Promoting and Implementing Biosafety and Biosecurity Management was held in Jakarta. The seminar was co-hosted by Indonesia, Norway and the Biological Weapons Convention Implementation Support Unit, with DNV and Eijkman Institute as technical organisers. More than 70 representatives from 17 countries took part in the seminar, which also benefited from substantive contributions by the World Health Organisation, the Asia Pacific Biosafety Association, and academia.
Need to enhance capabilities
The seminar did not negotiate any outcome documents, but the conveners of the event made several observations, including the clear need among countries in the region to further enhance their capabilities in addressing these challenges.
Increased co-operation between countries in the region was encouraged. “Adequate systems to address biosafety and biosecurity are critical,” said Ambassador Knut Langeland, of the Norwegian Ministry of Foreign Affairs.
“A number of actors have important roles in promoting biological safety and security: Governments, professional organisations, research institutions, international organisations, and international networks such as regional biological safety associations. We encourage partnerships.”
It was also noted that recent initiatives, and in particular the development of the Laboratory Biorisk Management Standard (CWA 15793) provide an opportunity to address many areas of concern regarding the proliferation of biological weapons and intentional misuse.
Richard Lennane, head of the Biological Weapons Convention (BWC) Implementation Support Unit, pointed out that the “spectrum of biological risk runs from naturally occurring diseases at the one end, through unintended consequences, accidents, lack of awareness and negligence, to deliberate misuse at the other. By looking at the spectrum it is evident that it is futile to attempt to tackle these risks individually, as isolated threats.”
Collective approach
He added, “It is imperative that we meet this challenge collectively. We need to coordinate and harmonize our efforts. With this in mind, this seminar is an important step.”
More recently, the UN held a meeting under the Biological Weapons Convention in Geneva to discuss measures to improve biosafety and biosecurity. The DNV-work performed in Indonesia, as well as the experiences and results from the Jakarta Seminar was presented. Representing Norway, Dr. Paul Huntly, also introduced a well-received position paper on the mentioned CWA Biorisk Laboratory Standard.
Meeting the requirements of the Laboratory Biorisk Management Standard is likely to further biosafety and biosecurity at laboratories containing harmful pathogens and toxins according to Dr McAdam. "As such, the Standard should serve well as a platform for awareness-raising, confidence building, as well as technical cooperation under the BWC. International standards can also play a role in the development of national regulations, guidelines and requirements," he says.
"The massive progress made in biotechnology and moves by organisations to relocate their research, development and production programmes to the emerging world, also adds to the complexity and potential for untoward events in Asia and elsewhere," warns Dr Huntly and concludes, "We need to address the issue collectively because there is a large and growing need for support in the regions who are struggling to manage real issues of potential global impact, and such needs are likely to grow in the future."
日付: 22 December 2008