Establishing a National Biosafety Program (Русский)
Despite a greater awareness of biosafety and biocontainment practices, handling infectious microorganisms remains a source of infection, and even mortality, among laboratory workers. Incidents of secondary transmission of disease to the public at large, which may be due to possible contamination of the environment or personnel, are also occurring. There is a steady increase in both the number of laboratories handling pathogens and in the number of scientists wishing to work with new or exotic strains for further study. Laboratory workers can minimize the risks associated with work involving these infectious agents through the application of appropriate biosafety and containment principles and practices. Increasing demands are also being placed on regulatory authorities to ensure that such pathogens are handled in a safe and secure manner.
National Ministries of Health are encouraged to establish a centre of expertise for biosafety and biocontainment, to ensure effective, evidence-based biosafety interventions through regulatory control, surveillance, applied research and timely dissemination of information. The goal and expected outcome of the Centre's programs is a reduction in the risks of occupationally acquired infection, environmental contamination and disease transmission to the public.
The strategies that should be employed by the biosafety centre of expertise to achieve this goal include:
- regulating the importation and use of human pathogens
- providing biocontainment and biosafety standards and guidelines
- ensuring compliance to these standards and appropriate biological containment
- conducting surveillance and applied research projects to develop evidence-based biosafety guidelines
- liaising with other government departments, standard setting associations, national committees and organizations
- building the national biosafety capacity through information dissemination and training
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Establishing a National Biosafety Strategy
Achieving a successful national biosafety strategy involves the partnering and integration of a number of key players including national health authorities, animal health authorities, and security authorities. Biosafety should ideally be incorporated within national public health security policies and programs. The four pillars of an effective strategy include enabling biosafety legislation, biosafety guidelines and standards, training, and the establishment of biosafety associations.
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Legislative Mandate
The International community has recognized and addressed the importance of proactively decreasing the risk of accidental or deliberate release of dangerous pathogens by implementing biosafety and biosecurity legislation.
Such legislation should generally consider the following elements:
- a list of dangerous pathogens where anyone in possession must register with the national health authority;
- a list of the most dangerous pathogens where the possession and use of which would be restricted to laboratories certified by the national health authority;
- enhanced security requirements for laboratories handling all dangerous pathogens; both in terms of containment and selected laboratory personnel;
- reporting requirements to the national health authority concerning anyone in possession, or with potential access to the most dangerous pathogens;
- issuance of import permits;
- Consultation with and inspection, certification and re-certification of containment laboratories;
- Compliance and enforcement activities;
- Collaboration with the animal health authorities on permits/inspections involving pathogens that infect both humans and animals; and
- Liaison with security authorities for security screening of personnel with access to dangerous human pathogens.
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Guidelines
Countries are encouraged to develop national guidelines for the safe handling of pathogenic microorganisms in laboratories within their geographical borders. Since 1983, many countries have used the guidance provided in the World Health Organization's Laboratory Biosafety Manual to develop such codes of practice. A third edition of the manual was published in 2005.
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Training
The key to success of a national biosafety program is on-going consultation and training for laboratory clients. Guidance should be provided to microbiology laboratories on interpretation of the requirements of the national biosafety guidelines including the planning of containment facilities from start-up to certification. National biosafety centre's of excellence should provide timely biosafety information and solutions to problems in biosafety.
Training courses and workshops should be provided on an on-going basis to ensure continued biosafety awareness within the laboratory community. Biosafety specialists will also require security training that outlines physical facility security mechanisms, personnel screening issues and pathogen inventory systems.
The increase in containment facilities has, in turn, brought increased demand for biosafety practitioners to oversee these facilities, as well as increased demand for biosafety training for those who design, build and work in containment facilities (e.g. engineers, architects, contractors, laboratory workers, laboratory supervisors, maintenance personnel).
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Biosafety Associations
Biosafety Associations comprise a network of individuals with interests in biosafety and provide a forum to:
- Promote biosafety
- Share biosafety knowledge
- Develop and exchange resources and guidelines
- Provide training seminars and workshops
- Advance biosafety as a scientific discipline
- Expanding biosafety awareness
These associations offer a unique opportunity for biosafety professionals to coordinate and develop a national biosafety forum for the sharing of information, development of common standards and collaboration in all aspects of biological safety.
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