CT: WHAT IS BIOSAFETY?
Biosafety is defined as, “The discipline addressing the safe handling and containment of infectious microorganisms and hazardous biological materials” (1). The practice of safe handling of pathogenic micro-organisms and their toxins in the biological laboratory is accomplished through the application of containment principles and the risk assessment.
Safety in the laboratory is achieved by application of layered, containment principles applied in accordance with the risk assessment to prevent exposure of laboratory workers to a pathogen or the inadvertent escape of a pathogen from the microbiological laboratory.
S: ChABSA – https://bit.ly/2BYJzhA (last access: 9 December 2018)
N: 1. Term composed of word-forming element “bio-” (especially used in scientific compounds; from Greek bios “one’s life, course or way of living, lifetime”; from Proto-Indo-European root *gwei- “to live”) and the word “safety” (early 14 century, from Old French sauvete “safety, safeguard; salvation; security, surety,” earlier salvetet , 11 century, Modern French sauveté; from Medieval Latin salvitatem “safety,” from Latin salvus “uninjured, in good health, safe”; from Proto-Indo-European root *sol- “whole, well-kept”).
2. In the international convention, ‘Biosafety’ refers to “principles, technologies, practices, and measures implemented to prevent the accidental release of, or unintentional exposure to pathogenic agents”.
3. The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement which aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account risks to human health. It was adopted on 29 January 2000 and entered into force on 11 September 2003.
4. The primary principle of biological safety (i.e., biosafety) is containment. The term containment refers to a series of safe methods for managing infectious agents in the laboratory. The purpose of containment is to reduce or eliminate human and environmental exposure to potentially harmful agents.
5. The OECD biosafety work programme aims:
- to promote international harmonisation.
- to consider all types of organisms (plants, trees, animals, micro-organisms) that can be the basis of new biotech products. A number of non member economies and observer organisations are associated with the work. Biotechnology products, particularly new crop varieties, are increasingly moving into global trade. In this context, international harmonisation of regulatory oversight in biotechnology will ensure that environmental health and safety aspects are properly evaluated, while limiting non-tariff trade barriers to these products.
- to encourage information sharing, promote harmonised practices and common approach to safety assessment and regulation. It aims to reduce a duplication of efforts among countries. The outputs are intended to be used by governments (risk and safety assessors, regulators), industry (biotech product developers and producers), other stakeholders, as well as the wider scientific community.
The major outputs of the OECD programme are biosafety Consensus Documents, which provide science-based information for the use in environmental risk/safety assessment. These documents contains elements on the biology of the host species, characteristics of the introduced traits, considerations on possible environmental impacts, and other aspects for facilitating harmonisation.
Another part of the programme is its outreach activity, including the development of BioTrack Online for disseminating the information worldwide and promoting harmonised biosafety frameworks. In addition to the Consensus Documents, Biotrack provides links to regulatory contacts in OECD countries, as well as to information on products via the BioTrack Product Database of modern biotechnology which have been released to the environment.
6. It is important to know the difference between “biosafety” and “biosecurity”:
- Biosafety: includes containment principles, techniques, and procedures that prevent unintentional exposure to pathogens or toxins, or their accidental release. International standards are not mandatory; regulations set at the local level or by laboratories.
- Biosecurity: includes measures designed to prevent and prepare for the deliberate misuse of biological agents or biotechnology. Domain of the arms control, security, or intelligence communities; regulations set at the national or international level.
S: 1. EO – https://bit.ly/2StQsNh (last access: 5 December 2018). 2. NCBI – https://bit.ly/2QBFMPv (last access: 6 December 2018). 3. CBD – https://bch.cbd.int/protocol (last access: 6 December 2018). 4. TS – https://bit.ly/2E7twPX (last access: 5 December 2018). 5. OECD –http://www.oecd.org/env/ehs/biotrack/environmentalbiosafety.htm (last access: 6 December 2018). 6. NTI – https://bit.ly/2EcfIVe (last access: 5 December 2018).
SYN: biological safety