Biorisk

Biorisk is a term in the public domain that has been used frequently for various purposes and references can be found already in the early 90s [Ecotoxicology of Soil Organisms: Conference : PapersBy Marianne H. Donker, H. Eijsackers, Fred HeimbachContributor Marianne H. Donker, H. Eijsackers, Fred Heimbach; CRC Press, 1994] [Pharmaceutical Dosage Forms: Parenteral MedicationsBy Kenneth E. Avis, Herbert A. Lieberman, Leon LachmanContributor Kenneth E. Avis; Informa Health Care, 1993] . Generally it refers to the risk associated with biological materials and/or infectious agents. Lately the term is also used within the laboratory setting combining the term biological safety (or biosafety) and biosecurity into one word. Biorisk is a DNV-trademarked term. [The Norwegian Industrial Property Office, "Norsk varemerketidende", no. 49, vol. 93, 2003.12.01, p. 36, http://www.patentstyret.no/upload/filarkiv/tidende/varemerketidende/2003/varemerketidende-nr49-2003.pdf ] The term is now gaining increasing recognition amongst regulators, laboratory personnel and industry alike and is used by the WHO. [The World Health Organization, Biorisk Management: "Laboratory Biosecurity Guidance" September 2006, WHO/CDS/EPR/2006.6http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6/en/index.html] An international Laboratory Biorisk Management Standard developed under the auspices of the European Committee for Standardization, defines biorisk as the combination of the probability of occurrence of harm and the severity of that harm where the source of harm is a biological agent or toxin. [The European Committee for Standardization, "Laboratory Biorisk Management Standard", CWA 15793:2008, p.9, www.cen.eu] The source of harm may be an unintentional exposure, accidental release or loss, theft, misuse, diversion, unauthorized access or intentional unauthorized release.

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