What kinds of materials are used in your organisation, and which security measures need to be taken accordingly? Does the research have dual-use aspects?
Working with high-risk materials poses safety and security risks. Due to their nature and characteristics, high-risk materials have significant potential for malicious use. For example, consider the availability, transmissibility and dispersibility of a pathogen, and the potential consequences for public health, the environment and the economy in the event of a deliberately caused outbreak. Therefore, a thorough risk assessment is essential so you can take appropriate biosecurity measures to prevent the materials or knowledge from being used maliciously.
High-risk biological material currently includes human and animal pathogens in biosafety risk groups 3 or 4 and plant pathogens that are on the list of quarantine organisms. In supplementation to the biosafety classification, there are several export checklists of pathogens and toxins that have been used previously in a biological weapons programme, have pandemic potential, are easy to disperse, or for which prophylaxis is difficult or impossible. These pathogens are therefore classified as high-risk biological material. Other classifications (based on the ADR) may apply to the transport of hazardous materials, see transport security.
For the Netherlands, the European dual-use regulation (2009/428/EU) is predominant. In the United States the Select Agents and toxins list applies. The Australia group strives for international harmonisation. Click here for a list containing pathogens in biosafety risk groups 3 or 4 and pathogens on the export control lists. Biosecurity measures should always be proportional to the material and activities within the organisation.
To safeguard materials security, the organisation should have an up-to-date overview of all high-risk materials that are present. This overview will enable employees to report misplaced or stolen materials and to provide up-to-date information quickly in case of a calamity. The overview describes where high-risk materials are stored or used and who is responsible for these materials. Registration and management can take place in various ways, for example by using an electronic ‘Laboratory Information Management System’ (LIMS). It is crucial that the registration and management overview can only be accessed, managed and checked by personnel who are authorised to do so.
Research on high-risk material is important. However, the corresponding knowledge and technologies, and the material itself, could also be used maliciously. This is the dual-use aspect of research in the life sciences. A dual-use assessment examines, among other things, which dual-use aspects apply to the high-risk pathogen and which risks are present for employees, the organisation and society. Furthermore, the organisation must consider the advantages and disadvantages of the proposed research, how it can deal with the research if approved and which biosecurity measures can be taken. Prior to and during the research, it is important to monitor whether malicious use of the material, knowledge or technologies is possible. If dual-use aspects are inherent to the research, this may have consequences for publication in international journals (see: ‘publishing and export control’ under the transport security, tab and 'confidentiality' under the information security tab). The Biosecurity Office can coach the organisation while it considers the steps and the substantiation that are involved in a dual-use assessment. The organisation is ultimately responsible for the research and for taking appropriate biosecurity measures. Please contact us for more information at firstname.lastname@example.org.