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Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories Summary of a Workshop (2012) / Chapter Skim
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E2: European Union
Pages 151-158

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From page 151...
... a Swedish Institute for Communicable Disease Control, Stockholm, Sweden b Institute for Virology and Immunoprophylaxis, Mittelhaeusern, Switzerland This report is partly based on the final report from the Consortium project BIOSAFETY-EUROPE, funded by the 6th Framework Program of the European Commission: Co-ordination, harmonization and exchange of biosafety and biosecurity practices within a pan-European network.1 BIOSAFETY-EUROPE, a coordination action within the European Commission 6th Framework, had the aims to explore harmonization and exchange of biosafety and biosecurity practices within a panEuropean network. The consortium included expertise in biosafety, biosecurity, risk assessment and control, containment measures, and on the underlying legal frameworks of the European Union and its Member States (MS)
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From page 152...
... whereas other countries have an independent government agency as the main authority for biosafety matters as in Sweden where this responsibility lies with the Swedish Work Environment Agency. It was clearly shown by the
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From page 153...
... BIOSAFETY-EUROPE - Biosafety Findings National biosafety regulations and practices derived from EU Directives 2000/54/EC1 and 98/81/EC2 varied from country to country. In many countries, the regulatory framework for genetically modified microorganisms (GMMs)
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From page 154...
... No EU level legislation exists that has been specifically developed to address the protection of biological agents in the laboratory from loss or willful misuse. However, due to the many synergies between biosafety and biosecurity, the EU Directives developed to protect workers from exposure to biological agents or GMMs address most of the issues related to laboratory biosecurity.
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From page 155...
... security in the European Union -- as an EU CBRN Action Plan.8 The overall goal is an all-hazard approach to reduce the threat of and damage from CBRN incidents of accidental, natural, or intentional origin, including acts of terrorism. The Action Plan has set up a number of goals within three areas: prevention, detection, and preparedness and response: Prevention • Develop EU lists of high risk CBRN materials and risk-based approaches to security; • Enhance the security of high risk CBRN facilities; 8 http://register.consilium.europa.eu/pdf/en/09/st15/st15505-re01co02.en09.pdf .
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From page 156...
... Preparedness and response • Improve emergency planning; • Strengthen countermeasure capacity; • Improve domestic and international information flows regarding CBRN emergencies; • Develop improved modeling tools and strengthen decontamination and remediation capacity; and • Improve the capacity to conduct criminal investigations. Actions encompassing all CBRN fields are listed as 67 horizontal actions whereas there are 14 B-specific actions listed, among them: • To assist the MS in the proper implementation of applicable procedures at "the laboratory bench level" and in developing mechanisms for assessing and monitoring its correct implementation; • The MS should establish: o a registry of facilities possessing any of the substances on the EU list of high risk biological agents and toxins; o a process to verify whether security arrangements of facilities are adequate, including diagnostic laboratories handling and possessing any of the EU list of high risk biological agents and toxins; o a mechanism within facilities storing biological agents and toxins on the EU list of high risk biological agents and toxins to regularly review the need for such biological agents and toxins; • The Commission together with the MS should take relevant steps so that: o a comprehensive overview of the relevant regulations or standards at hand and their relevance to biosecurity and biosafety is achieved; o facilities possessing substances on the EU list of high risk biological agents and toxins consider as appropriate the implementation of the CEN Workshop Agreement (CWA 157939)
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From page 157...
... The implementation of the EU CBRN Action Plan is now in its second year. Meetings with MS experts are frequently arranged by the Department of Home Affairs (former JLS)
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Key Terms

  • laboratory biosecurity
  • risk biological
  • action plan
  • risk cbrn
  • national regulatory

  • regulatory framework
  • cbrn action
  • genetically modified
  • disease virus
  • european union

  • containment facilities
  • biological facilities
  • cen standards
  • mouth disease
  • facilities possessing

  • cbrn materials
  • modified microorganisms
  • national regulations
  • european commission
  • standards available

  • biosecurity practices
  • european biosafety
  • european food
  • laboratories handling
  • lab activities

  • practical guidance
  • diagnostic laboratories
  • adopted minimum
  • future outlook
  • responsibilities appear


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