Safety and Security Regulations Against Biological Threats

  • Anna Bielecka-OderEmail author
Conference paper
Part of the NATO Science for Peace and Security Series A: Chemistry and Biology book series (NAPSA)


Biological threat agents include bacteria, viruses, fungi, parasites and their associated toxins. They have the ability to harmfully affect human health ranging from an allergic reactions to serious illnesses, even death. Water, soil, air, plants or animals can be a suitable habitat for their live and proliferation.

Because biological agents may reproduce rapidly and initially unnoticed, need minimal resources to survive and can infect at very small doses they can be used as biological warfare agent or bioweapon. Genetic modification may enhance their hazardous and lethal properties, or develop resistance to conventional treatments.

In effect, to protect people from dangerous biological agents as well as protect biological agents from intentional malicious acts both, biological safety and biological security measures should be implemented and respected. Because of wide scale of risks caused by biological agents, biosafety and biosecurity issues should be interpreted on many fields taking as priority protection of human beings and their surrounding environment.

The reader will familiarize with different point of views on biosafety and biosecurity issues in relation to occupational health and safety, public health and disease surveillance, biodiversity protection, genetic modification of microorganisms, transportation of dangerous goods, storage control of biological agents, dual-use technology, education and awareness raising, weapon of mass destruction threats and bioterrorism acts.

The main international agreements, the European Union regulations and principles supporting implementation of national legislation concerning biosafety and biosecurity areas are presented. The role of legally and not-legally binding instruments is highlighted, as well.


Biosafety Biosecurity Regulations Guidelines 


  1. 1.
    Dictionary of Military and Associated Terms. US Department of Defense 2005Google Scholar
  2. 2.
    BWC/MSP/2005/MX/WP.14, Infectious Diseases, Biosafety and Biosecurity – Prepared by Germany, 13 June 2005Google Scholar
  3. 3.
    WHO Biorisk Management, Laboratory biosecurity guidance, 2006Google Scholar
  4. 4.
    WHO Laboratory biosafety mannual, 3rd ed, 2004Google Scholar
  5. 5.
    OECD – Glossary of Terms. Scholar
  6. 6.
    Strengthening a Global Biosecurity/Biosafety Framework and Coping with the Biotechnology Revolution, BWC Implementation Support UnitGoogle Scholar
  7. 7.
    WHO, Biorisk Management: Laboratory Biosecurity Guidance, September 2006Google Scholar
  8. 8.
    Glossary of the FAO Basic Laboratory Manual for the Small-Scale Production and Testing of I-2 Newcastle Disease VaccinGoogle Scholar
  9. 9.
    Agenda item 5 of Annex 1: national, regional and international measures to improve biosafety and biosecurity, including laboratory safety and security of pathogens and toxins, BWC/MSP/2008/MX/3, Report of The Meeting Of Experts, 8 September 2008Google Scholar
  10. 10.
    BWC/MSP/2008/MX/INF.1 Biosafety and Biosecurity – Submitted by the Implementation Support Unit, 24 June 2008Google Scholar
  11. 11.
    BWC Convention, Article IGoogle Scholar
  12. 12.
    BWC Convention, Article IIGoogle Scholar
  13. 13.
    BWC Convention, Article IIIGoogle Scholar
  14. 14.
    BWC Convention, Article IVGoogle Scholar
  15. 15.
    BWC/CONF.VI/6, Final document of sixth review conference, 20 Nov–8 Dec 2006, GenevaGoogle Scholar
  16. 16.
    BWC Convention, Article V–VIGoogle Scholar
  17. 17.
    BWC Convention, Article VIIGoogle Scholar
  18. 18.
  19. 19.
    BWC Convention, Article XGoogle Scholar
  20. 20.
    The Cartagena protocol on biosafety to the convention on biological diversity, Article IGoogle Scholar
  21. 21.
    UN Security Council Resolution 1540, OP1–3Google Scholar
  22. 22.
    WHO International Health Regulations, 2005Google Scholar
  23. 23.
    Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)Google Scholar
  24. 24.
    Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organismsGoogle Scholar
  25. 25.
    Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EECGoogle Scholar
  26. 26.
    Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territoryGoogle Scholar
  27. 27.
    Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feedGoogle Scholar
  28. 28.
    Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/ECGoogle Scholar
  29. 29.
    Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organismsGoogle Scholar
  30. 30.
    Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birdsGoogle Scholar
  31. 31.
    Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and floraGoogle Scholar
  32. 32.
    Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions: our life insurance, our natural capital: an EU Biodiversity Strategy to 2020 (COM(2011) 244)Google Scholar
  33. 33.
    Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions: a new EU Forest Strategy: for forests and the forest-based sectorGoogle Scholar
  34. 34.
    Convention on International Trade in Endangered Species of Wild Fauna and Flora, 1975Google Scholar
  35. 35.
    European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR)Google Scholar
  36. 36.
    Regulations concerning the International Carriage of Dangerous Goods by Rail (RID, part of the Convention concerning International Carriage by Rail)Google Scholar
  37. 37.
    IATA Dangerous Goods Regulations 57th ed (DGR), Jan 2016Google Scholar
  38. 38.
    IATA Dangerous Goods Regulations 53rd ed, Guidance Document. Infectious substancesGoogle Scholar
  39. 39.
    International Maritime Dangerous Goods Code (IMDG Code, part of the International Convention for the Safety of Life at Sea)Google Scholar
  40. 40.
    Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goodsGoogle Scholar
  41. 41.
    Directive 2008/54/EC of the European Parliament and of the Council of 17 June 2008 amending Council Directive 95/50/EC on uniform procedures for checks on the transport of dangerous goods by road, as regards the implementing powers conferred on the CommissionGoogle Scholar
  42. 42.
    Commission Directive 2004/110/EC of 9 December 2004 adapting for the sixth time to technical progress Council Directive 96/49/EC on the approximation of the laws of the Member States with regard to the transport of dangerous goods by railGoogle Scholar
  43. 43.
    Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/ECGoogle Scholar
  44. 44.
    Council Regulation (EC) No 428/2009 of 5 May 2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use itemsGoogle Scholar
  45. 45.
    BWC/CONF.VI/WP.22 Bioterrorism – submitted by Italy on behalf of the European Union, 21 Nov 2006Google Scholar
  46. 46.
    EU Strategy against Proliferation of Weapons of Mass Destruction (WMD), 2003Google Scholar
  47. 47.
    Fight against the proliferation of weapons of mass destruction – EU strategy against proliferation of Weapons of Mass Destruction (WMD), Brussels, Dec 2003Google Scholar
  48. 48.
    Council Joint Action 2008/307/CFSP of 14 April 2008 in support of World Health Organization activities in the area of laboratory bio-safety and bio-security in the framework of the European Union Strategy against the proliferation of Weapons of Mass DestructionGoogle Scholar
  49. 49.
    A green paper on bio-preparedness, 2007Google Scholar
  50. 50.
    Communication from the Commission to the European Parliament and the Council on Strengthening Chemical, Biological, Radiological and Nuclear Security in the European Union – an EU CBRN Action PlanGoogle Scholar
  51. 51.
    The European Union Counter-Terrorism StrategyGoogle Scholar
  52. 52.
    Regulation (EC) No 1717/2006 of the European Parliament and of the Council of 15 November 2006 establishing an Instrument for StabilityGoogle Scholar
  53. 53.
    Science and Technology Center in Ukraine, Annual Report 2011, Ukraine, 2012Google Scholar
  54. 54.
    Regulation (EU) No 230/2014 of the European Parliament and of the Council of 11 March 2014 establishing the Instrument contributing to Stability and PeaceGoogle Scholar
  55. 55.
  56. 56.
    BWC/CONF.VIII/PC/WP.5 Position of the European Union relating to the Eighth Review Conference of the BWC, 12 Apr 2016Google Scholar
  57. 57.
    BWC/CONF.VI/WP.2 Biosafety and Biosecurity – submitted by Germany on behalf of the European Union, 20 Oct 2006Google Scholar
  58. 58.
    Workshop on the Implementation of the Biological Weapons Convention, Geneva, 3 Aug 2015Google Scholar
  59. 59.
    Bielecka A, Mohammadi AA (2014) State-of-the-art in biosafety and biosecurity in European countries. Arch Immunol Ther Exp 62(3):169–178CrossRefGoogle Scholar
  60. 60.
    Biological Weapon Convention. Report on National Implementing Legislation, VERTIC National Implementation Measures Programme, Switzerland, 2016Google Scholar
  61. 61.
    Spence S., 7th annual international symposium – biosecurity and biosafety: future trends and solutions, Milan, Italy, 22–24 March, 2017Google Scholar
  62. 62.
  63. 63.
  64. 64.
    Guidelines for Biosafety Laboratory Competency, Morbidity and Mortality Weekly Report, vol 60, CDC, April 2011Google Scholar
  65. 65.
    Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories, Morbidity and Mortality Weekly Report, vol 61, CDC, January 2012Google Scholar
  66. 66.
  67. 67.
  68. 68.
    ABSA Task Force on Biosecurity White Paper on Understanding Biosecurity, 2003Google Scholar
  69. 69.
  70. 70.
  71. 71.
  72. 72.
    WHO Laboratory biosafety manual 3rd ed, 2004Google Scholar
  73. 73.
    Extended Biosafety Advisory Group meeting report Geneva, Switzerland, 24–26 Nov 2014, WHO, 2015Google Scholar
  74. 74.
    Laboratory Biorisk Management: Strategic Framework for Action 2012–2016, WHO, 2012Google Scholar
  75. 75.
    Responsible life sciences research for global health security, WHO, 2010Google Scholar
  76. 76.
  77. 77.
  78. 78.
  79. 79.
    CWA 16335 – Biosafety professional competence, Sept 2011Google Scholar
  80. 80.
    CWA 15793 – Laboratory biorisk management standard, CEN Workshop Agreement, 2011Google Scholar
  81. 81.
    Biosafety in Microbiological and Biomedical Laboratories, 5th ed, US HHS, PHS, CDC, NIH, 2009Google Scholar
  82. 82.
  83. 83.
    OIE Biological Threat Reduction Strategy – Strengthening Global Biological Security, 2012Google Scholar
  84. 84.
    OIE Manual of Diagnostic Tests and Vaccine Production, 2011Google Scholar
  85. 85.
    OIE Manual of Diagnostic Test and Vaccines and Terrestrial Animals, 2016Google Scholar
  86. 86.
    OIE Quality Standard & Guidelines for Veterinary Laboratories, 2008Google Scholar
  87. 87.
    OIE Terrestrial Animal Health Code, 2016Google Scholar
  88. 88.
    OIE Aquatic Animal Health Code, 2016Google Scholar
  89. 89.
    Veterinary Containment Facilities: Design and Construction handbook, IVBWG, 2006Google Scholar
  90. 90.
    FAO Biosafety Resource Book, 2011Google Scholar
  91. 91.
    FAO Biotechnology for Agricultural Development, 2011Google Scholar
  92. 92.
    FAO/WHO framework for developing national food safety emergency response plans, 2010Google Scholar
  93. 93.
    FAO/WHO guide for application of risk analysis principles and procedure during food safety emergencies, 2011Google Scholar
  94. 94.
    FAO/WHO guide for developing and improving national food recall systems, 2012Google Scholar
  95. 95.
  96. 96.
    Biodiversity and World Food Security: Nourishing the Planet and Its People Conference, Ransom L., Preventing Biodiversity, Promoting Biosecurity and Biosafety: Australian Perspectives, 30 Aug–1 Sept, 2010, Canberra, AustraliaGoogle Scholar
  97. 97.
  98. 98.
  99. 99.
  100. 100.
    OECD Best Practice Guidelines for BRCs, 2007Google Scholar
  101. 101.
    OECD Best Practice Guidelines on Biosecurity for BRCs, 2007Google Scholar
  102. 102.
    WHO Guidance on regulations for the transport of infectious substances 2015–2016, 2015Google Scholar
  103. 103.
    The International Maritime Dangerous Goods (IMDG) Code, 2016Google Scholar
  104. 104.
    The International Ship and Port Facility Security (ISPS) CodeGoogle Scholar
  105. 105.
    ICAO The Technical Instructions for the Safe Transport of Dangerous Goods by Air, 2017–2018 editionGoogle Scholar
  106. 106.
    IATA Guidelines for Transport of Infectious Substances by AirGoogle Scholar
  107. 107.
    UNESC Recommendations on the Transport of Dangerous GoodsGoogle Scholar
  108. 108.
  109. 109.
    The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations (CDG)Google Scholar
  110. 110.
    The European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR)Google Scholar
  111. 111.
    IATA The Dangerous Goods RegulationsGoogle Scholar
  112. 112.
    HSE Guide to the Control of Substances Hazardous to Health (COSHH) RegulationsGoogle Scholar
  113. 113.
    Selgelid Michael J (2009) Governance of dual-use research: an ethical dilemma. Bulletin of the WHO 87:720–723Google Scholar
  114. 114.
    IAP Statement on Biosecurity, 2005Google Scholar
  115. 115.
  116. 116.
    Report of the Meeting of Experts of the BWC, 4–6 Aug 2014, Geneva, SwitzerlandGoogle Scholar
  117. 117.
    BWG A Code of Conduct for Biosecurity, 2007Google Scholar
  118. 118.
    Position of the European Union relating to the Eighth Review Conference of the BWC submitted by the European Union, 26–27 Apr and 8–12 Aug 2016, GenevaGoogle Scholar
  119. 119.
    WHO Life Science Research: Opportunities and Risks for Public Health. Mapping the Issues, 2005Google Scholar
  120. 120.
    “Dual Use Research on Microbes: Biosafety, Biosecurity, Responsibility” Symposium, 10–12 Dec 2014, Hannover, GermanyGoogle Scholar
  121. 121.
    Alchon SA (2003) A pest in the land: new world epidemics in a global perspective. University of New Mexico Press, AlbuquerqueGoogle Scholar
  122. 122.
    Oldston M (2010) Viruses, plagues, & history. Oxford University Press, New York CityGoogle Scholar
  123. 123.
    Carus W (2002) Bioterrorism and biocrimes: the illicit use of biological agents since 1900. Fredonia Books, AmsterdamGoogle Scholar
  124. 124.
    Thompson C (2006) The bioterrorism threat by non-state actors: hype or horror? Naval Postgraduate School, MontereyGoogle Scholar
  125. 125.
    EC Green Paper on Bio-Preparedness, 2007Google Scholar
  126. 126.
    Bioterrorism Agents/Diseases (by Category), Emergency Preparedness and Response, CDCGoogle Scholar
  127. 127.
    Hamburg, Margaret A (2002) Preparing for and preventing bioterrorism. Issues in Science and Technology 18(2) WinterGoogle Scholar
  128. 128.
    The Public health response to biological and chemical weapons: WHO guidance, 2004Google Scholar
  129. 129.
    WHO Health aspects of biological and chemical weapons, 2001Google Scholar
  130. 130.
    WHO Terrorist Threats to Food – Guidelines for Establishing and Strengthening Prevention and Response Systems, 2008Google Scholar
  131. 131.
    DaSilva Edgar J, (1999) Biological warfare, bioterrorism, biodefence and the biological and toxin weapons convention. EJB Electro J Biotechnol.2(3), Issue of Dec 15Google Scholar
  132. 132.
    Roffey R, Lantorp K, Tegnell A, Elgh F (2002) Biological weapons and bioterrorism preparedness: importance of public-health awareness and international cooperation. Clin Microbiol Infect 8(8):522–528CrossRefPubMedGoogle Scholar

Copyright information

© Springer Science+Business Media B.V., part of Springer Nature 2018

Authors and Affiliations

  1. 1.The Analysis TeamThe Epidemiological Response Center of the Polish Armed ForcesWarsawPoland

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