Contained use - Biological Risk Assessment Sheets, practical examples

(Note: cette page n'existe qu'en anglais - Nota: deze pagina bestaat enkel in het Engels)

Several guidelines and biosafety manuals are available in order to help the user to conduct a comprehensive and thorough risk assessment. For some international references see Guidelines for risk assessment, Biosafety Manuals (below).

However, it is important to be aware that a risk assessment should always be carried out on a case-by-case basis as all 'contained use' activities deal with unique features.

The examples below have been draw up to illustrate the methodology that has been used to conduct the risk assessment. Though each example deals with very different types of biological material and types of manipulation, risk assessment remains based on a common approach.

Title	Class of risk of the contained use	Recommended containment level
Overexpression of IL-1 in human cells by using retroviral vectors	2	BSL2
Salmonella-based DNA vaccine	1	BSL1
Cloning of promoters found in human tumors into Escherichia coli	1	BSL1
Vaccine production against Hepatitis B virus using a baculovirus vector	1	BSL1-Large Scale
Heterologous expression of Mycolactone in Mycobacterium smegmatis	2	BSL2
Construction of a chimeric vector using Human and Simian immunodeficiency viruses	2	BSL2
Injection of CD34+ hematopoietic stem cells tranduced with lentiviral vector to immunodeficient mice	2	BSL2

Guidelines for risk assessment, Biosafety Manuals

Canada

• Canadian Biosafety Standard (CBS), 2nd edition (2015)
• Canadian Biosafety Handbook (CBH), 2nd edition (2015)

EU

• Commission Decision 2000/608/EC of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms - from Council Directive 98/81/CE of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms

OECD

• Recombinant DNA Safety Considerations. 1986. (PDF file)
• Safety Considerations for Biotechnology. 1992. (PDF file)
• Safety Considerations for Biotechnology. Scale-up of micro-organisms as biofertilizers. 1993. (PDF file)
• Safety Considerations for Biotechnology. Scale-up of crop plants. 1993. (PDF file)

Russian Federation

• Safety in Working with groups I and II Pathogenicity Microorganisms: Sanitation Regulation SP 1.2011-94. State System for Sanitation-Epidemiological Standardization of the Russian Federation. LN069-99. (PDF file). Hard copy available on demand (JBetancourt@med.miami.edu)

UK

• AGCM Compendium of guidance from the Health and Safety Executive Commission's Advisory Committee on Genetic Modification.

UNEP

• International Technical Guidelines for Safety in Biotechnology, Chapter III: Assessment and Managment of Risks, Adopted by the Global Consultation of Government-designated Experts, December 1995.

USA

• CDC/NIH: Biosafety in Microbiological and Biomedical laboratories, 5th edition, 2009. Centers for Disease Control and Prevention, and National Institutes of Health.
• NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. April 2016. National Institutes of Health

WHO

• Laboratory Biosafety Manual, WHO/CDS/CSR/LYO/2004.11, Third edition, 2004. 
• Biorisk Management, Laboratory Biosecurity Guidance, WHO/CDS/EPR/2006.6, September 2006.