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Biological Risk Assessment Sheets :
Practical Examples of Risk Assessment and Biosafety Recommendations for the Contained Use of Genetically Modified (Micro-)Organisms

(Last revision: February 17, 2014 )
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Introduction

General considerations

List of practical examples (PDF files)

Introduction

Risk assessment is a methodology used to organize and analyze scientific information in order to estimate the probability and severity of an adverse effect. The adoption of this methodology, as outlined and illustrated hereunder (figure 1), leads to the implementation of an appropriate set of measures in order to provide maximal protection of human health and environment. For the risk assessment of ‘contained use’ activities, four subsequent steps are distinguished:

  1. Identification of biological hazards
  2. Determination of the class of risk of the genetically modified or pathogen organism
  3. Consideration of the type of activity in terms of probability of exposure to potential biological hazards
  4. Assignment of a class of risk to the contained use activity
  5. Implementation of recommended containment level (Risk Management)

Figure 1 : Biological risk assessment and risk management

1. and 2. Identification of biological hazards and determination of the class of risk of the genetically modified or pathogen organism

Classification lists of pathogenic microorganisms have been established and are a useful tool for performing a risk assessment. The Belgian Regional decrees classify human and animal pathogens into three classes of risk and plant pathogens into two classes of risk.

However, some pathogens and most genetically modified organisms are not classified into risk groups. In this case, the most critical properties inherent to the biological material that should be considered for a risk assessment and assignment to a risk group include:

  • importance of the disease or severity of the infection;
  • infectivity (virulence of the strain, infective dose, mode of transmission, natural route of infection);
  • host range of the micro-organism and spectrum of specificity of target-species;
  • biological stability;
  • potential of survival and dissemination in the community or the environment;
  • availability and effectiveness of prophylactic or therapeutic measures (such as vaccination or antisera, antibiotics, chemotherapeutic agents, taking into consideration the possibility of emergence of resistant strains).

The classification of the biological risk for the plant includes three additional criteria:

  • the prevalence of the micro-organism in the environment;
  • the presence of target-species around the installation or the site of waste disposal;
  • the 'exotic' character of the micro-organism.

In case of genetically modified (micro-) organisms, each element that has been used towards the achievement of the genetic modification should be evaluated as well:

  • the recipient micro-organism
  • the genetic material inserted (originating from the donor organism)
  • the vector
  • the donor micro-organism
  • the resulting GMM

see also Annex III of Directive 98/81/EC,  which describes in general terms the elements to be considered for performing a risk assessment of genetically modified micro-organisms. Guidance notes have been published in Commission Decision 2000/608/EC of 27 September 2000.


3. Consideration of the type of activity in terms of probability of exposure to potential biological hazards

Not only should risk factors inherent to the biological material be considered, factors associated with the type of operations/manipulations should be examined as well. This include:

  • potential for aerosol generation
  • scale of the activity
  • concentration and volume (e.g. cultures, supernatant)
  • type of work proposed (e.g., in vitro , in vivo , challenge studies, work with laboratory animals, non standardized manipulations)


4. Assignment of a class of risk to the contained use activity

The properties inherent to the biological agent and the characteristics of the activity are considered together in a final risk assessment, leading to the assignment of a class of risk of the contained use activity. The class of risk of the activity may be equivalent to the class of risk of the micro-organisms or it may be higher or lower.


5. Implementation of recommended containment level (Risk Management)

The class of risk of the activity defines the level of the recommended containment level. Each level of containment implies the set up of technical requirements, specific equipment, work practices and other protective measures (link in het Nederlands/ lien en français).


General considerations

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.

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.

Following examples (see Table of examples) 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.

List of practical examples
Table: Practical examples of Risk Assessment and Biosafety recommendations
Example
Title (PDF file size)
Class of risk of the contained use
Recommended containment level
1
2
2

1

3
1
4

Vaccine production against Hepatitis B virus using a baculovirus vector

1
5 Heterologous expression of Mycolactone in Mycobacterium smegmatis
2
6 Construction of a chimeric vector using Human and Simian immunodeficiency viruses
2
7

Injection of CD34+ hematopoietic stem cells tranduced with lentiviral vector to immunodeficient mice

2
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