Identification of the intrinsic hazard of the biological agent

Index:

• Classification of the biological agents. Risk groups
• Biological agents sheets
• Genetically modified organisms
• Further information

Classification of the biological agents. Risk groups

The dangerousness of a biological agent or its pathogenic capacity is largely established by its classification into a risk group. This classification is made according to the following criteria:

1. Ability to infect healthy people
2. Possibility of transmission between people or to the community
3. Severity of the disease it causes
4. Availability of pharmaceuticals or prophylaxis to combat the negative effects of the disease

According to these criteria, a biological agent can be:

• Group 1 biological agent: one that is unlikely to cause an infectious disease in humans.
• Group 2 biological agent: one that can cause a mild or moderate infectious disease in people and can pose a danger to workers, but is unlikely to spread to the community and effective prophylaxis or treatment is generally available.
• Biological agent of group 3: one that can cause serious illness in people and presents a serious danger to workers, with the risk of spreading to the community and there is generally an effective prophylaxis or treatment.
• Group 4 biological agent: one that can cause serious or very serious illness in people and poses a serious threat to workers, with a high probability of spreading to the community and generally without effective prophylaxis or treatment.

CLASSIFICATION OF BIOLOGICAL AGENTS IN RISK GROUPS Technical Guide RD 664/1997
Biological agent of the risk group	Infectious risk	Risk of spreading to the community	Prophylaxis or effective treatment
1	Unlikely to cause disease	No	Unnecessary
2	It can cause a disease and constitute a danger to workers.	Unlikely	Generally possible
3	It can cause serious disease and constitute a serious danger for workers	Likely	Generally possible
4	It causes serious disease and constitutes a serious danger to workers	High	Not currently known

The University of Barcelona does not have containment level facilities above biosafety level 2. Therefore, type 3 and 4 activities cannot be carried out at the UB due to the lack of adequate facilities.

This classification does not take into account the dangerousness of biological agents due to the possible allergenic and toxic effects they can produce. This differentiation provides the criteria for the classification of biological agents into four groups based exclusively on the risk of infection they pose to healthy people, and does not take into account the allergic and toxic risks, also considered in the definition of biological agent in the regulations (RD 664/97).

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Biological agents sheets

Although for biological agents there is no obligation to have “Safety Data Sheets”, equivalent to those existing for chemical agents, it is possible to find “Sheets of biological agents” and it is highly recommended to consult them. These sheets contain basic information on aspects such as: health effects (pathogenicity, infective dose, routes of exposure and transmission, incubation period, etc.), spread, viability, first aid and prophylactic measures, hazards for laboratory personnel, exposure control and protective measures, among others.

Some links to sources of information and databases of the main biological agents are attached below. The information contained in the sheets is very useful for the evaluation and prevention of biological risk.

Other sources of information on biological agents not included in the list in Annex II of RD 664/1997, or on biological agents whose perishability may vary from the species or species included in the aforementioned list are: the World Health Organisation (WHO); the Centers for Disease Control and Prevention (CDC), or the Food and Agriculture Organisation of the United Nations (FAO).

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Genetically modified organisms

Research projects and/or experimental procedures involving the creation or manipulation of Genetically Modified Organisms (GMOs) can only be initiated after a biological risk assessment has been carried out and the competent authority has been notified of the facilities for the contained use of these GMOs and the activities carried out with them (RD 664/1997, Llei 9/2003, RD 178/2004).

The pathogenic properties and any potential hazards associated with these organisms may be new and not well characterised. Therefore, it is necessary to evaluate the properties of the donor organism, the nature of the DNA sequences to be transferred, the properties of the recipient organism and the properties of the environment. These factors will help to determine the level of biosafety required for the safe handling of the resulting GMO, and to identify the biological and physical containment systems to be undertaken.

Risk assessments must be carried out by persons with the best knowledge of the particular characteristics of the organisms to be worked on, the equipment and procedures to be used, the animal models that can be used, and the means of containment available.

The laboratory director or principal investigator (PI) of the research project is responsible for ensuring that risk assessments are carried out properly and for collaborating closely with the biosafety committee and/or biosafety officers of the facility to ensure that appropriate equipment and resources are available for the work to be carried out.

Once carried out, risk assessments should be consulted periodically and revised whenever necessary, considering new data and any relevant information appearing in scientific publications that have an impact on the degree of risk.

Thus, in order to be able to work with GMOs, it will be necessary to carry out a prior research of the information and evaluation of each experimental and/or research project with GMOs, taking into account the characteristics of the donor organisms and the recipient/host organisms, i.e., the risk assessment of each particular case of work with GMOs is mandatory (‘case by case’ principle), which involves research and analysis of the following points:

1. La identificació de qualsevol efecte potencialment nociu de l’organisme modificat genèticament i, en particular, els relacionats amb:
   • the receiving organism,
   • the inserted genetic material from the donor organism or the donor organism itself (if used during the operation),
   • the vector,
   • the resulting genetically modified organism.
2. Analysis of the characteristics of the activity with genetically modified organisms, to estimate the severity of potentially harmful effects and the likelihood of these effects occurring. It is necessary to analyse the working conditions and aspects such as:
   • Purpose and scale (magnitude) of the activity.
   • Any non-standard operation (for example: inoculation of animals with GMOs, use of equipment that can generate aerosols, etc.).
   • The characteristics of the environment where the GMO may be exposed (for example, the presence of known fauna and flora that may be negatively affected by the microorganisms undertaken in the contained use activity).

Finally, according to the information obtained in the assessment of risks to human health and the environment, the activities of confined use are classified into four types, which determine the control and protection measures to be implemented: activities with no or negligible risk, low risk, moderate risk and high risk.

Activities
Tipus 1	Activities with no or insignificant risk
Tipus 2	Activities with low risk
Tipus 3*	Activities with moderate risk
Tipus 4*	Activities with high risk
*Type 3 and 4 activities cannot be carried out at the UB due to the lack of suitable facilities.

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Further information

• Confined facilities and activities with genetically modified organisms.
• Appendix 1 Biohazard in the contained use of GMOs. Technical Guide RD 664/1997 for the assessment and prevention of risks related to exposure to biological agents.
• Health and Safety Executive. Scientific Advisory Committee on Genetic Modification (SACGM). The SACGM Compendium of guidance. Genetically Modified Organisms.
• Chapter 16: Biosafety and recombinant DNA technology. Laboratory biosafety manual. 3rd edition. WHO; 2005.
• SECTION 2. Risk assessment. Laboratory biosafety manual, 4th Edition. WHO; 2021.