Types and categories of biological agents
Biological agents are substances such as microorganisms which can create a hazard to human health, for example, through infection, allergy, toxicity, etc.
On this page
- What is a biological agent?
- What is genetically modified material?
- What is not considered to be genetically modified material?
- Samples from human or animalsÌýplants
- Schedule 5Ìý
- Specified Animal PathogensÌý
- Zoonoses
- Lab Animal Allergens
ÌýWhat is a biological agent?
Biological agents include:
- micro-organisms such as bacteria, viruses, fungi, parasites, prions, protozoa
- toxins produced by biological agents
- genetically Modified microorganisms
- cell culturesÌýderived from humans / animals or insects
- the products of biological agents including animal dander, pollen or fluids such as urine, saliva or sap
- animals, arthropods (insects and arachnids) and plants used in research
- Hazard groupsÌý
This is the categorisation of wild type (naturally forming bacteria, viruses, fungi, parasites, protozoa and prions) are 1-4 with increasing hazard with the increasing number the groups are determined by the severity of disease. The higher the level of risk the more stringent controls are required to minimise the risk of exposure to as low as possible. ÌýÌýÌý
Hazard group Level of disease Spread Prophylaxis 1 Unlikely to cause harm N/A N/A 2 Can cause infection and disease but will recover Unlikely to spread to the wider community Effective and available prophylaxis 3 Cause serious disease May spread to the wider community Effective and available prophylaxis 4 Cause serious disease Likely to spread to the wider community Usually, no effective prophylaxis available Categorisation of Biological Agents is determined by
At °×С½ãÂÛ̳Ìýorganisms up to and including Hazard Group 3 can be handled. There are no containment level 4 facilities at °×С½ãÂÛ̳ to work with HG 4 organisms.
At °×С½ãÂÛ̳, onlyÌýorganisms up to Hazard Group 3 and Class 3 GMOs are handled. Only a limited number of facilities exist in the UK capable of containing Hazard Group 4 and Class 4 organisms.
The higher the risk rating, the more stringent the control measures are to ensure that the risk of exposure is kept as low as possible. There are standards for both procedures that have to be in place and the engineering controls that have to be present for each level of risk. These are referred to as the Containment levels.
What is Genetically Modified Material?
This is where the nucleic acids of an organism have been artificially manipulated by humans to produce an organism which does notÌýoccur in nature through mating or natural recombination.
What is not considered to be Genetically Modified Material?
Certain techniques are not considered to result in genetic modification:
- in vitro fertilisation
- natural transformation processes eg conjugation, transduction or transformation; andÌýpolyploidy induction
- mutagenesis
- cell fusions (including protoplast fusion) of eukaryotic species including the production of hybridomas and plant cell fusions
- self cloningÌýwhere the resultant organism is likely to cause disease or harm to humans
In addition, there are certain techniques where the bulk of the Regulations do not apply, provided they do not use recombinant genetic material or GMOs in the first instance:
- mutagenesis;
- cell fusion (including protoplast fusion) of cells of any eukaryotic species, including the production of hybridomas and plant cell fusions; and
- self-cloning where the resultant organism is unlikely to cause disease or harm to humans.
- Genetically Modified (GM)ÌýMaterialsÌý classificationÌý
GM MaterialsÌýdo not occur naturally,Ìýso they do not fit into the hazard groups like naturally occurring microorganisms. Instead, they are categorised by Class. The Classes are also numbered 1 to 4 and again with the increasing number there is an increase in the level of risk. The Class of a GMO is determined by the hazards of the final construct to human health or the environment as well as the activity being carried out. The Class is determined by the control measures needed e.g. ifÌýa single measure or multiple measuresÌýfrom CL2 are required the GMO would be Class 2.
ClassÌý Risk Controls usedÌý 1 non or negligable CL1 2 low CL2 3 medium CL3 4 high CL4 Categorisation of GMM is determined by risk assessment. The highest risk material worked with at °×С½ãÂÛ̳ is Class 2 which can only be conducted in specialised CL 3 facilities.
Samples from Humans and Animals
These are categorised according to the level of risk of pathogens being present that will impact human health or the health of the environment.
This will also be determined by the type of sample and potential diseases that could be present.Ìý
All these materials should be treated as if they are potentially infectious and must have suitable controls in place to protect employees and other lab users.Ìý
Hazard | Cell TypeÌý | Baseline containment |
---|---|---|
Low | Well characterised or authentic finite cell lines from human or primate origin with a low risk of pathogens being present and tested for the most serious pathogens | CL1 |
Medium | Finite and continuous cell lines or strains of human or primate origin not fully characterised or authenticated where there is a high risk of endogenous biological agents e.g. blood borne viruses | CL2 |
High | Cell lines with endogenous agents or deliberately infected cells Primary cells from blood or lymphoid cells of human or primate originÌý | Containment determined by the infective agentÌý containment determined by risk. A minimum of CL2 |
Where there is a risk of infectious aerosol the work should be carried out in a Microbiological Safety Cabinet.
Schedule 5
Schedule 5 is part of the Anti-terrorism, crime and security Act. The purpose of Schedule 5 is to prevent the unauthorised acquisition and use of dangerous pathogens and toxins for malicious use. The list has a range of human and animal pathogens and includes nucleic acids from these agents. To order and work with biological agents that feature in Schedule 5 and application of licencesÌýplease contact biochem@ucl.ac.uk.
- People who work with these agents should have appropriate experience and training.
- Only order what is needed and limit stocks to the minimum required
- Records should be kept on the amounts used and amounts disposed of, A regular check on Schedule 5 agents is carried out by Safety Services
- There should be a register of users with access to these agents
- These agents must be safely and securely stored to avoid unauthorised access
- Schedule 5 VirusesÌý
Chikunga virus
Middleburg virus
Congo-crimean haemorrahagic fever virus
Mobala virus
Dengue virus fever
Monkey pox virus
Dobrava / Belgrade virus
Mucambo virus
Eastern equine encephalitis virus
Murray Valley encephalitis virus
Ebola virus
Ndumu virus
Everglades virus
Nipah virus
Getah virus
Omsk haemorrahagic fever virus
Guanarito virus
Polio virus
Hantaan virus
Powassan virus
Hendra virus (Equine morbillivirus)
Rabies Herpes simiae (B virus) Ìý
Rift Valley fever virusÌý Influenza virus (pandemic strains)
Rocio virusÌý Japanese encephalitis virus
Sabia virusÌý Junin virus
Sagiyama virus Kyasanur Forest virus
Sin Nombre virusÌý Lassa Fever virus
St Louis encephalitis virus (Russian Spring-Summer encephalitis virus) Louping ill virus
Variola virusÌý Lymphocytic chloriomeningitis virus
Venezuelan equine encephalitis virus Machupo virus
West Nile fever virusÌý Marburg virus
Western equine encepalitis virusÌý Mayaro virus
Yellow fever VirusÌý - Rickettsiae
Coxiella burnettii Rickettsia rickettsii Rickettsia prowazeki Rickettsia typhi (formerly R. mooseri
- BacteriaÌý
Bacillus anthracisÌý Francisella tularensis Brucella abortusÌý Multi drug resistant Salmonella paratyphi Brucella canisÌý Mycobacterium tuberculosis Brucella melitensis Salmonella paratyphi A, B, C Brucella suis Salmonella typhi
Burkholderia mallei (Pseudomonas mallei)
Shigella boydii
Burkholderia pseudomallei (Pseudomonas pseudo mallei)
Shigella dysenteriae
Chlamydophila psittaci
Shigella flexneri
Clostridium botulinum
Vibrio cholerae Clostridium perfringens
Yesinia pestis Enterohaemorrhagic Escerichia coli, serotype 157 and Verotoxin producing strains
Ìý - Fungi
Cladophialophora bantiana Ìý Cryptococcus neoformans Ìý - Toxins
Abrin Saxitoxin Botulinum toxins Shiga and shiga-like toxins Clostridium perfringens eplison toxin Staphylococcus enterotoxins Clostridium perfringens enterotoxin Tetrodotoxin Conotoxin Viscum Album Lectin 1 (Viscumin) Modecccin toxin Volkensin toxin Ricin Ìý
ÌýZoonoses
Transmission of Zoonotic disease from laboratory animals is uncommon due to the health status of laboratory animals. However, there are a number of diseases that can be spread between animals and humans these include:
- Marburg Virus
- Simian Immunodeficiency Virus (SIV)
- Filoviruses
- Mycobacterium tuberculosis
- Herpes simae (monkey B virus)
- Transmissible Spongiform Encephalopathy (TSE’s) e.g. Bovine Spongiform Encephalopathy (BSE)
- SARS- CoV-2
Information on zoonosis can be found on the the HSE webpage or biochem@ucl.ac.uk.
Specified Animal Pathogen Order (SAPO)
SAPO is a specific element of the Animal Health Act. SAPO specifically lists animal pathogens that are not endemic to the Great Britain, and if introduced could have a significant impact and economic loss to the livestock industry e.g. Foot and Mouth outbreak in 2007. A list of SAPO agents can be found in . SAPO includes the wild type microorganisms, attenuated strains and genetically modified forms of any of the listed pathogens.
Please contact biochem@ucl.ac.uk for further information about working with these agents and licence applications.
Lab Animal Allergens (LAA)
Working with animals and animal samples can lead to the exposure to Lab Animal Allergens. The symptoms can be itchy red and or wateryÌýeyes can be found in animal dander, urine, droppings and bedding. To be able to enter these facilities an LAA questionnaire must be completed and returned to Workplace Health this is typically part of the Job HazardÌýForm process completed by the Manager of the personÌýworking in these areas. Face fit testing and aÌýHealth questionnaire will also be required before starting work where there is a risk of exposure to LAA.ÌýÌý
For information on Respiratory Protective Equipment.
Last updated: Thursday, December 1, 2022