Biological Security for Pathogens and Toxins

To prevent terrorism certain pathogens, toxins and their genetic materials are controlled under the Anti-Terrorism, Crime and Security Act (ATCSA). Principal investigators who wish to acquire, possess or use any of these pathogens, toxins or relevant genetic materials must obtain prior permission from their head of school and ensure that they are registered before they are brought into the University. Principal investigators must notify their School and the Safety and Environmental Protection Service (SEPS) by registering the pathogens, toxins and relevant genetic materials using the pathogen and toxin registration form. The Head of School or Institute must ensure that the possession of any of these pathogens or toxins is immediately notified by their unit to the Counter Terrorism Security Adviser (CTSA) at Police Scotland.

Security Standards for Schedule 5 Pathogens and Toxins

The Home Office and Police are the enforcing authorities for terrorism laws. General security guidance is available from the Home Office, National Counter Terrorism Security Office (NaCTSO) and the National Protective Security Authority.

 
The University must ensure that Schedule 5 pathogens, toxins and relevant genetic materials are securely managed and controlled according to Home Office security standards. The Home Office and Police carry out their duties through the NaCTSO and the local police Counter Terrorism Security Advisers. NaCTSO and the police CTSA provide guidance and advice on the controls for the secure storage, use and consignment of pathogens, toxins and relevant genetic material. The ACTSA Schedule 5 list of pathogens, toxins and relevant genetic materials is given at the end of this section. 

The Home Office sets detailed security standards which broadly involve physical, electronic and administrative measures and more detailed advice can be obtained from the University biological safety adviser. Specific controls are required for Schedule 5 pathogens, toxins and relevant genetic materials. For example, there is a legal duty to inform the Police and the Home Office before keeping or using any Schedule 5 listed pathogens, toxins and relevant genetic materials. An inventory of all listed materials and authorised users must be supplied on request to the Home Office. All Schedule 5 listed materials must be kept securely locked, access must be restricted to authorised users only and detailed records must be kept. Police have powers to inspect all listed premises and require specified information including details of people with access to materials and check authorised users against lists of persons known to have associations or contacts with terrorist organisations.

The police periodically visit the University to provide advice and conduct inspections of laboratories which hold pathogens or toxins to ensure that the possession and use of these materials is in accordance with the law. The police may want to meet managers and principal investigators and they have powers to give direction on security measures. The police are entitled to request and obtain full details of all the security arrangements and controls for the materials which may include full details of persons who have access to these materials, the locations of materials, quantities held, their use, storage; inactivation, waste disposal, and transmission of materials to other persons.

How to Notify the Police of Possession of Schedule 5 Pathogens and Toxins

The University biological safety adviser must be informed of all material requiring notification to the CTSA and Home Office to facilitate appropriate notification and subsequent liaison with the relevant parties to ensure appropriate security measures are in place prior to taking receipt of materials.

Please note that all enquiries that Schools or principal investigators receive from any sources about Schedule 5 materials must be referred to the safety coordinator and head of school and biological safety adviser before any information is provided. Please contact the biological safety adviser if you have any questions about Schedule 5 pathogens, toxins and relevant genetic materials or advice on security standards. The university biological safety adviser will provide support to the safety coordinator and heads of schools.

Anti-Terrorism, Crime and Security Act Schedule 5 List of Pathogens and Toxins

The current Schedule 5 list of materials falls into three broad categories: microorganisms, toxins and genetic sequences.

Viruses

Chikungunya virus
Congo-crimean haemorrhagic fever virus
Dengue fever virus
Dobrava / Belgrade virus
Eastern equine encephalitis virus
Ebola virus
Everglades virus
Getah virus
Guanarito virus
Hantaan virus
Hendra virus (Equine morbillivirus)
Herpes simiae (B virus)
Influenza viruses (pandemic strains)
Japanese encephalitis virus
Junin virus
Kyasanur Forest virus
Lassa fever virus
Louping ill virus
Lymphocytic choriomeningitis virus
Machupo virus
Marburg virus
Mayaro virus
Middleburg virus
Mobala virus
Monkey pox virus
Mucambo virus
Murray Valley encephalitis virus
Ndumu virus
Nipah virus
Omsk haemorrhagic fever virus
Polio virus
Powassan virus
Rabies virus
Rift Valley fever virus
Rocio virus
Sabia virus
Sagiyama virus
SARS Coronavirus
Sin Nombre virus
St Louis encephalitis virus
Tick-borne encephalitis virus (Far eastern encephalitis, formerly Russian Spring summer encephalitis virus)
Variola virus
Venezuelan equine encephalitis virus
Western equine encephalitis virus
West Nile fever virus
Yellow fever virus

Rickettsiae

Coxiella burnetii
Rickettsia prowazeki
Rickettsia rickettsii
Rickettsia typhi (mooseri)

Bacteria

Bacillus anthracis
Brucella abortus
Brucella canis
Brucella melitensis
Brucella suis
Burkholderia mallei (Pseudomonas mallei)
Burkholderia pseudomallei (Pseudomonas pseudomallei)
Chlamydophila psittaci
Clostridium botulinum
Enterohaemorrhagic Escherichia coli serotype 0157 and verotoxin producing strains
Francisella tularensis
Multiple-drug resistant Salmonella paratyphi
Salmonella paratyphi A, B, C
Salmonella typhi
Shigella boydii
Shigella dysenteriae
Shigella flexneri
Vibrio cholerae
Yersinia pestis

Toxins

Abrin
Botulinum toxins
Clostridium perfringens epsilon toxin
Clostridium perfringens enterotoxin
Conotoxin
Modeccin toxin
Ricin
Saxitoxin
Shiga and shiga-like toxins
Staphylococcal enterotoxins
Tetrodotoxin
Viscum Album Lectin 1 (Viscumin)
Volkensin toxin

Notes

1. Any reference in this Schedule to a microorganism includes:

(a) Intact microorganisms.
(b) Microorganisms which have been genetically modified by any means, but retain the ability to cause serious harm to human health.
(c) Any nucleic acid deriving from a microorganism listed in this Schedule (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious or replication competent forms of any of the listed microorganisms.
(d) Any nucleic acid sequence derived from the microorganism which when inserted into any other living organism alters or enhances that organism's ability to cause serious harm to human health.

2. Any reference in this Schedule to a toxin includes:

(a) Any nucleic acid sequence coding for the toxin.
(b) Any genetically modified microorganism containing any such sequence.

3. Any reference in this Schedule to a toxin excludes any non-toxigenic subunit.

Animal Pathogens

African horse sickness virus
African swine fever virus
Bluetongue virus
Classical swine fever virus
Contagious bovine pleuropneumonia
Foot and mouth disease virus
Goat pox virus
Hendra virus (Equine morbillivirus)
Highly pathogenic avian influenza (HPAI) as defined in Annex I(2) of Council Directive 005/94/EC
Lumpy skin disease virus
Newcastle disease virus
Peste des petits ruminants virus
Rift Valley fever virus
Rabies and rabies-related Lyssaviruses
Rinderpest virus
Sheep pox virus
Swine vesicular disease virus
Vesicular stomatitis virus

Notes

Any reference in this Schedule to a microorganism includes:

(a) Intact microorganisms.
(b) Microorganisms which have been genetically modified by any means, but retain the ability to cause serious harm to animal health.
(c) Any nucleic acid derived from a microorganism listed in this Schedule (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious or replication competent forms of any of the listed microorganisms.
(d) Any nucleic acid sequence derived from the microorganism which when inserted into any other living organism alters or enhances that organism's ability to cause serious harm to animal health.

Extremely small quantities of some of the above toxins do not have to be notified to the authorities. Less than 5mg total within a single secure area does not need to be notified. This lower limit does not apply to Clostridium botulinum and Clostridium perfringens (except alpha toxin) toxins. However, all toxins in Schedule 5 whatever the quantity even if it is below the limit must still be registered using the pathogen and toxin registration form.

Please check the relevant guidance and contact your safety coordinator and biological safety adviser for information and advice before acquiring any materials if you have any questions or are not sure what is required.