Pathogen and Toxin Registration

The possession or use of certain pathogens and toxins is controlled under health and safety, animal health, plant health, environmental and terrorism legislation and requires registration with your School and the Safety and Environmental Protection Service (SEPS). The purpose of this registration process is to ensure that the University and Schools can comply with legal requirements for work with pathogens and toxins by maintaining a complete list of certain pathogens, pathogen infected materials and toxins. The principal investigator has the primary responsibility for work with their pathogens and toxins and must ensure that the registration form is completed and submitted by providing information on the possession or proposed possession or use in advance of starting work.

Pathogen and Toxin Registration Form

Please register your pathogens, pathogen infected materials and toxins using this form but first read the guidance on this page to help you understand what does and does not need to be registered.

 

 

Pathogens, pathogen infected materials and toxins must be registered if they are already in the University and if this is the first use of the material by your group then well before they are obtained or brought into the university. This will enable any necessary advice to be provided to Schools and principal investigators by the safety coordinators and biological safety adviser.

Guidance on What Must be Registered

Please note that you only need to register the basic details of pathogens, pathogen infected materials and toxins and not the specific details of every strain or sample that you have or intend to bring into the University although you should provide additional details relating to any unusually virulent or novel strains. Only simple and straightforward information is needed. The purpose of registration is just to ensure that we maintain a list of the actual hazards in the University and School and not a list of all individual samples or their movement into and out of the University.

You will be asked to provide some basic information for the registration form including the name and email of the principal investigator who is the responsible person, School, name and email of your safety coordinator, details of the pathogens, pathogen infected materials or toxins, where they are to be obtained, where they are to be kept, whether they are genetically modified organisms and whether they require a Scottish Government or DEFRA animal health or plant health licence. Please submit one copy of the form for each pathogen species or toxin used by a research group. You should provide details of different strains of a pathogen or types of a toxin on the same form. You can choose to use a separate form for each pathogen or toxin or use a single form for multiple different pathogens, pathogen infected materials and toxins. You must use the official names of pathogens and toxins as supplied in the government guidance (eg HSE, DEFRA) but you can use the latest scientific names in addition if they are different. Keep the information simple as shown in the following example completed form.

 

 

Once you have completed the registration form then a copy should be sent by email to the principal investigator, safety coordinator and university biological safety adviser in SEPS. The principal investigator should keep a copy of the registration form for their records. The safety coordinator should keep a copy of all registration forms and a full list of all pathogens and toxins for the School records. SEPS will keep a copy of each registration form and a list of registered pathogens and toxins for records. In addition to registration, principal investigators are required to keep detailed records of the pathogens and toxins, strains, types, origin, or other identification of the pathogens or toxins and persons who have access to or use the pathogens or toxins. These records must also include all pathogens and toxins held or worked with by each individual and must be kept readily available for inspection and use in an emergency. Please contact your safety coordinator if you have any questions about how to register and whether or not your particular pathogen or toxin should be registered.

Do Not Register These Pathogens and Toxins

Do not register standard biological or clinical materials which may or may not be contaminated with listed biological agents pathogens or microorganisms unless there is a known or suspected higher risk of their presence in the materials. Do not register any toxins other than those on Schedule 5 list of pathogens and toxins.

Register These Pathogens and Toxins

Register any biological agents or pathogens classified in hazard group 2, 3 or 4 by the HSE Advisory Committee on Dangerous Pathogens (ACDP), the Scottish Government or DEFRA. Register any animal or plant pathogens or pests which require an animal health or plant health licence (eg SAPO licence). Register any pathogen, toxin or relevant genetic material listed on Schedule 5 of the Anti-Terrorism, Crime and Security Act (ACTSA). All genetic materials which are subject to ACTSA whether or not they are subject to the Genetically Modified Organisms (Contained Use) Regulations need to be registered using the pathogen and toxin registration forms.

Section A Biological Hazards

Please provide details of the biological hazards. Register only one biological hazard on a single registration form and use a separate form for different biological hazards.

Include

  • Biological hazards or materials which contain biological agents, pathogens or microorganisms classified in hazard group 2, 3 or 4 by HSE ACDP.
  • Biological hazards or materials which contain biological agents, pathogens or microorganisms classified in hazard group 2, 3 or 4 by the Scottish Government or DEFRA.
  • Biological hazards or materials which contain animal pathogens or plant pathogens or pests which require an animal health or plant health licence (eg SAPO licence).
  • Biological hazards or materials which contain pathogens or relevant genetic materials on the Schedule 5 list of pathogens and toxins of the Anti-Terrorism, Crime and Security Act.
  • Human tissues, cells, blood, fluids and other materials or samples originating from countries outside the EU, USA or Canada, irrespective of whether these are obtained from the original source or indirectly by way of a third party in the EU, USA or Canada.
  • Human tissues, cells, blood, fluids and other materials or samples from individuals who are either known to be or are likely to have been (eg high risk group) infected by any ACDP hazard group 3 or 4 pathogen.
  • Animals, animal tissues, cells or other material known or believed to contain any of the animal pathogens requiring an animal health licence.
  • Plants, plant tissues, cells or other materials known or believed to contain any of the plant pathogens or pests requiring a plant health licence.
  • Materials which contain or could potentially contain polio virus. For information on what needs to be registered see the polio virus guidance below and more information can be obtained from the Health Protection Scotland (HPS), Public Health England (PHE) and World Health Organisation (WHO).


Exclude

  • Most tissues, cells, blood, fluids and other materials or samples from EU, USA or Canadian sources, and most cell lines unless they satisfy one of above conditions.


Section B Biological Agents

Please provide details of the biological agents. Register only one biological agent on a single registration form and use a separate form for different biological agents. Different strains of a biological agent should be put on the same form.

Include

  • Biological agents, pathogens or microorganisms classified in hazard group 2, 3 or 4 by HSE ACDP.
  • Biological agents, pathogens or microorganisms classified in hazard group 2, 3 or 4 by the Scottish Government or DEFRA.
  • Animal pathogens and plant pathogens or pests which require an animal health or plant health licence (eg SAPO licence).
  • Pathogens or relevant genetic materials on the Schedule 5 list of pathogens and toxins of the Anti-Terrorism, Crime and Security Act.
  • You must also register any biological agents, pathogens or microorganisms, species, strains or isolates not appearing in any of the relevant lists when there are reasonable grounds for suspecting it might be a previously unrecognised human pathogen or capable of causing animal or plant disease.


Exclude

  • Well characterised species not listed in ACDP hazard groups 2, 3, or 4 and not included in the lists of species or materials requiring an animal health or plant health licence.
  • Poorly characterised species or isolates where there is no reason to suspect that it is likely to be pathogenic for humans or to cause animal or plants diseases.
  • Most strains of E. coli K12 or E. coli BL21. Although wild-type E. coli strains are assigned to either ACDP hazard group 2 or in a few specific cases hazard group 3, the E. coli strains that are most commonly used in genetic modification have been derived from highly disabled E. coli K12 or E. coli BL21 strains which are considered to be equivalent to ACDP hazard group 1. Such strains should be excluded from the register unless they contain cloned sequences that place them in one of the other categories specified on the form.


Section C Toxins

Please provide details of the toxins. Register only one toxin on a single registration form and use a separate form for different toxins. Different types of a toxin should be put on the same form.

Include

  • Toxins or relevant genetic materials on the Schedule 5 list of pathogens and toxins of the Anti-Terrorism, Crime and Security Act.


Exclude

  • Toxins not on the Schedule 5 list of pathogens and toxins of the Anti-Terrorism, Crime and Security Act.


Guidance on Pathogens and Toxins

If you are uncertain of whether any pathogen, toxin or material which might be contain pathogens or toxins should be registered then you should contact your safety coordinator. Excellent guidance on pathogens and toxins which you should find useful is available from the Health and Safety Executive (HSE), Scottish Government, Department for Environment, Food and Rural Affairs (DEFRA), Health Protection Scotland (HPS), Public Health England (PHE), World Health Organisation (WHO) and National Counter Terrorism Security Office (NaCTSO).

 


The details of human pathogens can be found in the HSE ACDP Approved list of biological agents on the HSE website. Details of animal pathogens which require a Scottish Government or DEFRA animal health licence (eg SAPO licence) can be found on the Scottish Government Animal Health and DEFRA Animal Health websites. Details of plant pathogens and pests which require a Scottish Government or DEFRA plant health licence is supplied on the Scottish Government Plant Health and DEFRA Plant Health websites. The list of pathogens and toxins in Schedule 5 of the Anti-Terrorism, Crime and Security Act is available in the Biological Security for Pathogens and Toxins section of the website and is also on the NaCTSO website. Please note that many microorganisms, biological hazards, biological agents, animal pathogens, plant pathogens, pests, genetically modified organisms, human tissues, animal tissues and plant tissues may require general or specific licences for their possession, use or importation into the country. Please check the relevant guidance and contact your safety coordinator for information and advice before acquiring any materials if you have any questions or are not sure what is required.

Guidance on Polio Virus

There is a global polio eradication programme to eliminate polio virus from the world and so it is necessary to record and notify the relevant regulator where any materials which may contain polio are held by laboratories. This guidance should help you to understand which materials may potentially contain polio virus and must therefore be registered.

Definitions of Polio virus and related materials
The following excerpt is from the WHO Global Action Plan for laboratory containment of wild polioviruses version 3 (Annex 4 Biorisk Management Standard for essential poliovirus facilities) and provides details of the materials which are the subject of the action plan for polio containment.

Poliovirus
A picornavirus consisting of three serotypes: 1, 2, and 3. Poliovirus serotypes are further sub-divided into wild (Circulating in nature) and Sabin strains (Attenuated strains of oral polio vaccines [OPV]).
 
Poliovirus (Wild)
Wild poliovirus are naturally occurring isolates known or believed to have circulated persistently in the community, attenuated strains not approved for vaccines (Cox / Lederle and Koprowski / Wistar series), and vaccine-derived polio viruses [VDPV] (Isolates consistent with an extensive period of virus excretion or transmission in the community, demonstrating 1-15% differences from parent OPV strains by full VP1 sequence homology). Wild poliovirus materials may be (a) infectious materials or (b) potential infectious materials.

Poliovirus infectious materials (Wild)
Wild poliovirus infectious materials include the following:

  • Clinical materials from confirmed wild poliovirus (including VDPV) infections, environmental sewage or water samples in which wild polioviruses are present.
  • Cell culture isolates, and reference strains of wild poliovirus Seed stocks and infectious materials from IPV production.
  • Infected animals or samples from such animals, including PVR transgenic mice.
  • Derivatives produced in the laboratory that have capsid sequences from wild polioviruses.
  • Full-length RNA or cDNA that include capsid sequences derived from wild poliovirus.
  • Cells persistently infected with poliovirus strains whose capsid sequences are derived from wild poliovirus.


Poliovirus potential infectious materials (Wild)
Wild poliovirus potential infectious materials include the following:

  • Faecal or respiratory secretion samples collected for any purpose in a time and geographic area of wild poliovirus (including VDPV) circulation.
  • Products of such materials in poliovirus permissive cells or animals.
  • Uncharacterized enterovirus-like cell culture isolates.
  • Respiratory and enteric virus stocks handled under conditions where poliovirus contamination or replication is possible.


Poliovirus (Sabin)
OPV/Sabin strains are attenuated poliovirus strains (approved for use in oral polio vaccines by national regulatory authorities, principally Sabin strains) and OPV-like polioviruses (isolates consistent with a limited period of virus excretion or person-to-person transmission, demonstrating less than 1% difference from parent OPV strains by full VP1 sequence homology). OPV/Sabin materials may be infectious (a) or potential infectious (b).
 
Poliovirus infectious materials (OPV / Sabin)
OPV/Sabin infectious materials include the following:

  • Cell culture isolates and reference OPV / Sabin strains.
  • Seed stocks and live virus materials from OPV production.
  • Environmental sewage or water samples in which OPV / Sabin strains are present.
  • Faecal or respiratory secretion samples from recent OPV recipients.
  • Infected animals or samples from such animals, including PVR transgenic mice.
  • Derivatives produced in the laboratory that have capsid sequences from OPV / Sabin strains.
  • Full-length RNA or cDNA that include capsid sequences derived from OPV / Sabin strains.Cells persistently infected with poliovirus strains whose capsid sequences are derived from OPV/Sabin strains.


Poliovirus potential infectious materials OPV/Sabin
OPV/Sabin potential infectious materials include the following:

  • Faecal or respiratory secretion samples collected for any purpose in a time and geographic area of OPV use.
  • Products of such materials from poliovirus permissive cells or animals.
  • Respiratory and enteric virus stocks handled under conditions where OPV / Sabin strain contamination or replication is possible.


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