Single Regulatory Framework for the Contained Use of Human & Animal Pathogens

SRF Briefing note (MS Word , 83kb)

What is the Single Regulatory Framework?

The investigation into the Foot & Mouth outbreak which began in Pirbright, Surrey, in 2007, highlighted the need for better regulation of animal pathogens. One of the key recommendations was that there should be a Single Regulatory Framework (SRF) to govern work with human and animal pathogens so that they can be managed in a more robust and consistent way. Another key recommendation was for the Health & Safety Executive (HSE) to become the single regulatory body for both human and animal pathogens, with responsibility for inspection and enforcement functions.

Current regulation of work with biological agents

Several regulations currently cover work with human and animal pathogens. These include:

Genetically Modified (Contained Use) Regulations: covers all our work with GM plants, animals and microorganisms (regulated by HSE). Purpose: protection of human health & the environment.
Control of Substances Hazardous to Health (COSHH): covers deliberate work with hazardous biological agents as well as incidental exposure to biological agents (regulated by HSE). Purpose: protection of human health.
Specified Animal Pathogens Order (SAPO): covers work with animal pathogens (regulated by Department for Environment, Food and Rural Affairs (DEFRA)). Purpose: protection of animal health.

Proposed new regulations for work with biological agents (human & animal pathogens)

The challenge has been to develop a streamlined, workable, risk based system that applies to all 'contained uses' with human and animal pathogens as well as GMOs. The SRF, for the regulation of human and animal pathogens, will be implemented as the 'Biological Agents & Genetically Modified Organisms (Contained Use*) Regulations 2010'

* The term 'Contained Use' is used for work activities involving biological agents where physical, chemical or biological barriers are used to limit their contact with, and to provide a high level of protection for, humans & relevant animals and, in case of GMMs, the environment.

What are the key changes to the regulation of biological agents?

Single regulatory framework based on current GM system
COSHH will no longer apply for work activities where deliberate work with biological agents (e.g. propagating or concentrating a biological agent) takes place, requiring containment measures to prevent or control the risk of exposure
Single regulatory body (HSE)
The categorisation of wild-type biological agents, approved by the Health & Safety Executive, into one of four combined hazard groups:
- agents categorised according to the risk to humans as set out in the four human hazard groups, and any additional risk to relevant animals
- human and animal pathogens will be placed on an 'Approved List 2010'
Common set of containment measures:
- for contained use of wild-type biological agents and GMOs
- application of containment measures outlined in new combined tables (1 – 4)
- ability to derogate where appropriate and when agreed by the 'Competent Authority' (HSE)
A proportionate risk based approach to be applied for the assessment for all activities involving human and animal pathogens:
- classification of activities into classes 1 to 4, reflecting the organism being used and the nature of the work activity itself (as for current GM work activities)
- Classification (1-4) of work activities based on the highest containment level from which a control measure is required (as for current GM work activities)
- Class 1&2 activities will represent lower risk activity requiring proportionate regulatory activity and greater self-regulation
- Class 3&4 activities will represent higher risk activities requiring more detailed regulatory activity
Integrated notification system:
- premises notification
- contained use notification
  - Class 2 activities
  - Class 3 & 4 activities (consent)
Cost recovery regime:
- in 'Managing Public Money'& it is HM Treasury policy to recover costs for publicly provided services
- HSE, therefore, to recover costs for:
  - notification
  - inspection
  - investigation
Establishment of genetic modification and biological safety committees:
- establishment of a GM safety committee (no change)
- establish a biological safety committee to provide advise on class 3 and 4 contained use activities (note: our University 'Biological Agents Safety Committee' already does this)

Timetable for the transition to the new regulations?

The Contained Use Regulations will probably come into force towards the end of 2011 / early 2012, with full implementation by the end 2012.
Table 1 (see SRF Briefing note (MS Word , 83kb)), shows the 'Timetable for Transition to the 'Biological Agents, Contained Use Regulations'. In summary:
- 2011 Premises information submitted by early 2012
- All ongoing contained use activities notified by early 2012
- All facilities brought up to standard by end 2012

What will the University have to do to meet the new requirements?

Table 2 (see SRF Briefing note (MS Word , 83kb)) summarises the key actions that are necessary for the University of York to meet the requirements of the new regulatory system.
Note: since the existing system for GM work will remain in place, there will be no need to re-notify notifiable activities to the HSE

Issues for consideration during the consultation period

Not clear at present whether work with potentially infectious material, e.g. human material, will be notifiable, especially if there is no intent to isolate any pathogens that might be present. Although it is recognised that this work needs to be undertaken in a containment laboratory, the need to apply the full process of classification and notification of this low risk work to the HSE is less clear. It has been suggested that such work be covered by a single 'generic' assessment and notification as for employers carrying out diagnostic work.
Cell cultures are covered by the regulatory definition of 'biological agent'. Cell cultures obtained from a reputable source or those having a long history of safe use and routinely screened could be classified as a Class 1 activity. However, work with unscreened primary human or animal cells will probably be classified as a Class 2 activity. Given the extent of such work in the academic sector and the likelihood that there would be no intention to isolate any contaminating biological agents, it was not clear why HSE needed to know about such activities given the low risk (even if handled at CL2). If notification of this type of work is necessary, the preparation of a single generic notification would be considered.