Briefing Note:
The Single Regulatory Framework for the Contained Use of
Human & Animal Pathogens
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.
What are the Key Changes to the
Regulation of Biological Agents?
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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 Use1) Regulations 2011’.
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1
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:
o agents categorised according to the risk to
humans as set out in the four human
hazard groups, and any additional risk to
relevant animals
o human and animal pathogens will be
placed on an ‘Approved List 2011’
Common set of containment measures:
o for contained use of wild-type biological
agents and GMOs
o application of containment measures
outlined in new combined tables (1 – 4)
o 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:
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.
Page 1 of 4
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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)
o 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)
o Class 1&2 activities will represent lower
risk activity requiring proportionate
regulatory activity and greater selfregulation
o Class 3&4 activities will represent higher
risk activities requiring more detailed
regulatory activity
Integrated notification system:
o premises notification
o contained use notification
 Class 2 activities
 Class 3 & 4 activities (consent)
Cost recovery regime:
o in ‘Managing Public Money’ it is HM
Treasury policy to recover costs for
publicly provided services
o HSE, therefore, to recover costs for:
 notification
 inspection
 investigation
Establishment of genetic modification and
biological safety committees:
o establishment of a GM safety committee
(no change)
o 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)
o
o
What will the University Have to do to
Meet the New Requirements?
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The Contained Use Regulations are expected to
come into force by end 2011 / early 2012 with full
implementation by the end of 2012.
Table 1, shows the ‘Timetable for Transition to the
‘Biological Agents, Contained Use Regulations’.
In summary:
o 2011 Premises information submitted by
end 2011
Table 2 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
Consultation Period
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Timetable for the Transition to the New
Regulations?
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All ongoing contained use activities
notified by early 2012
All facilities brought up to standard by end
end 2012
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.
D Nelson
Biological Safety Adviser
Version 3: January 2011
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Table 1: HSE’s Timetable for Transition to the ‘Biological Agents, Contained Use Regulations 2011
2011
2012
Transitional Period
Jan
Feb
Mar
Apr
May
Jun
GMO (Contained Use) Regulations
Control of Substances Hazardous to Health
Specified Animal Pathogens Order
Jul
Aug
Sept
Oct
Nov
Dec
Jan
Feb
Premises
Information
Submitted
All ongoing contained uses
notified
All facilities brought up to standard
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Mar
Apr
May
Jun
Jul
Full Compliance with
Biological Agents & GMO
(Contained use)
Regulations 2010
Table 2: University of York- Timetable of Actions to Meet the New Regulatory Requirements
Action
HSE to Consult with Stakeholders re. new
regulations
Brief all Group Leaders / Supervisors of work
activities involving biological agents on new
regulations:
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BSA2
BASC3
Revise risk assessment form for work with wild-type
biological agents
BSA
Premises notification
BSA
Ongoing contained use activity notification
3
Jan
Feb
Mar
HSE
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Revise University policy document to reflect
regulatory changes (The Biological Agents
‘Management Procedure’)
Review terms of reference for the Biological Agent s
Safety Committee
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2011
Completed
Biology Academic Staff Meeting
Email correspondence
Revision of all current work activities involving wild
type human / animal pathogens, including materials
(e.g. human material) that may contain them
Review assessments for GMO activities and revise, if
necessary, in light of new ‘contained use’ regs.
2
Who?
Includes all our Class 2 & 3 activities involving
non-GM human & animal pathogens
BSA
Group
Leaders
Group
Leaders
Group
Leaders /
BSA
University Biological Safety Adviser
Biological Agents Safety Committee
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Apr
May
Jun
Jul
2012
Aug
Sep
Oct
Nov Dec
Jan
Feb
Transitional Period
Mar