Memorandum 1
Submission from the Government, submitted
by the Department for Innovation, Universities and Skills
INTRODUCTION
1.1 Work with dangerous pathogens enables
us to understand better how infectious diseases of human and animals
develop and spread, which is essential if we are to develop effective
treatments and vaccines against them. In addition to protection
against naturally-occurring disease outbreaks, research involving
dangerous pathogens provides the UK and its Armed Forces with
safe and effective protection against the hazards of exposure
to biological warfare agents.
1.2 The UK university and research sectors
are very strong, and have a good international reputation. For
example the Health Protection Agency (HPA) is a world leading
contributor to research on human pathogens and the National Institute
of Biological Standards and Control (NIBSC) is the world leader
in many areas of biological standardisation. Both organisations
play a crucial role in frontline defence against future threats
such as pandemic influenza. Their work maintains UK capabilities
in a vital area for national security.
1.3 Research on animal pathogens has also
made a positive contribution to our ability to diagnose and understand
disease occurrence, spread and future disease threats:
— Research has developed methods
using full genome sequencing of Foot and Mouth Disease (FMD) viruses
that have facilitated the tracking of the spread of FMD and identication
of the order in which farms become infected within a complex outbreak.
— A simple molecular test to detect
FMD virus has been developed, which can be used as the basis of
a rapid and disposable device for field diagnosis.
— Work on the transmission dynamics
of avian influenza virus will add to the evidence base on suitable
control measures and risks to commercial poultry production from
wild birds.
1.4 UK industry has built on this work by
developing commercially successful vaccines against diseases such
as anthrax and smallpox.
1.5 As Sir Bill Callaghan noted in his Review
of the Regulatory Framework for Handling Animal Pathogens:[1]
"The ability to handle animal pathogens
in laboratories is essential if we are to fully understand infectious
diseases and to develop effective vaccines against them. The [...]
research carried out in UK laboratories plays an important role
in the international fight against existing and emerging diseases.
Without this research, there would be a significant adverse impact
on the well being of both people and animals around the world."
This point also applies to the ability to handle
human pathogens.
1.6 It is thus imperative that we continue
to maintain the capacity for research on dangerous pathogens in
the UK. But we also need to minimise the risks from that work.
This was highlighted in August 2007, when an outbreak of FMD was
traced to a site at Pirbright in Surrey where the virus was being
used in research and vaccine production.
1.7 Following this incident, two reviews
have been published which bear on the containment of dangerous
pathogens in UK research facilities. Both the Independent Review
of the safety of UK facilities handling foot-and-mouth disease
virus by Professor Brian Spratt[2]
and A Review of the Regulatory Framework for Handling Animal
Pathogens1 chaired by Sir Bill Callaghan made recommendations
to improve containment and biosecurity. The Government has fully
accepted all recommendations applicable to Government, most recently
in a written statement[3]
to the House on 13 December, when Sir Bill Callaghan's report
was published. In particular, the Government has agreed that the
role of the regulator of laboratories handling animal pathogens
should move from Defra to the Health and Safety Executive. In
addition, relevant Government Departments and Agencies are working
together to establish a single regulatory framework to rationalise
the control of human and animal pathogens.
1.8 This memorandum explains controls that
apply in research laboratories. It covers the situation in Great
Britain. Where relevant, it explains the changes being made in
response to the recent recommendations.
1.9 The legislation described in this memorandum
is concerned only with ensuring the biosafety and biosecurity
of research facilities. Such facilities will additionally have
to comply with any other relevant legislation, for example the
Animal (Scientific) Procedures Act 1986 for research involving
animals protected by the Act.
1.10 This memorandum represents the contributions
of the following Government departments and agencies:
— Department for Transport;
— The Health and Safety Executive
(HSE);
— Department for Innovation Universities
and Skills;
— The Foreign and Commonwealth
Office (FCO);
— Department for the Environment,
Food and Rural Affairs (Defra); and
— Ministry of Defence (MoD)
1.11 The FCO's Science and Innovation Network
will be responding to the Committee separately, as will the Devolved
Administrations and RCUK (a partnership of seven UK Research Councils).
2. The current capacity for research on dangerous
pathogenic material in the UK and the capability to conduct research
on the causative agents of disease that may emerge at a future
time
2.1 The sector working with dangerous pathogens
includes a workforce of approximately 250,000 scientists working
in a range of laboratory premises in healthcare, academia and
industry. The UK has a large network of research facilities and
diagnostic laboratories where work is undertaken with dangerous
pathogens. Details are given below of the number of facilities
which hold licences or are regulated to allow them to work on
dangerous pathogens.
2.2 We will describe separately laboratory
biosafety and laboratory biosecurity. Biosafety will be used to
refer to the appropriate containment of pathogens in the laboratory
environment, both to prevent exposure of workers within the laboratory,
and exposure of people, animals and other vulnerable organisms
in the external environment. Biosecurity will be used to refer
to the secure storage, use and transport of dangerous pathogens
and toxins to reduce the risk of malicious use.
2.3 Biosafety
2.3.1 Biosafety in laboratories is covered
by three separate pieces of legislation:
— Control of Substances Hazardous
to Health Regulations 2002 (COSHH)—regulated by HSE;
— Specified Animal Pathogens Order
1998 (SAPO)—currently regulated by Defra, Scottish Executive
and National Assembly for Wales; and
— Genetically Modified Organisms
(Contained Use) Regulations 2000 (GMO(CU)). There is a joint Competent
Authority—HSE and Defra in England and Wales, and HSE and
the Scottish Executive in Scotland. HSE acts as the lead Competent
Authority, and enforces the legislation in Great Britain.
2.3.2 With minor differences, each piece
of legislation indicates the appropriate Containment Level (CL)
for each facility, the level being dependent on the nature of
the micro-organisms in use:
— CL 1—appropriate for micro-organisms
posing no or negligible risk;
— CL 2—appropriate for micro-organisms
posing low risk;
— CL 3—appropriate for micro-organisms
posing moderate risk; and
— CL 4—appropriate for micro-organisms
posing high risk.
The legislation specifies which micro-organisms
require which levels of containment. This is covered in more detail
in section 4.
Effectively, work with dangerous pathogens is
restricted to CL 2, 3 & 4 laboratories, and the following
information applies to only these.
2.3.3 Pathogens for which CL1 is appropriate
are not considered to pose a risk to human health or the wider
environment, and the regulatory framework is minimal under COSHH
and SAPO. The Importation of Animal Pathogens Order 1980 as amended
(IAPO) prohibits the importation into Great Britain from third
countries of all risk groups of animal pathogens or carriers except
under the authority of a valid licence issued by Defra, the Scottish
Executive or Welsh Assembly. Under the GMO(CU) Regulations, all
centres working with genetically modified organisms (GMOs) must
notify the Competent Authority before commencing work for the
first time, including work at CL1. However, once a centre is notified,
no further notification is required for work requiring only CL1.
2.4 In this memorandum, the term "dangerous
pathogens" will be used throughout, and covers human and
animal pathogens as well as genetically modified micro-organisms
(GMMs) which require CLs 2, 3 and 4.
2.5 Organisations working with dangerous pathogens
at containment level 2, 3 and 4 under regulation by HSE and/or
SAPO
2.5.1 As Table 1 below shows, most work
with dangerous pathogens is done in Government and Research Council
laboratories, and is regulated by HSE only.
2.5.2 Similar work is carried out in 70
different universities (those working at level 3 are also included
in the 70 listed at level 2—ie all that handle CL3 pathogens
also handle CL2 pathogens).
Table 1
ORGANISATION OR SITE[4]
TYPE[5]
| Containment level
| Government | Private
| Research Council | University
|
| 2 | 212 | 230
| 17 | 70 |
| 3 | 202 | 98
| 7 | 40 |
| 4 | 5 | 2 |
3 | 0 |
2.5.3 The numbers of organisations working with dangerous
pathogens in Great Britain are presented in Table 2 below. The
term "organisation" is used at the employer level, eg
The University of Oxford. Organisations may have multiple facilities
for work with dangerous pathogens. For example, one university
has over 50 containment level 3 laboratories located on different
sites. The term "site" is used for the different departments/locations/campuses
where the laboratories are housed.
Table 2
NUMBER OF ORGANISATIONS IN GREAT BRITAIN
| Containment level | COSHH and/or GMO(CU) regulated only
| SAPO regulated only | HSE & SAPO combined
| Total |
| 2 | 494 | 7
| 28 | 529 |
| 3 | 323 | 5
| 19 | 347 |
| Number of sites |
| | |
| 4[6]
| 1 | 2 | 7 |
10 |
These data represent the situation at December 2007 and cover
a dynamic sector with frequent changes to organisations, facilities
and projects. As such, these figures may be subject to change.
2.6 Biosecurity
2.6.1 Biosecurity is covered by measures set out in the
Anti-terrorism Crime and Security Act 2001 (ATCSA), which are
implemented by the National Counter-Terrorism Security Office
(NaCTSO). Part 7 of the ATCSA provides the police with powers
to impose security measures at laboratories in the UK that hold
certain dangerous pathogens and toxins (as listed in Schedule
5 of the Act).
2.6.2 There are just over 100 pathogens and toxins caught
by Part 7 and Schedule 5 of ATCSA. Approximately 400 laboratories
in the UK are required to register under the legislation. This
includes university and hospital laboratories but not necessarily
diagnostic laboratories (which are an exception under the Security
of Pathogens and Toxins (Exceptions to Dangerous Substances) Regulations
2002 (Statutory Instrument 1281).
2.7 Emerging diseases
2.7.1 Many of these licensed facilities are involved
in work on diseases that may emerge at a future time, such as
NIBSC's work on pandemic influenza. There is a significant amount
of work carried out by the HPA, Medical Research Council and universities
on pathogens which may pose a threat to the UK in the future,
for example due to climate change or population movement.
2.7.2 Horizon scanning to identify existing and emerging
infectious disease threats to public health in the UK is undertaken
by the HPA's Microbial Risk Assessment team, supported by specialist
diagnostic expertise in the Special Pathogens Reference Laboratory.
2.7.3 The HPA is a key player in the European Commission's
public health infectious disease networks and provides consistent
UK surveillance data for many diseases, based on its specialist
microbiological services. It is the UK portal for the European
Union Early Warnings and Alerts and for Assistance Calls, and
its Centre for Emergency Preparedness and Response (CEPR) works
closely with other centres, particularly in Europe, North America
and Australasia.
2.7.4 Many staff at the CEPR are internationally renowned
experts in their field and often provide advice and consultancy
for the World Health Organization (WHO) and other international
agencies. The HPA also houses many WHO Collaborating Centres and
WHO Reference Laboratories for various infections (including polio
and SARS).
2.7.5 On behalf of the MoD and the Government, the Defence
Science and Technology Laboratory has the capability to safely
undertake both in vivo and in vitro research with dangerous pathogens.
The scope of the research programme is to provide effective protective
measures against the range of potential biological and toxin agents
which may be used aggressively by terrorists or in times of conflict.
2.7.6 Horizon scanning for future animal disease threats
is conducted in different ways. Outbreaks of disease in the member
countries of the Office Internationale des Epizooties (OIE) are
reported through a notification system and this gives valuable
information to allow global tracking of infectious diseases of
significance. An additional system, placing obligations on the
Member States to report outbreaks, is operated via the European
Commission.
2.7.7 In addition, both the Veterinary Laboratories Agency
(VLA) and the Biotechnology and Biological Sciences Research Council
sponsored Institute for Animal Health at Pirbright act as World
Reference Laboratories. In this capacity, they have regular dialogue
with the veterinary authorities and diagnostic laboratories in
many countries which, when pieced together with the consultancy
advice they provide, enable emerging trends to be identified.
The VLA has a well established programme of scanning surveillance
covering farmed livestock and wildlife disease diagnosis, to provide
baseline data on disease occurrence and assessment of potential
emerging diseases or infections.
2.7.8 Defra carries out veterinary risk assessments of
outbreaks overseas to inform their policies, and publishes Quarterly
International Disease Surveillance reports.
3. The state of biological containment facilities in the
UK
3.1 Assessment by HSE
3.1.1 HSE is responsible for inspection and enforcement
at facilities in Great Britain where work is undertaken with dangerous
pathogens and GMOs. The work is carried out by staff from Staff
from HSE's Biological Agents Unit.
3.1.2 The standard of compliance with regulations in
the UK is generally good. The standard of laboratories has improved
in recent years, and there is clear evidence of investment in
infrastructure.
3.1.3 Table 3 below shows that 514 inspections were carried
out by HSE between 2004 and September 2007. A small number of
improvement notices was served in that period, reflecting the
generally high standards of containment and management control
at biological containment facilities.
Table 3
ENFORCEMENT SUMMARY IN BIOLOGICAL AGENTS SECTOR
| Category | Type
| Detail | 2002-03
| 2003-04 | 2004-05
| 2005-06 | 2006-07
| Mid Year 2007-08 | Grand Total
|
| Enforcement | | Prohibition Notice
| | 1 | |
| | | 1 |
| | Crown Censure
| | 1 | |
| | | 1 |
| | Improvement Notice
| 4 | 3 | 5 |
2 | 8 | | 2
|
| | Notice Count
| 4 | 4 | 5 |
2 | 8 | | 22
|
| | Enforcement Total
| 4 | 5 | 5 |
2 | 8 | | 23
|
| Intervention | Inspection |
Inspection Count | |
| 179 | 121 | 145
| 69 | 514 |
| Investigation | RIDDOR[7]Accident
| | | 1 | 3
| 3 | 2 | 9 |
| | Complaint
| | | |
| 1 | | 1 |
| | RIDDOR Disease
| | | |
| 2 | | 2 |
| | RIDDOR Dangerous Occurrence
| | | 5 | 7
| 12 | 4 | 28 |
| | GMO Accident
| | | |
| 2 | | 2 |
| | GMO Report of Disease
| | | |
| 1 | | 1 |
| | RIDDOR Count
| | | 6 | 10
| 21 | 6 | 43 |
| | Intervention Total
| | | 185 |
131 | 166 | 75 |
557 |
3.2 Assessment of biological containment facilities by National
Counter-Terrorism Security Office (NaCTSO
3.2.1 NaCTSO assesses all laboratories required to register
under ATCSA using a "Traffic Light" system. Currently,
no laboratories are rated as "red" (of concern). There
are many new laboratories being built in the UK which will be
incorporating the "gold standard" of security measures
in their design, as defined in the Home Office document Security
Standards for Laboratories. This ensures a continuing improvement
in laboratory security across the UK.
3.3 Compliance with the Carriage of Dangerous Goods and Use
of Transportable Pressure Equipment Regulations 2007
3.3.1 The HSE is the enforcement authority for these
safety regulations, aided by the Vehicle Operators and Services
Agency and the police at the roadside. HSE inspectors undertake
inspections at premises often in conjunction with other enforcement
activities. Generally, there is no evidence of non-compliance
with these requirements.
3.4 Inspection activity since the accidental release of FMD
Virus from Pirbright
3.4.1 Following the publication of the investigation
report following the 2007 outbreak of FMD, HSE and Defra released
a Safety Alert on 7 September 2007. This was aimed at all high
containment laboratories, to draw attention to the issues arising
from the investigation. In addition, HSE and Defra committed to
undertake a programme of inspections.
3.4.2 The first phase of the Safety Alert inspection
programme focussed on CL4 facilities where work is undertaken
with Hazard Group (HG) four dangerous pathogens, including both
human and animal pathogens.
3.4.3 The inspections revealed no breaches of the legislation
and no formal enforcement action was taken. This process has provided
both the regulatory bodies and the operators of the laboratories
with the assurance that their facilities are well managed. The
inspections have also provided a useful opportunity to provide
advice and guidance on good practice. HSE will continue this series
of Safety Alert inspections to consider CL3 facilities based on
risk. The inspections will begin in January 2008 and will be completed
by the end of the year.
4. Laboratory inspection regimes and the rationale and
practicalities of the licensing system
4.1 Regulation and Licensing of work with dangerous pathogens
4.1.1 There is currently a complex regulatory framework
for work with dangerous pathogens with different regimes for different
types of pathogens, and the individual regimes are covered below.
However, the Callaghan review recommended that a single regulatory
framework should be developed to govern work with human and animal
pathogens. Work is in progress to establish how this can be achieved
in the recommended timescale. The following gives details of the
current systems.
4.2 Human Pathogens: Control of Substance Hazardous to Health
2002 (COSHH)
4.2.1 HSE is responsible for COSHH, and regulates compliance
in respect of deliberate work with human pathogens. Deliberate
work means carrying out activities such as propagation, for example,
as would occur in bacteriology, virology, mycology and parasitology
laboratories. HSE develops policy in consultation with other Government
Departments, including the Department of Health and Defra.
4.2.2 The COSHH regulations are wide ranging, covering
all workplace exposure to substances that are hazardous to health.
These include carcinogens, chemicals and other substances, such
as microorganisms and toxins. Specific requirements relating to
microorganisms are covered in Schedule 3 of the regulations, which
apply, primarily, to laboratory and large-scale work with dangerous
pathogens. The choice of control measures in laboratories is largely
based on the HG of the pathogen that is being used (or that may
be present). Pathogens are classified into one of four hazard
groups from HG1 (the lowest) to HG4 (highest, eg Ebola virus)
based on their ability to infect healthy adults. The classification
is set out in the Approved List of Biological Agents, which is
published on the HSE Website at http://www.hse.gov.uk/pubns/misc208.pdf
4.2.3 The HGs equate to the CLs—containment level
4 is required for hazard group four pathogens, etc. The list is
updated when new pathogens emerge, or when new evidence accrues
on the pathogenicity of individual strains.
4.2.4 In addition to using specific control measures,
those working with dangerous pathogens need to notify HSE at least
20 days in advance of any planned work where HG2, HG3 and HG4
are used for the first time, at particular premises. Notification
is also required of the subsequent use of certain organisms (ie
those in HG3 and HG4 and those in HG2 that are listed in Part
V of Schedule 3 of COSHH are used for the first time).
4.2.5 Although this is not an approval system, HSE requires
the notification to include sufficient information to demonstrate
that duty holders have identified hazards associated with the
organism which might arise from carrying out the work. This includes
circumstances where staff (and others) could be exposed to a source
of infection during the work, and the measures that will be applied
to prevent or control exposure. The supporting documentation can
include a risk assessment, a local code of practice or standard
operating procedures/protocols. Where sufficient information is
not provided, it may be requested.
4.2.6 Where necessary, technical advice can be obtained
from the Advisory Committee for Dangerous Pathogens (ACDP), whose
remit is to advise on risks to workers and others from exposure
to pathogens. The ACDP is an independent committee which advises
the Health and Safety Commission, HSE, Health and Agriculture
Ministers and their counterparts under devolution in Scotland,
Wales and Northern Ireland, as required, on all aspects of hazards
and risks to workers and others from exposure to pathogens. The
committee is made up from experts in microbiology and infectious
diseases recruited from academia, the health service, industry
and trade unions. It is serviced by a joint secretariat (HSE,
Defra, and the HPA).
4.2.7 Inspection under COSHH.
4.2.7.1 Although notification does not automatically entail
an inspection, the notification is used to inform inspection activities.
The expectation is that CL4 laboratories are inspected annually
and CL3 laboratories are inspected at least once every three years.
4.3 Animal Pathogens: Specified Animal Pathogens Order 1998
(SAPO)
4.3.1 The containment and transport of animal pathogens
is controlled by SAPO in Great Britain. Responsibility for the
Order rests with Defra in England and the devolved administrations
in Scotland and Wales (although there are no SAPO-approved laboratories
in Wales).
4.3.2 The purpose of SAPO is to prevent animals and poultry
in Great Britain being exposed to specified animal pathogens which
could cause serious disease and economic loss to the British livestock
and poultry industries. The Order does not apply to any animal
pathogen or carrier contained in licensed veterinary or human
medicines.
4.3.3 SAPO requires those working with any specified
animal pathogen (listed in the Schedule to the Order) to apply
for and obtain a licence. This stipulates the way in which the
specified animal pathogens must be handled to ensure their safe
containment and disposal, the areas of the laboratory in which
various types of work may be done and the persons responsible
for supervising the work.
4.3.4 Under SAPO, "specified animal pathogen"
means an animal pathogen listed in the schedule to SAPO, including:
(b) pathogens which have been attenuated or genetically
modified by any means, and
(c) any nucleic acid derived from an animal pathogen listed
in the Schedule which could produce that pathogen when introduced
into a biological system in which the nucleic acid is capable
of replicating.
4.3.5 Defra classifies animal pathogens for the purpose
of operating IAPO and SAPO. The classification is made for the
purpose of protecting animal health from escapes of organisms
from a laboratory. (IAPO is described in section 6.2.)
4.3.6 Specified animal pathogens are classified into
four categories:
— Group 1—Disease-producing organisms
which are enzootic (ie already present in the livestock population
at a low or stable level) and do not produce notifiable disease.
— Group 2—Disease producing organisms
which are either exotic (ie not present in the UK livestock population)
or produce notifiable disease, but have a low risk of spread from
the laboratory.
— Group 3—Disease producing organisms
which are either exotic or produce notifiable disease and have
a moderate risk of spread from the laboratory.
— Group 4—Disease producing organisms
which are either exotic or produce notifiable disease and have
a high risk of spread from the laboratory.
— Rabies—Special containment conditions
exist for Rabies and Rabies related viruses.
4.3.7 The animal pathogens in Groups 2, 3 and 4 and containment
requirements for Groups 2, 3 and 4 are described on the Defra
website (http://www.defra.gov.uk/animalh/diseases/pathogens/classification.
htm, http://www.defra.gov.uk/animalh/diseases/pathogens/category4.htm).
They are based on those described in the COSHH regulations, with
additional measures and procedures added to cover biosafety.
4.3.8 These containment requirements are intended only
as a guide, as decisions on the facilities and procedures required
to contain specified animal pathogens safely at individual establishments
are made on a case-by-case basis.
4.3.9 Licensing and Inspection under SAPO:
4.3.9.1 The SAPO licensing process includes inspection
of the applicants' laboratories and review of supporting documentation
(ie the operating procedures for work, risk assessment and appropriate
containment measures) prior to the licence being issued. Licences
are usually valid for five years. Inspections of laboratories
licensed under SAPO may be carried out at any time to ensure full
compliance with licence conditions and the Order.
4.3.9.2 These inspections are currently carried out by
Defra, the VLA and HSE. However, from April 2008, HSE becomes
lead inspector and will assume these functions, under new regulatory
powers which are currently being developed. This will apply across
Great Britain, with separate arrangements being developed for
Northern Ireland.
4.4 Genetically Modified Organisms (Contained Use) Regulations
2000 (as amended 2002, 2005)
4.4.1 Genetic modification of pathogens (human, animal
or plant) where barriers are necessary to prevent their release
is subject to compliance with the GMO(CU). GMO(CU) applies across
Great Britain, with parallel regulations in Northern Ireland.
The key requirement of GMO(CU) is that such pathogens may not
be created or brought into the laboratory until the regulator
is satisfied that the operator has assessed the risks of all activities
and made sure that any necessary controls are put in place. There
is a high priority given to the hazard identification of potentially
novel GMMs.
4.4.2 The containment levels and criteria are defined
in the European Directive 90/219/EC, and the amending Directive
98/81. These are detailed in the GMO(CU) Regulations. They differ
from COSHH in a number of areas, primarily because the GM regulations
are intended to protect both human health and the environment,
whereas COSHH only covers human health.
4.4.3 Responsiblity for the GMO(CU) has not been devolved
to Wales, although it has been devolved to Scotland. Thus in England
and Wales the Competent Authority is Defra and the HSE acting
jointly, while in Scotland it is the Scottish Ministers and the
HSE acting jointly. HSE acts as the lead competent authority on
risks to human health, and Defra/Scottish Executive on environmental
issues. HSE is responsible for inspecting and enforcing on all
aspects of GMO(CU).
4.4.4 The GMO(CU) Regulations require users to assign
containment on the basis of risk assessment. Once the containment
required to minimise human and environmental exposure has been
determined, the activity is assigned a "risk class"
based on that containment. The four risk classes essentially equate
to the containment level—CL1 is required for Class 1 activities,
CL2 for Class 2, etc.
4.4.5 Prior to Class 2, 3 or 4 activities commencing,
the notifier must submit a notification, including an assessment
of the hazardous properties of the GMMs and the proposed containment
for the planned activity. Specialist Inspectors at HSE and Defra
review these notifications for technical content and compliance
with the legislation placing an emphasis on the adequacy of the
risk assessment and requesting additional information where necessary.
4.4.6 For high hazard organisms (Class 3 and 4) the operator
may not proceed without the written consent of the Competent Authority.
4.4.7 Inspection under GMO(CU):
4.4.7.1 All Class 4 or novel genetic modification activities
are brought to the attention of the Scientific Advisory Committee
for Genetic Modification (SACGM), to provide independent scientific
advice to the Competent Authority on the adequacy and scientific
content of the hazard assessment. Where necessary, site inspection
may be required where novel containment requirements are proposed.
Once satisfied with the assessment of the hazard properties of
the proposed GMM and proposed containment, the Competent Authority
issues consent for the work to proceed.
4.5 Anti-Terrorism Crime and Security Act 2001 (ATCSA)
4.5.1 The secure storage and use of dangerous pathogens
and toxins to reduce the risk of malicious use is regulated by
ATCSA. Part 7 of ATCSA applies across the UK and provides the
police with powers to impose security measures at laboratories
that hold certain dangerous pathogens and toxins (as listed in
Schedule 5 of the Act). The ATCSA list does not correspond directly
to the classifications used in COSHH, SAPO or GMO(CU), as it has
been drawn up specifically with malicious use in mind. These powers
were introduced to improve the security of dangerous substances
that may be targeted or used by terrorists. Schedule 5 has recently
been updated to include further pathogens and toxins that could
cause serous harm to human health or damage, disruption and alarm
regarding animal pathogens (Part 7 of ATCSA (Extension to Animal
Pathogens) Order 2007 and Schedule 5 to the ATCSA 2001 (Modification)
Order 2007).
4.5.2 The list of registered laboratories, implementation
policy and training for the police has been provided by NaCTSO.
This is a national police unit co-located with the Centre for
the Protection of the National Infrastructure.
4.5.3 Security procedures for laboratories differ according
to containment level:
— CL 4 laboratories are subject to extensive
security measures with extremely limited access. All staff granted
access must undergo security clearance.
— CL 3 laboratories are subject to security
measures required by ATCSA and receive bespoke advice regarding
staff security checking.
— CL 2 laboratories are provided with bespoke
advice regarding physical and personnel security by Counter-Terrorism
Security Advisers (CTSAs).
4.5.4 Personnel Security Measures for Laboratories:
4.5.4.1 The document "Personnel Security Standards
for Laboratories" was published by the Association of
Chief Police Officers and the Home Office in April 2005. Since
then it has been circulated to laboratories subject to Part 7
and Schedule 5 of ATCSA. The document delivers detailed personnel
security advice to laboratories regarding new staff, existing
staff, visitors and contractors.
4.5.4.2 The document delivers specific guidance on good
practice relating to security checking of new staff, existing
staff, contractors, visitors and students/short term appointments.
The advice details how to check identities, checking references,
checking qualifications, employment history and criminal convictions.
It also provides guidance on what to do if concerns arise during
the process.
4.5.4.3 This document was designed to deliver practical
guidance without the false sense of security that can arise from
a criminal records check alone. Managers are advised to maintain
personnel security by way of good human resource management and
reporting, the wearing of security passes and the creation of
a "security aware" environment.
4.5.5 Inspection under ATSCA:
4.5.5.1 Since 2002 the legislation has been enforced by
police CTSAs. Premises working with Schedule five agents need
to notify the Home Office and will be visited by CTSAs. The CTSAs
assess the security of the laboratories and have powers under
part 7 of ATCSA to serve directions requiring security improvements.
Failure to comply with these directions is a criminal offence.
4.5.6 Home Office review of Hazardous Substances:
4.5.6.1 As the Prime Minister announced on 14 November
2007, the Home Office is carrying out further work to look at
what more might be needed to strengthen protection against the
use of hazardous substances for terrorist purposes. This review
is being led by Lord West and will report to the Prime Minister
later this year.
4.6 Inspection regimes
4.6.1 Regulatory activities in the sector.
4.6.1.1 HSE, Defra and the Scottish Executive currently
regulate work with dangerous pathogens in Great Britain. HSE is
responsible for the regulation and manages the statutory notifications
and permissioning schemes for work with human pathogens and GMMs
under GMO(CU) and COSHH, whilst Defra and the Scottish Executive
license work with animal pathogens under SAPO.
4.6.1.2 HSE provides technical and regulatory advice to
other government departments, agencies and the bioscience and
healthcare communities about working with dangerous pathogens.
HSE also develops standards and guidance at national and international
level on the control of dangerous pathogens, often based on advice
from the SACGM and ACDP.
4.6.2 Inspection by under COSHH and GMO(CU):
4.6.2.1 HSE inspectors undertake inspection and enforcement
activities at premises where work is undertaken with dangerous
pathogens under GMO(CU) and COSHH. The inspection unit is made
up of a team of specialists in the fields of microbiology and
biotechnology with a broad collective experience in the research,
clinical and industrial biosciences sectors.
4.6.2.2 Inspection of the physical containment of the
laboratories is supplemented by review of documentation and interviewing
staff to assess compliance with safety management systems. Where
significant breaches of legislation are identified, Specialist
Inspectors can use a full range of enforcement powers conferred
by the Health and Safety at Work Act 1974, which include stopping
work activities, issuing notices requiring specific improvements
by specific dates and prosecution.
4.6.2.3 For larger sites involving extensive work with
dangerous pathogens, an "Inspection Plan" is developed.
In essence this is a summary of the different interactions that
HSE will utilise to engage a particular duty holder over a particular
time period. The overall intention of the intervention plan is
to facilitate a partnership approach to raising standards of biological
safety. This approach can involve a range of activities including
traditional inspections, topic-specific or all-encompassing biosafety
audits, participation in training courses, and involvement in
biosafety committee meetings and providing presentations.
4.6.3 Inspection under SAPO:
4.6.3.1 In England up to March 2008, inspections of laboratories
working with SAPO Group four pathogens are carried out by a senior
veterinary official at Defra and HSE. From 2008, all other inspections
are being carried out by the VLA and HSE. It is planned that HSE
will take over sole responsibility for all inspections from April
2008. In Scotland, where there are no laboratories working with
SAPO Category 4 pathogens, inspections are carried out by a Veterinary
Advisor working in the Scottish Executive, assisted by veterinarians
from Animal Health.
4.6.3.2 If, during an inspection, an inspector identifies
non-compliance with the Order or the licence conditions, they
may recommend that Defra or the Scottish Executive amend, suspend
or revoke the licence. Any prosecution would be undertaken by
the relevant local authority (usually the trading standards department)
as local authorities are responsible for enforcement under SAPO.
Since Local Authorities do not inspect laboratories, they will
only become involved when the inspectors alert them to non-compliance
that might warrant a prosecution.
5. Biosafety training provision for staff working in containment
facilities
5.1 The only specific requirements for biosafety training
are made under the GMO(CU) regulations. However, there are general
duties placed on employers to provide appropriate staff training
and instruction.
5.2 All employers are bound under the Health and Safety at
Work Act 1974 " . . . to provide such information, instruction,
training and supervision as is necessary to ensure, so far as
is reasonably practicable, the health and safety at work of his
employees". This requirement is a general one, demanding
training but not specifying content.
5.3 The Management of Health and Safety at Work Regulations
1999, whilst not dictating content other than that it must be
"adequate", reinforce the general requirement specified
in the Act, and extend this by specifying the regime for training
(for example, on recruitment or on exposure to new or increased
risk).
5.4 COSHH extend the general requirements to provide
suitable and sufficient training with guidelines as to the content
of this training. Training and information provided must provide
the employee with details of the biological agent, including the
risk presented to health; the significant findings of any relevant
risk assessments; the appropriate precautions and actions to be
taken by the employee to safeguard himself and other employees;
results of any monitoring of exposure, and the collective results
of any health surveillance. Furthermore, the training provided
in the case of a HG4 pathogen or material which may contain such
an organism, must provide for written instruction and procedures
for the handling of such an agent specified in Regulation 12(2).
5.5 The above requirements for training are embedded
further in:
5.5.1 COSHH 2002 (as amended) Regulation 7(7) where it
is indicated that, where there is exposure to a substance hazardous
to health, control of that exposure will only be adequate if the
principles of good practice (set out in Schedule 2A) are applied.
This includes a necessity to inform and train all employees on
the hazards and risk from the substances with which they work
and the use of control measures developed to minimise the risks.
5.5.2 The GMO(CU) Regulations 2000 which require that
written training records are kept for work at CLs 3 and 4. Inspections
will cover training and instruction of staff, and involve a review
of records. The lack of enforcement action in this area highlights
a good level of compliance with the training requirements.
6. The maintenance and recording practices surrounding
the storage and transportation of dangerous pathogens
6.1 Storage
6.1.1 Safe storage of dangerous pathogens is a requirement
of all the current regulatory systems. The degree of security
of storage required depends on the nature of the organisms being
used. For the high hazard organisms, the legislation stipulates
"secure storage". Accompanying guidance on what is expected
is provided. At CL 4, organisms must only be stored within the
CL 4 laboratory. Fridges, freezers and storage containers should
be kept locked when not in use.
6.1.2 NaCTSO, through the CTSAs, have for some time been
carrying out their own security audits at sites that handle infectious
substances. Advice that has been given by CTSAs on these visits
is in line with the requirements for storage and use at premises
(Schedule 5 to ATCSA).
6.2 Transportation: under SAPO and the Importation of Animal
Pathogens Order 1980 (IAPO)
6.2.1 Licences under SAPO stipulate the way in which
the specified animal pathogens covered by the licence must be
handled to ensure their safe transport, containment and disposal.
SAPO applies to the specified animal pathogens, regardless of
their origin (Great Britain, European Union (EU) or third country)
6.2.2 IAPO prohibits the importation into Great Britain
from a third country (ie a country that is not a Member State
of the EU) of any animal pathogen or carrier except under the
authority of a licence and in accordance with the conditions of
that licence.
6.2.3 Licences issued under IAPO contain conditions prohibiting
any transfer of the imported animal pathogen and/or carrier and
its derivatives to any other person or laboratory without the
prior authority of the licensing authority.
6.2.4 Licences under IAPO usually stipulate the manner
in which the animal pathogen or carrier must be prepared, treated
and packed prior to importation, the containment conditions under
which it must be handled and the method by which it and its derivatives
must be disposed of, if it is not re-exported. The purpose of
imposing these conditions is to protect animals and poultry from
infection by animal pathogens imported into Great Britain from
outside the EU. Licences are normally valid for two years, to
provide for the importation of the material and the completion
of work on the material in the laboratory, following importation.
6.2.5 The Order also requires anyone who has in his possession
an animal pathogen or carrier which he knows to have been imported
in contravention of the provisions of the Order to report the
fact to a veterinary inspector as quickly as possible. The Order
does not apply to any animal pathogen or carrier contained in
a licensed medicinal product, the importation of which is permitted
under the Medicines Act 1968, or to importations made from other
Member States of the European Communities.
6.3 Transport: The Carriage of Dangerous Goods and Use of
Transportable Pressure Equipment Regulations 2007
6.3.1 Infectious substances transported in Great Britain
are subject to these Regulations, which transpose international
regulations originating in the UN and cover both safety and security
measures. The Regulations apply throughout Great Britain.
6.3.2 Classification of dangerous goods, including infectious
substances:
6.3.2.1 These Regulations set out nine classes of dangerous
good. Infectious substances are Class 6, division 6.2. The regulations
for infectious substances were developed by the UN Sub-Committee
of Experts on the Transport of Dangerous Goods with input from
specialised agencies including the WHO and the OIE.
6.3.2.2 Class 6.2 infectious substances are subdivided
into Category A, the more dangerous pathogens, and Category B.
Category A includes infectious agents which are capable of causing
permanent disability, life threatening or fatal disease in otherwise
healthy humans or animals. This category includes all the pathogens
listed in the COSHH HG4 and SAPO Group 4, and many of those in
HG3 and Group 3.
6.3.2.3 Category A substances are divided into those infectious
substances affecting humans, and those affecting animals only.
The Regulations give an indicative list of infectious substances
for both humans and animals. For example, the list for humans
includes Ebola virus and Lassa virus, while the list for animals
includes FMD virus cultures, and Rinderpest virus cultures. Category
B substances would typically include diagnostic specimens from
doctors' surgeries or veterinary surgeons where the consignor
is confident the samples do not contain Category A substances.
6.3.2.4 The Regulations make it clear that the indicative
lists are not exhaustive. New or emerging pathogens not on the
list but meeting the criteria for Category A must be assigned
to that category. Other infectious substances can be treated as
Category B.
6.3.3 Safety requirements for dangerous goods:
6.3.3.1 All Category A substances, regardless of quantity,
have to be packaged, labelled and marked according to the rigorous
safety requirements in the regulations and have the appropriate
documentation, and for road transport, the driver needs to hold
a vocational training certificate for Division 6.2.
6.3.3.2 The regulations for Category B substances recognise
the reduced risk posed by these substances, and provided they
are packaged in accordance with the regulations, most other provisions
are dis-applied. Category B substances are accepted by Royal Mail
for transport.
6.3.3.3 For road and rail transport the vehicle or rail
wagon transporting Category A pathogens has in most cases to carry
warning plates. All involved in the transport chain have to receive
safety training appropriate to their responsibilities. For road
transport, the driver has to have specific driver training when
carrying any Category A substances or other dangerous goods in
quantities above certain thresholds.
6.3.4 Security requirements for dangerous goods
6.3.4.1 The aim of the security elements of the Dangerous
Goods Regulations is to seek to prevent dangerous goods from being
stolen and misused by terrorists. The security measures apply
to all dangerous goods, except those that are nuclear and are
split into two levels:
(i) a general level applicable to the carriage of all dangerous
goods; and
(ii) a higher level for the carriage of high consequence dangerous
goods.
6.3.4.2 High consequence dangerous goods are defined as
those that, if misused, can cause a large loss of life or serious
damage to the economy or environment, and include Category A substances
as defined in section 6.3.2 above.
6.3.4.3 The security requirements apply to all those involved
in the transport "chain": consignors, loaders, carriers
and unloaders. Anyone involved in the transport of dangerous goods
must:
— Only offer dangerous goods to people, companies
or organisations that have been properly identified;
— Ensure temporary storage sites are secure;
— Implement a security awareness training programme
for staff;
— Create and put in place a detailed security plan
(if carrying high consequence dangerous goods) which includes
the need to maintain records of the specific goods carried and
the quantities. In addition to the requirement that records are
kept, it is recommended that they are retained for four years.
6.3.4.4 The Regulations are supported by comprehensive
guidance which has been the product of a close working relationship
between Government, Police and representatives of those who have
some part to play in the transport chain of dangerous goods. Various
Government departments are also represented where applicable.
The Department for Transport continues to cooperate with this
group (called the Industry Advisory Group) and holds regular liaison
meetings with them. Further information on supporting guidance
can be obtained from the Department for Transport's website at
http://www.dft.gov.uk/security/subdangerousgoods.
6.4 Review of Dangerous Goods Security
6.4.1 The Department for Transport is currently reviewing
its Dangerous Goods Security regime to ensure the requirements
remain effective and proportionate.
6.4.2 As part of this review, the Department has met
with the other regulators of pathogen work and confirmed that
their existing regulation and inspection regimes adequately cover
the security requirements for pathogens and toxins stored in transit.
6.4.3 However, within the category of high consequence
dangerous goods there are some substances which have greater potential
for misuse in a terrorist attack (termed "Very High Consequence
Dangerous Goods" or VHCDGs). The Department for Transport
is currently working with the Centre for Protection of National
Infrastructure, Home Office and others to identify a list of VHCDGs,
to assess the security measures currently in place to protect
them in transit, and to consider the case for more stringent security
requirements for these substances. This work will include pathogens
and toxins within its scope and thus there is the potential for
pathogens to be classified as VHCDGs and subject to enhanced containment
levels accordingly.
6.5 Regulation of transport under COSHH
6.5.1 Notification to HSE is required under COSHH where
HG4 pathogens are being moved from one site to another. Notification
needs to be made at least 30 days in advance of any planned movement
of the agent, although in practice, shorter times are often agreed
to allow clinical diagnostic work to be carried out.
7. Measures implemented when pathogenic material cannot
be accounted for
7.1 There are reporting systems in place under the Reporting
of Injuries, Diseases and Dangerous Occurrences Regulations 1995
(RIDDOR) and the GMO(CU) Regulations which would apply in cases
where material could not be accounted for.
7.2 The GMO(CU) Regulations require that accidents that
"involve a significant and unintended release . . . which
presents an immediate or delayed hazard to human health or to
the environment" are reported to the Competent Authority.
This would include any situation where material could not be accounted
for.
7.3 RIDDOR similarly requires notification to HSE as
a "dangerous occurrence", which would cover situations
where samples containing HG 3 or 4 micro-organisms were lost or
accidentally released. However, there is no specific requirement
to keep an inventory of organisms held, although it would be expected
as good practice. The requirement to ensure safe storage can only
be effectively met by knowing what is held, and ensuring that
it is kept safe.
7.4 HSE undertakes investigations of RIDDOR or GMO(CU)
reportable incidents involving dangerous pathogens. Incidents
range from dangerous occurrences which have the potential to expose
employees to pathogens, such as laboratory spillages, to cases
of laboratory acquired infections, via accidents such as needlestick
injuries. The incidents are investigated in accordance with HSE's
enforcement policy and operational investigation policy and procedures.
7.5 Licence holders under SAPO CL4 have agreed procedures
to notify the licensing authority (currently Defra) of either
the accidental release of pathogenic material (as defined within
SAPO) or of a "near miss". Defra would expect to be
notified immediately by telephone, with a written report to follow
within 24 hours. The responsibility for reporting rests with the
Biological Safety Officer (where one has been appointed) or other
competent individual at the licensed premises, who is required
to make an assessment of the risk and formulate Standard Operating
Procedures which set out the action to be taken. All such reports
are assessed by senior veterinary officials in Defra and further
action considered. For all relevant laboratories, provision for
handling general and biological agents is contained in the COSHH,
and for GM organisms in GMO(CU).
8. The role of universities in overseeing security clearance
for research students working with dangerous pathogens
8.1 In common with other Governments around the world,
the British Government is working hard to stop the spread of knowledge
and skills that could be used in the proliferation of weapons
of mass destruction (WMD) and their means of delivery. The Academic
Technology Approval Scheme (ATAS) is designed to ensure that people
who are applying to study certain sensitive subjects in the UK
do not have links to WMD programmes. The ATAS is administered
by the FCO and was introduced on 1 November 2007.
8.2 Non-European Economic Area nationals who require
leave to enter or remain in order to study in the UK and who are
seeking to undertake postgraduate study in the UK in specific,
limited subjects must hold an ATAS certificate before they can
apply for an entry clearance or extension of stay. The Immigration
Rules were amended on 30 November to make the possession of an
ATAS certificate a mandatory requirement. Students seeking leave
to enter or remain who require an ATAS certificate and who do
not hold one will be refused leave to enter/remain.
8.3 The MoD provided technical advice on which subjects
to include in fields such as engineering, technology, and the
sciences; a full list is available at www.fco.gov.uk/ATAS. The
scheme is focussed on those conducting postgraduate research (at
both Doctoral and Masters level) although students taking taught
Masters in the specific areas of Materials Science, Materials
Technology, Physics, Mechanical Engineering and Aerospace Engineering
also come within its remit.
8.4 An ATAS certificate can be applied for via a free,
on-line form resembling a CV. No supporting documentation is required.
The FCO aims to take decisions on the vast majority of applications
within 10 working days. Applicants are notified by email of the
decision and issued with a certificate if their clearance is confirmed.
At the same time Higher Education Institutions (HEIs) are informed
of decisions affecting their applicants.
8.5 The ATAS certificate is specific to both the programme
of study that the student intends to undertake and the HEI.
8.6 HEIs have a fairly limited involvement in this process.
They provide in their offer letters to students the relevant code
for the programme of study the student is to follow, which enables
the FCO to determine whether the programme of study is one which
is covered by the ATAS arrangements. For those students undertaking
postgraduate research the HEI also provides an agreed research
proposal of what area of research is anticipated.
8.7 Prior to the introduction of mandatory screening
through ATAS, there was a voluntary screening system known as
the Voluntary Vetting Scheme in place since 1994, also administered
by the FCO. HEIs were invited to refer any applicants to the FCO
for vetting. A recommendation was made to the HEI although they
did not have to accept that advice. The scheme was voluntary,
adherence to it by HEIs was patchy and it placed an undue burden
on those who did participate. A lengthy review led to the introduction
of the ATAS and the subsequent amendment of the Immigration Rules,
which gives the scheme proper effect.
January 2008
Annex A
ABBREVIATIONS USED
IN THIS
MEMORANDUM
| ACDP | Advisory Committee for Dangerous Pathogens
|
| ATAS | Academic Technology Approval Scheme
|
| ATCSA | Anti-terrorism Crime and Security Act 2001
|
| CEPR | Health Protection Agency's Centre for Emergency Preparedness and Response
|
| CL | Containment Level |
| COSHH | Control of Substances Hazardous to Health Regulations 2002
|
| CTSA | Counter-terrorism Security Advisers
|
| Defra | Department for the Environment, Food and Rural Affairs
|
| EU | European Union |
| FCO | Foreign and Commonwealth Office
|
| FMD | Foot and Mouth Disease
|
| GMM | Genetically Modified Micro-organism
|
| GMO | Genetically Modified Organism
|
| GMO(CU) | Genetically Modified Organisms (Contained Use) Regulations 2000
|
| HEI | Higher Education Institutions
|
| HG | Hazard Group |
| HPA | Health Protection Agency
|
| HSE | Health and Safety Executive
|
| IAPO | The Importation of Animal Pathogens Order 1980
|
| MoD | Ministry of Defence |
| NaCTSO | National Counter-Terrorism Security Office
|
| NIBSC | National Institute of Biological Standards and Control
|
| OIE | Office Internationale des Epizooties
|
| RIDDOR | Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995
|
| SACGM | Scientific Advisory Committee for Genetic Modification
|
| SAPO | Specified Animal Pathogens Order 1998
|
| VHCDGs | Very High Consequence Dangerous Goods
|
| VLA | Veterinary Laboratories Agency
|
| WHO | World Health Organization
|
| WMD | Weapons of mass destruction
|
1
http://www.defra.gov.uk/animalh/diseases/fmd/pdf/callaghan-reviewreport071213.pdf Back
2
http://www.defra.gov.uk/animalh/diseases/fmd/investigations/pdf/spratt_final.pdf Back
3
Government statement: http://defraweb/corporate/ministers/statements/hb071213.htm Back
4
For containment level 4, category of sites is given; for containment
level 2 and 3, the category of organisations is given. Back
5
This was difficult to assign with a high degree of confidence,
particularly separating out Government and Research Council (plus
others eg charities[0]). Back
6
For organisations with capacity to work at containment level 4,
the number of sites is given; for organisations with capacity
to work at containment level 2 and 3, the number of organisations
is given.[0] Back
7
Reporting of Injuries, Diseases and Dangerous Occurrences Regulations
1995. Back
| 
