Submission from Dr George McIlroy, Chief
Executive, Agri-Food and Biosciences Institute for Northern Ireland
The Agri-Food and Biosciences Institute (AFBI)
is a Non-Departmental Public Body (NDPB) sponsored by the Department
of Agriculture and Rural Development for Northern Ireland (DARD).
AFBI carries out work on pathogens up to HSE ACDP (Advisory Committee
on Dangerous Pathogens) hazard group 3 and monitors for pathogens
up to DEFRA hazard group 4 ( SAPO (Specified Animal Pathogens
Order) pathogens that may cause animal or plant diseases or food-borne
illness. This work is carried out in laboratories up to ACDP biocontainment
level 3. I believe that the recommendations of the Callaghan Review
would greatly simplify licensing and inspection arrangements,
and significantly improve the effectiveness of biosecurity measures
for work on human and animal pathogens.
& BIOSCIENCES INSTITUTEWWW.AFBINI.GOV.UK
The Agri-Food & Biosciences Institute (AFBI)
was created on 1 April 2006 as an amalgamation of the Department
of Agriculture and Rural Development for Northern Ireland (DARD)
Science Service and the Agricultural Research Institute of Northern
Ireland (ARINI). AFBI is a Non-Departmental Public Body (NDPB)
sponsored by DARD.
AFBI carries out high technology research and
development, statutory, analytical, and diagnostic testing functions
for DARD and other government departments, public bodies and commercial
AFBI's NDPB status enables it to be innovative
and entrepreneurial in its approach to business development. AFBI
is forging new partnerships with other scientific institutes and
research organisations and extending the range of services it
offers. This enables AFBI's unique breadth of scientific capabilities
in the areas of agriculture, animal health, food, fisheries, environment
and biosciences to be offered to a wider prospective national
and international customer base.
AFBI has an independent Board which is also
responsible for monitoring its performance.
AFBI carries out surveillance and research work
on food-borne pathogens and other infectious agents that pose
a threat to animal and plant health. Some of these agents are
of zoonotic importance. Maintaining an emergency responses capability
to outbreaks of serious animal and plant disease, to food and
environmental emergencies and to chemical and biological incidents
affecting public safety is an important component of AFBI's work
Current capacity for research on dangerous pathogenic
material in AFBI and the capability to conduct research on the
causative agents of disease that may emerge at a future time
AFBI does not hold nor carry out research on
SAPO (Specified Animal Pathogens Order) category 4 pathogens.
At present it is unable to do so because of the absence of a SAPO
level 4 biocontainment laboratory in Northern Ireland.
AFBI carries out work on several hazard group
3 level pathogens that can cause serious disease in animals and
humans. The institute has a large number of skilled staff with
laboratory expertise for work on a wide variety of animal, plant
and food-borne pathogens. This pool of expertise is available
for work on new pathogens that could emerge in the future. Surveillance
for the emergence of new animal, plant and food-borne pathogens
is an important component of AFBI's work.
The state of biological containment facilities
A suite of modern, state-of-the art ACDP biocontainment
level 3 laboratories, which will substantially supplement existing
facilities, is currently in the final stages of commissioning
at AFBI. It is planned that these laboratories will be occupied
in spring 2008. They will replace several older laboratories which
will then be de-commissioned.
AFBI is seeking funding for the construction
of a biocontainment laboratory for surveillance work on DEFRA
and SAPO hazard group 4 pathogens that pose a threat to the agri-food
industry and may be of importance to human health eg avian influenza
in Northern Ireland.
AFBI also has recently constructed modern animal
biocontainment accommodation for work on hazard group 3 pathogens
Laboratory inspection regimes and the rationale
and practicalities of the licensing system
AFBI laboratories are subject to inspection
by the Health and Safety Executive (Northern Ireland) (HSE (NI),
DARD, the Department of the Environment for Northern Ireland and
the Environment and Heritage Service Radiochemical Inspectorate.
Several AFBI laboratories have security approval from the Police
Service of Northern Ireland antiterrorism office for work on schedule
5 pathogens as listed in the Anti-Terrorism, Crime and Security
I support the recent recommendations of the
Callaghan Review. In particular, I agree that the use of both
animal and human pathogens should be governed by a single independent
regulatory framework, with responsibility for regulation of these
pathogens passing to the Health and Safety Executive. I also strongly
support the Callaghan recommendation that risk assessment should
be a key element of the regulatory framework for handling animal
pathogens, as it is currently for human pathogens and genetically
modified organisms. I agree with the recommendation that the Advisory
Committee on Dangerous Pathogens is asked to draw up guidance
on a single set of containment requirements for human and animal
pathogens, to complement the single regulatory framework when
it is introduced.
I believe that the recommendations of the
Callaghan Review would simplify licensing and inspection arrangements,
and improve the effectiveness of biosecurity measures for work
on human and animal pathogens.
Biosafety training provision for staff working
in containment facilities
Biosafety training for staff in AFBI includes
in-house and externally procured training. For example, a number
of staff have received training at Porton Down and receive regular
refresher training. Staff from the Health Promotion Agency, Porton
Down will be coming to AFBI in Spring 2008 to provide a week-long
course in biosafety to another group of AFBI staff. AFBI staff
also participate in international conferences and workshops on
All research undertaken in AFBI is accredited
to ISO 9001 and, where relevant, to GLP (Good Laboratory Practice)
standards of accreditation. Analytical tests in many laboratories
are also accredited to the ISO17025 standard Application of the
standard operating procedures required for these standards is
an important element in strengthening biosafety protocols within
The maintenance and recording practices surrounding
the storage and transportation of dangerous pathogens
Staff and contractors who are to work on the
site are security vetted by DARD. Security of stored pathogens
in AFBI has several levels. The sites at which hazard group 3
pathogens are held are protected by 24-hour security staff and
a perimeter fence. All visitors to AFBI must report to security
staff on arrival where they are issued with passes which must
be displayed at all times while on-site. Visitors must be accompanied
by members of AFBI staff who must display visible ID at all times.
Access to areas in which hazard group 3 pathogens are held is
controlled by a proximity card and/or proximity card and "PIN"
number and there is a record kept of visitors/ contractors to
these laboratories. Within these secure areas, hazard group 3
pathogens are held in locked containers (normally refrigerators).
Written records are maintained of all stored hazard group 3 and
schedule 5 pathogens. AFBI's Veterinary Sciences Division was
highly commended following a recent inspection of schedule 5 facilities
by the PSNI.
A significant number of AFBI staff have received
training in packaging of samples of pathogenic material to International
Air Transport Association (IATA) standards and are used for packaging
and dispatching such material for transport.
Measures implemented when pathogenic material
cannot be accounted for
There have been no examples of such unaccounted
loss in AFBI. In the event of an unaccounted loss, the immediate
area would be restricted until evidence gathering and assessments
have been made. The visitor and contractor access records would
be examined. Security vetting for contractors who have worked
on site since last audit of cultures would be reviewed to ensure
there have been no lapses in vetting. The PSNI would be informed
and forensic services sought for evidence gathering. DARD would
be informed of the incident.
The role of universities in overseeing security
clearance for research students working with dangerous pathogens
While AFBI is not a university, a small number
of university research students work in AFBI laboratories. Unless
working in a laboratory approved by the PSNI for work on schedule
5 pathogens, there is no formal security clearance process for
these students. However, the number of students who might work
on hazard group 3 pathogens is very small and they are closely
supervised by AFBI staff all of whom have an appropriate level
of security clearance.