Memorandum 4
Submission from the Institute of Safety
in Technology and Research
The opportunity to participate in the discussion
concerning this important topic is welcomed by the Institute of
Safety in Technology and Research (ISTR).
The ISTR is a professional association of in
safety professionals from the whole spectrum of public, government
and commercial research and high technology organisations with
similar research and technological interests. The organisation
was formed in 1982.
The members, currently 250, come from across
research organisations but are mostly universities and are highly
qualified and have a huge body of experience.
Its aims are to further the advancement of safety
skills and knowledge among its membership; the maintenance of
the professional standards; the preservation and enhancement through
representation to bodies of influence; the promotion of communication
and exchange of information; the maintenance of dialogue with
other professional bodies in areas of related interest.
With the increased activity in bioscience and
biotechnology within members' workplaces, a Bio sub-group has
been established within ISTR. There are three regional groups
meeting several times a year and one major symposia on a current
topic.
The Institute runs skills workshops, and three
open symposia each year. Recent subjects of symposia have included:
Animal facilities, Benefits of improving health & safety;
The GMO regulations 2000; Laboratory containment; Student placements;
Off site working; Biological safety, Improving Health and Safety,
Managing contractors, Legislation update, Transport safety, Laboratory
design, Biosafety auditing, Novel technologies, physical agents..
In addition to the meetings there is web based
information, discussion forum, award programme for outstanding
performance, membership directory, twice yearly publication and
a new accreditation scheme. The Institute and its members interact
on a regular basis with regulators especially NATSCO and HSE.
This document brings together the comments of
a component of the research community comprised of professional
safety practitioners working in the areas of cutting edge biological
research in UK universities, government laboratories, commercial
biopharm industry, hospitals and charities.
There is an active UK biosafety/biosecurity
community which liaises with regulators and others in the related
biological areas such as animal containment and welfare, occupational
diseases, gene-therapy, technology and product manufacturers.
Also engaging with other countries and international GOs/NGOs
to exchange and share experiences.
In Europe and beyond there are a number of initiatives
on improving biosafety bio-risk and biosecurity (WHO, EU, CEN,
EBSA).
Laboratory Standard
http://www.ebsaweb.eu/EBSA+Activities/Laboratory+Standard/Background.html
Review of EU Arrangements for Biosafety
http://www.ebsaweb.eu/EBSA+Activities/Biosafety+Europe.html
Biopreparedness
http://www.ebsaweb.eu/ebsa—media/Downloads/EBSAActivities/com2007—0399en01BioPreparedness-view—image-1-called—by-ebsa-original—site--original—page-355.pdf
SUBMISSION
Summary
— Specialist Biosafety Advisors,
— Researchers and undergraduates, and
— Architects and engineers in containment.
— Implementation of existing regulation
evenly.
— Learning from European and World
Experiences.
— Co-ordination of funding of
containment facilities including infrastructure.
Who we are
Institute of Safety in Technology and Research;
has members represent professional safety practitioners in the
field of high technology research in universities and other research
organisations. We are the only national forum for biosafety and
biosecurity in the UK and as such represent the experts in biosafety
and biosecurity for the United Kingdom. In addition many of our
members are active in European activities to promote better bio
controls and uniformity of standards
RESPONSE
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
The UK has a comprehensive range of university,
governmental and private laboratories researching into health,
medical, animal, plant and immunology and diagnosis and detection
systems for dangerous pathogens. The community works closely at
a scientific level and is well regarded around the world. However,
source of funding is wide ranging and disparate. The lack of co-ordinated
research is lacking. This leads to overlap and duplication. The
capacity exists within the scientist's expertise and facilities,
as long as the funding can be made available. Many funders appear
to be unwilling to acknowledge that running the sorts of containment
facilites which are required is an expensive business, however,
and seem unwilling to contribute towards the necessary overhead
costs.
Further there are organizations with little
experience of pathogens and genetic modification engaging in new
fields with little prior experience. The ability for regulators
to respond quickly to emerging infections which the UK plays a
significant part in national response is questionable as illustrated
with participation in global outbreak while addressing local outbreaks.
The state of biological containment facilities
in the UK
A recent survey (HSE) of the highest containment
level 4 laboratories in the UK identified 10 facilities. The procedures
for human pathogen-related work generally are satisfactory. The
issues related to animal pathogen work are more complex The majority
are old or ageing. There has been a lack of coherent strategy
for UK contained research leading to "silo" operation
and varying standards and levels of investment in infrastructure
or maintenance. Grant based research often covers research and
some refurbishment and thus does not address basic of secure services
and ongoing costs. These laboratories have been very expensive.
Note US experience of "explosion" of new facilities
with no confirmed on going funds or ability to provide sufficient
trained staff.
The number of containment laboratories in UK
has grown as interest in dangerous pathogen research has grown.
The skills and training has not matched this as experience staff
have drifted away. Understanding of containment construction and
a caucus of engineering knowledge has added to diverse engineering
standards and lack of UK based specialist containment architects
and engineers.
Laboratory inspection regimes and the rationale
and practicalities of the licensing system
Some institutes are frequently inspected (HSE,
DEFRA, EA, CPA, MHRA) and high operational standards are expected.
Other laboratories, perhaps those not normally associated with
biology are less scrutinized. This has resulted in severe differences
in operational standards related to biosecurity. The field of
biosafety/biosecurity requires broad experience current inspectors
of HSE or DEFRA do not have sufficient range of experience. The
context of the work is very important. Why are diagnostic standards
lower than in research, it is the nature of the risk to workers,
the community and the environment.
Frequent and non risk based legislation and
elevated inspection expectation discredits risk based controls.
Many parts of the world have laboratory certification.
This variously involves local authority or national highly commercial
schemes. Varying levels of federal regulation often sets the acceptance
criteria. The burden not only to administer such schemes but also
prepare for certification is highly time consuming taking researchers
away from project time, adds time to project start sometimes by
years and thus cost and delay. The value and benefit of any licensing
should be considered in relation to risk from unregulated work
and advantages of bureaucratic oversight.
The process of lab notification has worked well
in the UK. Licences for working with certain most dangerous agents
has to date been adequate. Additional and conflicting list of
agents can dilute the emphasis on "most dangerous" cf
Schedule 5. It may seem attractive to raise standards across the
board but risk based controls and restriction that is proportionate
without affecting the "health" of UK science and global
public health.
Biosafety training provision for staff working
in containment facilities
In many parts of the world biosafety and biosecurity
are included in undergraduate and masters programmes in biological
subjects. This is rare in the UK. Principle investigators are
required to ensure that researchers are competent including in
safe working. This is difficult where their own experience/training
is limited. There are few courses and mostly offered in house
thus perpetuate current practice.
Disiplines outside biology and health (structural
and electronic engineers) are increasingly using biological agents
with no basic knowledge. It is essential to ensure adequate controls
are maintained is the role of the "biological safety officer"
also referred to as biosafety specialist. Currently there is no
regulatory description of the role or knowledge require. The ISTR
has been developing an accrediation programme for training providers
developing foundation and professinal level courses in biosafety/biosecurity
topics. Further the scheme which is ISTR funded develops and recognises
personal development as a specialist and will increase the number
and quality of providers. The quality and standing of advice to
employers on the complex range of safety and regulatory matters
from enforcers and specialists needs shoring up with well desigend
training programmes.
This would place biosafety specialists on a
par with radiological, pharmacy and medical laboratory specialists
accreditation.
The maintenance and recording practices surrounding
the storage and transportation of dangerous pathogens
Historically research laboratories accumulate
collections of biological agents and the accuracy of the accounting
is variable. There is a valid argument to consolidate master stocks
into fewer appropriate holdings where security and inventory control
is maintained.
The provenance of holdings is scientifically
important and proper accountability is essential for valid result
reporting. The conditions under which agents are held also vary
due to diverse locations and underinvestment. Appreciation of
the "value" of biological material is not well understood
or well resourced.
The recently revised transport of dangerous
goods regulations (IATA/ADR) including pathogens has a generally
high compliance where there is understanding.
Measures implemented when pathogenic material
cannot be accounted for
Key to the control of the most dangerous pathogens
is proper accounting and a foil to that is a loss response system.
It is therefore part of good general management of dangerous pathogens
that procedures to readily identify loss, detect theft or misappropriation
and to intervene and thus require education as well. ISTR is well
placed to assist in developing training in biosecurity risk evaluation
and controls.
The role of universities in overseeing security
clearance for research students working with dangerous pathogens
The success of research is collaboration between
institutes nationally and internationally, exchange of students
and research to ensure best brains and the advancement of scientific
knowledge. To exclude such transit would have a profound and disproportionate
impact on UK science. There is no consistent UK procedure for
undertaking identity and background checks. For those individual
wishing to conceal affiliation this may not be adequate. Any system
must be easy, swift and at modest cost. Systems operated in US
(CFR 49) have been hampering programmes, added cost and considerable
delay.
RECOMMENDATIONS
There is considerable misunderstanding and use
of some of the related terminology in the fields of biosafety,
and biosecurity. It is essential that common internationally applied
terms are used or referenced. http://en.wikipedia.org/wiki/Biosafety
The ISTR would welcome funding stream to assist
in developing training for undergraduate, principle investigators
and specialists in biosafety, bio security and bio containment.
The ISTR would welcome interaction with policy
makers and participation in developing control measures with policy
makers and regulators.
The ISTR would welcome support to participate
in European initiatives to ensure UK interests are properly represented
cf CEN workshops require funding matching before EU funds are
available. Also participants must self fund to participate in
meeting held in various locations in Europe, thus travel budgeting
has to be found. ISTR is a voluntary organization and has limited
funds from membership fees only.
ISTR suggests development of training programmes
for researchers, regulators and containment construction specialists
in physical and personnel security in relation to the handling
and holding dangerous pathogens.
January 2008
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