 Disarmament Diplomacy
Issue No. 85, Summer 2007
Representation from the Trenches: Ongoing Monitoring for
Implementing the BWC
Filippa Lentzos
States parties to the 1972 Biological and Toxin Weapons
Convention (BWC) will hold their next Meeting of Experts in Geneva
from 20-24 August 2007. This follows the decision made by the Sixth
Review Conference to continue the 'intersessional process' of
2003-2005. As described by Richard Guthrie in the last issue of
Disarmament Diplomacy,[1] the Review Conference agreed a work programme for
2007-2010 comprising an annual one-week Meeting of States Parties
preceded each year by a one-week Meeting of Experts. States parties
also agreed topics to be discussed at each year's meetings, and
that the meetings would additionally cover 'recurring topics'.
The two set topics for the 2007 meetings relate to national
implementation.[2] This was
also the subject of the 2003 intersessional meetings, where debate
focussed heavily on implementing legislation without meaningfully
considering wider issues relating to effective national
implementation of the Convention. It is anticipated that in the
2007 meetings, states parties will once again restrict their
discussions, focussing on criminalization, cross-boundary transfer
controls and law enforcement.[3]
Whilst acknowledging the importance of such matters, this paper
suggests that a more comprehensive discussion of national
implementation is needed. It argues that enacting legislation and
putting institutional mechanisms in place to implement that
legislation are not going to be enough. National implementation of
the BWC is an ongoing process; to monitor relevant life science
activities effectively, states parties need to establish oversight
mechanisms at multiple stages in the research and development
(R&D) process, with successive systems overlapping to ensure
maximum confidence in the information collected.
After presenting some background to this argument, the paper
provides detailed examples of different oversight mechanisms that
states parties might find helpful in identifying gaps in their
existing national oversight frameworks. It concludes with a
discussion on the roles of statutory and voluntary/self-governance
mechanisms for life science oversight, arguing that while statutory
mechanisms are requisite to effective oversight, informal
monitoring systems also play a critical role.
National implementation is an ongoing process
National implementation comprises three components:
- Legislation to transpose treaty obligations into national
law.
- Means of enforcing the legislation once breaches are
identified.
- Methods for monitoring relevant work with biological agents and
toxins within the national territory.
The discussion on national implementation at the 2007
intersessional meetings needs to consider all three components. For
states parties that have not yet implemented their BWC commitments,
dialogue needs to continue on how to transpose treaty obligations
into national law - through legislation specifically designed for
this purpose, through legislation that encompasses more than the
objectives of the BWC, or through an array of already existing
legislation.
Also important is a continuation of the discussion on
appropriate means of enforcement once breaches are identified. This
discussion must not limit itself to 'big stick' enforcement actions
like levying fines, arrests, prosecuting and imprisonment. It also
needs to consider 'softer' approaches to regulation like requiring
changes in research procedures, serving improvements notices or
prohibition notices, and withdrawing consent for questionable
research.
However, enacting legislation and enforcing that legislation
only form part of national implementation. The third component, the
ongoing day-to-day monitoring of the life sciences, seems to have
been left off the agenda for the 2007 meetings. This is a
significant omission, as effective oversight frameworks or
risk regulation regimes must possess all three components with
clear linkages between them.[4]
Ongoing monitoring is particularly important in the context of
the BWC because biological weapons and their associated
technologies have a large dual use overlap; they use identical
components to a vast array of legitimate activities, including
biomedical, bioscience and biodefence R&D. Because of this, and
the comprehensive nature of the BWC's prohibitions, implementation
of the Convention needs to include the continuous oversight of
peaceful, prophylactic and protective life science activities to
prevent their misuse or misapplication.
States parties - particularly those that already have
legislation transposing BWC obligations into national law - need to
focus their efforts on the adequacy of the oversight frameworks
they have in place. They need to consider how their present
oversight frameworks operate in practice and how best to address
any gaps that may exist.
There is a range of methods for monitoring relevant work with
biological agents and toxins that covers various stages in the
R&D process. This fact, combined with the different kinds of
relevant life science activities and the varying national contexts,
means that appropriate oversight mechanisms or monitoring systems
will vary between states parties. There is no one-size-fits-all
approach to address the potential misuse of biological agents and
toxins, and, more broadly, the misapplication of the techniques and
knowledge developing in the life sciences.
Successive stages of monitoring
Focussed exclusively on the research end of the R&D process,
this article will now outline several ways of monitoring life
science research ranging from initial risk assessments, through
monitoring of work in progress, to publication of results. Some of
these mechanisms are already in place in some BWC states parties,
but few countries have made a concerted effort to draw up a
comprehensive overview of their national frameworks. While not an
exhaustive list, the following overview highlights several key
elements as a starting point for further elaboration and
discussion.
Project concept and design
Risk assessments carried out at the initial project concept and
design stage are one way to monitor relevant work with biological
agents and toxins. However, few guidelines have to date been
developed on how to carry out these assessments with potential
misuse or misapplication specifically in mind. A prominent
exception is the draft guidance provided by the US National Science
Advisory Board for Biosecurity (NSABB). Established by the US
government in 2004 to provide advice, guidance and leadership on
dual use research oversight, the Board has developed a criterion
for identifying "dual use research of concern": "Research that,
based on current understanding, can be reasonably anticipated to
provide knowledge, products, or technologies that could be directly
misapplied by others to pose a threat to public health and safety,
agriculture, plants, animals, the environment, or material".[5]
NSABB has outlined seven categories [6] of information, products or technologies that might
be especially likely to meet the threshold within the criterion for
dual use research of concern. These are knowledge, products or
technologies that could:
- Enhance the harmful consequences of a biological agent or
toxin.
- Disrupt immunity or the effectiveness of an immunization
without clinical and/or agricultural justification.
- Confer to a biological agent or toxin, resistance to clinically
and/or agriculturally useful prophylactic or therapeutic
interventions against that agent or toxin, or facilitate their
ability to evade detection methodologies.
- Increase the stability, transmissibility, or the ability to
disseminate a biological agent or toxin.
- Alter the host range or tropism of a biological agent or
toxin.
- Enhance the susceptibility of a host population.
- Generate a novel pathogenic agent or toxin, or reconstitute an
eradicated or extinct biological agent. [7]
NSABB recommends that if the knowledge, products or technologies
related to a proposed project are judged to apply to one of these
categories, the project should undergo a more thorough review to
determine whether it does indeed constitute dual use research of
concern, and if so, how the potential for misuse should be
managed.
This review should address:
- The potential for, and the ways in which, information from the
research could be misused to pose a threat to public health and
safety, agriculture, plants, animals, the environment or
materiel.
- The likelihood that the information might be misused.
- The potential impacts of misuse.
- Strategies for mitigating the risks that information from the
research could be misused.[8]
Funding applications
An additional way of monitoring relevant work with biological
agents and toxins is to conduct similar risk assessments at the
funding application stage. One example where this has been
implemented is provided by the Wellcome Trust - a major funder of
biomedical research based in the UK - who noted its commitment to
this in 2003 in its Position Statement on Bioterrorism and
Biomedical Research. Together with the UK's Medical Research
Council and the Biotechnology and Biological Sciences Research
Council, the Trust has made changes to its funding application
forms, developed guidance for funding committees, and modified
organizational guidelines on good practice in research.[9]
Initiation of research
Once funding has been sought and granted for a research project,
yet another layer of monitoring may be applied at the project
initiation stage. In some states parties, such as those that are
members of the European Union, there are already requirements that
regulatory authorities[10] be
notified of certain types of work - like the genetic modification
of micro-organisms or work with particularly hazardous or dangerous
pathogens - before the work starts. Some states parties may also
require that consent for certain types of work be explicitly
granted by regulatory authorities before such work is undertaken.
In either case, notifications and applications for consent provide
the regulatory authorities with an overview of, or some control
over, the kinds of research carried out under their
jurisdiction.
Individual risk assessments focussed on the safety and/or
security of proposed work often form a central part of both
notifications and applications for consent. These tend to address
the agent's hazardous properties, such as its pathogenicity,
epidemiology, infectious dose, routes of transmission, medical
data, and environmental stability. They will also often address the
nature of the work to be carried out, including where the work will
be conducted and who will carry it out, the amount of agent used
and procedures to be undertaken, the equipment to be used and how
it will be decontaminated, whether the work is routine, one-off or
undertaken out of hours or by lone workers, whether it could create
aerosols or splashes, etc. These sorts of risk assessments are then
used to inform what adequate and/or appropriate safety and security
measures would be.
In some countries, risk assessments of proposed projects with
biological agents and toxins may be reviewed internally through
local review committees rather than through scrutiny by external
regulators. Depending on the size and kind of institution
(academic, private, commercial, military), these reviews may range
from the quite informal to the very formal and bureaucratic.
Sometimes the meetings of local review committees are open to
the public, or minutes of the meetings and submitted documents are
available to the public on request. For other states parties,
public registers of information on projects with biological agents
and toxins may be kept by regulators or funders. This is the case
in the UK, for example, where information[11] on all contained-use work with genetically
modified micro-organisms is held in a central register and made
available to the public in hard copy at the Health and Safety
Executive or electronically online.
Ongoing research
There are several ways to monitor research with biological
agents and toxins while it is being carried out, the most prominent
of which is inspection by regulatory authorities of laboratory
premises and the working practices of the researchers there. A
health and safety inspection of a biological laboratory in the UK,
for example, would typically comprise both scrutiny of laboratory
documentation - particularly going through the various risk
assessments the laboratory had carried out for its projects - and a
visit to the actual laboratory, during the course of which the
inspectors would speak to the researchers working there to check
that the written policies and procedures were being adhered to.[12]
There may also be inspections of laboratory premises and
routines through accreditation regimes (for example the ISO
standards of the International Organization for Standardization or
the Good Laboratory Practice and Good Manufacturing Practice
standards) or through inspection programmes internal to
institutions. These are often carried out by individuals in
departments specifically dedicated to health and safety and
environmental concerns.
Less formalized, although as important, are inspections by
peers, who take on the role of biosafety officers alongside their
principal jobs as researchers. Even less formalized but still a
highly significant oversight mechanism is day-to-day peer
observation in the laboratory. As NSABB, among others,[13] has noted: "Researchers are
the most critical element in the oversight of dual use life
sciences research. They know the work best and are in the best
position to anticipate the types of knowledge, products, or
technologies that might be generated, the potential for misuse and
the degree of immediacy of that threat".[14]
The same point was made by a laboratory head at a large San
Francisco Bay Area biotechnology company in a particularly candid
interview carried out as part of a study looking at the
implementation and impact of biosafety and biosecurity regulations
in laboratories.[15] He noted
that early on, for a small company, "the biosafety people tend to
be very technical as they are usually still working as researchers
and only doing the biosafety job on a part time basis. At around
150 employees companies can no longer rely on part-time biosafety
officers. Ironically, it is when professional biosafety people are
employed that you loose an understanding of what's going on. They
are administrators in inclination and ability. They only know the
regulations you have to comply with. Mid-size companies move away
from using scientists towards administrators that don't know what's
going on at the bench top level".
He went on to say that "EH&S [Environment, Health &
Safety] don't deal with the real safety issues, they only handle
the bureaucracy. They are administrators. They may chair the safety
committee, but even so they pretty much just turn the wheels. Most
EH&S safety people are technically incompetent, and completely
antithetical to people in research. There is a natural schism
between EH&S and scientists, and the earlier you are in the
R&D process the bigger the gulf". He showed me a copy of the
Atlanta-based Centers for Disease Control (CDC) publication
Biosafety in Microbiological and Biomedical Laboratories,
and commented, "See, it only applies to standard viruses. There is
no guidance for genetically modified viruses or for very large
volumes of viruses. In the synthetic virus era you have to make
your own rules - it has to be self-policing; you cannot have a set
standard".
His laboratory works on genetically engineering viruses: "We can
derive strains that are more infectious than HIV. Yet, the
biosafety officers are busy pushing airborne pathogens regulations.
The real safety issues are inherently self-policed. The pursuit of
following safety regulations is a distraction. You can't develop
regulations fast enough to follow evolving research. With basic
research you have to depend on representation from the trenches to
know what is going on".
One way to harness or strengthen the effect of peer observation
in the laboratory, as well as to raise awareness among individual
researchers themselves, is to find constructive ways of
incorporating concern about potential misuse into the professional
norms of biological scientists, their training and research
practices, and their manuals and standard operating procedures.
These may, for instance, be institutional policies outlining
specific biological hazards (like how to safely handle infectious
materials) and procedures for controlling them, or policies
describing requirements for onsite containment facilities and
appropriate practices for that type of containment (such as when to
display biohazard warning signs, when to use biosafety cabinets,
how to disinfect work areas, how to control access, etc).
Documentation on how these policies and procedures are followed can
provide a useful oversight mechanism. Laboratory notebooks - where
the concept, intent and design of experiments are recorded along
with observations made during the experiment and any resulting data
where it is practical to do so - and their review by peers would be
another example of documentary oversight.
Publication of manuscripts
Relevant work with biological agents and toxins can also be
monitored at the publication stage of the research process. For
instance, in 2003, the Journal Editors and Authors Group -
comprising 32 leading life science journals - stated that
"scientists and their journals should consider the appropriate
level and design of processes to accomplish effective review of
papers that raise security issues", and that this may, on occasion,
lead an editor to conclude that "the potential harm of publication
outweighs the potential societal benefits [and that in such
circumstances] the paper should be modified, or not be
published".[16]
The American Society for Microbiology journals provide one
example of journals that have specific policies and procedures in
place. Following the terrorist attacks in 2001 and the ensuing
anthrax letters, the Society "adopted specific policies and
procedures for its journals to provide a degree of careful scrutiny
in the peer review process of submitted manuscripts dealing with
dangerous pathogens".[17] Its
Publications Board review process now "seeks to determine if an
article contains details of methods or materials that might be
misused or might pose a threat to public health or safety".[18] Other high-profile journals, such
as Science, the Proceedings of the National Academy of Sciences
and Nature, have developed or put in place similar review
procedures.
The NSABB in the United States has drafted a set of principles
for the responsible communication of research with dual use
potential.[19] The Board
argues that if the communication of dual use research is considered
to pose potential security risks, a risk-benefit analysis of
communicating the information should be conducted: "After
weighing the risks and benefits of communicating dual use research
findings, the decision regarding communication is not necessarily a
binary (yes/no) one. Rather, a range of options for communication
should be identified and considered. The options available will
depend on the research setting, e.g. academia, government, private.
They could range from full and immediate communication, to delayed
and/or modified communication, to restricted/no communication, and
could be recommended singly or in appropriate combinations on a
case-by-case basis, depending on the nature of the dual use finding
and the potential risks associated with its communication".[20]
The Board also argues that "it is important to consider not only
what is communicated, but also the way in which it is communicated"
and that "thought should be given to the need for the inclusion of
contextual and explanatory information that might minimize [public]
concerns and misunder-standings".[21]
Complementing statutory measures with informal oversight
mechanisms
Some of the oversight mechanisms I have outlined in this paper
are prescribed by statutory measures, others are based on voluntary
guidelines from regulators or professional organizations, and some
are based on the tacit rules of the life sciences. The extent to
which oversight of peaceful, prophylactic and protective life
science research is best provided through statutory means or
through self-governance by the scientific community is the subject
of ongoing debate.
The National Research Council in the United States, which began
focussing on dual use oversight fairly early on in this debate,
highlighted three recent examples of "contentious" life science
research in its 2004 report Biotechnology Research in an Age of
Terrorism,[22] and argued
that "these cases illustrate that, to balance the risks [for
potential misuse] against the obvious benefits, one must depend
upon expert scientific judgement".[23] It made the further point that: "The qualitative
and case-by-case nature of these judgements is the primary reason
the committee believes it is better to rely on self-governance
to manage this aspect of the problem rather than to attempt to
define appropriate or inappropriate research via regulation".[24]
The draft report of the NSABB Working Group on Oversight
Framework Development, which was presented and discussed at the
April 19, 2007 meeting of the NSABB, echoed this observation.
Noting that "The foundation of oversight of dual use research is
investigator awareness, peer review, and local institutional
responsibility", it recommended a mix of self-governance and
non-statutory guidelines: "The responsible conduct and
communication of dual use research of concern depends largely upon
the individual conducting such activities. No criterion or guidance
document can anticipate every possible situation. Motivation,
awareness of the dual use issue, and good judgement are key to the
responsible evaluation of research for dual use potential. It is
incumbent upon the institution and the investigator to adhere to
the intent of such guidance as well as to the specifics".[25]
In contrast, the UK government has taken a very different view.
In a Working Paper submitted to the BWC Meeting of Experts in
August 2003, setting out the UK views on core elements needed for
effective national measures to ensure the security and oversight of
biological agents and toxins, it stated that: "The UK believes that
some states parties may have limited numbers and types of
facilities handling pathogens and toxins of key concern. In such
cases, such facilities may be largely under direct or indirect
control by the government, which may therefore not find it
necessary to enact legislation in order to ensure that biosecurity
measures are in place. In other countries, including the UK, the
broad range of owners and operators of such facilities and the
wider extent of the legitimate work undertaken (and, therefore, the
greater number of targets for unauthorized acquisition) is such
that legislation is likely to be necessary to ensure that effective
biosecurity measures are fully adopted and implemented nationally.
In this situation, relying on facilities to self-regulate
biosecurity is likely to be an inadequate approach, and
government-based formal oversight arrangements based on legislation
would be necessary".[27]
The UK working paper goes on to list key regulatory determinants
of 1) which pathogens and toxins should be controlled, 2) what
premises - and activities underway within the premises - are
covered, and 3) what measures must be instituted at them. Noting
that in many states parties these would need to be created by
domestic legislation, it also lists a number of oversight
mechanisms: notifications, inspections, appropriately-trained and
resourced officials, etc - to ensure that biosecurity measures are
fully and consistently implemented and maintained.
The UK argument is persuasive, and one that I support. However,
as this article demonstrates, other forms of oversight are also
important. Oversight should not be limited to an exclusively
governmental function; there are important roles for individual
scientists, laboratory managers, professional bodies, trade
associations and others in monitoring work and activities with
biological agents and toxins.
Conclusion
"Representation from the trenches" - through peer review of
draft projects, funding applications, laboratory documentation and
manuscripts for publication as well as through peer observation in
the laboratory - is fundamental to providing effective oversight of
the rapid pace and nature of change in the life and biomedical
sciences and must be actively supported by national
governments.
Although the debate over the relative balance of formal and
informal monitoring systems is important, it should not detract
from the central points of this article: first, that the ongoing
monitoring of activities relevant to the BWC is an essential
component for effective implementation of the Convention; second,
that national oversight frameworks must comprise overlapping
methods for monitoring relevant work with biological agents and
toxins at multiple stages in the R&D process in order to
adequately protect against the potential misuse and misapplication
of relevant life science activities; and third, that in addition to
putting formal monitoring systems in place, states parties must
actively encourage the development of informal monitoring
systems.
Notes
[1] Richard Guthrie,
'Rising Out of the Doldrums: Report on the BWC Review Conference',
Disarmament Diplomacy 84, (Spring
2007).
[2] Specifically: "(i)
Ways and means to enhance national implementation, including
enforcement of national legislation, strengthening of national
institutions and coordination among national law enforcement
institutions. (ii) Regional and sub-regional cooperation on
implementation of the Convention" See Final Document of the Sixth
Review Conference, Geneva 2006, BWC/CONF.VI/6
[3] Letters dated May 24
and July 10, 2007 to the Permanent Representatives in Geneva of the
States Parties to the BWC from Masood Kahn, Chairman of the 2007
Meeting of Experts and Meeting of States Parties.
[4] Filippa Corneliussen,
'Regulating Biorisks: Developing a Coherent Policy Logic Part I',
Biosecurity and Bioterrorism, Vol.4(2) (2006), pp 160-167,
and Filippa Lentzos, 'Regulating Biorisks: Developing a Coherent
Policy Logic Part II', Biosecurity and Bioterrorism,
Vol.5(1) (2007), pp 55-61. For a more general discussion on
coherent oversight frameworks or risk regulation regimes see: C
Hood, H Rothstein, and R Baldwin, The Government of Risk:
Understanding Risk Regulation Regimes (Oxford: Oxford
University Press, 2001).
[5] NSABB Draft Guidance
Documents, July 2006, available at www.biosecurityboard.gov
[6] These categories draw
to some extent on the seven "experiments of concern" outlined in
the 2004 National Research Council report Biotechnology Research
in an Age of Terrorism. The NSABB categories, however, have a
different purpose and meaning. While "the seven experiments of
concern are classes of experiments that ... illustrate the types of
endeavours or discoveries that will require review and discussion
... The NSABB categories ... are descriptors of information,
products, or technologies that if produced from life science
research, might define that research as meeting the criterion for
being dual use research of concern". (ibid p 17)
[7] Draft report of the
NSABB Working Group on Oversight Framework Development, presented
and discussed at the 19 April 2007 meeting of the NSABB and
available at www.biosecurityboard.gov
[8] ibid
[9] A joint BBSRC, MRC and
Wellcome Trust policy statement on "Managing risks of misuse
associated with grant funding activities" September 2005, http://www.wellcome.ac.uk/doc_wtx026594.html
[10] Regulatory
authorities may be at a local, state or national level.
[11] This includes
information on the premises, the nature of the work to be carried
out at the premises, the purpose of individual activities, and the
characteristics of the genetically modified micro-organisms
involved.
[12] For more detail on
how the Biological Agents Unit of the British Health and Safety
Executive carries out its inspections see: Filippa Corneliussen,
'Regulating Biorisks: Developing a Coherent Policy Logic Part I',
Biosecurity and Bioterrorism, Vol.4(2) (2006), pp
160-167.
[13] Such as the National
Research Council of the National Academies in the United States or
the Royal Society in the United Kingdom.
[14] See note 8
[15] Wellcome Trust
Postdoctoral Research Fellowship No. 068431/Z/02/Z October 1
2003-September 30 2006 entitled 'Social and Ethical Aspects of
Governing Dual-Use Biomedical Research and Development'. The
interview referred to was conducted on a non-attributable basis, on
the understanding that I would publish the results.
[16] The Journal Editors
and Authors Group, 'Statement on the Consideration of Biodefence
and Biosecurity', Nature, February 2003.
[17] American Society for
Microbiology, 'The professional responsibilities of scientists,'
presentation to the BWC Meeting of Experts, Geneva, 16 June
2005.
[18] ibid
[19] See note 5
[20] See note 5
[21] See note 5
[22] The mousepox virus,
total synthesis of the poliovirus genome and recovery of infectious
virus, and comparison of the immune response to a virulence gene
from vaccinia and smallpox. National Research Council,
Biotechnology Research in an Age of Terrorism, 2004, pp
25-29.
[23] ibid, p 109.
[24] ibid, pp 109-10,
author's emphasis.
[25] See note 7
[26] The UK understands
'biosecurity measures' to be those designed to prevent the
unauthorised acquisition of pathogens, toxins or other bioactive
substances of biological origin, specifically to prevent their
potential misuse inconsistent with the provisions of the BTWC.
[27] United Kingdom
working paper, 'The Design of National Mechanisms to Maintain the
Security and oversight of Pathogenic Microorganisms and Toxins',
July 15, 2003, BWC/MSP.2003/MX/WP.7/Rev.1, author's emphasis.
Dr. Filippa Lentzos is a Senior Research
Fellow at the London School of Economics' BIOS Centre. She is also
Managing Editor for BioSocieties, an interdisciplinary journal for
social studies of life sciences.
The article was made available for use before
and during the Meeting of BWC Experts in Geneva from August 20-24,
2007. It expands on the 'Making Legislation Work' briefing note by
Daniel Feakes, Filippa Lentzos, Caitríona McLeish and Angela
Woodward circulated to Missions and individual diplomats in Geneva
on 11 June 2007, and available at www.lse.ac.uk/collections/bios
and at www.vertic.org.
© 2007 The Acronym Institute.
|
