20th Pugwash Workshop Study Group on the
Implementation of the CBW Conventions:
The BWC Intersessional Process towards the Sixth
Review Conference and Beyond
Geneva, Switzerland, 8-9 November 2003
Papers | Workshop
Report | Participants | Photos
Preparing for the First Meeting of the
States Parties:
National Implementing Legislation and Security and
Oversight of Pathogenic Microorganisms and Toxins
by Graham S. Pearson and Nicholas A Sims
Introduction
1. The Meeting of Experts of the States
Parties to the Biological and Toxin Weapons Convention in Geneva on
18 to 29 August 2003 was held, in accordance with the decision taken
by the Fifth Review Conference
[1] , to prepare for the annual meeting of the States
Parties of one week duration to be held in 2003 to discuss,
and promote common understanding and effective action on:
i. The adoption of necessary, national measures
to implement the prohibitions set forth in the Convention, including
the enactment of penal legislation;
ii. National mechanisms to establish and maintain
the security and oversight of pathogenic microorganisms and toxins;
The first week of the Meeting of Experts
addressed the first topic and the second week the second topic. 83
States Parties participated in the Meeting of Experts which heard
national overview statements on national measures to implement the
prohibitions of the Convention from 16 States Parties on Monday 18
August and then on subsequent days during the first week heard a total
of 37 thematic presentations on this topic [2] . During
the second week, national overview statements on national mechanisms
to establish and maintain security and oversight of pathogenic microorganisms
and toxins were heard from 14 States Parties on Monday 25 August and
then on subsequent days during the second week a total of 36 thematic
presentations were heard on this topic [3] . During the two week
period, 66 Working Papers were presented by States Parties on the
two topics.
2. Although previous Briefing Papers [4]
[5] had urged the States Parties in the report of
the Meeting of Experts to start to identify the common understandings
and effective action that had emerged as it was recognised that
there would be little time to develop agreed language for such common
understandings and effective action during the one week Meeting of
the States Parties on 10 to 14 November 2003, the Meeting of Experts
has produced only a factual report. This is in accordance with the
requirement in the decision of the Fifth Review Conference that "The
meeting of experts will prepare factual reports describing their work."
but it did not offer draft text for the Meeting of States Parties
to work on, as had been hoped.
3. The Report of the Meeting of Experts
in August 2003 is in two parts. Part I
[6] provides a four page procedural report of the
meeting to which is attached Annex I providing a list of the documents.
Part II [7] is a 172 page document prepared to
meet the decision of the Meeting of Experts that "all the
statements, presentations and contributions made available to the
Chairman by the States Parties would be attached to this Report, in
the language of submission, as Annex II". However, Annex
II in Part II is preceded by a note from the Secretariat that:
"the statements, presentations and contributions
included in this part of the report are presented in the languages
of submission. In cases where the language of submission is not English,
the text as submitted is followed by an informal transcript of the
English interpretation, made from the tape recording of the meeting.
These transcripts are not an official record, and are provided solely
as a convenience to delegations. They may differ from the texts submitted.
Statements, presentations and contributions which were submitted as
working papers are not included in this Annex; please refer to the
Annex I for the list of working papers."
It is not easy to analyse the information
provided in Annex II as no indication is provided as to where statements,
presentations and contributions which were submitted as working papers
-- and thus are not included in Annex II -- were made during the Meeting
of Experts, nor is there any indication in Annex II as to where the
statements, presentations and contributions fit into the agreed detailed
programme of work [8] which
broke down the two topics into subtopics and further detailed subelements.
4. This paper starts from the material
presented in Briefing Papers No. 6 and No. 7 and develops this in
the light of the material presented by States Parties at the Meeting
of Experts in order to propose language for the two topics -- national
measures to implement the prohibitions in the Convention and national
measures to establish and maintain the security and oversight of pathogenic
microorganisms and toxins -- for the Report of the First Meeting of
States Parties in November 2003. It is recognised that the time
available at the Meeting of the States Parties will be extremely limited
and consequently it would be unrealistic to expect the Report to consist
of more than a couple of pages -- about a page on the first topic
and another on the second topic. The aim here is thus to propose
language for about a few page report on the two topics. As in Briefing
Papers No. 6 and No. 7, the proposed language for the common understandings
and effective action that could appear in the Report of the First
Meeting of States Parties in the context of the forthcoming Sixth
Review Conference is based on the extended understandings agreed
at previous Review Conferences.
The Meeting of Experts in August 2003:
The First Week
5. The Meeting of Experts considered
the national measures to implement the prohibitions in the Convention
during the week of Monday 18 to Friday 22 August 2003. National
overview statements were made on the first day by 16 States Parties
and contributions and presentations were made by States Parties on
their national implementing measures which included Argentina, Australia,
Brazil, Bulgaria, China, Cuba, Czech Republic, Finland, Germany, India,
Iran, Japan, Republic of Korea, Malaysia, Mexico, New Zealand, Netherlands,
Poland, Russian Federation, South Africa, Thailand, Turkey, Ukraine,
United Kingdom and the United States. In addition, 12 (Austria,
Belgium, Finland, France, Germany, Ireland, Italy, the Netherlands,
Portugal, Spain, Sweden and the UK) of the 15 EU countries contributed
detailed information on national implementing measures to a composite
Working Paper
[9] . It was evident that most of the States Parties
which made statements, contributions and presentations to the Meeting
of Experts had enacted national legislation to implement the prohibitions
of the Convention and had national export control legislation and
regulations.
6. During the week, statements, presentations
and contributions were made on successive days as the various subtopics
of national implementing measures set out in the agenda were considered:
A. Legal, Regulatory and Administrative Systems.
B. Prohibitions
C. Restrictions
D. Practical Implementation and Enforcement
E. Criminalization and Law Enforcement.
Although Annex II in Part II of the Final
Report includes statements, presentations and contributions made on
each day, the material available together with the Working Papers
do not fall neatly into the various Agenda item headings and subelements.
It is also evident, as noted above, that a detailed analysis leading
to an extensive set of detailed common understandings and hence of
possible effective action would not be feasible given the reality
of the one week duration of the Meeting of States Parties and hence
the impossibility of agreeing a report of more than a few pages.
7. The situation is assisted, however,
by the fact that some of the contributions and Working Papers address
the issues conceptually identifying core elements. It is also very
clear that there are indeed common understandings among the States
Parties of the need for national measures to implement the prohibitions
of the Convention. Furthermore, such national measures need to be
implemented effectively through appropriate national institutional
mechanisms.
8. The central prohibitions of the Convention
are in Article I and in Article III. Article I states that:
Each State Party to this Convention undertakes never in any
circumstances to develop, produce, stockpile or otherwise acquire
or retain:
(1) Microbial or other biological agents, or toxins whatever
their origin or method of production, of types and in quantities
that have no justification for prophylactic, protective or other
peaceful purposes;
(2) Weapons, equipment or means of delivery designed to use such
agents or toxins for hostile purposes or in armed conflict.
Each State Party to this Convention undertakes
not to transfer to any recipient whatsoever, directly or indirectly,
and not in any way to assist, encourage, or induce any State, group
of States or international organizations to manufacture or otherwise
acquire any of the agents, toxins, weapons, equipment or means of
delivery specified in article I of this Convention.
It follows that the core elements for
national implementing and penal legislation should include:
a. Prohibitions of the development, production, stockpiling,
acquisition, retention, use and transfer of microbial and other biological
agents, or toxins whatever their origin or methods of production,
of types and quantities that have no justification for prophylactic,
protective or other peaceful purposes.
b. Prohibitions of weapons, equipment or means of
delivery designed to use such agents or toxins for hostile purposes
or in armed conflict.
c. Penal provisions specifying the penalties for any
persons breaching such prohibitions.
d. Extraterritorial application of these prohibitions
if undertaken by a State Party or by a State Party person, whether
individual or corporate.
e. Provisions for offences by corporate bodies as
well as individuals.
f. Powers of search and for obtaining evidence in
cases of suspected breaches of the legislation.
g. Corresponding changes in military law so as to
ensure that these prohibitions apply without exception to members
of the armed forces.
h. Prohibition of the provision of assistance to
others, whether within the State Party or elsewhere, to breach any
of the prohibitions in the Convention.
9. Insofar as the prohibitions in Article
III of the Convention are concerned which prohibit the transfer to
any recipient whatsoever or in any way to assist, encourage, or induce
any State, group of States or international organizations to manufacture
or otherwise acquire any of the agents, toxins or weapons, equipment
or means of delivery specified in Article I of the Convention, provisions
need to made nationally for a mandatory licensing system which can
track the movement of specified materials, such as agents and toxins
and certain items of equipment. Such transfer monitoring and export
control regulations should include:
a. A list of biological agents and toxins,
and of related genetic material, and equipment for which a license
is required prior to export and internal transfer.
b. A "catch all" clause that
would require any person transferring such items to another to seek
a license where that person suspected or had been informed by the
national government that the item concerned may be for use in breach
of the prohibitions in the Convention.
c. Controls on the transfer of sensitive
technology by intangible means such as by e-mail or facsimile.
d. Penal provisions specifying the penalties
for any persons breaching such prohibitions.
e. Provision for changes to be made
to the lists of agents and toxins and equipment in the light of changing
circumstances.
10. The common understandings relating
to national measures to implement the prohibitions in the Convention
are thus that these national measures should include provisions such
as those outlined in the above two paragraphs and the effective action
would be to encourage all States Parties to review their existing
national measures in the light of the information provided by the
other States Parties and amend their national measures as necessary
to strengthen them. It will be recalled that the States Parties
have already agreed at previous Review Conferences to provide information
on national legislation or other measures to implement the Convention
-- see, for example, the language agreed at the Fourth Review Conference
[10] in 1996:
... some States Parties, as requested by the Second
Review Conference, have provided to the United Nations Department
for Disarmament Affairs information on the texts of specific legislation
enacted or other measures taken to assure domestic compliance with
the Convention. These States Parties are invited, and all States Parties
are encouraged, to provide such information and texts in the future.
In this regard the information provided by States Parties in response
to the confidence-building measure agreed to at the Third Review Conference
entitled "Declaration of legislation, regulations and other measures"
is welcomed. In addition, all States Parties are encouraged to provide
any useful information on the implementation of such measures.
Moreover, as stated in Briefing Paper
No. 6 [11] , it should be recognised that, as
agreed at the Third Review Conference, from 15 April 1992 States Parties,
under Confidence-Building Measure E,
shall be prepared to submit
copies of the legislation or regulations or written details of other
measures on request to the United Nations Department for Disarmament
Affairs or to an individual State Party. [12] [Emphasis added]
Each State Party can now, therefore, request
these details bilaterally under the authority of the Third
Review Conference, instead of depending solely upon the circulation
of texts made available to the United Nations. Although this extension
to provide for bilateral requests has not been recorded explicitly
in any Final Declaration, it is still one part of the politically
binding requirement of CBM 'E'. It therefore represents one of the
common understandings which have evolved out of Article IV. This
bilateral approach should become more important as States Parties
take a greater interest in the status and effectiveness of their own
legislation as well as other States Parties' legislation, and whether
it is sufficiently strong and comprehensive to contribute to security
overall. They can check one another's legislative performance individually,
and make their own assessment of its adequacy. The possibility of
requesting these details bilaterally could be used to bring diplomatic
pressure to bear on any State Party which was thought, by reason of
the inadequacy of its national measures, to be leaving open loopholes
which bioterrorists or others might exploit to the detriment of everyone's
security. To "be prepared to submit copies of the legislation
or regulations or written details of other measures on request"
is to accept that these texts are of legitimate interest to individual
States Parties and that their requests are in accord with the common
understanding of what Article IV implies for each State Party.
11. Consequently, these existing agreed
understandings should be used by the States Parties to provide information
on the outcome of national reviews of their national implementing
measures during 2004 and successive years. This would provide information
that should enable the Sixth Review Conference in 2006 to review how
effective had been the action agreed on national implementing measures
as the outcome of the Meeting of Experts in 2003, and in particular
of the opportunity it provided for the comparison of measures among
States Parties, thereby contributing an international dimension to
the reviews undertaken nationally.
The Meeting of Experts in August 2003:
The First Week
12. The Meeting of Experts considered
national measures to establish and maintain the security and oversight
of pathogenic microorganisms and toxins during the week of Monday
25 to Friday 29 August 2003. National overview statements were made
on the first day of the week by 14 States Parties and contributions
and presentations were made by States Parties on their national measures
which included Argentina, Australia, Brazil, Bulgaria, Canada, China,
Cuba, Czech Republic, France, Germany, India, Iran, Japan, Republic
of Korea, Libya, Malaysia, Mexico, New Zealand, Netherlands, Poland,
Romania, Russian Federation, Sweden, Ukraine, United Kingdom and the
United States. In addition, 12 (Austria, Belgium, Finland, France,
Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden
and the UK) of the 15 EU countries contributed detailed information
on national implementing measures, which included national measures
addressing the handling of human, animal and plant agents and toxins,
to a composite Working Paper
[13] . It was evident that most of the States Parties
which made statements, contributions and presentations to the Meeting
of Experts had enacted national measures that addressed the security
of pathogenic microorganisms and toxins whether from a biosafety or
biosecurity viewpoint.
13. During the week, statements, presentations
and contributions were made on successive days as the various subtopics
of national implementing measures set out in the agenda were considered:
A. Legal, Regulatory and Administrative Systems.
B. Facilities
C. Personnel
D. Transport and Transfer
E. Oversight & Enforcement.
Although Annex II in Part II of the Final
Report includes statements, presentations and contributions made on
each day, the material available together with the Working Papers
do not fall neatly into the various Agenda item headings and subelements.
It is also evident, as noted above, that a detailed analysis leading
to an extensive set of detailed common understandings and hence of
possible effective action would not only be difficult but is also
unwarranted given the reality of the one week duration of the Meeting
of States Parties and hence the impossibility of agreeing a report
of more than a few pages.
14. The situation is assisted, however,
by the fact that some of the contributions and Working Papers address
the issues conceptually identifying key principles. It is also very
clear that there are indeed common understandings among the States
Parties of the need for national measures to establish and maintain
the security and oversight of pathogenic microorganisms and toxins.
Furthermore, there are common understandings that such national measures
need to be implemented effectively through appropriate national institutional
mechanisms.
15. The central requirement for the security
and oversight of pathogenic microorganisms and toxins stems from the
general purpose criterion in Article I of the Convention which states
that:
Each State Party to this Convention undertakes never in any
circumstances to develop, produce, stockpile or otherwise acquire
or retain:
(1) Microbial or other biological agents, or toxins whatever their
origin or method of production, of types and in quantities that have
no justification for prophylactic, protective or other peaceful purposes;
It is thus clear that each State Party
needs to take national measures to ensure that, never in any circumstances,
are pathogenic microorganisms and toxins used for other than prophylactic,
protective or other peaceful purposes.
16. It follows that national measures
to address the security of pathogenic microorganisms and toxins should
address a number of areas:
• Physical access to facilities holding such pathogenic
microorganisms and toxins;
• Storage of pathogenic microorganisms and toxins
within those facilities;
• Access to pathogenic microorganisms and toxins within
those facilities;
• Transfer of pathogenic microorganisms and toxins
between facilities;
• Integrity of facilities holding and of personnel
handling pathogenic microorganisms and toxins;
National measures to address these should
include:
a. Determination of which pathogenic microorganisms
and toxins should be the subject of such national measures -- referred
to as listed pathogenic microorganisms and toxins.
b. Registration and licensing of all national facilities
holding listed pathogenic microorganisms and toxins.
c. Scrutiny and licensing of all personnel working
with listed pathogenic microorganisms and toxins.
d. Facility handling procedures to ensure the security
of listed pathogenic microorganisms and toxins.
e. Requirements for the physical security of facilities
and storage areas holding listed pathogenic microorganisms and toxins.
f. Requirements for the security and licensing of
transfers between facilities of listed pathogenic microorganisms and
toxins.
17. The oversight of pathogenic microorganisms
and toxins was seen as covering two different areas in the statements,
presentations and contributions made to the Meeting of Experts. In
many States Parties, oversight was used to refer to measures to ensure
the effective and consistent implementation in all facilities holding
pathogenic microorganisms and toxins of the national measures addressing
the security of such materials. In some States Parties, oversight
was also used to refer to national measures requiring the prior approval
of certain work involving listed pathogenic microorganisms and toxins.
Both types of oversight contribute to enhancing the national implementation
of the Convention through ensuring that pathogenic microorganisms
and toxins are not used for purposes other than those permitted under
the Convention.
18. Such oversight mechanisms should
include provisions for:
• A requirement for the regulatory authority to be
notified of the names and addresses of facilities holding any listed
pathogenic microorganisms and toxins. The prior approval of the
regulatory authority may be required prior to the facility holding
any such listed pathogenic microorganisms and toxins.
• A requirement for approval to be sought from the
regulatory authority prior to the carrying out of particular types
of work involving listed pathogenic microorganisms and toxins.
• Powers for the regulatory authority to inspect and
search facilities and individuals, to instruct work to stop, to remove
listed pathogenic microorganisms and toxins or require them to be
destroyed, and to restrict access by specified individuals to the
listed pathogenic microorganisms and toxins.
• Appropriately trained officials in the regulatory
authority who are authorised to inspect facilities, make assessments
and take any enforcement action.
19. The common understandings relating
to national measures to establish and maintain the security and oversight
of pathogenic microorganisms and toxins are thus that these national
measures should include provisions such as those outlined in the above
paragraphs and the effective action would be to encourage all States
Parties to review their existing national measures in the light of
the information provided by the other States Parties and amend their
national measures as necessary to strengthen them. It is also clear
that these common understandings regard the national measures to establish
and maintain the security and oversight of pathogenic microorganisms
and toxins as integral to the national measures to implement the prohibitions
in the Convention and, in particular, to ensuring the national implementation
of the general purpose criterion in Article I that pathogenic microorganisms
and toxins are not used for purposes other than those permitted under
the Convention.
20. As already noted in the discussion
on the first week, the existing agreed understandings should be used
by the States Parties to provide information on the outcome of national
reviews of their national measures to establish and maintain the security
and oversight of pathogenic microorganisms and toxins during 2004
and successive years. This would provide information that should
enable the Sixth Review Conference in 2006 to review how effective
had been the action agreed on national measures on security and oversight
as the outcome of the Meeting of Experts in 2003.
Outcome of the First Meeting of States
Parties
21. As the Meeting of Experts did not
include any language in its Report which lends itself to the drafting
of language for the outcome of the Meeting of States Parties, the
development of such language and its agreement will need to be achieved
during the one week Meeting of the States Parties from 10 to 14 November
2003. Two points are immediately clear. First, the outcome cannot
realistically be more than a few pages focussing on the central elements
and second, the language should be developed from that agreed by States
Parties at the Fourth Review Conference as the Meeting of States Parties
in November 2003 is part of the inter Review Conference process
between the Fifth and Sixth Review Conferences. Language developed
from that of the Fourth Review Conference offers the prospect of easy
assimilation and further development by the Sixth Review Conference
as the cumulative review process resumes.
22. Consequently, the outcome language
proposed at the end of Briefing Paper No. 6 and No. 7 has been reviewed
and shortened to reflect the reality of what is achievable in a one
week Meeting of the States Parties. The proposed language for the
outcome of the November 2003 Meeting of States Parties is as follows:
OUTCOME OF THE FIRST MEETING
1. The First Meeting reaffirmed the commitment
of States Parties to take the necessary national measures under Article
IV in accordance with their constitutional processes. These measures
must ensure the prohibition and prevention of the development, production,
stockpiling, acquisition or retention of the agents, toxins, weapons,
equipment and means of delivery specified in Article I of the
Convention anywhere within their territory, under their jurisdiction
or under their control, in order to prevent their use for purposes
contrary to the Convention.
2. The First Meeting noted those measures
already taken by a number of States Parties in this regard, including
the adoption of penal legislation, and urged any State Party that
has not yet taken any necessary measures to do so immediately. Such
measures should apply within its territory, under its jurisdiction
or under its control anywhere. The First Meeting invited each State
Party to consider the application of such measures also to actions
taken anywhere by natural persons possessing its nationality.
3. The First Meeting encouraged each
State Party that is in a position to do so upon request to afford
the appropriate form of legal assistance to other States Parties to
facilitate the implementation of the obligations in Article IV of
the Convention.
4. The First Meeting recognised that
national measures to implement the prohibitions in the Convention
need to utilize identical language to that of Article I of the Convention
and also to embrace the extended understandings that have emerged
from the successive Review Conferences. The First Meeting recommended
that States Parties should take effective action by reviewing their
national measures to ensure that they do indeed prohibit and prevent
the activities defined in Article I.
5. The First Meeting recognised that
national measures to implement the obligations of Article III of
the Convention need to utilize essentially identical language to that
of Article III of the Convention. These measures require to be effective
internationally, nationally and subnationally. The First Meeting recommended
that States Parties should take effective action by reviewing their
national measures to ensure that they do indeed implement the obligations
of Article III.
6. The First Meeting noted that some States
Parties, as requested by the Second Review Conference, have provided
to the United Nations Department for Disarmament Affairs information
on the texts of specific legislation enacted or other measures taken
to assure domestic compliance with the Convention. The First Meeting
invited these States Parties, and encouraged all States Parties, to
provide such information and texts in the future both to the United
Nations Department for Disarmament Affairs and, upon request, to an
individual State Party. In this regard the First Meeting welcomed
information provided by States Parties in response to the confidence-building
measure agreed to at the Third Review Conference entitled "Declaration
of legislation, regulations and other measures".
7. The First Meeting emphasized that
national implementing legislation needs to include prohibition of
development, production, stockpiling, retention, acquisition and use
of biological weapons with language that applies to both biological
and toxin agents and to the weapons, equipment and means of delivery.
It was recommended that language used in the national legislation
should be identical to that in the Convention so as to avoid any loopholes.
8. The First Meeting recognized the importance
of ensuring that national measures are applicable to all natural
persons and furthermore apply to activities carried out not only within
but also outside the territory of the State Party. The First Meeting
recommended that States Parties review their national measures to
ensure that they apply to all natural persons and that there are no
exclusions and also to ensure that they are applicable to natural
persons anywhere.
9. The First Meeting recognized that
effective national implementation of the prohibitions of the Convention
requires the mounting of an effective and continuing campaign to ensure
that all those working with biological agents and toxins both now
and in the future are aware of the prohibitions of the Convention
and of the national legislative, administrative and other measures
to implement these prohibitions.
10. The First Meeting noted that the
effectiveness of drawing up national measures to implement the prohibitions
of the Convention can be enhanced through making draft national measures
available for consultation by seeking proposals for amendment from
the public in general and the community that will be affected by and
implement the measures in particular. Advisory committees including
representatives of the community that are affected by the measures
can enhance the implementation of the national measures.
11. The First Meeting recognized that
the national measures to implement the prohibitions of the Convention
need to be enforced effectively, in order to ensure the prevention
of all the prohibited activities, and recommended that each State
Party should review the effectiveness of its enforcement of the prohibitions.
12. The First Meeting recognized that
similar approaches are being taken by States Parties nationally, regionally
and more widely to address the safety in storage, handling and use
of pathogenic microorganisms and toxins and of genetically modified
microorganisms and that such approaches will include considerations
of biocontainment and thus the physical security of such materials.
However, it was also recognized that these safety related approaches
are frequently different for human, animal and plant pathogens and
for toxins. It was noted that the national legislation and regulations
and administrative procedures being used to ensure such materials
are stored, handled and used safely can provide a basis which can
be strengthened further to prevent unauthorized access or unauthorized
acquisition of such materials.
13. The First Meeting urged all States
Parties to review their existing national legislation and regulations
to determine whether additional provisions are required to prevent
unauthorized access to or unauthorized acquisition of the agents of
concern.
14. The First Meeting recognized the
benefits that standards, best practice and codes of practice could
provide towards ensuring the effective and consistent implementation
nationally of legislation and regulations addressing the safety, security
and oversight of pathogenic microorganisms and toxins. States Parties
were urged to share information on the standards, best practice and
codes of practice on the safety, security and oversight of pathogenic
microorganisms and toxins so that individual States Parties could
review the adequacy of their national standards, best practice and
codes of practice and determine whether any modification or amendment
was required.
15. The First Meeting noted that in many
States Parties the national regulations relating to pathogenic microorganisms
and toxins required all those engaged in activities involving such
materials to be appropriately trained and qualified. Such qualified
and trained personnel contribute to ensuring that pathogenic microorganisms
and toxins are handled safely and appropriately and thereby contribute
to ensuring the security of such materials.
16. The First Meeting recognized that
the national institutional frameworks in States Parties are frequently
separate and different for human, animal and plant pathogens and toxins.
It was noted that there are benefits in States Parties holding annual
oversight fora at about annual intervals involving all the different
government agencies concerned in the implementation of national legislation
and regulations addressing human, animal, and plant pathogens and
toxins to review the effectiveness of the implementation and the comprehensiveness
of national legislation and regulations to ensure that there are no
loopholes or perceived loopholes or deficiencies.
17. The First Meeting recognized that
the determination as to which pathogenic microorganisms and toxins
are of concern needs to be carried out nationally as the precise composition
of the national list of agents of concern will reflect national circumstances.
The principles of risk assessment to be used in drawing up the national
list of human, animal and plant pathogens and toxins of concern should
be broader than just the inherent properties of the agent. States
Parties were urged to share information on their national list of
agents of concern so that individual States Parties could review the
adequacy of their national list of agents of concern and determine
whether any modification or amendment was required.
18. The First Meeting noted that the
biocontainment levels required in many States Parties for facilities
handling pathogenic microorganisms reflect the hazards posed by such
materials and consequently contribute to ensuring the security of
such materials, and, in particular, those materials presenting the
greatest hazard. Several other biosafety requirements for facilities
handling pathogenic microorganisms such as perimeter access, access
to collections and stored pathogenic microorganisms and the logging
and recording of those working in the facility and requirements for
storage, containment, custody and disposal of pathogenic microorganisms
also contribute to ensuring the security of such materials and provide
a basis on which to add further or more stringent security requirements
as judged appropriate by the State Party. The First Meeting urged
all States Parties to review from a security viewpoint their existing
requirements for biocontainment, for perimeter access, for access
to collections and to stored pathogenic microorganisms, and for the
logging and recording of those engaged in working with pathogenic
microorganisms and requirements for storage, containment, custody
and disposal of pathogenic microorganisms in order to determine whether
these requirements and measures need to be made more stringent.
19. The First Meeting in considering
personnel issues related to security and oversight recognized the
importance competence, training and further education of all
personnel engaged in activities involving pathogenic microorganisms
and toxins. They recommended that States Parties should review their
national requirements for the competence, training and further education
to consider what modification or amendment was required to address
security aspects.
20. The First Meeting noted that many
States Parties had already adopted international standards for the
transportation of pathogenic microorganisms and for toxins (which
are generally treated as chemicals) which also include the requirements
for the containers and/or packaging to be used for such transportation.
The First Meeting urged all States Parties to adopt such international
standards.
21. The First Meeting recognized that
for human, animal and plant health reasons many States Parties have
legislation and regulations to control the import of human, animal
and plant pathogens, which are judged by that State Party to present
a particular risk from a health viewpoint, into the State Party, to
control the export of such pathogens and to control transfers of such
pathogens within the State Party. States Parties are urged
to review, from a security viewpoint, their existing national legislation
and regulations for the control of transfers, both nationally and
internationally, of human, animal and plant to determine whether these
provisions require strengthening for pathogenic microorganisms and
toxins of concern.
22. The First Meeting noted in regard
to legislation and regulations addressing involving pathogenic microorganisms
and toxins that these were frequently different for human, animal
and plant pathogens and for toxins. Consequently, the First Meeting
urged that all States Parties instigate an annual oversight process
in which all the government authorities concerned with the implementation
of national legislation and regulations for human, animal and plant
pathogens and for toxins review their comprehensiveness to ensure
that there are no loopholes or perceived loopholes and the effectiveness
of their enforcement.
23. The First Meeting recognized that
a few States Parties already have national regulations and procedures
for the oversight and prior approval of certain activities involving
pathogenic microorganisms and toxins of concern. The First Meeting
encouraged all States Parties to share information on their national
regulations and procedures for the oversight and prior approval of
certain activities involving pathogenic microorganisms and toxins
of concern so that individual States Parties could review the adequacy
of their national regulations and procedures and determine whether
any modification or amendment or new regulations and procedures were
required.
24. The First Meeting recognized that
a number of States Parties already have national regulations and procedures
for the licensing and accreditation of facilities working with pathogenic
microorganisms and toxins of concern. The First Meeting encouraged
all States Parties to share information on their national regulations
and procedures for the licensing and accreditation of facilities working
with pathogenic microorganisms and toxins of concern so that individual
States Parties could review the adequacy of their national regulations
and procedures and determine whether any modification or amendment
or new regulations and procedures were required.
25. The First Meeting recognized that
a few States Parties already have national regulations and procedures
for the licensing of individuals working with pathogenic microorganisms
and toxins of concern. The First Meeting encouraged all States Parties
to share information on their national regulations and procedures
for the licensing of individuals working with pathogenic microorganisms
and toxins of concern so that individual States Parties could review
the adequacy of their national regulations and procedures and determine
whether any modification or amendment or new regulations and procedures
were required.
26. The First Meeting noted that in a
number of States Parties consideration was being given to what information
should be made publicly available and what should not be disclosed.
The First Meeting observed that in striking a balance between transparency
and security that States Parties should provide enough detail so that
the public -- and other States Parties -- acquire an accurate understanding
of the activities concerned and so gain confidence yet not providing
so much detail as to expose vulnerabilities or to aid those seeking
to acquire biological weapons.
23. The First Meeting of States Parties
on 10 to 14 November 2003 needs to seize the opportunity to agree
in its report a coherent and comprehensive set of common understandings
and effective action. Beyond November, the significance of the report
of the First Meeting is to add value to the Inter Review Conference
process and to set the pattern of the meetings scheduled for 2004
and 2005 on the remaining topics identified by the Fifth Review Conference.
The process should therefore contribute, within the limits of the
agenda topics and the mandate for the meetings agreed by the Fifth
Review Conference, to the recovery and strengthening of the BTWC through
a return to the cumulative development of extended understandings
leading to effective action at the Sixth Review Conference.
