BIOSAFETY, BIOSECURITYAND BIOWEAPONS Three Agreements on Biotechnology, Health, and the Environment, and Their Potential Contribution to Biological Weapons Control
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BIOSAFETY, BIOSECURITYAND BIOWEAPONS
Three Agreements on Biotechnology, Health,
and the Environment, and Their Potential Contribution
to Biological Weapons Control - extracted text
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Three Agreements on Biotechnology,
Health and the Environment, and
Their Potential Contributions
to Biological Weapons Control
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the sunshine project
TWN
THIRD WORLD NETWORK
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BIOSAFETY, BIOSECURITY AND BIO WEAPONS
Three Agreements on Biotechnology, Health,
and the Environment, and Their Potential Contribution
to Biological Weapons Control
is published by
The Sunshine Project
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Copyright © Sunshine Project and TWN, 2003
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ISBN: 983-2729-18-1
the sunshine project
Many biological weapons are rapidly destroyed by bright sunlight.
The Sunshine Project works to bring facts about biological weapons
to light! It is an international non-profit organization with offices in
Hamburg, Germany and Austin, Texas, USA. It works against the
hostile use of biotechnology in the post-Cold War era. Through its
research and publications it seeks to strengthen the global consensus
against biological warfare and to ensure that international treaties
effectively prevent development and use of biological weapons.
www.sunshine-project.org
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Third World Network
Third World Network (TWN) is a network of groups and indi
viduals involved in bringing about a greater articulation of the
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NOTE
Research and writing of this report was supported by a grant to
the Sunshine Project from the German Peace Research Founda
tion (DSF).
Contents
Page
1
Introduction
1
2
Biosecurity and Biosafety: Two Words,
Many Concepts, One Framework
3
The Cartagena Biosafety Protocol of the
Convention on Biological Diversity
9
4
The International Plant Protection Convention
19
5
Office International Des Epizooties
29
6
Conclusion: Towards a Binding International
Instrument on Biocontainment Facilities
41
Endnotes
45
3
7
Introduction
1 his paper introduces and discusses the provisions of three interna
tional agreements related to controlling disease and managing bio
technology risks to protect health and the environment. These are the
Cartagena Biosafety Protocol (CBP), the International Plant Protec
tion Convention (IPPC), and the Office International de Epizooties
(OIE).1
This paper relates these agreements to the Biological Weapons Con
vention (BWC) and discusses how they can contribute to the preven
tion of hostile use of biology. The agreements discussed in this paper
address issues of biosecurity and biosafety, broadly conceived. They
are critical elements of a global biosecurity framework.
Other multilateral activities of relevance to the BWC, for example,
the World Health Organization's global health response to the delib
erate use of biological weapons, are also treated. They are, however,
discussed in lesser detail because the BWC relevance of the OIE and,
especially, the CBP and IPPC have been insufficiently discussed, de
spite the fact that the contribution of these agreements is routinely
(but vaguely) mentioned in arms control debate and discussed by
States Parties in meetings of the BWC.2
A closer look at these agreements is also merited because of the cur
rently poor prospects for progress at the BWC itself. Following the
2001 collapse of negotiations for the BWC Verification Protocol, States
Parties agreed to a series of annual and experts' meetings in the lead
up to its Sixth Review Conference in 2006.
1
However, a combination of sensitivities resulting from the failed Pro
tocol, plus the narrow scope of meetings, and resignation before the
highly uncooperative stance of the US currently limit the possibility
that the meetings will result in binding multilateral measures to
strengthen the BWC.
The agreements discussed here also merit more profound considera
tion because of their critical role in the international regulation of bio
technology. Biological weapons risks posed by the development and
dissemination of biotechnology are nearly universally recognized. Yet
there is presently very little prospect of reining in these risks through
the BWC, whose parties generally recognize the dangers of biotech
nology but have been unable to adequately respond.
In contrast, the CBP is the first international agreement specifically
developed to address biotechnology risks — to the environment, ag
riculture, animal and human health — and it possesses a vibrant proc
ess. The CBP and the IPPC and OIE are presently developing and
implementing enforceable international rules and standards to con
tain threats, limit harm, and impose liability for damages resulting
from biotechnology. These provide opportunities and synergies to
strengthen the global ban on biological weapons.
This paper provides a background and a summary of critical provi
sions of each of the three agreements, indicating actions that can be
taken to address biological weapons risks. It also discusses the need
for addressing biosecurity and biosafety in a comprehensive frame
work, and concludes by discussing the need for a binding interna
tional instrument on biocontainment facilities.
2
Biosecurity and Biosafety: Two Words,
Many Concepts, One Framework
The term "biosafety" shifts in meaning in the diplomatic and scien
tific context. Its two major usages relates to laboratory containment
and to biotechnology hazards.
"Biosecurity" is a closely related term increasingly heard in arms con
trol and in health and agriculture, but which also lacks a consistent
usage. In animal health, it sometimes refers to preventative disease
management. In Australia and New Zealand, it often refers to inva
sive alien species, while in the US it is increasingly used in reference
to anti-terrorism measures related to agriculture ("farm security").
Still others use biosecurity to refer to access to a safe and appropriate
food supply.
Biosafety, as it arose in microbiology, is shorthand for "safety in bio
logical containment". In other biosciences and policy related to ge
netically modified organisms (GMOs), the term appeared as a con
traction of "safety in biotechnology", most often, but not exclusively,
in reference to release of GMOs into the open environment. Overlap
between the usages has become apparent, and "laboratory biosafety"
is now often used to refer to the subset of safety issues specifically
related to containment, be it of pathogens, GMOs, or GMO-pathogens.
Confusion about meanings of biosafety and biosecurity in English
deepens in translation. The logical translation of biosecurity into Span
ish, French, and other Romance languages is the same word as that
used for biosafety (bioseguridad in Spanish, biosecurite in French).
3
Translators at the UN Food and Agriculture Organization (FAO) were
unable to come up with a word for biosecurity in Chinese.3 Then
again, the term did not exist in English until it was coined in inde
pendent instances to refer to different aspects of human and envi
ronmental safety from biological threats.
We submit that there is little need, conceptually, to differentiate be
tween biosafety and biosecurity and that some meanings of both terms
sometimes utilized in arms control4 are counterproductive because
they are too restrictive.
Whether at the BWC, in health, in the laboratory, or in sanitary meas
ures, security and safety are largely synonymous, and in the field or
in containment, many of the measures that apply to potentially dan
gerous pathogens also apply to GMOs (and their products) and, of
course, pathogens that are GMOs.
On a very practical level, there may be differences between means to
prevent an unintended release into the environment (sometimes re
ferred to as "biosafety") and means to prevent abuse or theft (some
times referred to as "biosecurity"). But conceptually, legally, and in
terms of organization and implementation, there are broad overlap
ping areas.
A wide and shared conceptual framework that integrates sectoral
notions of 'biosafety' and 'biosecurity' is required in order for each
sector (agriculture, human and animal health, disarmament, envi
ronment) that addresses them to be efficient and effective.
Outside of arms control, but prompted by many of the same con
cerns, there are a number of efforts presently underway to enhance
biosafety and biosecurity. In addition to World Health Assembly
(WHA) Resolution 55.16 (discussed on page 38), the World Health
Organization (WHO) is revising the interim guidelines of its Labora
tory Biosafety Manual, a process relevant to biodefense programs
and which has become more important in the international public
4
eye following the September, 2003 SARS escape from a Singapore BSL3 laboratory.
The FAO and intergovernmental partners are conducting innovative
work in articulating a broad conceptual framework encompassing
biosecurity/biosafety issues, and its biosecurity initiative promotes
"out of the box" thinking, at least for those approaching from an arms
control perspective (see IPFSAPH, below).
Biological weapons experts, who are beginning to articulate links to
agreements like the Cartagena Protocol,5 should embrace this work
to broadly conceptualize biosecurity/biosafety and articulate their
ideas into that framework, rather than developing sui generis defini
tions of the terms.
Cooperation and the Biosecurity Portal (IPFSAPH)
FAO is leading partners including the OIE, WHO, World Trade Or
ganization (WTO), and the Convention on Biological Diversity (CBD)
in work to rationalize the disjointed international biosecurity frame
work, which is plagued by "sectoral approaches" that have inhibited
cooperation between agriculture, health, environment, and disarma
ment. A loose international framework for biosecurity presently ex
ists in international agreements, principally the standards setting "sis
ters" (OIE, IPPC, and Codex Alimentarius) plus the CBD, CBP and
the BWC.
Biosecurity in Food and Agriculture, an important paper framing these
issues was drafted by FAO for its March 2001 Committee on Agricul
ture Meeting.6 FAO's Biosecurity working group held an initial inter
national consultation in Thailand in January 2003.
Suggestions made by the United States to the BWC Meeting of Ex
perts in August 20037 make curious references to the biosecurity-related work of FAO, WHO, and OIE. These are addressed at the end of
5
this paper, following detailed discussion of the IPPC, Cartagena Pro
tocol, and OIE.
An early fruit of biosecurity cooperation by intergovernmental bod
ies is the development of an internet portal (website) to serve as a
central access point for regulations, standards, and other information
related to food safety, animal and plant disease, introduction of ge
netically modified organisms and their products, and invasive alien
species.
The portal, developed at FAO, would facilitate access to information
developed by and collected (generally from Parties) by the IPPC, OIE,
Codex Alimentarius, SPS, CBP, and the CBD.
FAO's Biosecurity Portal is officially known as the (ungainly) "Inter
national Portal for Food Safety, Plant, and Animal Health" (IPFSAPH).
Due to debut in early 2004, the Biosecurity Portal has the potential to
pull together access to an enormous range of information relevant to
biological weapons control. FAO is planning to train government of
ficials in how to use its resources. The portal will use a controlled and
consistent vocabulary, and it is planned to be available in English,
Spanish, French, Chinese, and Arabic.
Despite the considerable effort of FAO to centrally index and relate
varied biosecurity sources, IPFSAPH's present scope is smaller than
it should be. IPFSAPH can include more data and enable examina
tion of more relationships related to disarmament. This could include,
for example, information on national laboratory biosafety law and
regulations, including restricted access agents, legislation to imple
ment the BWC and other information submitted to the BWC by State
Parties, as well as the WHO national preparedness program for de
liberate epidemics. Governments and NGOs working on biological
weapons issues can reach out to the effort to help it integrate these
issues into the portal.
6
Describing Biosafety and Biosecurity
FAO, 2003, articulation of the biosecurity concept:
Biosecurity is a strategic and integrated approach that encompasses the policy
and regulatory frameworks (including instruments and activities) that ana
lyse and manage risks in the sectors offood safety, animal life and health, and
plant life and health, including associated environmental risk. Biosecurity
covers the introduction of plant pests, animal pests and diseases, and zoon
oses, the introduction and release ofgenetically modified organisms (GMOs)
and their products, and the introduction and management of invasive alien
species and genotypes.8
Barletta, Sands, Tucker, 2002, biosecurity treaty rationale:
...the United States should promote an international biosecurity convention,
which would be distinct from the bioweapons treaty but would complement it
by primarily addressing the threat of bioterrorism. In addition, the biosecurity
convention should build on the ongoing implementation of the 1992 Biologi
cal Diversity Convention and its 2000 Cartagena Protocol on Biosafety, zohich
includes provisionsfor the safe handling, transfer, and use ofgenetically modi
fied organisms.9
Cartagena Biosafety Protocol, 2000, objective:
In accordance zoith the precautionary approach contained in Principle 15 of
the Rio Declaration on Environment and Development, the objective of this
Protocol is to contribute to ensuring an adequate level of protection in the
field of the safe transfer, handling and use of living modified organisms re
sulting from modern biotechnology that may have adverse effects on the con
servation and sustainable use of biological diversity, taking also into account
risks to human health, and specifically focusing on transboundary move
ments.10
World Conservation Union (IUCN), 1999, definition of "biosecurity
threats":
... means those matters or activities zohich, individually or collectively, may
constitute a biological risk to the ecological zuelfare, or to the zuell-being of
humans, animals or plants, of a country."
7
co
At a Glance: Agreements Discussed in this Paper
Agreement
Date
Of Text
Auspices
(Secretariat)
Governing
Body
Meetings Budget
(US$mO3)
Staff12
Parties
International
Plant
Protection
Convention
(IPPC)
1951
1979
1997
FAO
(Rome)
Interim
Commission
on
Phytosanitary
Measures
Annual
1.1
2.8513
124
Office
International
des Epizooties
(O1E)
1924
None
(Paris)
International
Committee
of the 01E
Annual
4.3M
23
164
Cartagena
Biosafety
Protocol
(CBP)
2000
UNEP
(Montreal)
Conference
of the
Parties
Annual
2.2
7
79
(As of
12 Jan 04)
Convention
on Biological
Diversity
(CBD)15
1992
UNEP
(Montreal)
Conference
of the
Parties
1-2 years 10.4
42
187
The Cartagena Biosafety Protocol of the
Convention on Biological Diversity
Background
The Cartagena Protocol on Biosafety is the first (only) global agree
ment on genetically modified organisms. The Protocol's diplomatic
origins can be traced to the 1992 Summit of the UN Conference of
Environment and Development, held in Rio de Janeiro, Brazil.
The Conference concluded with the adoption of four international
agreements on environment, among these the Convention on Bio
logical Diversity (CBD), the objective of which is the conservation
and sustainable use of biological diversity and the fair and equitable
sharing of the benefits arising out of the utilization of genetic resources.
In the negotiation of the CBD, sharp lines were drawn between de
veloping countries (where most of the world's biological diversity is
located) and governments of the North, whose interest lay in main
taining inexpensive and easy access to biological resources. The late
1980's and early 90's surge of concern in Europe and the US about
tropical forests and animals was not necessarily viewed as friendly in
biodiverse developing countries.16
The authorization of utility patents on DNA, microorganisms, plants
and animals in the United States led to bitter battles as biodiverse
countries, often backed by NGOs, sought to protect their interests in
the face of emerging intellectual property protections that permitted
privatization of biological resources (also discussed in the then un
der-negotiation WTO Agreement).
9
The compromise that was struck pleased most governments and some
environmental NGOs, the latter of which were, at the time, convinced
that marketing natural products through "bioprospecting" and other
commercial efforts would benefit biodiversity.
Some politically-influential constituencies were less certain, includ
ing a number of developing countries, advocates for farmers, oppo
nents of life patenting, and many indigenous peoples. They feared
that the CBD's enshrinement of national sovereignty over biological
diversity coupled with its provisions on access to and patenting of
biodiversity would prove destructive to community rights and re
sources.17
Nearly universal, the CBD has 187 parties. The United States, which
signed the CBD in Rio in 1992, remains the only industrialized coun
try that has not ratified it. While the Clinton administration officially
supported ratification, a concerted effort was not undertaken in the
US Senate. Today, the US retains reservations that the CBD impairs
its commercial interests. Despite being only a signatory, the US is a
vocal and sometimes aggressive player in CBD negotiations.
The Convention operates under the UN Environment Programme
(UNEP), headquartered in Nairobi, Kenya. The CBD Secretariat is
located in Montreal, Canada. The CBD Conference of the Parties (COP)
takes place every one and a half to two years and informally rotates
between major (bio)geographic regions.18
A Subsidiary Body on Scientific, Technical and Technological Advice
(SBSTTA) usually meets in Montreal and provides technical input. It
and the COP sometimes address topics of relevance to the BWC such
as biological control and alien invasive species.
The Cartagena Protocol
The Cartagena Biosafety Protocol on genetically modified organisms
prohibits the introduction of a GMO into a country without that coun
10
try's consent. It arises from Article 19.3 of the CBD, which instructed
the Parties to "consider the need for and modalities of a protocol setting out
appropriate procedures, including, in particular, advance informed agree
ment, in the field of the safe transfer, handling and use of any living modi
fied organism resulting from biotechnology that may have adverse effect on
the conservation and sustainable use of biological diversity".
The road towards the adoption of the Protocol was a bumpy one. The
negotiations formally started in 1995 with the adoption of Decision
II/5 at the 2nd Conference of the Parties of the CBD in Jakarta, Indo
nesia. That decision led to the creation an Open-ended Ad Hoc Group
on Biosafety, whose mission was to draft a protocol on biosafety.
The negotiations lasted five years and, on several occasions, nearly
collapsed. The Protocol is named after the city of Cartagena (Colom
bia), where it was hoped that the Protocol text would be finished in
1999. However, differences prompted the adjournment of the
Cartagena meeting without an agreement. The following year, one
was finally reached in Montreal. The Protocol required fifty
ratifications for entry into force. With Palau's ratification on June 13,
2003, the Protocol entered into force on September 11, 2003. As of 12
January 2004 there were 79 parties.
During the negotiation of the Protocol, states aligned themselves
around two opposing groups. Led by the United States were the ma
jor exporters of GMOs for food with allied agricultural exporters
whose potential future interests included relatively unrestricted in
ternational movement of GMOs. Joining the US were Argentina,
Australia, Chile, Canada, and Uruguay, forming the "Miami Group".
Opposing this small but powerful group was the much larger "Like
Minded Group of Developing Countries", led by Ethiopia. As poten
tial importers of biotechnology products and hosts of greater part of
the world's biodiversity, the Like Minded Group felt vulnerable to
the environmental and socio-economic impacts of GMOs and wished
to establish a comprehensive regulatory framework. In the endgame
of the negotiations, the European Union's position was, generally,
11
supportive of the Like Minded Group, lending additional pressure to
finalize the agreement.
Main features
The Protocol reaffirms the Precautionary Approach, adopted as a prin
ciple in the 1992 Rio Declaration on Environment and Development.
It mandates that when facing a threat to the environment, the lack of
scientific certainty due to insufficient scientific information and knowl
edge shall not prevent States from taking action in order to avoid or
minimize adverse effects of the threat19. This approach acquires par
ticular relevance in the case of GMOs, the safety of which is vigor
ously debated worldwide.
Although the Protocol is basically an environmental instrument, it
includes within its objective the protection from possible impacts of
GMOs on human health. The Protocol recognizes that there are in
trinsic risks associated with GMOs — both to the environment and
human health — and promotes biosafety by setting the rules for the
safe transfer, handling and use of GMOs, focusing on the
transboundary movement of GMOs intended for the release into the
environment.20
Scope
The scope of the Protocol is limited, reflecting the compromise be
tween opposing groups. It applies the core of its provisions to "living
modified organisms" (LMOs)21 intended for field release, and applies
to a different, lesser, extent to other GMOs, such as for those intended
for direct use as food or feed. The distinction was made in response
to the Miami Group's demand to exclude products derived from
GMOs (e.g., oil or starch from genetically modified crops). The Proto
col applies mainly to the transboundary movement of all LMOs, and
has less restrictive provisions for the transit, handling and use of
LMOs.
12
Also excluded from the main provisions of the Protocol are GMOs
that are pharmaceuticals for humans (Art. 5) because it was argued
by the Miami Group countries that they are addressed by other inter
national agreements or organizations. This exclusion has yet to take
practical effect because presently there are no international agreements
that specifically address safety of human pharmaceutical GMOs (e.g.,
"gene therapy" products, which remain experimental). As a result,
many countries, including the Africa Group, maintain that the
Cartagena Biosafety Protocol applies to GMO pharmaceuticals in the
interim. Biotech pharmaceuticals for animals are covered by the Pro
tocol.
Advanced Informed Agreement (AIA)
The core provision set up by the Protocol is the requirement by the
exporter of LMOs to obtain prior advanced informed agreement from
the importer before the "first international transboundary movement of
LMOs intended for intentional introduction into the environment of the
party of import" takes place. In other words, it is prohibited for one
country to introduce a LMO into another without that country's con
sent. This requirement means that a party can, legally, refuse the in
troduction of any LMO that it considers a threat to its biological di
versity or human health. Annex I of the Protocol details the mini
mum information that the exporter must submit to the importer (the
notification).
Risk assessment and management
The decisions of importing parties to allow or refuse the introduction
of LMOs must be based on risk assessment. The Protocol provides
the guidelines that the assessments must follow. The assessment must
take into consideration the information provided by the exporter as
well as the other scientific evidence available "in order to identify and
evaluate the possible adverse effects of living modified organisms on the con
servation and sustainable use of biodiversity, taking also into account risks
to human health." (Art. 15). Annex m of the Protocol provides guide
13
lines and methodologies for conducting risk assessments.
Additionally, all Parties are obliged to establish and maintain appro
priate mechanisms, measures and strategies to regulate, manage and
control risks identified in the risk assessment. Among these, coun
tries must take measures to prevent unintentional transboundary
movement of LMOs.
Limited regulations
While the Protocol focuses on the transboundary movement of LMOs
intended for planting in fields, it does not exclude from its scope LMOs
intended for other uses, such as food and feed, rather, it establishes a
less restrictive set of regulations for them.
GMOs that are in transit or intended for contained use (i.e., labora
tory utilization) are exempted from the AIA requirement, however,
states have the right to regulate the transit of such GMOs through
their territories, to require a risk assessment prior the importation of
any GMO, and to set standards for contained use (i.e., laboratory
biosafety).
GMOs that are intended for direct use as food or feed, or for process
ing must be labeled indicating that they "may contain" GMOs "and
are not intended for intentional introduction into the environment, as well
as a contact point for further information" (Art. 18).
The Protocol establishes a minimal requirement for all LMOs that
countries must approve for domestic use, including placing on the
market, whenever those organisms "may be subject to transboundary
movement, as well as for those intended for direct use as food, processing or
feed. In such cases, countries must make available the decision by which
such use was authorized by the producing country at the "Biosafety Clear
ing-House", an internet based information sharing mechanism (Art.
ID-
14
Annex II of the Protocol lists the minimal information that must be
made available at the Biosafety Clearing House, providing potential
importers a means to begin their decision-making process on intro
duction of GMOs within their boundaries
National authorities
Parties are required to designate national authorities responsible to
carry out the obligations set up by the Protocol and to serve as liaison
with the Secretariat of the Protocol. Parties have to notify the Secre
tariat the name find contact information of such authorities (Art. 19).
Minimally, the national authority must be legally-enabled to carry
out the import/export requirements of the Protocol.
While establishing national authorities, many countries, especially
developing countries, are setting up more comprehensive domestic
biosafety legislation. These processes present opportunities to spe
cifically address the hostile use of GMOs and will lead to the estab
lishment of focal points of expertise in biotechnology risk assessment
and management in member states.
In Africa, for example, a Model Law on biosafety to implement the
Cartagena Protocol has been developed and adopted by the African
Union, for national implementation in member states. This Model
Law includes criminal penalties for deliberate abuse of genetically
modified organisms.
Secretariat and Conference of the Parties
The governing body of the Protocol is its Conference of Parties, whose
responsibility is to review implementation and to take the decisions
necessary to promote effective implementation. Only Parties to the
Protocol are entitled to fully participate. Non-parties may attend as
observers. The Secretariat of the CBD serves also as Secretariat of the
Protocol (Art. 31).
15
Compliance, Liability and Redress
The issues of compliance and of liability for damages resulting from
transboundary movement of GMOs were ones on which the Parties
could not reach agreement during the negotiation of the Protocol.
Instead, they decided to defer until the first COPs (Art. 34 and 27).
The first COPs serving as the meeting of the Parties to the Protocol
will take place in Kuala Lumpur from 23-27 February 2004, and com
pliance, liability and redress are on the agenda.22
Recommendations
With the entry into force of the Cartagena Protocol, the development
of concrete links between it and the BWC has become more possible.
The Cartagena Protocol will face challenges in its early meetings, in
cluding what promise to be difficult negotiations over liability and
redress and the potentially less than constructive participation of some
observer countries.
First steps that can be taken by the BWC and/or the Cartagena Proto
col include:
Internationally
(a) the Conference of the Parties to the Cartagena Protocol may re
quest observer status for the Protocol at meetings of the Biological
Weapons Convention:
•
governments should nominate persons with expertise in biologi
cal weapons control to the Protocol's Roster of Experts and sup
port their participation in Protocol activities;23
•
training courses and capacity building for the Cartagena Biosafety
Protocol — currently underway on a large scale — should include
components on the BWC and biological weapons control;
16
(b) the Conference of the Parties to the Cartagena Protocol should
explore the Protocol's relationships with the BWC by:
•
requesting that the Secretariat study how the Protocol's require
ments on transboundary movement of LMOs relate to non-prolif
eration of biological weapons and,
•
developing tools to integrate criteria related to the potential for
hostile use of LMOs into the process of risk assessment under the
Protocol;
(c) likewise, States Parties to the BWC may request the BWC Secre
tariat to prepare a study on the relationships between the BWC and
the Cartagena Protocol.
Nationally, governments may:
(a) assess how financial and technical support for Cartagena Proto
col capacity building programs can increase awareness and help coun
tries fulfill obligations under the BWC;
(b) implement the Biosafety Protocol with the provisions of the BWC
(particularly Article IV) in mind and, to the maximum extent possi
ble, within a linked legal framework;
(c) adopt biosafety law that establishes criminal penalties for the de
liberate abuse (hostile use) of GMOs. These penalties should apply to
all persons, including individuals, government officials (in private
and official capacities), corporations, and other organizations; and
(d) integrate criteria related to the potential for hostile use of LMOs
into the process of risk assessment under the Protocol.
17
4 The International Plant Protection
Convention
Background
The main international phytosanitary (i.e., plant health) agreement,
the International Plant Protection Convention (IPPC) was negotiated
under the auspices of the United Nations Food and Agriculture Or
ganization (FAO). It seeks international cooperation to prevent the
introduction and spread of pests of plants and products and to con
trol such pests.
Adopted in 1951, the IPPC came into force in April 1952. The original
Convention was also referred to as "Phytosanitary Certificate", be
cause its main feature was the provision of a form issued by Parties
to exporters of plants and plants products to certify that exports were
free of organisms designated as plant pests by importing countries.24
Since its adoption more than a half-century ago, two major revisions
have been made to the text of the Convention. The first revision proc
ess started in 1973 and was adopted in 1979. The revision aimed, in
essence, to update the terminology of the Convention, to more clearly
define the obligations of Parties, and to update the Phytosanitary
Certificate.25 For example, in the 1979 revision, terms such as "pests"
and "containers" were defined.
The revised text added a model for a new certificate for "re-export"
of plants and plant products (Art. V). This first revision entered into
force for all contracting parties in 1991, after it was accepted by two
thirds of the parties to the original IPPC.
19
A second revision process was triggered by the 1994 conclusion of
the Uruguay Round of multilateral trade negotiations, which gave
rise to the WTO. Along with the creation of the WTO, an Agreement
on Sanitary and Phytosanitary Measures — the SPS Agreement —
was adopted in 1994.
The SPS Agreement sets the basic rules for food safety and animal
and plant health standards with the objective of preventing countries
from using sanitary and phytosanitary regulations as trade barriers.
It does so by encouraging the development and adoption of interna
tional standards, a process known as “harmonization".
Countries retain the right to depart from international standards and
adopt their own health regulations but those regulations must be
based on science and justified by circumstances.26
The standard-setting required by the SPS harmonization process is
not carried out by the WTO, but by a set of specialized international
agreements. These currently are the standards-setting bodies known
as the "three sisters", namely the joint FAO-WHO Codex Alimentarius
(food safety), the IPPC (plant health), and the OIE (animal health).27
New standards-setting bodies may be named, provided that mem
bership in them is open to all WTO members.
The second revision to IPPC was directed specifically to fulfill the
new role assigned to it by WTO, particularly standard-setting. The
revision negotiations started in 1995 and were concluded in Novem
ber 1997, when the FAO Conference approved a revised text. This
latest text has not entered into force. Like its predecessor, the 1997
EPPC requires acceptance of two-thirds of contracting Parties in or
der to enter into force. Only 45 countries have done so to date.28
An additional problem is that it has proven difficult to reach consen
sus on how many countries make up the two-thirds required, since
the number of parties is in flux. New countries joining the IPPC have
usually but not always agreed to accept the new text, while in the
20
1990s some older state parties disappeared or divided into new ones.
Nevertheless, some provisions from the 1997 version have come into
play early because of interim measures adopted by the Parties, in
cluding the amendments made to the phytosanitary and re-export
certificates; the establishment of an Interim Commission on
Phytosanitary Measures (ICPM), the adoption of its terms of refer
ence; and approved interpretations of various articles29.
Principal Features of the IPPC
(a) Purpose
Defined in Article I, the purpose of the IPPC is "securing common and
effective action to prevent the spread and introduction of pests of plants and
plant products, and to promote appropriate measures for their control". The
1997 version adds text stating that nothing in IPPC will compromise
the obligations of parties under other international agreements, a ref
erence to SPS and other WTO obligations.
Scope
(b)
The IPPC applies to plants and plant products, as well as storage
places, containers, packing material, soil and — in the 1997 version
— "any other organism, object or material capable of harboring or
spreading pests, deemed to require phytosanitary measures, particu
larly where international transportation is involved".
Like the 1979 IPPC, the 1997 revision undertook to clarify terms used
in the Convention. The 1979 revision added a definition of pest —
"any pathogenic agent, injurious or potentially injurious to plants and plant
products". This definition was further elaborated in the revised text of
1997, to include also "any species, strain or biotype, animal or patho
genic agent" injurious to plants or plant products.
21
The definition of plants was also widened in the 1997 version, add
ing "germplasm" and extending the scope of protection to wild flora
(Art IV). Tire aim was to provide a comprehensive framework for
dealing with issues of plant protection, including aspects of environ
mental protection.
This new wider scope has increased the relevance of the IPPC to is
sues such as invasive alien species and biosafety, both of which are
also issues addressed under the CBD30 and are relevant to the BWC.
(c) National Plant Protection Organization (NPPO)
The Convention calls for the designation of a NPPO to be responsible
for the core obligations assumed by states under the IPPC, among
them (Art. TV):
• inspection of growing plants, areas under cultivation, storage of
plant products with the object of reporting pests outbreaks. The
1997 revision added "wild flora" and "laboratories" to the areas
under surveillance;
•
inspection of consignments of plants and plant products moving
in international traffic, to prevent the introduction or spread of
pests;
•
issuance of phytosanitary certificates to consignments moving in
international traffic, regarding their phytosanitary condition;
•
making provision for the distribution of information regarding
regulated pests and their means of prevention and control;
•
research and investigation in the field of plant protection, and the
issuance of phytosanitary regulations.
In 1979 the issuance of re-export certificates was added and, in 1997,
"the protection of endangered areas and the designation, maintenance
22
and surveillance of pest free areas and areas of low prevalence", and
"the conduct of pest risk assessments" were added. NPPOs are cur
rently registering and reporting pest outbreaks which may be also of
relevance to the BWC where under the 1992 Confidence Building
Measures (CBMs) an "exchange of information on outbreaks of infec
tious diseases... that seem to deviate from the normal pattern"31 (CBM
B) is taking place.
(d) Control over imports
One of the main features of the IPPC is the regulation of Parties' right
to control imports of materials that might introduce or spread pests
within their territories. The original IPPC text granted Parties the right
to:
•
place restrictions and requirements on the importation of plants
and products;
• prohibit the importation of particular plants and plant products;
•
detain particular consignments; and even
•
"treat, destroy or refuse entry to particular consignment of plants
and products, or require such consignments to be treated or de
stroyed" (Art. VI of 1959 and 1979 texts).32
In 1979, those rights were pared down to allow the destruction and
refusal of entry only to consignments that entered in violation of im
porting country's existing regulations. Parties were also to "list pests
the introduction of which is prohibited or restricted because they are
of potential economic importance to the country concerned".
The aim of those 1997 changes was to limit Parties' ability to regulate
imports under the SPS Agreement. While parties still have the right
to adopt phytosanitary measures, including prohibiting or restrict
ing entry of consignments, and to require that consignments be treated
23
before entrance, a set of limitations has been imposed on exercising
those rights. Among them are:
•
all actions must be based on phytosanitary measures that are "tech
nically justified";
•
parties must publicize their phytosanitary regulations immedi
ately after adoption;
•
other parties may request the rationale behind phytosanitary meas
ures, and
•
importing countries must report to concerned exporting countries
cases of non-compliance with phytosanitary certification.
Under SPS, failure to technically justify phytosanitary measures pro
vides grounds to challenge them (see "US Bioterrorism Law Collides
with the WTO", p. 35).
Importation of biological agents is covered under the regulations of
importation of plants (Art. VI, VII in the 1997 version). The 1951 text
granted the right to countries to make provisions for the importation
"for purposes of scientific research ofplants and plant products and of speci
mens of plants pests and disease causing organisms under conditions af
fording ample precaution against the risk of spreading plants diseases and
pest".
In 1979 education was added to the purposes for which importation
of disease causing organisms, and a reference to biological control
was introduced: "Adequate safeguards likewise need to be taken when in
troducing biological control agents and organisms claimed to be beneficial".
In 1997, the purposes for importing biological agents were further
widened as was the scope of biological material: "Nothing in this arti
cle shall prevent importing contracting parties from making special provi
sion, subject to adequate safeguards, for the importation, for the purpose of
24
scientific research, education, or other specific use, of plants and plant
products and other regulated articles, and of plant pests." (Emphasis
added on new 1997 additions.)
(e) Standard-setting process
Although a standards process was started within IPPC in 1990 and
the first set of international standards were approved in 1993 by a
FAO Conference resolution, the standard-setting process is formally
established in the (as yet not-in-force) 1997 IPPC revision.33
The 1997 version also creates the Commission on Phytosanitary Meas
ures as the IPPC's decision-making organ and the body responsible
for the adoption of standards. Membership in the Commission is open
to all contracting parties. Because the Commission cannot be officially
constituted until the new text enters into force, however, the "Interim
Commission on Phytosanitary Measures" (ICPM) serves until the
amendments come into force. The ICPM is open to all FAO members,
as it was established under the provisions of the FAO Constitution
and Basic Texts.
As such, IPPC Parties are not currently obliged to follow the ICPM's
international standards, although they are strongly encouraged to do
so. A Party may choose to establish protection levels above the inter
national standards, in which case it has to provide scientific justifica
tion. In such cases, Parties must also inform other Parties possibly
affected by the measures.
This new provision goes along with SPS's requirement that
phytosanitary measures be applied for no purpose other than that of
ensuring plant health. Indeed, SPS further requires that regulations
are applied in such a way that they do not result in unfair or dis
guised restrictions on trade.
The drafting of the standards themselves can take place at the IPPC's
Secretariat, or at any of the expert groups organized by the Secre
25
tariat. They may originate as national or regional initiatives. The ICPM
reviews draft standards and circulates them among Parties prior to
adoption. So far, 19 standards have been adopted by the ICPM, and
more are under consideration.
Among the notable adopted standards are No. 3: "Code of Conduct
for the import and release of exotic biological control agents", which
covers importation of exotic biological control agents capable of self
replication, outlining responsibilities for both importer and exporter
countries, before the importation, during the exportation and after
the release and No. 11: "Pest Risk Analysis for Quarantine Pests".34
Drafts currently under consideration include a supplement to No. 11
on genetically modified organisms.
(e) Settlement of Disputes
In the original IPPC, the procedure for settlement of disputes was to
request the Director-General of FAO to appoint a committee of ex
perts to consider the question in dispute. The Committee, which would
also include representatives from the corm tries in dispute, would pro
duce a report and send it to the Director-General, who in turn, trans
mitted it to the parties in dispute and other parties. The Committee's
recommendations, while not binding, constituted a basis for renewed
consideration by the feuding parties.
The text of 1997 establishes, as first resort (prior to discussion at WTO
SPS), an opportunity for the concerned parties to consult among them
selves with a view to resolving the dispute. If the dispute cannot be
resolved through direct consultation, one of the parties or all parties
concerned may request the FAO Director-General to appoint the ex
pert committee. The newly created Commission is charged with the
task of approving the rules and procedures that must be followed by
any expert committee in the preparation of their report.
Finally, the 1997 text highlights that IPPC settlement of disputes "shall
be complementary and not in derogation of the dispute settlement
26
1
procedures provided for in other international agreements dealing
with trade matters", a clear reference to WTO procedures. The In
terim Commission has established a subsidiary body for dispute reso
lution, although the interest of states parties to date has been rather
limited.
Future IPPC Standards
Unlike its "sisters" OIE (1924) and Codex Alimentarius (1964), IPPC
is new to setting international standards, having only received a mem
date to do so as a result of the SPS agreement. Presently the IPPC
adopts an average of two new standards per year. Some Parties (par
ticularly developed countries) wish to increase the Secretariat's budget
and staff in order to increase the rate of standard adoption.
Some Parties, such as the US, propose procedures to facilitate adop
tion of draft standards developed outside of the IPPC. Other Parties
prefer a slower approach, in large measure because of the IPPC's re
lationship to SPS, where many developing countries feel the cards
are stacked against them in the event of a dispute with a larger power.
Many of the same countries are unenthusiastic about "outsourcing"
the standards-drafting process if it affords undue influence to indus
try, which might develop standards itself and then have them shep
herded through the IPPC by a friendly government.
In November 2002, the ICPM polled countries on their suggestions
for new international standards.35 Among the suggestions were new
standards on detection, monitoring, and control of a number of patho
gens of BW (and economic) concern, including plum pox potyvirus,
Xanthomonas and Ralstonia bacteria, fungi including Tilletia (kamal
bunt), Synchytrium endobioticum (potato wart disease) and types of
Fusarium oxysporum, as well as insects that are plant pests, such as
Thrips palmi. The IPPC may also consider specific biotechnology risks,
such as adoption of standards on herbicide and insect resistant crops
as pests, which presently exist as draft guidelines authored by the
27
FAO Plant Protection Service.
Of particular interest in limiting broader BW-related risks are IPPC
"concept" standards, which relate not to specific pests but to proce
dures, methods, regulations, and facilities for controlling plant pests
more generally. Concept standards have been proposed for identifi
cation of plant pests, for monitoring and surveillance, and for high
security (i.e., biocontainment) quarantine facilities.
Office International Des Epizooties
Background
Based in Paris, the Office International des Epizooties (world animal
health organization) focuses on preventing the spread of animal dis
eases, including zoonoses (animal diseases that can also be transmit
ted to humans), while enabling international trade of animals and
animal products.
OIE came about in the aftermath of a 1920 outbreak of rinderpest in
Belgium, which was caused when infected cattle passed through the
port of Antwerp. The episode prompted the negotiation of an inter
national agreement that was adopted in 1924 by 28 countries in the
League of Nations.
Building on commitments made during the Second World War, at the
end of that conflict the United Nations quickly moved to establish
two specialized agencies, the Food and Agriculture Organization
(FAO, 1945) and the World Health Organization (WHO, 1948).
Both FAO and WHO's functions partially overlap with those of the
OIE. This situation prompted initiatives to dissolve the OIE between
1946 and 1951. OIE's role in the modern multilateral framework was
clarified in 1952 when it signed a formal agreement with FAO and
again in 1960 following an agreement with WHO.
Other international organizations with whom OIE has signed coop
eration agreements include: the European Community (1957); the
Inter-American Institute for Cooperation on Agriculture (DC A, 1993);
29
the World Trade Organization (1998); Organismo Internacional Re
gional de Sanidad Agropecuaria (OIRSA, 1999); Organization of Af
rican Unity - Interafrican Bureau for Animal Resources (OAU-IBAR,
2002); World Veterinary Association (WVA, 2002); International Fed
eration for Animal Health (IFAH, 2002), and CAB International (C ABI,
2002).
The 1924 Agreement establishing OIE, provided a framework upon
which its work has evolved. The obligations contained in the Agree
ment are basic: the contracting parties agree to the creation of the
Office, based in Paris; they establish a decision making body that has
authority over the Office; they set up a Committee comprised of del
egates of contracting parties; and they create a flexible scheme to make
any changes that parties consider necessary, provided it is done by
consensus.
The statues for the OIE were appended to the Agreement and out
lined the Office's main objectives, elaborated the Committee's rules,
and included some additional obligations for contracting parties.
Article 4 of the statutes established the main objectives of the Office
as:
(a) To promote and co-ordinate all experimental and other research
work concerning the pathology or prophylaxis of contagious diseases
of livestock for which international collaboration is deemed desir
able.
(b) To collect and bring to the attention of the Governments or their
sanitary services, all facts and documents of general interest concern
ing the spread of epizootic diseases and the means used to control
them.
(c) To examine international draft agreements regarding animal sani
tary measures and to provide signatory Governments with the means
of supervising their enforcement.
30
In turn, Parties committed themselves to inform the OIE immediately
if any outbreaks of rinderpest or foot and mouth disease (FMD) oc
curred in their territories and to periodically report on the presence
and distribution of certain diseases. The list of diseases may be modi
fied by Parties at any time. Additionally, Parties must submit to OIE
the regulations they adopt to protect against animal diseases, par
ticularly those that apply to imports (Art. 5).
Thus, the OIE is a versatile organization that works on several fronts
simultaneously: it adopts standards on animal health to be applied
to international trade of animals and animal products (these are rec
ognized by the WTO SPS Agreement); it collects and disseminates
among members information on animal diseases outbreaks; it pro
motes research on animal diseases and disseminates relevant scien
tific information; and it provides a framework for international co
operation for the control of animal diseases.
Standards and Manuals
The most important collection of OIE sanitary standards are the Ter
restrial Animal Health Code and the Aquatic Animal Health Code,
aimed at preventing the introduction of infection agents and diseases
pathogenic to animals and humans through the international trade
of animals, animal genetic material and animal products. As stand
ards, the codes also have a major role in preventing parties from us
ing animal sanitary measures as trade barriers.
The terrestrial and aquatic codes, as they are known, are periodically
updated through revisions carried out by OIE specialist commissions.
The commissions are composed of experts in the field, and revisions
to the text are approved by OIE's Committee following consultations
among delegates. Each code is published in English, Spanish, and
French, which are the OIE's only official languages. The Terrestrial
Code has been translated into Russian.
The codes contain a list of definitions, disease notification criteria,
procedures for international reporting of diseases, principles for im
port risk analysis, the organization of import and export procedures.
Both codes include a list of priority transmissible animal diseases,
but in case of terrestrial animals, they are divided into categories A
and B.
In List A are transmissible diseases "which have the potential for very
serious and rapid spread". Countries must report the occurrence of
these diseases promptly, following the guidelines provided in the
Code.
List B includes eighty transmissible diseases that are not regarded as
severe a threat for rapid spread as those contained in List A, but which
are of economic importance.36 Parties must report on the status of
List B diseases annually following the guidelines provided in the Code.
The Acquatic Code lists 35 diseases of fish, molluscs, and crustaceans
and also includes reporting requirements.
Emergency reports of List A dis
ease outbreaks filed by the veteri
nary authorities of member coun
tries are posted by OIE in a
weekly publication, Disease Infor
mation, which is available online.37
Annual data on outbreaks of List
B diseases, including zoonoses
such as anthrax, brucella, and
types of equine encephalitis, are
published in the annual report
World Animal Health. A database,
Handistat II, lists this information
online, but is described as a "pro
totype" and is not up to date.
The Terrestrial Code provides
32
OIE List A Diseases
Terrestrial Animal Health Code
Section 1.1, chapter 1.1.2
Foot and mouth disease
Vesicular stomatitis
Swine vesicular disease
Rinderpest
Peste des petits ruminants
Contagious bovine pleuropneumonia
Lumpy skin disease
Rift Valley fever
Bluetongue
Sheep pox
Goat pox
African horse sickness
African swine fever
Classical swine fever
Highly pathogenic avian influenza
Newcastle disease
general standards for risk analysis (for import/export) followed by
specific definitions and criteria for each List A and B disease. Both
codes contain a series of models of international veterinary certifi
cates, aimed at assisting in the harmonization process mandated by
the WTO SPS Agreement.
Additionally, the terrestrial code includes appendices with recom
mendations for collection and handling of semen and embryos, sani
tation of hatcheries and incubators and transport of animals, along
with standards for the epidemiological surveillance of some animal
diseases. The Aquatic Code also has appendices that include recom
mendations on health control and hygiene.
Scope
Although OIE focuses on the spread of animal diseases and zoonoses
due to international movement of animal and animal products, its
scope is wider, to include, besides traditional animal products,
biologicals for veterinary use and, in general, any product capable of
carrying animal diseases and zoonoses. The Terrestrial Code states
(Part 1, Chapter 1.5.1):
All products, including biologicals for veterinary use, derived from animals
have some capacity to transmit animal disease. The level of this capacity
depends on the inherent nature of the products, their source, the treatment
that they might have undergone, and the purpose for which they are in
tended. Biologicals for in vivo use in particular will have the highest prob
ability of exposure to animals and as such present the highest risk. Products
used for in vitro purposes can introduce disease into animal populations
through deliberate or inadvertent use in vivo, contamination of other
biologicals, or spread by other means. Even products for diagnosis and re
search have the potential for close contact with animals. Exotic micro-or
ganisms, some highly pathogenic, which may be held for research and diag
nostic purposes in countries free from infection or the diseases they cause,
could possibly contaminate other biological products.
33
Veterinary administrations of importing countries shall make available spe
cific procedural requirements for approval or licensing of biologicalsfor vet
erinary use. They may limit supply to registered institutions or in vitro use
or for non-veterinary purposes where such assurance cannot be provided.
The Code addresses biologicals for veterinary use other than veteri
nary vaccines, including a number of types of laboratory and medi
cal supplies, such as preserved specimens, sera, cell lines, geneticallymodified microorganisms (for veterinary use), etc. Countries are
charged with carrying out risk analysis for all those products before
international trade takes place, for which the manual provides guide
lines.
To complement the standards, OIE has also developed two manuals:
the Manual of Diagnostic Test and Vaccines for Terrestrial Animals
and the Manual of Diagnostic Test for Aquatic Animals. The manuals
provide standards for laboratory diagnostic tests and protocols, for
the production of biological products for veterinary use, including
vaccines; international transfer and laboratory containment of ani
mal pathogens, and laboratory biosafety. These are published in Eng
lish only.
Both standards and manuals are periodically revised and amended
by Specialist Commissions.
Early Warning System
The OIE, FAO and WHO have been working, since the late 90s, on
the development of an early warning system to provide alerts on the
outbreak (or potential outbreak) of major epizootic diseases such as
those on the OIE List A.36
Momentum for the system has been built by recent outbreaks of FMD
in Europe and also by diseases such as African swine fever, which,
the FAO reports, has resulted in the loss of 50% of the West African
34
pig population between 1996 and 1999. The system is currently called
the "Global Information and Early Warning System for Transboundary
Animal Disease", and uses the unwieldy acronym "GIEWS-TADs".39
In 2003, regional consultations on the system are planned in South
Asia and Southeast Asia. The system is also being designed to have
predictive capabilities and could also be used to detect and alert in
cases of deliberate spread of diseases.
US Bioterrorism Law Collides with the WTO
A showdown looming between the US and countries that export food
to it demonstrates how measures intended to limit biological threats
can conflict with World Trade Organization (WTO) rules.
Passed in 2002, the US Public Health Security and Bioterrorism Pre
paredness and Response Act of 2002 (Bioterrorism Act) mandates the
US Food and Drug Administration (US FDA) to develop rules to regis
ter companies exporting food to the US, to require that notification be
made to the FDA prior to export, to require new types of (tracking)
records to be kept, and to enable the FDA to detain food imports sus
pected of posing a human or animal health threat.
Detentions can be made on the basis of confidential or classified infor
mation. Failure to obey the regulations could lead to US civil and crimi
nal penalties and a ban on future food imports to the US by a violating
entity. 40
The draft FDA regulations are being discussed in sessions of the WTO
SPS and it is quite likely that the FDA's rules will run afoul of the WTO.
While countries have expressed support for the principle of the US
law, many also see the FDA rules as creating "unfair" trade practices
that the WTO prohibits. The food focus of the regulations makes them
particularly sensitive because of ongoing WTO controversies over farm
subsidies that led to the collapse of its September 2003 meeting in
Cancun, Mexico.
35
At the April 2003 session of the SPS Committee, the planned US regu
lations were roundly criticized by Asian, Latin American, and Euro
pean countries, many of whom say that the rules appear duplicative
and who question if they can distinguish between accidental and de
liberate food contamination.41
The European Commission's comments on the regulations include
poking fun at the FDA's inadequate justifications for the regulations
and thinly veiled threats to take the US before a WTO tribunal if the
regulations proceed as presently drafted. The EU argues that the law
has not been presented in the manner required by the SPS Agreement
(including prior performance of a risk assessment) and that the draft
regulations impose unfair requirements on imports that are not im
posed on domestic producers.42
The EU and others also argue that detentions can be of a duration so
long that, even if detained shipments are ultimately allowed entry (as
is the case nearly 50% of the time under current US sanitary law), they
may spoil or miss their market niche (e.g., nouveau wines or seasonal
foods). The food industry largely agrees.43
However the food import conflict is resolved, the case demonstrates
how WTO rules impose significant limits on the ability of WTO mem
bers to freely adopt biosecurity measures that impact trade. That is,
biosecruity measures that impact saleable items, including intellectual
property. And because there are no international biosecurity stand
ards (using "biosecurity" in a typical arms control sense), regulations
to protect against bioweapons that impact trade are inherently "higher"
than the international norm. Hence, WTO barriers to their implemen
tation are increased.
The situation demonstrates the need to develop agreed international
standards to reduce biological weapons risks that would enable con
sistent and enforceable national legislation.
While the existing standards-setting bodies (Codex, IPPC, and OIE)
plus the Cartagena Protocol, which will contain its own liability and
36
compliance measures, have relevant scientific expertise, they have nei
ther experience nor mandate on security, per se. While the BWC does
possess mandate, at present, it is actually less well-equipped to estab
lish standards to reduce the risk of a biological weapons attack arriv
ing in commercial disguise.
37
WHO Resolution on Global Health Response
to Deliberate Use of Biological Weapons
On 18 May 2002, the 55th World Health Assembly adopted Resolution
WHA55.16 on the "global public health response to natural occurrence,
accidental release or deliberate use of biological and chemical agents
or radio-nuclear material that affect health".
WHA55.16 contains a provision which may contribute to strengthen
ing the BTWC regime through stronger national implementation, re
questing the Director-General: "to provide tools and support for Member
States, particularly developing countries, in strengthening their national health
systems, notably with regard to emergency preparedness and response plans,
including disease surveillance and toxicology, risk communication, and psy
chosocial consequences of emergencies".
A significant number of requests have been made to the WHO for tech
nical assistance by the health sector of Member States for the assess
ment of their national preparedness programmes. Based on the man
date provided for in WHA55.16, the WHO initiated a project on
"Strengthening National Health Preparedness and Responses to the
Deliberate Use of Chemical and Biological Agents" within the WHO's
Department of Communicable Disease Surveillance and Response.
As of September 2003, guidelines are being developed to help WHO
Member States in assessing their national health preparedness pro
gramme on deliberate disease. Based on these guidelines, WHO staff
and/or domestic experts will assess the overall structure and perform
ance of preparedness activities in a Member State, making recommen
dations to the Ministry of Health of Member States.
One important dimension of this assessment framework is national
policy. While this will mainly relate to policy and legislation in the
health and emergency sector, one part of this assessment could include
a review of national legislation to prevent the deliberate use of chemi
cal and biological agents. If the assessment reveals room for strength
38
ening BTWC and CWC implementing legislation, such a recommen
dation could be made to the Member State.
Article IV of the BTWC obliges States Parties to "take any necessary meas
ures to prohibit and prevent the development, production, stockpiling, acqui
sition, or retention of the agents, toxins, weapons, equipment and means of
delivery specified in article I of the Convention", but not all States Parties
have fulfilled this obligation. Hence, the WHA55.16 process provides
for an opportunity to strengthen the global ban on biological (and
chemical) weapons by strengthening national legislation.
Implementing national legislation on the chemical and biological weap
ons bans could contribute to the goal of the WHA55.16 mandate, as it
would further build government awareness of biological (and chemi
cal) threats and thus contribute to a stronger commitment to health
preparedness in response to the use of biological and chemical weap
ons.
In most instances, the WHO has been cautious to focus its activities
and recommendations on health related issues and to exclude biologi
cal disarmament issues from its activities. This appears to be neces
sary to build confidence in and foster cooperation of many countries
on sometimes sensitive health related issues.
In the specific case of WHA55.16, however, it appears to be supportive
for the mandated WHO goal to include provisions in its assessment
guidelines that may have a beneficial effect from an arms control per
spective. This is a particular chance to strengthen the BTWC regime as
there appears to be a widespread interest in WHO Member States to
receive technical assistance by WHO staff to assess their bioweapons
preparedness. This openness and political momentum on the part of
of the Member States may ease the way towards stronger national im
plementation legislation for BTWC (and CWC).
In August 2003, Draft WHO Guidelines on "Preparedness for Deliber
ate Epidemics" were made available a WHO network of experts ad-
39
vising and reviewing this project. Based on this draft, it was recom
mended to the WHO project staff to include an assessment of national
legislation to prevent the deliberate use of chemical and biological
weapons in its guidelines. Based on expert comments and field tests of
the draft guidelines in Member States, the final guidelines will be pre
pared.
40
Conclusion: Towards a Binding
International Instrument on
Biocontainment Facilities
JtSach of the agreements discussed in this paper offers possibilities
within its own processes to manage biotechnology dangers and en
hance awareness and implementation of the BWC.
Through OIE and IPPC, opportunities exist to develop new interna
tional standards on monitoring and management of biotechnology
and disease that will reduce risks — by improving detection, inte
grating bioweapons concerns into risk assessment.
In the case of the Cartagena Biosafety Protocol, we have proposed a
number of immediate, concrete actions, most important among them
— integrating bioweapons concerns into the risk assessment and le
gal frameworks that are modified or created by countries that ratify
the agreement.
Studies should be immediately performed under the auspices of the
Cartagena Protocol and the BWC that assess the relationships and
how they can be more mutually supporting.
Looking beyond the individual processes of the IPPC, OIE, BWC, and
CBP there are a number of factors mitigating in favor of the creation
of a binding international instrument on biocontainment facilities.
Biocontainment facilities were largely left out of the Cartagena Pro
tocol by exclusions on its application to GMOs for "contained use",
creating a logical need for complementary agreement on
biocontainment.
The efforts of the Ad Hoc Group of the BWC to negotiate a binding
41
protocol to strengthen the BWC, which would have focused in sig
nificant measure on such facilities, failed. Apart from some (enforce
able) OIE standards of a restricted scope, and WHO's laboratory
biosafety guidelines, which are interim and non-binding,
biocontainment facilities are not properly addressed in any agree
ment.
The lack of a binding international instrument on biocontainment has
been justified by the argument that regulating the facilities is purely
a question of national law. A "Biosecurity Convention" focusing spe
cifically on preventing improper diversion of pathogens has also been
suggested. Yet recent cases involving accidents and security failures
at biocontainment facilities demonstrate that national law and a sim
plistic arms control "sectoral" focus on pathogen security are inad
equate.
The September, 2003 case of a SARS infection acquired in a Singapore
biosafety level 3 facility44 is one example: The small city-state of Sin
gapore is a global trade and transportation hub. The biocontainment
breach in Singapore could have very quickly affected its neighbors
or, due to air and sea travel, almost any country in the world.
A 1994 laboratory escape of sabia virus (causative agent of Brazilian
Hemmoraghic Fever) in the US demonstrates the same potential.45
The US anthrax letters of late 2001 utilized a type of anthrax that is
likely to have been illicitly acquired in a biocontainment facility. Traces
of the anthrax, and innumerable hoax letters, were carried interna
tionally by the postal system, generating problems not only in the
United States but across the world.
An interesting paper tabled by the United States at the BWC Meeting
of Experts in August 2003 recommends that the BWC "receive infor
mation" and "request the WHO, FAO, and OIE to expand or develop, as
necessary, their voluntary guidelines for security... ".46 The paper con
spicuously omits reference to the binding Cartagena Protocol gov
erning transboundary movement of GMOs, and repeatedly terms to
the relevant activities of FAO, OIE, and WHO as "voluntary".
42
As discussed here, the standards-setting activities of IPPC, FAO, and
WHO (through Codex) are hardly "voluntary". They are enforced
through the WTO SPS Agreement and may be ignored — but at the
cost of potentially devastating trade sanctions. As discussed above,
one of the US' own bioterrorism laws is encountering difficulties at
the WTO, the first of what could become many tests pitting one coun
try's vision of biosecurity against the powerful international trade
agreement.
Immediately, the SPS-enforceable standards-setting possibilities at
IPPC and OIE, as well as the Cartagena Protocol, present opportuni
ties to reign in risks that the BWC has been unable to address. The
trade fight over the US Bioterrorism Act demonstrates that trade agree
ments are powerful mechanisms for compliance, but the SPS Com
mittee is a trade body and should not have the final say in shaping
biological weapons control standards and related measures. The WTO
SPS is structured in a way that discourages adoption of national laws
impacting trade that are not supported by approved international
standards.
An agreement on biocontainment facilities that addresses safety and
security should be negotiated under the joint auspices of those inter
national agreements whose purpose directly relates to biosecurity —
FAO, WHO, OIE, CBD, and the BWC.
The agreement should complement the Cartagena Protocol by con
trolling all aspects of "contained use" of GMOs and pathogens, con
tain relevant standards developed by WHO, FAO, and OIE, and
achieve to the maximum extent possible the mandate of the BWC Ad
Hoc Group.
The agreement should contain a dispute settlement mechanism pro
viding for physical inspections. Elements of the agreement may be
enforceable through existing mechanisms such as WTO SPS (for trade)
and the Cartagena Protocol (e.g., for international liability due to con
tainment failure).
43
Such abroad-based international negotiation is required for the indi
vidual pieces — security, health, biodiversity, agriculture — to add
up to a whole that achieves biosecurity and biosafety.
44
ENDNOTES
1
Established by the International Agreement of 25 January 1924.
2
See, for example, Working paper by Mexico and Peru, BWC/
CONF.V/COW/WP.26 or Background Paper on New Scientific
and Technological Developments Relevant to the[BTWC] Convention,
BWC/CONF.V/4/Add.l.
3
FAO 2003. Biosecurity in Food and Agriculture, Discussion Paper
(COAG/2003/9), Committee on Agriculture, 17th Session, Rome,
April.
4
In, for example, The Design of National Mechanisms to Maintain
the Security and Oversight of Pathogenic Microorganisms and Toxins
(BWC/MSP.2003/MX/WP.7/Rev.l), paper prepared by the
United Kingdom for the BWC Experts Group, Geneva, August
2003 (URL: (i) below) and Barletta M. Biosecurity Measures for
Preventing Bioterrorism, Monterey Institute Center for Nonpro
liferation Studies, November 2002 (URL: (ii) below) and proposed
definitions in VERTIC, Time to Lay Down the Law, August 2003
(URL: (iii) below).
http://www.opbw.org/new process/bwc msp.2003 mx wp07
rev.l.pdf
(i)
(ii) http://cns.miis.edu/research/cbw/biosec/pdfs/biosec.pdf
(iii) http://www.vertic.org/assets/TimeToLayDownTheLaw.pdf
5
See, for example, Barletta, M. et.aL (2002). Keeping track of an
thrax: The case for a biosecurity convention, Bulletin of the Atomic
Scientists, May/June, or the Bradford University's Genomics
Gateway.
http://www.bradford.ac.uk/acad/sbtwc/gateway/index.html
6
FAO 2003. Biosecurity in Food and Agriculture (COAG 01 /8).
45
7
See Security of Dangerous Pathogens and Toxins (BWC/MSP.2003/
MX/WP.5), paper presented by the US at the BWC Meeting of
Experts, Geneva, August 2003.
http://wwnv.opbw.org/new_process/bwc_msp.2003_mx_wp05.pdf
8
FAO, Biosecurity for Food and Agriculture, program website.
http: // www.fao.org/biosecurity/
9
Barletta, M. et.al. 2002. Keeping track of anthrax.
10
Cartagena Biosafety Protocol, Article 1.
http: //www.biodiv.org/biosafety/protocol.asp
11
IUCN 1999. Draft IUCN Guidelines for the Prevention of
Biodiversity Loss Due to Biological Invasion, Background paper
for the Fourth Meeting of the CBD SBSTTA, Montreal, Canada,
21-25 June 1999.
12
Total staff at United Nations "P" or "D" grade.
13
Plus one associate professional position funded by the US and
seconded from USDA. Two IPPC staff split their time with other
duties at FAO.
14 EUR 3,934,000, at exchange rate of 1 Sept 2003 (EUR 1 = USD
1.099).
15
Parent of the Cartagena Biosafety Protocol.
16
Calls such as that made in 1988, by Jacques Mitterrand, to "inter
nationalize" the Amazon Basin were obviously unhelpful in pro
moting unity behind a multilateral agreement to protect
biodiversity.
46
17
The CBD's conclusion necessitated the renegotiation of the FAO
Undertaking on Plant Genetic Resources for Food and Agricul
ture, the primary international instrument on agricultural
germplasm. The Undertaking had been developed with such
resources considered a "common heritage of mankind", rather
than subject to state sovereignty. Those negotiations were suc
cessfully concluded in 2001 with the adoption of the Interna
tional Treaty on Plant Genetic Resources for Food and Agricul
ture. See the website of the Commission on Genetic Resources
for Food and Agriculture:
http: //www.fao.org/ag/cgrfa/default.htm
18
The next Conference of the Parties will be held in February, 2004
in Kuala Lumpur, Malaysia. The COP has previously met in Nas
sau (1994), Jakarta (1995), Buenos Aires (1996), Bratislava (1998),
Nairobi (2000), and Tire Hague (2002).
19
Principle 15 of the Rio Declaration reads: "In order to protect the envi
ronment, the precautionary approach shall be widely applied by States
according to their capabilities. Where there are threats of serious or
irreversible damage, lack offull scientific certainty shall not be used as
a reason for postponing cost-effective measures to prevent environmen
tal degradation." The full text of the Rio Declaration can be found
at:
http:/ / www.un.org/documents/ga/confl51 / acont'15126lannexl.htm
20 Mauro, F. 2000. Possible Linkages Between the Cartagena
Biosafety Protocol and the Biological and Toxin Weapons Con
vention, Istituto Diplomatico "Mario Toscano", Rome, p. 2.
21
The term "living modified organism" was promoted by coun
tries who considered it more friendly-sounding than "geneti
cally modified organism".
47
22
See Provisional Agenda, UNEP/CBD/BS/COP-MOP/1/1.
http://www.biodiv.org/doc/meeting.asp?wg=MOP-01
23
The Protocol's Roster of Experts was created to identify and pro
vide assistance to countries in their implementation of the Proto
col. As of September 2003, of the 491 persons nominated to the
Roster, only two indicated bioweapons control expertise among
their credentials.
http://bch.biodiv.org/Pilot/Roster/GettingStarted.aspx
24
FAO 2002. Toward "Safe Trade", in Agriculture 21, March 2002.
http:/ / www.fao.org/ag/magazine/0203sp2.htm
25
The IPPC's texts are online at
http: //www.ippc.int.
26
WTO 1998. Sanitary and Phytosanitary Measures: Introduction. Un
derstanding the WTO Agreement on Sanitary and Phytosanitary Meas
ures. May, 1998.
http://vvnvnv.wto.org/english/tratop_e/sps_e/spsund_e.htm
27
Wolff, C. 2001. Resolving Possible Conflicts Between Domestic and
International Biotechnology Regulations and WTO Rules, paper pre
sented at ICTSD Workshop on Biotechnology, Biosafety and
Trade: Issues for Developing Countries. Bellevue, Switzerland
18-20 July 2001. p. 4.
28
An updated list of contracting parties is available at FAO's
website.
http://www.fao.org/legal/treaties/004s-e.htm
29
FAO 1997. Conference 29th Session. Rome, 7-18 November 1997.
30
FAO 2002. An Introduction to International Plant Protection Con
vention and the Environment, IPPC Information Sheet 4.
48
31
See document BWC/CONF.V/2, 5th Review Conference of the
BWC.
http://www.opbw.org/rev_cons/5rc/docs/rev_con_docs/i_docs/
V-02.pdf
32
New articles were inserted in the 1997 text, changing article nu
meration.
33
FAO 2002. A Summary of Current International Standards for
Phytosanitary Measures, IPPC Information Sheet 2.
34
FAO 2002. Key Aspects of Currently Adopted International Stand
ards for Phytosanitary Measures, IPPC Information Sheet 3.
35
See Topics and Priorities for Standards (03/14) and Other Work Pro
gramme Related Information, (03/8), Fifth Session of the IPPC
ICPM, Rome, April 2003.
36
A tally of the entire OIE List B can be accessed at:
http: / / www.oie.int/eng/normes/mcode/a_00004.htm
37
See http://www.oie.int/eng/info/hebdo/a_info.htm
38
See http://www.fao.org/DOCREP/004/Y3649E/y3649e05.htm
39
FAO currently maintains a Global Information and Early Warn
ing System for Food and Agriculture.
http:/ / www.fao.org/giews/english/giewse.htm
40
See the US FDA's Bioterrorism Act web page.
http://www.fda.gov/oc/bioterrorism/bioact.html
41
WTO Committee on Sanitary and Phytosanitary Measures, Sum
mary of the Meeting Held on 2-3 April 2003, document G/SPS/R/
29,17 June 2003.
49
42 See Comments sent by the European Commission on implementing
rule of US Bioterrorism Act, 8 July 2003.
http://europa.eu.int/comm/agriculture/ external/wto/usbta/
consump.pdf
43 See Grocery Manufacturers of America (GMA) Comments on Ad
ministrative Detention of Food for Human or Animal Consumption
Under the Public Health Security and Bioterrorism Preparedness Act
of2002.
http://www.gmabrands.com/publicpolicy/docs/
comment.cfm?DocID=1180
44 See WHO, Biosafety and SARS Incident in Singapore September 2003,
available on the Singapore Ministry of Health website.
http: / / www.gov.sg/moh/sars/pdf/Report_SARS_Biosafety.pdf
45 See Centers for Disease Control, Arenavirus Infection — Connecti
cut 1994, MMWR Weekly, September 02,1994 /43(34);635-6.
46 See Security of Dangerous Pathogens and Toxins (BWC/MSP.2003/
MX/WP.5), paper presented by the United States at the BWC
Meeting of Experts, Geneva, August 2003.
http:/ / www.opbw.org/new_process/bwc_msp.2003_mx_wp05.pd
50
BIOSAFETY, BIOSECURITY,
AND BIOWEAPONS
Three Agreements on Biotechnology, Health,
and the Environment, and Their Potential
Contribution to Biological Weapons Control
Biological weapons risks posed by the development and dissemination of
biotechnology are nearly universally recognized. Yet there is presently
very little prospect of reining in these risks through the Biological
Weapons Convention (BWC), whose parties generally recognize the
dangers of biotechnology but have been unable to adequately respond.
This booklet introduces and discusses the provisions of three international
agreements related to controlling disease and managing biotechnology
risks to protect health and the environment:
• the Cartagena Biosafety Protocol (CBP)
• the International Plant Protection Convention (IPPC) and
• the Office International de Epizooties (OIE).
It relates these agreements, which are critical elements of a global
biosecurity framework and play a critical role in the international
regulation of biotechnology, to the BWC and discusses how they can
contribute to the prevention of hostile use of biology.
The CBP and the IPPC and OIE are presently developing and implementing
enforceable international rules and standards to contain threats, limit
harm, and impose liability for damages resulting from biotechnology.
These provide opportunities and synergies to strengthen the global ban
on biological weapons.
This paper provides a background and a summary of critical provisions of
each of the three agreements, indicating actions that can be taken to
address biological weapons risks. It also discusses the need for addressing
biosecurity and biosafety in a comprehensive framework, and concludes
by discussing the need for a binding international instrument on
biocontainment facilities.
Other multilateral activities of relevance to the BWC, for example, the
World Health Organization's global health response to the deliberate use
of biological weapons, are also treated.
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