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GE - Policy and Science Updates #24: The BioSafety Working Group

                         The BioSafety Working Group
                       Policy and Science Updates #24
                            September 22, 1999

To:    BioSafety Working Group Delegates.
From:  The Australian GeneEthics Network, Council for Responsible Genetics
        (USA) and Washington Biotechnology Action Council (USA).

Dear Delegates,

Here are the Earth Negotiations Bulletin team's briefing notes on your
recent discussions in Vienna.

We will be happy to consider for publication in future Updates any
commentary or critique sent to us, on these most crucial negotiations.

Best wishes,

Bob Phelps


Update Compilers:

"Bob Phelps" <>
"Prof. Phil Bereano" <>
"Dr Doreen Stabinsky" <>


1. ENB Notes on the informal Biosafety Protocol talks, Vienna, 15-19/9/99




Monday, 20 September 1999

Written and edited by Stas Burgiel <> of the Earth
Negotiations Bulletin Team. Edited by Paola Bettelli <>.
Managing Director - Langston "Kimo" Goree <>.

Editor's note: The CBD Bureau approved the presence of the ENB during the
final two days of negotiations with the following conditions:

a) only one writer;
b) no country citations, only references to groups;
c) only a summary report (no daily issues).

We hope you can read between the vagaries.

Kimo Goree


        15-19 SEPTEMBER 1999

The Informal Consultations regarding the Resumed Session of
the Extraordinary Meeting Of The Conference of the Parties
(ExCOP) for the Adoption of the Protocol on Biosafety to the
Convention on Biological Diversity met in Vienna, Austria,
from Wednesday, 15 September to Sunday, 19 September 1999.
Approximately 300 representatives from over 115 governments
and 70 representatives from intergovernmental,
nongovernmental and industry organizations attended. The
first two days of the meeting were devoted to consultations
within negotiating groups; the third day was for informal
exchanges between groups; and the final two days were
devoted to resolving differences between groups on pending
core issues. This briefing note covers only the final two
days of consultations. During the final two days of
discussions, negotiating groups addressed the issues of
commodities, the protocol's relationship with other
international agreements, the protocol's scope and
application of the advance informed agreement procedure.
Negotiating groups agreed on a basic set of concepts for
commodities and relations with other international
agreements, while acknowledging that the central differences
on those and other issues remain. The results will be
forwarded as a President's Summary to the resumed session of
the ExCOP, currently scheduled for 20-28 January 2000.


The Convention on Biological Diversity (CBD), negotiated
under UNEP's auspices, was adopted on 22 May 1992 and
entered into force on 29 December 1993. Article 19.3 of the
CBD provides for Parties to
consider the need for and modalities of a protocol setting
out procedures in the field of the safe transfer, handling
and use of living modified organisms (LMOs) that may have an
adverse effect on biodiversity and its components. The first
Conference of the Parties (COP-1) to the CBD, held in
Nassau, the Bahamas, from 28 November - 9 December 1994,
established an Open-ended Ad Hoc Group of Experts on
Biosafety, which met in Madrid from 24-28 July 1995. This
meeting's report (UNEP/CBD/COP.2/7) noted that most
delegations favored the development of an international
framework on biosafety under the CBD, and listed elements
with unanimous and partial support. At COP-2 in Jakarta,
Indonesia, in November 1995, delegates considered the need
for and modalities of a protocol on biosafety, and adopted
compromise language (Decision II/5) calling for "a
negotiation process to develop in the field of the safe
transfer, handling and use of living modified organisms, a
protocol on biosafety, specifically focusing on
transboundary movement of any LMO that may have an adverse
effect on biological diversity." COP-2 also established an
Open-ended Ad Hoc Working Group on Biosafety (BSWG) to
elaborate the protocol  based on elements from the Madrid
report. The BSWG met six times between July 1996 and February
1999, where it developed draft text for a protocol on biosafety.

The sixth and final session of the BSWG, in Cartagena de
Indias, Colombia held 14-22 February 1999, was followed by
the first Extraordinary Meeting of the Conference of the
Parties to the Convention on Biological Diversity, held from
22-23 February 1999. Despite ten days of intense
negotiations, delegates were not able to agree on a
protocol. The main areas of contention centered on trade
issues, treatment of commodities and domestic vs.
international regulatory regimes. The ExCOP adopted a
decision to suspend the meeting and request the ExCOP
President, Juan Mayr, Environment Minister of Colombia, and
the COP-4 Bureau to decide when and where the session would
resume. The COP Bureau met in Geneva on 25 May 1999, and
agreed that a consultation with the major negotiating groups
formed under the BSWG would take place around the Fourth
meeting of the CBD's Subsidiary Body for Scientific,
Technical and Technological Advice and the First
Intersessional meeting on the Operations of the Convention,
held in Montreal from 21-30 June 1999. On 1 July 1999, the
spokespersons for the groups met with President Mayr. The
major groups include: the Central and Eastern European
countries; the Compromise Group (Japan, Mexico, Norway,
South Korea and Switzerland); the European Union; the Like-
minded Group (the majority of developing countries); and the
Miami Group (Argentina, Australia, Canada, Chile, the United
States and Uruguay). At the meeting the groups expressed
their political will to finalize negotiations, and it was
agreed to hold this series of informal consultations prior
to resuming the ExCOP.


ExCOP President, Juan Mayr, opened the informal
consultations among the five groups, expressing appreciation
to Austria, Canada, the Central African Republic, Denmark,
the European Community, Finland, France, Kenya, Namibia,
Norway, Sweden and the United Kingdom for their financial
support of the meeting. He reviewed the results of a
consultation, held on 1 July 1999 in Montreal, with the
spokespersons of all the major groups, where all expressed
their commitment to successfully completing a protocol. He
stated that the task at hand was to clarify positions and
identify solutions, focusing only on areas of disagreement.
The consultation would strive to develop mutually agreed
concepts, not drafting text, for consideration by the
resumed ExCOP.

He explained that the meeting's format would continue in the
same format as the final discussions at the ExCOP in
Cartagena, where each of the five groups designated two
spokespersons. Designated spokespersons for the informal
consultations included: Central and Eastern Europe (CEE) -
Gábor Nechay (Hungary) and Andrey Ivanov (Russian
Federation); the Compromise Group - Beat Nobs (Switzerland)
and Peter Schei (Norway); European Union (EU) - Christoph
Bail (European Community) and Carl Arne Hartman (Finland);
the Like-minded Group - Tewolde Berhan Gebre Eghziabher
(Ethiopia); and the Miami Group - Richard Ballhorn (Canada)
and Ricardo Ernesto Lagorio (Argentina).

Hamdallah Zedan, Executive Secretary of the CBD, welcomed
participants and thanked the United Nations Office of Vienna
for hosting the meeting.

President Mayr then requested the spokespersons to provide a
brief overview of their group discussions over the past
three days. The EU noted the efforts made in Cartagena
stating that time may have been insufficient or that
conditions were not yet ready for compromise. He said that
new ideas were being generated on including commodities in
the protocol and the protocol's relation to other
international agreements. The CEE stated that the final
discussions in Cartagena revealed packages with clear
flexibility, and that a fresh approach could be
constructive. The Miami Group noted that discussion in
Cartagena had moved from bracketing options to the actual
issues, and mentioned commodities and documentation as
issues for further work. The Compromise Group highlighted
their efforts to develop tenable and equitable solutions and
recalled the obligations for sustainable development agreed
upon in Rio. The Like-minded Group noted its representation
of the overwhelming majority of the world's population. He
stressed the importance of commodities, both food and seed,
for the survival of its peoples.


President Mayr raised commodities as the first
agenda item, and asked the groups to present their position
and any proposals. The EU noted that inclusion of
commodities under the protocol was the most problematic
issue, noting concerns of both exporting industries and
developing countries. He stressed the importance of the
links between commodities, risk assessment and the
precautionary approach; information sharing; and the needs
of importing countries. The Miami Group noted its inclusion
of three developed and three developing countries and
stressed an overall concern for harmonizing environmental
protection with sustainable growth of agricultural
economies. He stated the question is not zero-sum and that
the negotiations need to develop a cooperative solution
between environment and trade. The Compromise Group noted
four primary concepts for addressing commodities within the
protocol, including: information sharing and notification;
identification as a means to monitor LMO movements; the
right for a Party to make reasoned decisions on LMO imports;
and respect for countries' differing capacities to respond
to notifications and information. The CEE stated that
commodities were the most important item on the agenda,
noting a rise in public concern and the potential for
segregating LMO and non-LMO commodities. He supported
further work on the possibility of a simplified advanced
informed agreement (AIA) procedure for commodities. The
Like-minded Group stressed the central importance of
applying the precautionary principle to commodities and the
need for further precision on information and capacity-
building. He stated that sustainable development in the
national context needs to be compatible with the sustainable
growth of other countries. Finally, he noted that a system
differentiating between commodities and non-commercial LMOs
might work, but legal obligations are necessary.

>From such statements, President Mayr proposed four areas of
agreement: the need to account for the concerns of importers
and exporters, inclusion of commodities in the protocol,
availability of information including notification, and
needs-driven capacity-building for implementation. The Miami
Group stated that commodities could be considered under the
protocol, but the key question is how they relate to the AIA
procedure. The Like-minded Group stated that the AIA
procedure is the fundamental starting point for the
agreement. The Compromise Group proposed including
identification, as related to labeling, segregation of
commodities and decisions by the importer. The Miami Group
suggested using the term documentation, which the EU and CEE
supported. The Like-minded Group noted that both
documentation and identification are important, and the key
to both is content. The Miami Group asked where the boundary
between the AIA procedure and national regulatory systems

President Mayr also solicited feedback on the importing
Party's right to take, maintain and implement decisions on
the movement of LMOs into its territory. The Like-minded
Group stated that the right to take decisions is essential,
especially regarding decisions outside the scope of AIA. He
stressed that a robust AIA system and recognition by both
importer and exporter is crucial for maintaining decisions,
which may be challenged by other international agreements.
The EU supported the right to take decisions with
appropriate information, such as scientific risk
assessments, and the possibility for reviewing decisions as
delineated in Articles 8 (Decision Procedure), 9 (Review of
decisions) and 10 (Simplified procedure). He stressed that
there has been no dispute over the right to take decisions,
although there has been no discussion on cooperation with
the exporter to implement a decision. The Miami Group noted
that Article 5 (Application of the AIA) includes the right
to take a decision consistent with the AIA and based on
scientific input. He noted that every country has the right
to regulate, but the problem lies with adequate enforcement.

The Compromise Group affirmed the right to decide and noted
the focus on applying the AIA procedure to commodities. He
distributed a draft framework listing the general concepts
of the existing AIA procedure in Articles 6 through 9 and
possible alternative concepts for LMOs for food, feed and
processing (LMO-FFPs). Under the alternative concepts for
LMO-FFPs on Article 6 (Notification), Parties are obligated
to notify the biosafety clearing-house and national focal
points of domestic approval for large-scale releases of
LMOs, including relevant information. On Article 7
(Acknowledgement of receipt of notification), Parties have
the right to require additional information, indicate needs
for assistance and cooperation and provide information on
domestic legal or administrative measures related to the
import of LMO-FFPs. On Article 8, the importing Party has
the right to take a decision based on legitimate concerns,
such as the precautionary approach and risk assessments. The
proposal listed Article 9 (Review of decisions), but had not
developed a corresponding concept for LMO-FFPs. The proposal
also flagged two additional concepts for discussion on
documentation requirements for LMO-FFPs and cooperation in

In response, the EU inquired about countries that have no
approval systems for releases, the time-frame for
acknowledgement of receipt and further detail on assistance
and cooperation. The Miami Group asked about the time-frame
for notification after approvals; the need to include a
mechanism to ensure receipt of information; and the basis
for decisions by the importing Party. He suggested adding
the right to review decisions based on new scientific
information, and addressing the capacity building issue
under Article 19 (Capacity-building). Finally, he noted that
such conceptual work on the AIA was provisional, as there
are still issues to be resolved in those articles. The Like-
minded Group stressed that such an alternative system should
be as robust as the existing AIA system, and that gaps need
to be closed when moving from general concepts to specific
language. The CEE suggested changing language on large-scale
releases under notification to reflect commercial activity
of any scale.

Based on these suggestions, the Compromise Group re-drafted
the proposal with participation by different groups,
presented the results on the morning of Sunday, 19
September. New elements in the revised draft included: a
time-frame for notification of domestic approval for
commercial LMO releases; national mechanisms to respond to
notifications and requests for information and assistance; a
provision for the review of decisions; and a new element on
illegal traffic. The CEE expressed its general support for
the formulation. The Miami Group suggested further work on
the time-frame for notification of approvals, specific
information to be provided, delineation of responsibility
for information provision and review of decisions based on
new scientific information. He also expressed concern over
basing an importer's decision on "legitimate concern," which
should instead be risk assessments using sound science. He
noted that a reference to a paragraph embodying the
precautionary principle in Article 8 would be the first
operationalization of it in an environmental agreement.
Given the potential implications of such language, he
stressed the need to maintain a provision maintaining
consistency with rights and obligations under other existing
international agreements.

The Like-minded Group supported the concern over cross-
referencing articles that have not been finalized and
presumed that the proposal was conditional on their
successful conclusion. He also expressed concern that a
reference to Article 23 (Illegal transboundary movements)
might not be sufficient to address lost or unauthorized
shipments, and noted that consideration of illegal traffic
may require more proactive work by the Party of export. He
affirmed the need to use the AIA as a departure point and
asserted that the proposal for LMO-FFPs should provide a
sufficient substitute. The EU suggested including a time-
frame for providing information and assistance, as well as
for responses and decisions. He noted the need to examine
documentation requirements, and noted Article 23's current
sufficiency regarding illegal traffic. The Compromise Group
inquired about the operationalization of the precautionary
approach in the World Trade Organization's (WTO) Agreement
on Sanitary and Phytosanitary Measures (SPS). The Miami
Group responded that the SPS is not an environmental
agreement, and that further discussion is needed on applying
the precautionary approach in the environmental arena.

After a break, the Miami Group made a statement clarifying
its overall position, which, inter alia: suggested that
national regulatory frameworks are the only effective way to
address the range of views on commodities; recognized the
need for countries to take action to protect their
environment; recognized the need for more information for
national regulatory systems; noted that broad obligations
cannot be undertaken regarding the movement of agricultural
commodities; and recognized the need to clearly delineate
the responsibilities of importing and exporting Parties, as
well as commercial actors, in decision procedures for
commodities. The EU supported the need to clarify the
balance and responsibilities between the obligations of the
protocol at the international level and the role of national
legal systems. The Like-minded Group expressed concern that
the Miami Group's position would not subject commodities to
a full or equivalent AIA, and stressed that provision of
information is not sufficient. He stated that seed for
planting and seed for consumption have identical impacts,
thereby requiring an AIA procedure for commodities.

A small working group reviewed the draft framework on
governing transboundary movements of LMO-FFPs to address
areas of conflict. The working group chair noted new
revisions. The concept on notification specifies that a
Party notify  the biosafety clearing-house and national
focal points of domestic approvals for placing LMOs on the
market within ten days, which should include relevant and
accurate information. On acknowledgement of notification,
Parties may require additional information, indicate needs
for assistance and cooperation and refer to applicable
domestic legal and administrative measures. The
responsibility to reply in a timely fashion still needs to
be clarified. On the decision-making rights of importing
Parties, a Party of import may take a decision with respect
to imports under the protocol based on concepts addressed in
Article 8 (which remain to be determined). The chair noted
that "under the protocol" was in conceptual brackets, given
concern over countries that may not have regulatory
decision-making processes in place. On review of decisions,
Parties may review decisions in light of new scientific
information addressed in Article 9. Finally, the paper notes
three areas still to be discussed in the context of other
articles, including: adequate and differentiated document
requirements for LMO-FFPs as related to Article 15
(Handling, transport, packaging and identification);
cooperation in capacity-building as related to Article 19;
and illegal traffic and the need for cooperation as related
to Article 23.

Noting the formulation's contingency on resolving the
contents of Article 8, concern over the existing brackets
and the need for more discussion, President Mayr closed the


President Mayr asked the
groups about their positions on Article 31 (Relationship
with other international agreements) as related to the
discussion on commodities and how their views have
progressed since Cartagena. The Like-minded Group stated
that it had not had enough time to develop a firm position.
He noted that superiority or subordinancy of the protocol to
other agreements could be detrimental, and stressed the need
to find a middle ground where environmental protection is
secured. The CEE stated that the current formulation of
Article 31 undermines the protocol by subordinating it to
other agreements, and that it should not be included in the
operative section. He also suggested looking at how
agreements on hazardous materials have addressed the issue.
The Miami Group stressed the need to harmonize environment
and trade agreements, noting that trade is tantamount to
growth and sustainable development. He stated that the
protocol needs a savings clause acknowledging rights and
obligations under existing international agreements and that
the protocol has to be consistent with such agreements
without necessarily being inferior or superior. He stressed
the need to prevent the introduction of artificial trade
barriers to non-harmful LMOs, while also not allowing trade
to harm the environment. The Compromise Group stressed that
these negotiations should concentrate on environmental
questions, as the WTO can take care of itself. He noted that
the relevance of such protocols will arise at the WTO
ministerial meeting in Seattle and that it is important that
environmental conventions project their voice into the
upcoming round of trade negotiations. The EU noted the need
to define the rights and duties of importing countries in a
manner consistent with other agreements and with no
unjustifiable discrimination between imported and domestic
LMOs. He stated that a conflict between an exporter and
importer over a decision based on a risk assessment would
most likely arise in the context of the WTO. He stressed
that the importer needs to be able base the decision on the
protocol's obligations, keeping in mind the WTO's exception
for environmental issues.

In the ensuing discussion on concepts, groups debated the
conceptual use of specific terms, including "consistency,"
"non-hierarchical relations" and "mutual supportiveness."
The EU noted that maintaining consistency with other
agreements establishes an implicit hierarchy.  The Like-
minded Group noted the need for flexibility in breaking new
ground in environmental protection, which the term
consistency challenges. The Compromise Group supported
consistency and mutual supportiveness, and the Miami Group
supported consistency along with mutual supportiveness and a
non-hierarchical structure. The discussion concluded with
agreement on two general concepts: the main purpose of these
negotiations is biosafety, and there are other relevant
agreements for sustainable development with rights and

On Sunday, discussion on relations with other international
agreements continued. The Like-minded Group again stressed
the importance of not being constrained by being
"consistent" with existing international law, given the need
to address new problems. He stated that the protocol must
relate to other instruments on an equal basis and that
sectoral concerns must also be weighed equally. The Miami
Group suggested that the article be addressed later, as
other issues, such as the precautionary approach,
socioeconomic considerations and commodities, require
resolution before making a final decision on Article 31. The
EU stated that Article 31 should be removed, and suggested
that there was still some room for agreement on the
discussion of concepts held the previous day. The Compromise
Group stated that it did not have unified position, although
its majority prefers removing the article. He stated that
according to the Vienna Convention, if a savings clause is
included in the protocol then previous agreements will
prevail, whereas without it the more recent agreement
prevails. He suggested that lawyers examine specific
language to achieve a balance.

Delegates then resumed discussions on language relating the
protocol with other agreements, debating the terms "mutually
supportive," "compatible," "equally important," "consistent"
and "of equal standing." A small working group convened and
developed a list of agreed concepts, including: the main
purpose of the protocol is biosafety; other international
agreements related to sustainable development with rights
and obligations are recognized; the protocol and other
international agreements are of equal status; and trade and
environment agreements and policies should be mutually
supportive. After some debate and clarification of meanings,
the groups agreed to the concepts on the understanding that
they need to be translated into legal language, that they
are without prejudice to the groups' views on Article 31 and
that the list of concepts is not closed.


On Sunday, President Mayr opened a
discussion on Article 4 (Scope) by soliciting the groups'
preliminary comments. The Miami Group, EU and CEE expressed
support for the existing formulation in the ExCOP's draft
report (UNEP/CBD/ExCOP/1/L.2/Rev.1). The EU noted that it
reflects a delicate balance, and the Miami Group stated that
commodities can be considered within protocol, but the
question is how. The Compromise Group stated that although
it does not have a unified position on all issues, it can
basically accept the existing text. The Like-minded Group
stated that the scope of the protocol should simply cover
all LMOs and that exceptions listed in the existing
formulation should be addressed under specific articles.

Later in the day, President Mayr re-opened discussion on
Article 4 in combination with Article 5. The Like-minded
Group presented a draft proposal on the articles, which
shifts existing exceptions under Article 4 into Article 5.
Thus, the scope under Article 4 applies to all LMOs.
Concepts for Article 5 included: application of the AIA
procedure to the first transboundary movement of an LMO;
notification by Party of export or the exporter to the
national authority of the Party of import prior to any
movement; allowance for the Party of import to decide not to
apply the AIA procedure to LMOs that are pharmaceuticals for
human use or destined for research in contained use, which
should be communicated to the biosafety clearing-house; and
notification of transit of LMOs by the Party of export or
exporter to the national authority of the Party of transit.

The Compromise Group and the EU noted that the need to
further consider the proposal's implications on scope,
exemptions and application of the AIA, as well as contained
use and transit. The EU, Miami Group and Compromise Group
noted their support for working with the existing text of
Article 4. The Like-minded Group clarified that its
reservations regarding Articles 4 and 5 had been expressed
in Cartagena, as referenced in paragraph 52 of the draft
report (UNEP/CBD/ExCOP/1/L.2/Rev.1), and that they should be
revisited. The CEE noted modification of Article 4 and 5
might be acceptable, but that certain concepts in Article 5
should be further clarified.

President Mayr closed the discussion, noting that most
groups needed more time to examine the concepts.


In closing the informal consultation, President
Mayr posed three questions to the groups: do they have the
political will to conclude a protocol; can the groups
progress to the ExCOP to conclude the negotiations; and what
are the groups' assessments of the progress made here and
the key issues still to be addressed? All the groups re-
confirmed their political will to conclude a protocol and
their support for concluding negotiations at the resumed
session of the ExCOP.

Regarding the third question, the Miami Group noted that
there was movement at the conceptual level, although such
concepts need to be translated into text. He cited the need
to further develop conceptual agreement on commodities, as
well as socioeconomic considerations and the precautionary
approach. The CEE noted that progress on Article 31 was
obscure and suggested that there be similar informal
consultations prior to the ExCOP. The Compromise Group noted
the need to develop a package of solutions and to galvanize
political will, such as that shown in the final negotiations
of the Kyoto Protocol. The Like-minded Group noted that
progress was made, but questioned whether that progress was
sufficient. The EU noted areas of progress on commodities
and relations with other agreements, but stated that the
most politically difficult questions have not been resolved.
He cited these two issues along with the application of the
precautionary approach as the most important questions

László Miklós, Minister of Environment of Slovakia and COP-4
President, reviewed a COP Bureau decision on the resumed
ExCOP. It would be held in Montreal from 20 to 28 January
2000, and include two days of informal group meetings, one
day of informal consultations between groups, one day for
groups to communicate with their governments, two days for
negotiations within the ExCOP and one or two days for a
high-level session under the ExCOP. Miklós noted that the
Bureau would convene again to finalize the details, taking
into account comments from the final session.

This informal issue of the Earth Negotiations Bulletin (c) <>
is written and edited by Stas Burgiel <>  of the Earth
Negotiations Bulletin Team. Edited by Paola Bettelli <>.
The Managing Director is Langston "Kimo" Goree <>.

Sustaining Donors of the Bulletin are Netherlands Ministry of Foreign
Affairs, Government of Canada (through CIDA), United States (through
Swiss Agency for Environment, Forests and Landscape, and the
United Kingdom Department for International Development (DFID).

General support for the Bulletin during 1999 is provided by the
German Federal Ministry of Environment (BMU) and the German
Federal Ministry of Development Cooperation (BMZ), the Government
of Australia, the Danish Ministry of Foreign Affairs, the European
Community (DG- XI), the Ministries of Environment and Foreign
Affairs of Austria, the Ministries of Foreign Affairs and
Environment of Norway, the Ministry of Foreign Affairs and
Ministry of Environment of Finland, the Government of Sweden, the
United Nations Development Programme (UNDP), the Global
Environment Facility (GEF) and the Ministry for the Environment in

The Bulletin can be contacted by e-mail at <> and
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Bob Phelps
Australian GeneEthics Network
PO Box 2424, Fitzroy MC 3065 Australia
Tel: (03) 9416.2222 Fax: (03) 9416.0767 {Int Code (613)}
email: (Bob Phelps)
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