The Cartagena Protocol on Biosafety
by
Hartmut Meyer
| Keywords: |
Biosafety, Convention on Biological Diversity |
| Correct citation: |
Meyer, H. (2000), "The Cartagena Protocol on Biosafety." Biotechnology and Development Monitor, No. 43,
p. 2-7. |
On 30 January 2000,
the Cartagena Protocol on Biosafety (CPB) was adopted in Montreal by
delegates of 128 Parties to the Convention on Biological Diversity
(CBD). This must be seen as a landmark in the development of multinational
environmental agreements. With it the Precautionary Approach (PA) became
the guiding principle for the import of genetically modified organisms
(GMOs). It subjects this import to an Advance Informed Agreement (AIA)
and secured its legal status in relation to the World Trade Organization
(WTO). By 15 September 2000, 75 governments including those of 44 developing
countries had signed this environmental agreement.
The CPB is to set internationally binding safety
standards for the import of genetically modified organisms (GMOs), and
defaults for the risk assessment of these GMOs for biological diversity taking
also into account risks to human health. It is also intended to guarantee the
right of member states to make a decision about the import of GMOs after being
informed in advance. These GMOs can, amongst other things, be food. However,
such food that does not contain living organisms is not regulated by the CPB
but by national or regional regulations like the Regulation (EC) No 258/97
of the European Parliament and of the Council of 27 January 1997 concerning
novel foods and novel food ingredients. Minimal standards for risk
assessment and safety measures for the transboundary movement of GMOs can be
set using the CPB. This is particularly significant for importing countries
that do not yet have GMO regulations. The CPB can thus be seen as an instrument
that protects biological diversity in developing countries and this explains
why it has received such strong support from these quarters.
The Precautionary Approach
Two of the documents from the United Nations
Conference on Environment and Development held Rio de Janeiro (Brazil) in
1992 deal with the role of genetic engineering in sustainable development. Agenda
21 and the Convention on Biological Diversity (CBD) both contain
provisions for avoiding or minimizing possible risks from GMOs. These protocols
contain contradictions, however, reflecting the different legal approaches to
GMOs in the USA and the European Union (EU). The European Precautionary
Principle (PP) enables states to take preventive measures in situations of
scientific uncertainty or before full scientific proof has been provided. The
Precautionary Approach as laid down in Principle 15 of the Rio Declaration is a
lighter version of the PP and was accepted as a compromise by the USA in 1992.
It is referred to in the CBD. By contrast there is no mention of precautionary
measures in Agenda 21. The Principle of Familiarity is mentioned as
fundamental to risk assessments which, according to the regulatory system in
the USA, serves as the basis for decision-making procedures.
The PA is invoked four times in the CPB. In the
Preamble, Article 1, Annex II and in Article 10.6/11.8 where it is stated that
“lack of scientific certainty due to insufficient relevant scientific
information and knowledge shall not prevent [the importing country] from taking
a decision, as appropriate, with regard to the import of that living modified
organism […] in order to avoid or minimize such potential adverse effects.”
This includes the possibility of prohibition, as was formulated in the draft
text in 1999, but is not seen as a trigger for possible WTO actions against the
CPB (see article of van Dommelen)
The regulations
The CPB regulates the transboundary movement of
specific categories of GMOs.
- Definition of GMOs: The Rio documents do not mention either genetically
engineered or genetically modified organisms (GEO, GMO), but
introduced the term living modified organism (LMO) as a biological
entity to be regulated under a biosafety agreement. This followed USA
regulations that define any bred organism as “genetically modified”.
During the biosafety negotiations the legal concepts used by the majority
of countries prevailed. These rely on a process orientated definition and
regard genetically engineered organisms, modified by “modern
biotechnology”, as separate entities. The CPB has widened the concept of
“modern biotechnology” by including methods of cell fusion (see glossary). Within in the CPB the term “commodity” has also been replaced
by “living modified organism intended for direct use as food or feed, or
for processing” (LMO-FFP).
- Advance Informed Agreement (AIA) Procedure: The first importation of a GMO is subject to an
approval procedure in which the exporter has to provide information on the
GMO and to perform an appropriate risk analysis. The demand for an AIA was
a consequence of the negative experiences of developing countries used as
dumping grounds for toxic wastes and pesticides. The internationally
agreed term Prior Informed Consent was avoided because industrialized
countries feared that this might imply a link between the risks of
hazardous chemicals and GMOs. According to Article 8 of the CPB the “Party
of export shall notify, or require the exporter to ensure [written]
notification to […] the competent national authority of the Party of
import prior to the intentional transboundary movement”. The minimal
information required about the GMO, such as identification methods,
centres of origin or risk assessment reports, have been laid down Annex I.
Within 90 days, the Party of import has to confirm the reception of the
notification.
Article 9 of the CPB agreement gives the importing Party two significant
rights: first if relevant national laws have not been developed the
provisions of the CPB can be used; and second a “failure by the Party of
import to acknowledge receipt of a notification shall not imply its
consent to an intentional transboundary movement.”
A national authority has to be formed
by the time the CPB comes into force or a national focal point has to be
designated that can fulfil the necessary tasks. Until now 63 Parties have
appointed Intergovernmental Committee for the Cartagena Protocol on
Biosafety (ICCP) focal points, most of them CPB negotiators from
environmental ministries and more than half of them have been established
in developing countries.
- Labelling and Segregation: An earlier version
of the biosafety protocol required that LMO-FFPs would be accompanied by
documentation that “clearly identifies them as living modified
organisms”, but in the final hours of negotiation Argentina claimed
that, as a developing country, it would not be able to implement an
adequate identification system. The final text (Article 18.2) now states
that LMO-FFPs have to be accompanied by documentation that “clearly
identifies that they “may contain” [LMOs] and are not intended for
intentional introduction into the environment, as well as a contact point
for further information.” This text does not fulfil the provisions of
many existing national labelling laws and fails to provide clear
information.
The parties to this protocol are supposed to decide on a more detailed
procedure including specifying identity and unique identification within
two years of the protocol coming
into force. As a result, the CPB requires the type of mandatory labelling
already demanded by the EU and Japan, who are currently the main importers
of GMOs. The majority of emerging biosafety laws of in developing
countries also adhere to the European concept of mandatory labelling and
the international markets are about to accept and implement such labelling
and segregation conditions in response to consumer demands.
Scope of the CPB
The CPB regulates the transboundary movement of GMOs
but there are several exceptions with modified regulations.
Commodities
During the biosafety negotiations a new category of
GMOs was created: living modified organisms intended for direct use as food
or feed, or for processing (LMO-FFPs). It replaces the expression
“commodities” and makes a clear distinction between GMOs as seeds, and GMOs
that are intended for food or feed and which are therefore not supposed to be
released into the environment. This distinction does not take into account that
in crisis situations in developing countries GMOs intended for food might also
be used as seeds.
While the draft text totally excluded LMO-FFPs from
the AIA procedure, the final negotiations in Montreal led to the development of
a weaker form of AIA for LMO-FFPs. This ‘AIA-light’ is closely connected to the
development of an internet-based Biosafety Clearing House (BCH), an
information system that is part of the clearing house mechanism of the CBD. The
BCH will be a central portal with basic information and links to other relevant
web pages. Meanwhile there are 144
national CBD focal points, 122 of them with e-mail, but only 52 with a CBD
clearing-house mechanism website. The CBD has started an international project
that will try to improve this situation within the next four years paying
particular attention to the development of the BCH structure.
Every Party to the Protocol must be informed about any
approval given for the market introduction of an LMO by another Party either in
writing or through the BCH. However, the actual import itself does not have to
be announced. The potential importing Party “may request additional
information” and “may take a decision on the import [...] under its domestic
regulatory framework that is consistent with the objective of this Protocol”
(Article 11). Most developing country expressed their concerns about this
procedure which imposes the burden of monitoring the world-wide registration of
LMO-FFPs on the potential importing countries and which relies entirely on
highly developed telecommunication systems that are often not accessible to
developing countries.
Under the regular
AIA procedure, explicit consent is needed for the import of an LMO. However,
Art. 11.7 states that the “failure by a Party to communicate its decision [...]
shall not imply its consent or refusal to the import” of LMO-FFPs. The Party’s
decision has to be announced through the BCH. In practice, this might lead to a
matrix showing which country has allowed the import of which LMO-FFP. This
matrix can help exporters decide whether a particular consignment of
agricultural commodities that “may contain” LMO-FFPs can be exported legally
into a given country or not.
Exporting countries
How do the three main GMO growing countries and other
potential GMO growers react on these CPB requirements? The USA as the main
producer of GMOs cannot be a Party to the CPB until they ratify the CBD, which
at present seems very unlikely. It is also unclear whether Canada as the third
biggest exporter of GMOs and Australia as a potential GMO growing country will
sign the CPB. On the other hand, the developing countries Argentina, the second
biggest GMO exporter, and Chile, both members of the Miami-Group, signed the
CPB very early on.
It will be extremely difficult if major exporting
countries refuse to enter the CPB and accept its obligations. In the draft
text, the transfer of LMOs from non-Parties to Parties was forbidden, but this
provision could not be maintained. The CPB now states that the movement of LMOs
between Parties and non-Parties “shall be consistent with the objective of this
Protocol” and might be performed under bilateral agreements. Non-Parties shall
be encouraged “to adhere to this Protocol and to contribute appropriate
information to the [BCH].”
Transit
LMOs in transit or intended for contained use are
included in the CPB but they are neither subject to the AIA procedure, nor to a
risk assessment. The exclusion of LMOs for contained use from risk assessment
does not reflect the position of the majority of the Parties to the CBD or
‘green’ NGOs, and has the potential to counteract the spirit of the CPB. This
provision invites exporters to evade risk assessment by declaring that the
imported LMOs are meant for contained use, for example, by postponing field
releases for a year. In such cases, the responsibility for risk assessments
would be shifted from the exporter to the importing country; that is if
national legislation exists in that country. Furthermore, the definition of
contained use as “any operation, undertaken within a facility, installation
or other physical structures, which involve living modified organisms that are
controlled by specific measures that effectively limit their contact with, and
impact on, the external environment” is extremely vague. The introduction
of the term “or other physical structures” by the USA may encourage exporters
to claim, for instance, that field trials surrounded by hemp plants or other
pollen traps can be regarded as contained use.
Pharmaceutical LMOs
The CPB “shall not apply to the transboundary
movement of living modified organisms which are pharmaceuticals for humans that
are addressed by other relevant international agreements or organisations”
(Article 5). To date, the only pharmaceutical LMOs are living, genetically
modified viruses serving as vaccines. Currently no other agreement explicitly
addresses their transboundary movement and effects on biodiversity. They have
to be approved after a medical risk assessment conducted according to national
and international pharmaceutical legislation. It is still unclear whether and
how this open issue of the CPB will be solved.
The exclusion of
pharmaceutical LMOs from the Protocol reflects the common interest of countries
with powerful pharmaceutical industries. Many developing countries fear that
genetically engineered plants that produce vaccines or drugs might fall under
this article and will be able to enter their territory unannounced. Such plants
will exhibit substantial variability in vaccine or drug concentration due to
variations between each organism, climate, soils etc. Taking into account the
unpredictable concentration of the active ingredient in a particular plant, the
plants will not fulfil the criteria that would lead to them being classified as
drugs. They will provide the raw material for industrial processes, in
contained use, necessary to extract the active ingredient and produce pure
drugs. The importation of this type of plants is therefore most likely to fall
under Article 6 (Transit and Contained Use) since they cannot be used as
medicine themselves. This still implies import without the application of AIA
and a biodiversity risk assessment. However, labelling requirements will have
to be fulfilled and this will enable LMOs to be monitored and/or become subject
to national legislations.
Relation to the WTO
During negotiations about the biosafety protocol, the
Miami Group tried to subordinate the CPB to WTO regulations despite the strong
objection of the other countries involved. A subordination such as that
formulated in the so-called saving clause Article 31 of the draft text would
have devalued the PA as a political guideline. The Miami Group regarded the WTO
as a bulwark against attempts to impose “unjustified” import restrictions on
GMOs. According to WTO regulations, such restrictions can only be imposed after
damage has occurred and its cause has been identified. Without any statement
about its relation to other international treaties, and in accordance with the Vienna
Convention on the Law of Treaties, the CPB as the more recent and more
specific agreement would prevail over the WTO. As a compromise, the CPB
preamble reads that the parties “recognis(e) that trade and environment
agreements should be mutually supportive with a view to achieve sustainable
development, emphasiz(e) that this Protocol shall not be interpreted as
implying a change in the rights and obligations of a Party under any existing
international agreements, understand that the above recital is not intended to
subordinate this Protocol to other international agreements”.
Nonetheless, it is
unclear how the formal equalization of the CPB and WTO agreements would fare in
a law suit arising from an import restriction. The WTO has its own jurisdiction
and is able to impose fines worth millions of dollars. This makes it
structurally much stronger than the Rio documents, which cannot be enforced in
court.
Technical assistance and capacity building
The CPB calls for co-operation between Parties with
regard to financial and technical assistance and to capacity-building. Canada
and the USA, and some EU countries have been funding biosafety meetings for
many years. These mainly serve to promote modern biotechnology and the Technical
Guidelines of the United Nations Environment Programme (UNEP) which
are not legally binding, are not based on the Precautionary Principle and do
not anticipate labelling. The promotion of these guidelines can be seen as an
extension of the USA regulatory system. It would be fatal for the biosafety
process if the implementation of the CPB were to be led by countries that are
opposed to the Precautionary Principle and the spirit of the CPB.
Conclusion
What does the adoption of international environmental
safety standards for the transboundary shipment of GMOs mean for the export of
such organisms as seed and/or food to developing countries? Will the commodity
markets of these countries be flooded with GMOs because of the weaknesses in
the CPB as mentioned above, the absence of appropriate national regulations and
a lack of local capacity to deal with the problem? As far as LMO-FFPs are
concerned this seems unlikely because, in the first place, commodity flows
follow market capacities. The big, prosperous commodity markets are in Europe
and in some Asian-Pacific countries not in developing countries. Those markets
are the target of GMO exports from the three GMO growing countries - USA,
Canada and Argentina - even though in most of these importing countries strong
biosafety legislation exists.
The GMO market entered a critical stage when European
and Japanese retailers reacted to the wide spread critical consumer attitude
towards genetically modified (GM) food and started to import GMO free
raw products. The USA reacted to this by stabilizing the market for GMOs by
indirect agricultural subsidies. Non-marketable harvests could be sold to the
government and then distributed in food aid programmes. The amount of GMOs
entering developing countries in this way - and not following the provisions of
the CPB - may well be grossly in excess of regular commodity flows. NGOs from
developing countries have been critically analysing this issue recently.
The import of GM seeds into developing countries will
be subject to the full provisions of the CPB. The analysis of the ongoing
development of modern biotechnology in developing countries show that the major
efforts of private and public development programs focus on establishing
research facilities that can produce GMOs on national territory. This investment
is closely connected to efforts to convince the countries concerned to
establish the legal framework for exclusive intellectual property rights, e.g.
through patents on plants or through the adoption of the International Union
for the Protection of New Varieties of Plants (UPOV) agreement from 1991.
Given this
situation, the necessary biosafety evaluation depends exclusively on the legal
framework of the individual developing country. Recognizing the efforts being
made by developing countries to elaborate a CPB with high protective standards,
attempts must now focus on implementing the CPB and on drafting of appropriate
national biosafety legislation. They must be supported by the industrialized
countries that signed the CPB.
Hartmut Meyer
Co-ordinator Working Group on Biological Diversity, German NGO Forum on Environment & Development, Kleine Wiese 6, D-38116 Braunschweig, Germany.
Phone (+49) 531 5168746; Fax (+49) 531 5168747; E-mail hartmut.meyer@bund.net
Sources
Cartagena Protocol on Biosafety: http://www.biodiv.org/biosafe/Protocol/Protocol.html
Convention on Biological Diversity: http://www.biodiv.org/conv/background.html
Catalogue of Biosafety Documents: http://irptc.unep.ch/biodiv/docs01.html.
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