512 NATURE BIOTECHNOLOGY VOL 17 JUNE 1999 http://biotech.nature.com

COMMENTARY

Article 19.3 of the Convention on BiologicalDiversity establishes the need to create alegally compelling instrument, whichincludes the concept of advanced informedagreement (AIA), to regulate the transfer,handling, and use of “living modified organ-isms” (LMOs) produced by modern biotech-nology that could have an adverse effect inthe conservation and sustainable use of bio-diversity. Thus the first meeting of theConference of the Parties of the Convention(COP I), held in Nassau, Bahamas, in 1994,established a Group of Experts to study theformalities of such a protocol. This groupmet in Cairo in 1995, and subsequently thesecond Conference of the Parties in Jakarta,held in 1995, established an ad hoc workinggroup of open composition, which, based onthe recommendations of the Cairo Group ofExperts, was charged to define the terms of aprotocol restricted to the transboundarymovement of LMOs.

The open-composition ad hoc group heldfive meetings between 1996 and 1998 inAarhus, Denmark (1996) and, Montreal,Canada (May and October 1997, Februaryand August 1998) in preparation for therecent session in Cartagena, Colombia(February 14–19, 1999), where it was intend-ed that a protocol would be ratified. The planhad been to follow the Cartagena gatheringby an extraordinary session of theConference of the Parties of the Protocol atwhich the protocol was to be officially adopt-

ed in order to open it for formal signing by allcountries within three months. Yet despitethe enormous effort expended during almostfive years of often tortuous discussions andalways difficult negotiations, there remainedso many unresolved issues and sharp dis-agreements that the Biosafety Protocol (BSP)was not adopted, and the delegates agreed tosuspend the anticipated first extraordinarysession of the Conference of the Parties.

Perhaps the main reason for this is that, inaddition to the technical considerationsinvolved with the transfer, handling, and useof LMOs, the development of the draft of theBSP included new issues related to commer-cial, environmental, and socioeconomic con-siderations, which partitioned a new set ofnegotiating blocks and strategies. During ses-sions 1–5 of the ad hoc working group, coun-tries were aligned in three main blocks: thedeveloped countries, the group of developingcountries (G-77) and China, and the coun-tries with transition economies.

At Cartagena a new working scenario,with new players, suddenly appeared, inwhich the commercial component occupiedcenter stage in the discussions. This scenariowas presented by the “like-minded countries,”whose apparently convergent interests soughtto assume the representation of the develop-ing countries and China; the “compromisecountries,” represented by Switzerland, Japan,Mexico, South Korea, Norway, and NewZealand; the countries of central and easternEurope; and the new actor, the “Miamigroup,” composed of the USA, Canada,Australia, Argentina, Chile, and Uruguay. TheEuropean Union (EU) presented its own pro-posal.

For the “like-minded countries,” a BSPneeded to reflect an adequate balancebetween environmental and social considera-tions. This was the fundamental argumentfor the inclusion of aspects such as the

Precautionary Approach, AdvancedInformed Agreement (AIA), articles relatedto responsibility, indemnification, and com-pensation, socioeconomic aspects, the build-ing of institutional capacity, the establish-ment of a clearinghouse mechanism, and thetransfer of financial and technologicalresources.

The EU, on the other hand, sought aninstrument that reflected a balance betweentrade and environmental concerns, and thuspresented a basis for the protocol items relat-ed to the assessment of risk based on scientif-ic knowledge, prior experience, specific char-acteristics of a given LMO, and its anticipateduse. They also favored the PrecautionaryApproach application, the inclusion of article8 (g) of the Convention of BiologicalDiversity, compliance with existing multilat-eral agreements (such as those of the WorldTrade Organization, WTO), the labeling ofthe products of LMOs, the development ofinstitutional capacities through agenciessuch as the Global Environmental Facility(GEF), and the application of UN-mandatedbiosafety guidelines.

Distinct from this position, the “Miamigroup” favored the consideration of tradeand commercial considerations over theenvironmental and the social ones. This posi-tion might be related to the fact that four ofits constituents (United States, Argentina,Canada, and Australia) had, between 1997and 1998, 98% of the total world acreage oftransgenic crops, with a market value thathas increased approximately 20 times from1995 to 1998, from US $75 million in 1995 toUS $1.2–1.5 billion in 1998 (ISAAA BriefsNo. 8. 1998)..

Given these polarities, it is somewhat sur-prising that 128 delegates (representing 134countries) actually reached consensus on 24of the 39 articles under consideration. Theareas where agreement was clear are: inclu-

BIOSAFETY PROTOCOL

Four views from CartagenaA few months ago, representatives of 134 countries met in Cartagena, Colombia, with the ostensible purpose of agreeing on a near universal set of proto-cols to ensure that the expanded use of the techniques and products of modern biotechnology, especially into the “developing world,” does not produceunintended and indeed harmful effects. As the commentaries below illustrate, the failure of the Cartagena gathering to reach such an agreement is, likethe issue of biosafety itself, amenable to multiple interpretations in the manner of the classic Japanese film, Roshomon, in which several highly crediblewitnesses to an assault have partially overlapping but discernibly different views of what actually transpired. The text of the Biosafety Protocol (BSP), aswell as other relevant documents of the Convention on Biological Diversity (CBD), can be found at: www.biodiv.org/biosafe/bswg6/bswg6.html#excop.

The Editors

New confrontations

Elizabeth Hodson-de-Jaramillo and Rafael H. Aramendis

Elizabeth Hodson-de-Jaramillo and Rafael H.Aramendis are with the Programa Nacional deBiotecnología–Instituto Colombiano para elDesarrollo de la Ciencia y la TecnologíaFrancisco José de Caldas, COLCIENCIAS,Bogotá, Colombia Transversal 9A # 133-28(ehodson@colciencias.gov/co;raramend@colciencias.gov.co).

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NATURE BIOTECHNOLOGY VOL 17 JUNE 1999 http://biotech.nature.com 513

COMMENTARY

Boon or threat to international trade in biotechnology?

Edward L. Korwek and Lisa W. Zannoni

sion of the effects of the use of LMOs onhuman health; acceptance of previous notifi-cation by the exporter; the acceptance ofprocesses of risk assessment and manage-ment as constituent elements for decisions inbiosafety; the inclusion of confidentialityclauses within the documentation; thestrengthening of institutional capacity inbiosafety; the adoption of information sys-tems and the inclusion of clauses of responsi-bility and compensation.

The major point of discord centeredaround article 5, which addressed the require-ment for the Advanced Informed Agreementto apply to genetically modified agriculturalcommodities meant for eating or processing,

as opposed to planting; and article 31, whichrelated the BSP to other international agree-ments, especially those of the WTO.

The outcome of the Cartagena gathering,at least from our perspective, is the inevitableconfusion that comes from the introductionof completely new items at the end stages ofcomplicated negotiations. In this case, whathad been essentially technical discussionsbecame embroiled in a dispute betweenadvocates of trade and agendas driven byenvironmental concerns. The underlyingconflict in these disagreements is economic,and this dynamic generated a new confronta-tional scenario for the European Union andUnited States, already at loggerheads over

bananas and the import of meat from cattletreated with recombinant drugs.

We remain concerned about the risks ofLMOs, not only in terms of their safety, butalso in terms of the impact of their use on thedeveloping world, and we are troubled thatdiscussions appear to have moved from therelatively clear guidelines of the Conventionon Biological Diversity to those of the WTO.It is clear that renewing the discussions willdepend on the results of other internationalforums. In the meantime, without an inter-national instrument, individual countriesmust develop and clearly define their ownlaws subject to future challenge under therules governing world trade.

Edward L. Korwek is a partner and Lisa W.Zannoni is an associate (Brussels office) withHogan & Hartson, Columbia Square, 555 13thStreet, NW, Washington, DC 20004-1109.

The first international law specifically direct-ed at certain products of modern biotechnol-ogy—in particular, at “living modifiedorganisms”(LMOs)—has emerged in specificdetail, but has yet to be finalized. Recentnegotiations of the Conference of the Partiesof the United Nations Convention onBiological Diversity (CBD) in Cartagena,Colombia have stalled. Another meetingwithin the next 11 months is expected toresult in a final protocol that can be signedand ratified by the parties. The current draftof the BSP contains 39 articles dealing withissues ranging from public information torisk assessments and liability. It also containstwo annexes covering information requiredin notifications of importation of LMOs andin risk assessments on LMOs. Similar tomany international treaties, the BSP isfraught with ambiguity. Interpretative diffi-culties loom, portending myriad approachesto regulation of LMOs at the individualcountry level.

Developing countries that are parties tothe BSP will likely be the most affected withrespect to implementing the treaty. Currently,they lack the necessary regulatory procedures,information, and expertise to evaluate effec-tively imports of LMOs. Industrialized coun-tries, on the other hand, probably will needonly to conform their current regulatory sys-tems to the requirements of the BSP, althoughthis may not always be easily accomplished,given its wide scope and ambiguity.Nonsignatories to the CBD, such as the US,

can also be affected considerably, to the extentthat they are exporters of LMOs. Roughly 170nations are parties to the CBD.

Since the BSP has not yet been finalized,the provisions that have emerged thus far maychange in the final negotiation. Even so, thecurrent language is instructive of its potentialscope and ramifications. The BSP is meant tooutline a minimal regulatory approach totransboundary movements of LMOs.Countries often maintain a sovereign right toapply more stringent provisions.

The CBD was developed in 1992, as aresult of a United Nations Earth Conferenceheld in Rio de Janeiro. Under the auspices ofthe UN, the CBD is an international treatythat is intended to conserve and sustain bio-logical diversity. The treaty requires the estab-lishment of a BSP setting up appropriate pro-cedures, including Advance InformedAgreement (AIA), in the safe transfer, han-dling, and use of any LMO that may have anadverse effect on the conservation and sus-tainable use of biological diversity. Six meet-ings have been held on the subject of the cov-erage and language of the BSP.

As a result of the most recent Februarymeeting held in Cartagena, Colombia, theBSP contains, in addition to the AIA mecha-nisms covering notification and consent pro-cedures for importation, a variety of provi-sions covering diverse subject areas. The pro-tocol identifies simplified procedures thatmay be used instead of the more formal AIAprocedures for importation of an LMO; theuse of bilateral and multilateral agreementsand other arrangements in place of the BSP,provided they are consistent with the objec-tives of the BSP; risk assessment and riskmanagement requirements; emergency mea-sures; handling, transport packaging, and

identification requirements; the establish-ment of a Biosafety Clearinghouse (BSC) tofacilitate information exchange on LMOsand on their regulation; the handling of con-fidential information; socioeconomic con-siderations and liability provisions; and therelationship of the BSP to other internationalagreements, among other topics.

The BSP clearly states that, in general, itshall apply to the transboundary movement,handling, and use of LMOs that may have anadverse effect on the conservation and sus-tainable use of biological diversity, takingalso into account risks to human health. Theterm “living modified organism” is definedas “Any living organism that possesses a novelcombination of genetic material obtainedthrough the use of modern biotechnology.”“Living organism” is defined as any “biologi-cal entity capable of transferring or replicat-ing genetic material, including organisms,viruses, and viroids.” “Modern biotechnolo-gy” is defined to mean the application of invitro nucleic acid techniques, includingrecombinant DNA and indirect injection ofnucleic acid into cells or organelles, and thefusion of cells beyond the taxonomic family,that overcome natural physiological repro-ductive or recombination barriers and thatare not techniques used in traditional breed-ing and selection.

These process-based definitions, thoughproblematic for a variety of reasons, includingthe difficulty of proving novelty, imply cover-age of a broad range of products, unless theyare otherwise excluded. Seeds for planting, cutflowers, human and other animal pharmaceu-ticals, such as vaccines, foods such as yogurt oryeast used in food production, bulk agricul-tural commodities, such as grains or oil seedsused for human food or veterinary feed uses,

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