Summary report, 12–16 May 1997
2nd Meeting of the Open-ended Ad Hoc Working Group on Biosafety (BSWG-2)
The second meeting of the Open-ended Ad Hoc Working Group on Biosafety(BSWG-2) met from 12-16 May 1997 in Montreal and continued its discussions on the elaboration of a protocol on safety in biotechnology. Working from aide-memoirestabled by Chair Veit Koester (Denmark), delegates discussed a range of issues,including: objectives; procedures for transfer of living modified organisms; competentauthorities, information sharing and a clearinghouse mechanism; capacity-building; andrisk assessment and management. BSWG-2 also convened contact groups to consider theproposals on definitions of key terms and studies to be completed by the Secretariat inpreparation for BSWG-3.
Koester opened BSWG-2 by urging delegates concentrate on core issues and identify theelements of a biosafety protocol for their next session. Under his guidance, delegatesdisplayed a cooperative spirit and agreed to a structure for discussions and theprogramme of work for this meeting as well as future meetings. After previous meetingscharacterized by some as “talk shops,” many BSWG-2 delegates left Montreal satisfiedthey had at last begun to move from generalities to specifics and taken substantial stepstoward a protocol. Despite this progress, some fundamental disparities of opinion,particularly on the scope of the protocol, remain, which threaten to derail the processwhen negotiations get underway.
A BRIEF HISTORY OF THE BIOSAFETY ISSUE
Since the early 1970s, recombinant DNA technology — the ability to transfer geneticmaterial through biochemical means — has enabled scientists to genetically modifyplants, animals and micro-organisms rapidly. Modern biotechnology can also introduce agreater diversity of genes into organisms, including genes from unrelated species, thantraditional methods of breeding and selection. Organisms genetically modified in thisway are referred to as living modified organisms derived from modern biotechnology(LMOs).
Biotechnology has led to advances in medicine, and promises to improve agriculturalproducts and industrial processes as well. Agricultural biotechnology can improve theresistance of plants to pests or environmental stresses, and can increase the commercialvalue of agricultural products. Other uses for biotechnology include environmentally-friendly industrial processes that may reduce the use of harsh or toxic chemicals.
Although modern biotechnology has demonstrated its utility, there are concerns about thepotential risks to biodiversity and human health posed by LMOs. Many countries withbiotechnology industries already have domestic legislation in place intended to ensure thesafe transfer, handling, use and disposal of LMOs and their products (these precautionarypractices are collectively known as “biosafety”). However, there are no bindinginternational agreements addressing situations where LMOs cross national borders.
Two categories of intended use of LMOs — contained use and field release — arerecognized. LMOs intended for contained use are usually research material and aresubject to well-defined risk management techniques involving laboratory containment.LMOs developed for agricultural and, in some cases, industrial biotechnology, areintended for field release. Field testing of LMOs is a new undertaking, and the interactionof LMOs with various ecosystems continues to generate questions about safety. Some ofthe concerns about field release of LMOs include: unintended changes in thecompetitiveness, virulence or other characteristics of the target species; the possibility ofadverse impacts on non-target species and ecosystems; the potential for weediness ingenetically modified crops; and the stability of inserted genes.
BIOSAFETY UNDER THE BIODIVERSITY CONVENTION
The Convention on Biological Diversity (CBD), which was negotiated under the auspicesof the United Nations Environment Programme (UNEP), was adopted in May 1992 andwas opened for signature at the Earth Summit in Brazil on 5 June 1992. It entered intoforce on 29 December 1993. As of 23 April 1997, 168 countries had become Parties tothe Convention.
Article 19.4 of the Convention provides for Parties to consider the need for andmodalities of a protocol, including advance informed agreement (AIA) in particular, toensure the safe transfer, handling and use of living modified organisms derived frommodern biotechnology that may have an adverse effect on biological diversity and itscomponents.
The first Conference of the Parties to the CBD, which was held from 28 November - 9December 1994, established an Open-ended Ad Hoc Group of Experts onBiosafety. This Group met in Madrid from 24-28 July 1995. According to the report ofthe meeting (UNEP/CBD/COP.2/7), most delegations favored the development of aninternational framework on biosafety under the Convention. The proposed elements ofsuch a framework, as drafted in Madrid, are divided into two categories — those favoredunanimously and those favored by a subset of delegates representing primarilydeveloping countries. In the annex to the report, paragraph 18(a) lists the formerelements, which include: all activities related to LMOs that may have adverse effects onbiodiversity; transboundary movement of LMOs, including unintended movement;release of LMOs in centres of origin/genetic diversity; mechanisms for risk assessmentand management (RAM); procedures for advance informed agreement; facilitatedinformation exchange; capacity-building; and implementation and definition of terms.Paragraph 18(b) lists the latter elements, including: socio-economic considerations;liability and compensation; and financial issues.
In another meeting relevant to the biosafety process, the UNEP Panel of Experts onInternational Technical Guidelines for Biosafety met in Cairo, Egypt, from 11-14December 1995 to adopt a set of international technical guidelines for biosafety (UNEPGuidelines). The UNEP Guidelines (UNEP/Global Consultations/Biosafety/4) areintended to provide a technical framework for risk management commensurate with riskassessment, without prejudice to the development of a biosafety protocol by the COP ofthe CBD.
At COP-2, which took place in Jakarta, Indonesia, from 6-17 November 1995, delegatesmet to consider the need for and modalities of a protocol on biosafety. From the outset itwas clear that delegates intended to set in motion a negotiation process to develop aprotocol on biosafety. While developed country delegations wanted to focus on“transboundary transfer of any LMO”, developing countries preferred a “protocol onbiosafety in the field of the safe transfer, handling and use of LMOs.” The compromiselanguage that was adopted by the COP calls for “a negotiation process to develop in thefield of the safe transfer, handling and use of living modified organisms, a protocol onbiosafety, specifically focusing on transboundary movement of any LMO that may havean adverse effect on biological diversity, setting out appropriate procedures for advanceinformed agreement.”
The decision also established an Open-ended Ad Hoc Working Group onBiosafety (BSWG) to meet to “elaborate, as a priority, the modalities and elements of aprotocol based on appropriate elements from paragraph 18(a)” of the report of the Madridmeeting, and to “consider the inclusion of the elements from paragraph 18(b) asappropriate.” Other terms of reference for the BSWG (UNEP/CBD/BSWG/1/2) state thatthe Working Group shall: elaborate key terms and concepts; consider AIA procedures;identify relevant categories of LMOs; and develop a protocol whose effective functioningrequires that Parties establish national measures and that takes into account theprecautionary principle. The Working Group shall also: develop a protocol that providesfor a review mechanism and seeks to minimize unnecessary negative impacts onbiotechnology and does not hinder unduly access to and transfer of technology; take intoaccount gaps in the existing legal framework; develop a protocol with a view to thelargest possible number of ratifications; and use the best available scientific information.
BSWG-1, which was held in Aarhus, Denmark, from 22-26 July 1996, began theelaboration of a global protocol on safety in biotechnology. Although the meetingproduced little in the way of written results, it represented a forum for defining issues andarticulating positions characteristic of the pre-negotiation process. The meeting revealedseveral interesting dichotomies, including a fracture in the G-77/China bloc over elementsto be included in the protocol, as well as strikingly divergent perspectives onbiotechnology. Nonetheless, governments listed elements for a future protocol, agreed tohold two meetings in 1997 and outlined the information required to guide their futurework.
By adopting decisions III/5 (additional guidelines to financial mechanisms) and III/20(biosafety issues), COP-3 affirmed its support for a two-track approach through which thepromotion of the application of the UNEP International Technical Guidelines for Safetyin Biotechnology can contribute to the development and implementation of a protocol onbiosafety, without prejudicing the development and conclusion of such a protocol, andendorsed recommendation II/5 of SBSTTA-2 with regard to capacity-building inbiosafety.
An International Workshop to Follow-up on the UNEP International TechnicalGuidelines for Safety in Biotechnology was held in Buenos Aires on 31 October - 1November 1996.
The nineteenth meeting of the UNEP Governing Council, held from 27 January – 7February 1997 in Nairobi, adopted decision 19/16 on biosafety. The decision urgesgovernments and subregional and regional organizations to promote the implementationof the Guidelines by designating focal points in countries to apply the Guidelines, andurges governments to promote safety in biotechnology by contributing relevantinformation to UNEP’s International Register on Biosafety. The Governing Council alsorequested the Executive Director to: continue to promote the implementation of theUNEP International Technical Guidelines for Safety in Biotechnology, particularly indeveloping countries; explore with other UN and international bodies the mutual sharingof information about organisms with novel traits; and organize within two years a secondinternational workshop on the state of the art of the implementation of the Guidelines.
REPORT OF BSWG-2
BSWG Chair Veit Koester (Denmark) opened the session on Monday, 12 May 1997, andrecalled that COP-3 had entrusted the Working Group to complete its work on a biosafetyprotocol by the end of 1998. He noted that the Commission on Sustainable Development(CSD) at its most recent meeting had called upon the BSWG to complete its workrapidly. He stated that the meeting must concentrate on core issues and identify elementsthat would enable delegates to review a draft text for a protocol at BSGW-3 in October.
Mr. Zedan (UNEP) highlighted a number of developments since BSWG-1, includingactions taken by SBSTTA, COP-3, the Bureau of the African Ministerial Conference onthe Environment and the nineteenth UNEP Governing Council. He also noted that manycountries have begun formulating national biosafety mechanisms and submitting theirproject proposals for GEF support.
CBD Executive Secretary Calestous Juma summarized the activities of the secretariatsince COP-3, including the first expert group meeting on marine and coastal biodiversityand implementation of the clearinghouse mechanism. He stated an expert workshop onthe modus operandi of the CBD would be convened in November.
Delegates completed their discussions on the composition of the Bureau, which willremain in office until COP-4 in May 1998. The Bureau consists of the followingmembers: Diego Malpede (Argentina); Veit Koester (Denmark); Behran Gebre EgziabherTewolde (Ethiopia); Sandra Wint (Jamaica); Sateeaved Seebaluck (Mauritius); ErvinBalazs (Hungary); David Gamble (New Zealand); Alexander Golikov (RussianFederation); Antonio G.M. La Vina (Philippines); and Bum Soo Kwak (Republic ofKorea).
Delegates then emphasized a number of priority issues for consideration. MALAYSIA,supported by SOUTH AFRICA, proposed focusing on the objective of the protocol, adefinition of LMO, AIA, mechanisms for risk assessment, capacity-building, financialissues, and liability and compensation. With the PHILIPPINES, he also sought inclusionof socio-economic considerations. The EU stressed the importance of establishingprocedures in case of international transboundary movement of LMOs. JAPAN,NORWAY and the REPUBLIC OF KOREA emphasized that the protocol should beconsistent with the objectives of the CBD and should not exceed its scope. AUSTRALIAsupported limiting the scope of the protocol to key issues such as information sharing andcapacity-building. The US highlighted AIA and information sharing as the two centralitems for consideration. NORWAY emphasized risk assessment and capacity-building.Delegates raised a number of other considerations. The REPUBLIC OF KOREA andARGENTINA said the protocol needs to be flexible to accommodate future advances inscience and rapid technological change. The REPUBLIC OF KOREA, ARGENTINA,AUSTRALIA, JAPAN and SOUTH AFRICA said the protocol must be consistent withWTO rules. JAPAN and the REPUBLIC OF KOREA called for minimizing negativeimpacts on biotechnology or limitations on access to biotechnology. ETHIOPIA notedthat African countries were “once bitten twice shy” and had accordingly submitted adetailed draft protocol.
The GREEN INDUSTRY BIOTECHNOLOGY PLATFORM stressed that the protocolshould only apply to organisms that had been modified using recombinant DNAtechniques and threaten to have an effect on biodiversity. Products of LMOs should notbe included. The THIRD WORLD NETWORK called for the inclusion of: theprecautionary principle; ethical, social and human health risks; public participation; andstrict liability. She called for a moratorium on the release of LMOs until a legally-bindingprotocol is concluded.
ORGANIZATION OF WORK
During the meeting, delegates discussed a range of issues relevant to the formulation of aprotocol, including: objectives; procedures for the transfer of LMOs, including AIA;competent authorities; information sharing and a clearinghouse mechanism; capacity-building; and risk assessment and management. Delegates had the following documentsbefore them: a compilation of views of governments on the contents of a future protocol(UNEP/CBD/BSWG/2/2); a background document on existing international agreementsrelated to biosafety (UNEP/CBD/BSWG/ 2/3); a bibliography concerning potential socio-economic effects of biotechnology (UNEP/CBD/BSWG/2/4); and a glossary of termsrelevant to a biosafety protocol (UNEP/CBD/BSWG/2/5).
On the basis of his review of items that have been addressed by government submissions,the Chair tabled a number of conference room papers as aide-memoirs, whichcontained specific questions under each issue area and provided a structure fordiscussions. Delegates’ views on these issues were compiled by the Chair in several“elements papers” and reviewed once more by delegates, who added items and proposedmodifications. The Chair’s final drafts of the “elements papers” were compiled andannexed to the report of the meeting. These papers, along with new and existingsubmissions from countries, will serve as the basis for discussion at BSWG-3.
Delegates established a contact group to consider action on the proposals regardingdefinitions. The group did not attempt to define terms but recommended work on aconsolidated document dealing with definitions for BSWG-3. Contact groups were alsoestablished to consider proposals made during BSWG-2 on studies to be completed bythe Secretariat in preparation for BSWG-3.
The Chair distributed an informal aide-memoire on the aim of the protocol thatstated: “The aim/objective of the protocol is to establish international action on biosafetythat should offer an efficient and effective framework for the development ofinternational cooperation aimed at ensuring safety in biotechnology through effective riskassessment and management for the transfer, handling and use of any LMO resultingfrom modern biotechnology that may have adverse impacts on the conservation andsustainable use of biological diversity, taking into account the risks to human health andtaking also into account Articles 8(g) and 19 of the Convention.” He acknowledged a lackof consensus on the protocol’s objective and requested that delegates temporarily acceptthe text, which was drawn from the Jakarta Mandate and the Madrid meeting.
CANADA, JAPAN, AUSTRALIA and the EU proposed incorporating language from theJakarta decisions on the protocol and mentioning that the aim should focus ontransboundary movements. AUSTRALIA, supported by the EU, noted that the text onlydrew from the preamble of the Jakarta Mandate and proposed using language from thebody of Decision II/5 (capacity-building). MALAYSIA and INDIA said the languagelacked specificity and called for a clearer statement of intent. Delegates decided to revisitthe issue at BSWG-3.
PROCEDURES FOR LMO TRANSFERS
The Chair introduced an informal aide-memoire that presented a series ofquestions for consideration of procedures for specific transfers of LMOs. The text askswhat procedures should be included in the protocol and states that the central question iswhether protection requires explicit consent, implicit consent or both. Explicit consent, asseen in the Basel Convention procedure for Prior Informed Consent (PIC), implies thatthe absence of a reply from the importing country within a specified time frame does notconstitute consent, but is instead a violation of the Protocol, which can be addressedaccording to the Protocol’s dispute settlement mechanism. Implicit consent implies thatconsent is deemed given if no reply from the importing country has been received withinthe specified time.
The EU noted two objectives: providing relevant information and giving importers theright to deny or accept movement of LMOs. Supported by SWITZERLAND, he stresseda choice of AIA (explicit consent) or simple notification (implicit consent). Responseoptions could include consent with or without conditions, a request for additionalinformation, a rejection of the application for movement or a notification of a need formore time for consideration. NORWAY favored explicit consent for all initial transfers ofsubstances, but with an obligation for the importing country to respond within 90 days.For subsequent exports a notification procedure could be used. CANADA defined LMOscovered by specific AIA procedures as including only those with adverse effects andnoted that explicit consent should be given in a timely fashion. Acknowledgement ofreceipt of application for movement should also be required. NEW ZEALAND favoredboth forms of consent, stressing flexibility and transparency as guiding principles.AUSTRALIA highlighted several components of AIA, including: the need for a systemfor notification of intent; a definition of the LMOs to be covered; and principles for riskassessment. The US said the decision of whether to apply implicit or explicit consenthinges on the type of LMO and that AIA explicit consent should only apply to the firstshipment.
ZAMBIA, BRAZIL, the PHILIPPINES, SRI LANKA, CAMEROON andBANGLADESH stressed the need for explicit consent, stating that implicit consent at thisstage is unacceptable as it could give importing countries an unfair responsibility arisingfrom their different bureaucratic or communication conditions. COLOMBIA said AIAshould be applied in every case and, with ZAIRE, called for a procedure requiring theexporter to notify a competent authority in the importing country of all potential risks andto wait for explicit consent from the importing country. INDONESIA noted that explicitconsent systems would generate information-sharing opportunities. The GERMANWORKING GROUP ON BIODIVERSITY and the THIRD WORLD NETWORK notedthat the consequences of LMO movements may not be visible until later and that explicitconsent for all movements allows an opportunity for revision.
PERU suggested that the decision of whether to apply explicit or implicit consent shouldlay with the importing country, which should mandate the standards for notification andimportation. CHINA supported inclusion of both types of consent, but noted that theterms of implicit consent should be determined on a bilateral basis. MAURITIUSsupported explicit consent but reserved judgement on a total ban on implicit consent.MALAYSIA noted that the decision of applying implicit or explicit consent should bemade when LMOs have been determined. BRAZIL said a simplified procedure should beconsidered for subsequent transboundary movements of the same LMO. TheMARSHALL ISLANDS, JAPAN and INDIA called for explicit consent, but in a mannerdifferent from that of the Basel Convention.
The aide-memoire also asked whether the applicable procedures for consentshould be fixed within the protocol or left for the importing country to decide. ZAMBIAsupported minimum information requirements to protect poorer countries. CANADA andNORWAY supported fixed criteria in order to provide predictability and consistency.SWITZERLAND and JAPAN said the protocol should provide for flexibility inprocedures. INDIA said that importing countries should have the right to decide abouttheir procedures.
On the question of which LMOs the procedures should apply to, many countries,including INDIA, BELARUS, SRI LANKA, ZAMBIA, PHILIPPINES, NEWZEALAND, MAURITIUS, LESOTHO, MALAYSIA, CUBA and UGANDA, favoredapplying the AIA procedure to all transfers. BRAZIL noted that a simple procedure couldprovide maximum flexibility to importers and exporters. BANGLADESH and theCENTRAL AFRICAN REPUBLIC called for post-release monitoring activities. TheEDMONDS INSTITUTE stated that even if an LMO’s characteristics are known onecannot predict its effects in all environments.
BURKINA FASO specified coverage of LMOs that are the result of biotechnology. Othercountries, including JAPAN, the EU, the US, CANADA, the REPUBLIC OF KOREA,NORWAY, THAILAND, CHINA and MYANMAR, specified LMOs that pose apossible risk for biodiversity and/or human health. JAPAN also favored excluding thoseLMOs not reproducible in the environment, covered under another internationalagreement, and for which risk has not been established. NORWAY noted this view isconsistent with the CBD. THAILAND noted that products created from LMOs, such asvaccines and food products, might be covered under trade regulations. CHINA warnedthat dealing with LMOs according to type and use may not always be consistent under theprotocol.
MALI asked how developing countries could know the risks they would run in acceptingLMOs. TOGO, supported by the CENTRAL AFRICAN REPUBLIC, pointed out that thestability and behavior of many LMOs are still not ascertained, thus risks will continue toexist. AUSTRALIA, NIGER, MEXICO and CUBA advocated a flexible approachallowing an importing country to decide which LMOs needed an AIA, based on risk andother factors such as intended use. CHINA favored this for exceptional cases.
On the question of intended uses to which the procedure should apply, BRAZIL, the EU,SRI LANKA, BURKINA FASO, BANGLADESH, ZAMBIA, MAURITIUS,LESOTHO, MALAYSIA, UGANDA and the EDMONDS INSTITUTE favored applyingAIA to LMOs for all intended uses. The PHILIPPINES favored flexibility on proceduresdepending on purpose, such as a simpler procedure for LMOs in transit. JAPAN statedthat LMOs for research should not be restricted if there are adequate health andenvironmental safety measures. INDIA also said that LMOs for research could be treateddifferently from LMOs for commercial uses. CANADA, NORWAY andSWITZERLAND favored excluding LMOs intended for contained use. The US,supported by MYANMAR, specified applying AIA to LMOs intended for field testing orfirst growth in the importing country.
On the question of distinguishing between initial and subsequent transboundarymovements of LMOs, INDIA, SRI LANKA, BANGLADESH, ZAMBIA, MAURITIUS,LESOTHO and the EDMONDS INSTITUTE favored making no distinction. ThePHILIPPINES preferred AIA for all movements but said the procedure might differdepending on timing. NORWAY felt that notification with implicit consent might beused for subsequent movements. NEW ZEALAND, NIGER, MALAYSIA and the EUfavored subsequent streamlining where there are no changes in use. UGANDA andAUSTRALIA proposed leaving this question to the importing party.
On whether there should be special provisions for LMOs for which commercializationhas been prohibited within an exporting country, NORWAY said the protocol should notcontain a ban on domestically prohibited products per se, but should provide aspecial procedure. Information about such prohibitions should be made available throughthe clearinghouse mechanism. MALAYSIA and BURKINA FASO said that no exportsshould be permitted for domestically prohibited products.
The US stated that the reasons for prohibiting an LMO domestically could hinge on itseffects within domestic ecosystems, which could be different within other countries’ecosystems. The EC said there is no need for specific provisions for these cases.CANADA emphasized that the decision to import lies with the importer, but the exportershould provide complete information. CHINA, supported by NEW ZEALAND,cautioned that the inclusion of specific provisions within this protocol could lead toconfusion where transfer of an LMO is already prohibited under another internationalagreement. INDIA supported information sharing on LMOs, but said the importingcountry should decide. The RUSSIAN FEDERATION said there should be no obligationon the exporter to provide information, but the importer should have the right to requestand obtain information.
On whether there should be special provisions for transferring an LMO that is alsoproduced in the country of import, a number of delegations noted that if the LMO inquestion was exactly the same as a domestically-produced LMO, the issue should beaddressed under rules concerning non-discriminatory trade practices. INDIA, ETHIOPIA,GEORGIA and COLOMBIA warned of the difficulty involved in determining whether anLMO to be imported has the exact genetic makeup as that of a domestic LMO.THAILAND noted the difficulty of determining when a product becomes domestic andprovided an example wherein rice genes were once imported and are now growndomestically. The Chair proposed noting that the issue would be addressed underprovisions on non-discrimination.
Many delegations addressed the issue of whether the importing country, after receivingnotification of a shipment, should have the opportunity to choose between a general orsimplified procedure and whether there should be a general provision that permitsunilateral or bilateral deviation from the general procedure, and the use of a simplifiedprocedure or no procedure at all. COLOMBIA said the protocol should contain a highlevel of detail for AIA procedures. The US stated that the level of complexity was not asimportant as the act of notification itself. JAPAN called for flexibility in the protocol andhighlighted the use of bilateral declarations. ETHIOPIA, ZAMBIA, NORWAY andINDIA noted that a decision regarding LMOs in one country could affect many in aregion and called for agreed minimum standards and procedures. With ZAIRE, theynoted that many countries need capacity-building assistance. MALAYSIA said theprotocol should contain minimum standards and not allow for unilateral derogation. Shesupported using simplified procedures, provided that the specific terms are defined. NEWZEALAND called for a case-by-case approach.
The US supported cooperative agreements that eliminate the need to apply AIA in allcases, provided they are concluded in a voluntary and non-discriminatory manner, andpointed to the PIC procedure for hazardous chemicals contained in the Basel Convention.ETHIOPIA noted the major differences between hazardous chemicals and biologicalmaterials and stated that careless decisions regarding LMOs could affect neighboringcountries. He opposed the elimination of AIA. JAPAN said unilateral decision-makingwas not acceptable. ZAMBIA said the use of bilateral agreements regarding the transferof LMOs defeats the purpose of the CBD. The COUNCIL FOR RESPONSIBLEGENETICS called for strong regulatory regimes in exporting countries.
The aide-memoire asked whether there should be one or more types of simplifiedprocedures for cases in which the general procedures do not apply. It also notes that thesesimplified procedures could include implicit consent if the general procedure is defined asrequiring explicit consent or a simple notification procedure with no possibility for theimporting country to react. MALAYSIA noted that the protocol may define specificcircumstances where general notification procedure requirements may not apply.AUSTRALIA said importing States should make decisions regarding the subsequentimportation of the same LMO at the time of first import. The US called for a singlesimplified procedure, noting the administrative burden of establishing a shipment-by-shipment procedure. CAMEROON called for a simplified procedure incorporatingexplicit consent. CHINA sought flexibility for importing countries.
On who should trigger the procedure, the EU, the PHILIPPINES, COLOMBIA, NEWZEALAND and JAPAN said the exporting country should trigger the procedure in theimporting country. ZAMBIA and CAMEROON said the exporting country should notifythe competent national authority in the importing country. CAMEROON added that theimporting country should have sovereignty to designate its authorities. AUSTRALIA saidthe protocol should be flexible to allow notification to come from the entity that is mostappropriate. THAILAND said the product-owner should trigger the procedure. BRAZILsaid the importing State should trigger AIA.
On the kind of information to be provided, the PHILIPPINES and ETHIOPIA said theexporting country should notify the importing country regarding characteristics of theLMO, the venues of intended release and all potential risks. JAPAN stated it would bebetter to prepare the list later, once LMOs have been identified. NORWAY said riskassessment should be carried out prior to the first export of an LMO and submitted to thecompetent authority of the importing State. The EU called for the establishment of atechnical annex and LMO-specific risk assessment guidelines. AUSTRALIA said riskassessment should begin with the initial exportation and include a description of theLMO, its biological characteristics, an assessment of the receiving environment, themethod of transfer and the reproductive capacity of the LMO.
MALAYSIA urged that information be timely and complete to allow the importingcountry to make an informed decision. She sought inclusion of information regarding safedisposal in case of accidental release, intended uses of the LMO and its effects on humanhealth and the environment. ZAMBIA supported the PHILIPPINES and said theexporting country should also be required to provide certification that release of the LMOis not banned in the country of origin. CHINA said the importing country should apply toits own government for importing procedures, as it is ultimately a government action.
The MARSHALL ISLANDS warned against restricting information for purposes ofbusiness confidentiality. Full risk assessment depends on capacity and risk assessmentmechanisms. NEW ZEALAND listed categories of information from its own legislationand stressed an ongoing interchange of information, with allowances for confidentiality,as appropriate. COLOMBIA supported Malaysia and added that the competent nationalauthority of the importing country should be able to ask for additional information. Shesaid the protocol must have a clause on handling the confidential information given to theimporting country. SRI LANKA called for the protocol to provide a system for scientificverification of information. CAMEROON noted that information should be provided inthe official languages of the importing country, and should include a description ofLMOs, safety requirements, mitigation measures in case of accidental release and riskassessment.
The REPUBLIC OF KOREA listed five information elements: specific regulations forsafe handling and use; preliminary risk assessment; risk management procedures;practical information on transfer of the LMO; and assessment of socio-economicimplications. The RUSSIAN FEDERATION called for information requirements to bebased on OECD and other international regulations, with some flexibility. The THIRDWORLD NETWORK and the EDMONDS INSTITUTE called for information oninsurance coverage for adverse effects in the host country.
On the prescribed period of time for a response from a competent authority regarding anLMO transfer, the EU called for time limits depending on various factors such as whetherthe competent authority has requested further information. JAPAN agreed, noting that thetime limit should start from the date the applicant submits all necessary information.NEW ZEALAND, supported by AUSTRALIA, called for a reasonable but not infiniteperiod, noting that the protocol creates a contractual arrangement giving balanced rightsand obligations to all Parties.
NORWAY proposed a 90-day limit that would allow an importing country to ask foradditional time. The RUSSIAN FEDERATION stated that any time limit would dependon the amount of information received and the country’s ability to digest it. INDIA,supported by MALAYSIA, SRI LANKA and MAURITIUS, opposed a time limit onresponse. Response is subject to factors such as capacity constraints and the adequacy ofinformation provided. The PHILIPPINES and PAPUA NEW GUINEA stated that anytime limit should be used only as a guideline, without consequences for failure torespond. CAMBODIA noted that developing countries lack the resources for studies toobtain adequate information, thus flexible and sufficiently long periods for response areneeded. MAURITIUS suggested a time limit on acknowledgement of application.
On the kind of actions to be taken in response to the information within notifications,JAPAN stated that an importing State can accept or reject with reason or request moreinformation. MALAYSIA said the types of action taken by an affected country are itsprerogative and can include consent or prohibition, either absolutely, provisionally orconditionally. NORWAY noted that the importing country can consent specifically orprovisionally provide an interim consent or decline. Where information is lacking, theburden of proof lies with the State of export. ETHIOPIA said that a non-response shouldnever amount to implicit consent for import and neighboring countries should beinformed of decisions. PERU recommended that each country develop domesticlegislation assuring that they would respond within a reasonable amount of time.
Regarding a review mechanism on decisions taken by the importing country, NORWAYsaid if there is new information the importing country can alter the AIA. Duty to informabout new information should be shared with all importing States. An exporter of anLMO should be able to ask for review when new information emerges. Also, a third partyor a neighboring country should be taken into account in environmental impactassessments. MALAYSIA said an affected country should trigger a review when newinformation arises. The exporting country could trigger it if the review is agreed jointlyby both sides. The US said this is a decision for the exporting country and did not supportan independent review body. The REPUBLIC OF KOREA suggested interested Partiesor neighboring countries should be given the right of consultation during the review. TheAUSTRALIAN GENE ETHICS NETWORK said that adjacent countries and citizensshould have access to the appeal process and socio-economic consideration should begrounds for appeal.
On 14 May, the Chair presented his draft element paper on procedures for specifictransfers of LMOs (UNEP/CBD/BSWG/2/ CRP.4). The Chair informed delegates thiswas not a negotiated document but should be viewed in conjunction with the Report ofthe Meeting and submissions from governments. The paper contains sections onnotification, information that may be required, periods of time for response and reviewmechanisms. The paper also addresses the cases in which the procedures should applyand contains sections that allow for no deviations or exceptions, sections allowingdeviations or exceptions under certain circumstances and sections addressing specificcases, such as banned chemicals. The paper also contains a range of options regardingsimplified procedures and consent.
The section on the information that may be required contains a chapeau noting thechannels through which information will flow, primarily competent authorities of States.The EU, the US and JAPAN all supported language noting that information may becommunicated to the importing State’s competent authority directly from the privatesector, rather than through the exporting State’s competent authority. The US alsoproposed noting the private sector’s potential as a source for information. The EUproposed addressing AIA and simple notification procedures in separate sections andincluding a paragraph noting that confidentiality must be ensured.
The elements paper also contains a list of 22 types of information that may be required,such as: origin, name and taxonomic status of recipient organisms; purpose of geneticmodification; results of risk assessments and tests; and intended use of the transferredLMO. The EU and US proposed noting that the list is neither exhaustive nor agreed byall. INDONESIA proposed adding “the status of the donor organism” and “the way andmethod of genetic modification.” CANADA requested “information on relevant previousnotifications and decisions.”
On the period of time allowed for response, the EU added a paragraph to prolong the timeperiod if the organization is waiting for requested information. INDIA suggested havingno time limit. On the review mechanism, NORWAY warned against implying that amechanism should be established to overrule a State’s sovereign decision. The USopposed setting up a new review mechanism beyond that mentioned in Article 27 of theCBD on dispute settlement. The section was deleted.
Regarding exceptions and deviations from the consent procedure, the EU proposed notingthat the simplified consent procedure should not pertain to an LMO bound for containeduse. NORWAY proposed that all initial exports of an LMO shall be subject to anAIA procedure requiring explicit consent and notification shall apply to subsequentexports of LMOs requiring specific consent. The PHILIPPINES proposed replacingreferences to “explicit consent” with “AIA procedures,” but INDIA noted that theprotocol applies to transfers other than shipments. The US proposed new paragraphsstating, inter alia, that the transfer of LMOs covered by other agreements shouldbe governed by those agreements and detailing the procedures and coverage for AIA.
Regarding simplified procedures, the US called for provisions on cooperative agreementsfor imports and exports and allowing a Party to indicate that that the AIA procedures donot apply. INDIA added language noting that the protocol shall allow a single, explicitand standardized procedure “in all cases.” On consent, the EU proposed that a singlenotification and consent could cover several similar transboundary movements to thesame party of import.
During the final Plenary, delegates accepted the Chair’s draft element paper(UNEP/CBD/BSWG/2/CRP.4), which will reflect these amendments. They also acceptedan addendum to the draft report of the meeting, which contains, inter alia, asummary of discussions on transfers of LMOs, including AIA(UNEP/CBD/BSWG/2/L.1/Add.1).
COMPETENT AUTHORITIES/FOCAL POINTS
The Chair’s aide-memoire on competent authorities(UNEP/CBD/BSWG/2/CRP.2) asked: should the protocol require Parties to designatecompetent authorities or focal points or both; should there be a single competent authorityor focal point per Party; and should there be an option for regional focal points. Theaide-memoire also noted possible responsibilities such as: receiving notifications;transmitting information to other Parties; evaluating risk assessment; taking decisions onnotifications under AIA; transmitting decisions on AIA; and enforcement. The aide-memoire also asks when the competent authorities or focal points should bedesignated.
Delegates offered a range of views on the designation and number of authorities and focalpoints. The EU and the RUSSIAN FEDERATION said there could be many competentauthorities and preferred one focal point per Party. SOUTH AFRICA favored more thanone focal point and/or competent authority and noted that the responsibilities woulddepend on whether the focal point is the same body as the competent authority.SWITZERLAND and SRI LANKA favored an obligation to appoint one of thecompetent authorities to be a focal point. NORWAY called for one authority, regardlessof the title, with clear responsibilities. MALAYSIA favored a competent nationalauthority with a more formal role than a focal point. CANADA distinguished the “pointof contact” role of the focal point from the decision-making role of the competentauthority.
Many delegations, including the EU, CAMEROON, PAPUA NEW GUINEA, SRILANKA, SWITZERLAND, CANADA, RUSSIA and PERU, favored including an optionfor regional focal points. A number of delegations, including the EU, NORWAY, PERU,SWITZERLAND and AUSTRALIA, said the responsibilities for competent authoritiesshould not be prescribed or fixed because of countries’ different capacities. CANADAadded risk assessment to the proposed responsibilities. MALAYSIA said the competentauthority should make regulations on transfer and release, risk assessment andmanagement decisions, and should impose national procedures beyond those in theprotocol if necessary.
The EU, PAPUA NEW GUINEA and SWITZERLAND said competent authoritiesshould be designated as soon as possible. NORWAY and CANADA proposed that theybe established no later than the entry into force of the protocol. CAMEROON said eachcountry should designate their authority prior to ratifying the protocol. The MARSHALLISLANDS, supported by MAURITIUS, PAPUA NEW GUINEA and MALAYSIA,noted that national authorities may be “responsible,” but that without technical andfinancial assistance many of them will not be “competent” to handle biosafety matters.
In the final Plenary, delegates accepted the Chair’s draft element paper on competentauthority(ies)/focal point(s) (UNEP/CBD/ BSWG/2/CRP.8). The paper outlines theoptions presented by delegates regarding the number and type of competentauthority(ies)/focal points, the time by which they should be designated and theirresponsibilities.
INFORMATION SHARING AND THE CLEARINGHOUSE MECHANISM
The Chair introduced an aide-memoire on Information Sharing/Capacity-Building/Public Awareness/Participation (UNEP/CBD/BSWG/2/CRP.3). The aide-memoire posed a number of questions related to information sharing between Parties,such as: should there be a provision for sharing of information on actions taken under thetransfer procedures; if so, should the provision apply only to Parties; and whatinformation on actions should be shared. On publicly available information, the aide-memoire asked: should the protocol contain a provision for information sharing throughthe CBD clearinghouse mechanism (CHM); what information should be provided tothrough the CHM; and who should provide information to the CHM.
On information sharing between Parties, NORWAY, supported by INDIA, mentionedthat the CBD already obliges Parties to provide all the information they have. Numerouscountries, including the US, CANADA, MALAYSIA, COLOMBIA, SOUTH AFRICA,MALAYSIA, INDONESIA and MAURITIUS, however, distinguished between generalinformation and information-sharing through the AIA procedure.
BRAZIL called for as broad a range of data as possible on all LMOs. COLOMBIA notedthat information on AIA procedures might be confidential and provided bilaterally. Theprotocol should have a clause to deal with information the exporting country feels isconfidential, in order to give it appropriate treatment. The EU also called for a provisionon confidentiality. The Chair noted that confidentiality is related to whether informationshould be restricted to the Parties. CANADA said a database or clearinghouse mechanismhas two roles, increasing public awareness and access and providing information onregulatory notification and actions, the former requiring complete public access and thelatter requiring limited access for inputting data for decision-makers.
On the type of information to be supplied, a number of ideas were suggested, including:
- information on LMO-related products (EU);
- all publicly available information on LMOs (US, INDIA) and safety assessments of them (US);
- focal points/competent authorities and national legislation and changes made in the AIA system (NORWAY, JAPAN);
- refusals of LMOs, measures taken to implement the protocol, environmental and/or health effects, and accidental movements or release of LMOs (NORWAY);
- transboundary movements of LMOs (NORWAY, INDIA, AUSTRALIA);
- risk assessments and management (CANADA, AUSTRALIA);
- summaries of regulatory requirements (CANADA) and actions (US);
- decisions made (INDIA, JAPAN);
- LMOs prohibited by individual countries and those that have passed risk assessment procedures under AIA (AUSTRALIA);
- ongoing post-release monitoring by regulatory authorities (AUSTRALIAN GENE ETHICS NETWORK); and
- an international list of experts in different countries (BANGLADESH).
JAPAN warned that information on individual transfers is technically difficult andperhaps not needed. MAURITIUS noted that information sharing and LMO movementare part of technology transfer. CAMEROON, supported by the US, stressed inclusion ofinformation from other groups, such as NGOs, and other countries, as contained in theAfrican Group’s submission.
The RUSSIAN FEDERATION differentiated between information sharing and aclearinghouse mechanism. He sought clarification on who should supply information towhom and whether focal points should be the central nodes. JAPAN favored aclearinghouse mechanism but the Secretariat of the protocol may play a role in compilingnational regulations and any changes in them. Information from exporters could also beprovided to the Secretariat through national competent authorities for further distribution.BRAZIL stated that national competent authorities should be responsible for depositinginformation on national actions and public data on LMOs that have been reviewed in thecountry. SOUTH AFRICA felt national focal points should be the suppliers ofinformation to the clearinghouse mechanism, other focal points and national competentauthorities and the users of LMOs. CUBA, BRAZIL and the US favored drawing onexisting structures for information-sharing.
On whether there should be a common format for information, CANADA called for astandard format or template regarding the naming of LMOs and the treatment ofconfidential information. The EU requested the Secretariat to submit a draft format forconsideration at later meetings. The US noted that relevant information varies accordingto LMO and there are many complicating factors that must be taken into account.BANGLADESH called for a technical subcommittee to produce a draft format.MALAYSIA called for the provision of information regarding use and biologicalcharacteristics of an LMO in the format.
On including a mechanism to revise information and provisions for confidentiality,SOUTH AFRICA, SRI LANKA and ZAMBIA said that confidentiality should notimpede information exchange or undermine decision making. CANADA agreed toconfidentiality provisions but noted the need to clarify modalities. The US saidconfidential business information should not be part of general information exchange butcan be revealed as appropriate to national focal points. He called for a mechanism forensuring that information remains confidential.
Regarding publicly available information, the aide-memoire asked: whether theprotocol should provide for an article on public awareness; what mechanism should beused to promote public awareness; what action should be addressed; and who isresponsible for public awareness. CANADA said that means of communication otherthan electronic access require further exploration and that no new institutions regardingthe CHM should be established. He also said that delegates should have a betterunderstanding of the way in which transfers of LMOs were currently taking place and thevolume of those transfers, particularly those involving commodities. Supported by theUS, he proposed forming a contact group to develop precise instructions for theSecretariat regarding the preparation of a report on the methods and volume of LMOtransfers, particularly regarding commodity transfers.
On 14 May, NEW ZEALAND reported on the contact group on commodities. He notedthe group’s recommendation that the Secretariat prepare a study to define the range ofLMOs in commodity transactions. Upon being asked to adopt the recommendation, theG-77/CHINA said its approval would hinge on approval for four other studies, on thesocio-economic implications of biotechnology and on the impacts of LMOs on animals,fisheries and indigenous farming. Further discussion of the proposed studies wasdeferred. During the final Plenary, delegates accepted a document on the future work ofthe BSWG (UNEP/CBD/BSWG/2/L.1/Add.3), which notes inter alia thatCANADA modified its proposal and will arrange for an informal roundtable on thesubject at or before BSWG-3.
During the final Plenary, delegates also accepted the Chair’s draft element paper oninformation sharing (UNEP/CBD/BSWG/ 2/CRP.9). The paper contains the optionspresented by delegates related to information sharing between Parties and includesexamples of the type of information that could be shared, such as information onaccidental LMO movements, LMOs released on the market and the amount of LMOsexported. The paper also contains options related to the CHM, protection of confidentialinformation and a standardized format for information sharing.
CAPACITY-BUILDING/PUBLIC PARTICIPATION/ PUBLIC AWARENESS
Discussions on capacity-building, public participation and public awareness were basedon the Chair’s aide-memoire on Information Sharing/Capacity-Building/PublicAwareness/Participation (UNEP/CBD/BSWG/2/CRP.3).
CAPACITY-BUILDING: The aide-memoire asked: what is the primaryaim of capacity-building; would a capacity-building mechanism serve other functions,such as providing advice on queries from importing Parties; and should the protocolcontain specific provisions related to capacity-building.
A number of aims for capacity-building were suggested. ZAMBIA and SOUTH AFRICAhighlighted strengthening indigenous capacities to implement the biosafety protocol,including developing biotechnologies suitable to their situations. BRAZIL stressedstrengthening implementation of the protocol, legislation and monitoring, and ensuringcompliance with biosafety regulations. JAMAICA highlighted strengthening informeddecision-making on LMO transport and risk assessments. AUSTRALIA noted the needfor capacity-building for developing countries particularly and, supported by SOUTHAFRICA, highlighted risk assessment and management. CUBA’s aims includeddevelopment of policy and information systems, biotechnology capacity, and technicalcompetence to identify and control risks in the use and dissemination of LMOs.
ZAMBIA, the EU, BRAZIL and SWITZERLAND referred to the UNEP InternationalTechnical Guidelines for Safety in Biotechnology. A number of other ongoing efforts topromote capacity-building were also mentioned, including CBD Article 18.2 on thepromotion of technical and scientific cooperation (SWITZERLAND), COP decisionsIII/20 and III/5 on GEF financing (EU, BRAZIL), UNIDO, (EU), the SBSTTA, Agenda21 organizations, WHO, FAO and bilateral alliances (AUSTRALIA).
The EU proposed that the protocol refer to the need for capacity-building but not includea specific provision. AUSTRALIA noted that capacity-building can be enhanced throughinformation-sharing. However, the REPUBLIC OF KOREA stressed the priority ofcapacity-building needs. The RUSSIAN FEDERATION stressed identification of needsand priorities at the national level and steps to be taken. SOUTH AFRICA noted that theprovision of resources, such as training and expert advice, is a component of capacity-building, both at the regional and national levels. BRAZIL said a capacity-buildingmechanism should include a list of expert advisors, a data base, training and provision ofother resources. TOGO and NIGER also stressed that financial assistance must come in atimely way to ensure capacity-building strengthens application of the protocol.ETHIOPIA expressed dissatisfaction with the lack of commitment to new resources forcapacity-building. The Chair pointed out that financial aspects would be discussed at latersessions.
In the final Plenary, delegates accepted the Chair’s draft elements paper on capacity-building (UNEP/CBD/BSWG/2/ CRP.10). The paper states that the aim of capacity-building includes: facilitating the elaboration of national legislation related to biosafety;permitting the competent authority to make informed decisions on risk assessment; andpromoting the establishment of appropriate institutional mechanisms. The paper alsocontains proposals made by delegations related to a clearinghouse specifically forbiosafety information and regional training centers.
PUBLIC AWARENESS/PARTICIPATION: With regard to public awarenessand participation, the Chair’s aide-memoire asked: should the protocol provide foran article on public awareness; what mechanism should be used to promote publicawareness; what action should be addressed; and who is responsible for public awareness.It also asked whether the protocol should provide for public participation, what it shouldaddress and who would define the level of participation.
A number of delegations, including BANGLADESH, NORWAY, AUSTRALIA, the EU,ETHIOPIA, MALI and CAMEROON, supported the inclusion of public awarenessprovisions. COLOMBIA called for national and international mechanisms. BRAZILnoted the need to protect confidential information. MALI emphasized the importance ofNGO involvement. NEW ZEALAND, the RUSSIAN FEDERATION and JAPAN didnot support including a specific mechanism and said each Party should decide for itself.SOUTH AFRICA noted that Article 13 (public education and awareness) of the CBDalready covers this issue. The THIRD WORLD NETWORK recalled that confidentialityconcerns were second to the rights of citizens and that prior informed consent cannot beleft at the domestic level.
The EDMONDS INSTITUTE and ECOROPA stressed the need for public participation.The PHILIPPINES supported the importance of NGO participation. BRAZIL said theprotocol should not mandate public participation in regulatory affairs. The EU, NEWZEALAND and INDIA supported public participation provisions. The US noted thatwithout public participation the actual effect of LMOs is hard to gauge.
During the final Plenary, delegates accepted the Chair’s draft element paper on publicawareness and participation (UNEP/CBD/BSWG/2/CRP.11). The paper includesproposals on whether the protocol should specifically address public awareness andpotential public awareness mechanisms. The paper also contains options regarding thetypes and levels of public participation, some of which highlight NGO roles.
RISK ASSESSMENT AND MANAGEMENT
On 14 May, the Chair introduced UNEP/CBD/BSWG/2/CRP.5, an aide-memoireon risk assessment and risk management. Most speakers favored putting provisions forrisk assessment in the protocol. SWITZERLAND and the US, however, did not fullyagree. Most speakers favored provisions as the basis for decisions for transboundarymovement, rather than just for information sharing. ETHIOPIA, supported by SOUTHAFRICA and the US, added that risk assessment is the basis for decision-making ingeneral. SRI LANKA stressed risk assessment for the safe transfer, handling, and use oforganisms that may have adverse effects. SWITZERLAND offered the alternative aim ofguaranteeing a minimum level of harmonization in risk assessment.
ETHIOPIA, supported by NORWAY, SRI LANKA, INDIA and the US, stated that theprotocol should contain general principles, detailed provisions and minimum standards.BANGLADESH preferred detailed provisions; SWITZERLAND and NEW ZEALAND,general principles; SOUTH AFRICA, general principles as well as minimum standards.COLOMBIA agreed on minimum standards, and warned that States must be able to makedetailed standards that do not conflict with national laws.
ETHIOPIA, NORWAY, SRI LANKA and BANGLADESH called for the provisions tobe legally-binding. SWITZERLAND preferred provisions as reference points only. NEWZEALAND, supported by the US, favored leaving “implementing methods” to nationalcompetent authorities. ETHIOPIA, SRI LANKA, INDIA BANGLADESH, NEWZEALAND and SOUTH AFRICA suggested that general provisions be included as anarticle of the protocol, with details possibly provided in an annex.
Numerous bases for risk assessment were proposed, including information about therelevant organism and the relevant receiving environment (NORWAY), availablescientific information (SRI LANKA), information provided by the exporter or exportingcountry (INDIA, SOUTH AFRICA, COLOMBIA), environmental impact assessments,the clearinghouse mechanism and public participation (BANGLADESH), and anyinformation the assessor considers relevant (SOUTH AFRICA).
Countries generally concurred that the sources for the provisions could include UNEPguidelines and other sources such as country submissions. Most speakers said competentauthorities in the importing country should be responsible for risk assessment. To thiswere added: an institution accredited by the competent authority, or an applicant to export(SRI LANKA, SOUTH AFRICA) and focal points (BANGLADESH). The US said thatthe importer is ultimately responsible but risk assessment could be facilitated throughthird parties in the short term or through regional centers of excellence.
The EU stated that all decisions should be based on prior scientific risk assessment andthat competent authorities must have access to information relevant to risk assessment.General positions on risk assessment should be in the protocol and more detailedinformation in an annex. AUSTRALIA said the protocol should include generalprinciples, not specific procedures, which should serve as guidelines only.
MALAYSIA supported incorporating specific requirements to provide information as theprimary basis for decisions. Supported by most developing countries, she said decisionscould also be based on socio-economic and ethical considerations. If they lack thetechnical capacity, specific provisions for assistance will be necessary. ZAMBIA,INDONESIA, CUBA, MALI and THAILAND called for general principles establishingthat the Parties will perform risk assessments and adopt measures and said the protocolmust have a detailed annex with the minimum standard of information that would berequired for risk assessment.
Regarding who should perform the risk assessment, the EU said assessments are theresponsibility of the importer and the exporter should provide information. MALAYSIAnoted that the applicant should be responsible for the assessment and decisions shouldrest with national authorities. Financial responsibility lies with the country trying toundertake the transfer. NORWAY and INDONESIA noted that the exporting State bearsresponsibility for providing information and the importing State has the responsibility toanalyze and decide on the risk assessment. The US stated that the risk assessment shouldbe provided by the exporting company, but it is up to the importing country to analyze it.The REPUBLIC OF KOREA and the RUSSIAN FEDERATION said that responsibilityfor risk assessment lies with the importing State, but stressed that the exporter, companyor State, must perform risk assessment and provide information. SAMOA andTHAILAND said that risk assessment is the responsibility of authorities andgovernments.
The COUNCIL FOR RESPONSIBLE GENETICS said that risk assessment mustconsider the distribution of potential harms among different groups within a society. TheAUSTRALIAN GENE ETHICS NETWORK, supported by ZAMBIA, stated thatdiscussions should focus on assessment of risks versus benefits. Socio-economicelements should be included and given equal emphasis with other factors. TheBIOTECHNOLOGY INDUSTRY ORGANIZATION, supported by SRI LANKA, statedthat any risk assessment exercise needs to be focused and the first step is hazardidentification.
Many delegations supported the inclusion of a provision for risk management in theprotocol. CAMEROON, INDIA, BRAZIL, CHINA, NORWAY, NEW ZEALAND,BURKINA FASO and TOGO stated that Article 8(g) — which states that each Party tothe CBD shall establish or maintain means to regulate, manage or control the risksassociated with the use and release of LMOs that are likely to have an adverseenvironmental impacts — was relevant to the issue of risk management and should bereferenced in the protocol. MALAYSIA noted the relevance of Article 8(g) but said itneed not be included in the protocol as it already appears in the CBD. The US did notsupport the inclusion of Article 8(g) in the protocol.
Regarding the purpose of the risk management provision, MALAYSIA, CAMEROON,INDIA, BRAZIL, CHINA and MAURITIUS said the purpose should be to provide abasis for decisions on transboundary movement. CAMEROON and theBIOTECHNOLOGY WORKING GROUP sought recognition of the need to provide forliability, insurance and compensation. INDIA stated that the purpose of the riskmanagement provision should also be to assign responsibilities in case of accidents.NORWAY and BURKINA FASO said the purpose of a risk management provisionshould be for information sharing and to provide a basis for decision making. SRILANKA said the purpose should be to provide a basis for safe transfer and handling.NEW ZEALAND said a risk management provision should serve as a basis to managethe likely effects of movements of LMOs.
On the format of the risk management provision, INDIA, CHINA, MAURITIUS, the USand BURKINA FASO supported the use of general principles. MAURITIUS andBURKINA FASO also supported the use of detailed provisions in an annex. BRAZILsupported the use of detailed provisions. ZAMBIA called for the inclusion of detailedminimum standards. SRI LANKA supported the use of general principles, detailedprovisions and minimum standards.
Regarding the enforcement capabilities in the risk management provisions, MALAYSIA,CAMEROON, CHINA, NORWAY, BURKINA FASO, TOGO and MAURITIUSsupported legally-binding risk management provisions. AUSTRALIA and NEWZEALAND disagreed. SRI LANKA sought liability compensation covered by nationallegislation.
As to the form of the provisions, MALAYSIA, NEW ZEALAND and BURKINA FASOcalled for the inclusion of risk management provisions in an article within the protocol.SRI LANKA, MAURITIUS and TOGO sought inclusion of risk management provisionsin an annex. CHINA said the format for risk management provisions should be flexible.The majority of delegations supported the use of the UNEP Guidelines as well as othersources for the elaboration of provisions on risk management in the protocol. NEWZEALAND, BURKINA FASO and TOGO said both the exporting and the importingcountry should share responsibility for risk management. ECOROPA recommendedtapping the capacity in risk assessment and management of the insurance sector; this willdepend on the final position taken on liability and compensation.
During the final Plenary, delegates accepted the Chair’s draft elements paper on riskassessment and management (UNEP/CBD/BSWG/2/CRP.12). The paper containsproposals on whether to include risk assessment provisions and the level of specificityrequired. The paper also reflects delegates’ proposals on: the Party responsible for riskassessment, whether the provisions for risk assessment will be legally-binding; andoverall aim and basis of risk assessment.
UNINTENTIONAL TRANSBOUNDARY MOVEMENTS
The Chair introduced an aide-memoire on unintentional transboundary movementof LMOs/handling, transport, packaging, and transit requirements for transboundarymovement of LMOs (UNEP/CBD/BSWG/2/CRP.6). The aide-memoire asked:should unintentional transboundary movement be covered by the protocol and, if so,which procedure should apply, who should trigger it and should information on themovement be shared with Parties.
UNINTENTIAL TRANSBOUNDARY MOVEMENT: Most speakers felt thatunintentional transboundary movement (UTM) should be covered by the protocol.CHINA asked whether the concept includes natural disasters or actions. He noted that if itcovers accidents due to UTMs it is related to Article 14.1(c) of the CBD. AUSTRALIAand NORWAY specified that it should cover unintended releases or accidents, whichwould be covered by AIA procedures, as well as unintended movement. ZAMBIApreferred a separate provision for purely accidental or natural releases such as pollen. TheEU specified LMOs that are likely to have adverse effects. INDONESIA asked how todefine UTM of LMOs and the extent to which it has occurred, and whether there wouldbe a time limit on identifying it. SWITZERLAND, supported by JAPAN, felt that UTMsare already covered adequately in Article 14.1(c) and (d) of the CBD, but reference mightbe made to them in the provisions on information-sharing.
Most speakers felt that full information should be given by the party from which theUTM originates to the affected party, and that information should also be shared withthird parties. BRAZIL noted that all experience with LMOs is to be eventually depositedin the information-sharing mechanism. At the time of movement, information should begiven to any third party that might be affected. He called for linkage to a liability andcompensation clause for the protocol. AUSTRALIA emphasized information-sharingthrough the proposed clearinghouse mechanism. NIGER stressed the importance ofgiving information for risk assessment and management generally and sharinginformation with all Parties notwithstanding confidentiality. The EU stressed speed andeffectiveness in whatever procedure is adopted, so that appropriate measures may betaken rapidly.
As to who should trigger the procedure, proposals included the originating party, theaffected party, and other States, particularly potentially affected third parties, dependingon where the UTM or release is first identified. NORWAY and the EU noted that thisquestion covers legal responsibility. Ultimately the country where the release hasoccurred must take action, which will require developing a legal basis under CBD Article14. MOZAMBIQUE specified that the procedure should be triggered through thecompetent authority of the originating State or the affected State. MAURITANIA notedthat Article 8 of the CBD requires the Party responsible for the release to trigger theprocedure or, if not, the affected country or any other country that might be affected. SRILANKA specified the exporting party as the trigger, through its competent authority.BRAZIL and ZAMBIA specified the affected country’s competent authority; the countryof origination should alert that authority. BELARUS said for natural disasters theoriginating country should trigger the mechanism. For illegal activities, the damagedparty or a third party could trigger the procedure.
MAURITIUS reiterated the need to strengthen developing countries’ capacity to dealwith these risks. INDIA added that compatibility with Article 14.2 of the CBD requiresredress measures in the protocol. BELARUS called for a mechanism modeled on theCBD procedure for dispute settlement.
HANDLING, TRANSPORT, PACKAGING AND TRANSIT: On the handling,transport, packaging and transit requirements for transboundary movement of LMOs, theaide-memoire asked: to what extent should handling, transport, packaging andtransit be covered by the protocol and to what extent are these issues already covered byother international agreements. Many delegates, including INDONESIA, BARBADOS,UGANDA, LESOTHO, NORWAY and BRAZIL, agreed that these issues should becovered by the protocol. BARBADOS and BURUNDI emphasized the importance ofthese issues for trans-shipment countries. LESOTHO urged the inclusion of “labelling”among the items. NORWAY said the LMO must be accompanied by movementdocumentation from origin to use or release. Provisions in the protocol should be generaland the Parties could develop a detailed packaging provision.
The EU, supported by NEW ZEALAND, said that questions related to transfer should bereferred to the ECOSOC committee of experts on the transfer of dangerous goods.BRAZIL said these issues should be explicitly covered by the protocol and detailsincluded in an annex. NEW ZEALAND said the protocol should not be prescriptive butshould encourage all interested Parties to observe appropriate safety considerations.MALAYSIA said that handling and transit are separate issues and noted that transit issuesare not adequately covered by international agreements. ECOROPA supported consistentlabelling procedures for LMOs “from cradle to grave.”
During the final Plenary, delegates accepted the Chair’s draft element paper onunintentional transboundary movement of LMOs, including accidental and emergencycases (UNEP/CBD/BSWG/2/ CRP.13) and on handling, transport/packaging/and transitrequirements for transboundary movements of LMOs (UNEP/CBD/BSWG/2/CRP.15).These papers include all of the proposals made by delegates during discussion.
MONITORING AND COMPLIANCE
The Chair introduced his aide-memoire on monitoring and compliance(UNEP/CBD/BSWG/2/CRP.7). On monitoring, the aide-memoire asked: is there aneed for individual Parties to report on the implementation of their commitments; if so,what matters should the reports address (e.g., the operation of the AIA and notificationprocedures; adoption of national regulations); and how should the reports be processed(e.g., referred to the COP; scrutinized by an expert committee). On compliance, theaide-memoire asked if the provisions of the protocol would be sufficientlynormative in character to justify establishing a procedure for reviewing theimplementation of commitments by individual Parties. If so, what type of process shouldbe developed, who should trigger it, how should it operate and what should be itsobjective.
Many delegations agreed that Parties should report on the implementation of theircommitments and the provisions of the protocol would justify some type of reviewprocess. Delegates expressed a range of views on the level of reporting and type ofreview. UGANDA said that reports should be processed through the clearinghousemechanism and, on compliance, the procedure should be cooperative, conciliatory andjudicial when necessary. Its objective should be sharing of experience and information.CAMEROON and NEPAL also supported a fixed system for monitoring implementation.JAMAICA called for a prescribed format for required information that could be updatedannually and said that a review process should not interfere with State sovereignty. Withthe US and BRAZIL, he said a Party on its own behalf or the Secretariat through acommittee established by the COP could trigger the review. SOUTH AFRICA expressedconcern regarding the financial implications of establishing a standing review body.
The EU stated that individual Parties should report on implementation and all reportsshould be made available to the COP. With the US and BRAZIL, he said the provisionsshould be cooperative, transparent, non-judicial and advisory. The goal should be friendlysettlement of differences through practical guidance and assistance. AUSTRALIA andBRAZIL said that firm positions on compliance procedures should be deferred until theobligations are clearer. JAPAN stated that monitoring will be covered under information-sharing provisions and separate section was unnecessary. ETHIOPIA, supported byLESOTHO, said monitoring should not focus only on whether obligations are beingfulfilled but whether the consequences of LMOs within a country are being checked. Oncompliance, there may be situations when judicial powers would be required.
Following this discussion, the Chair presented two additional questions for delegates:should the protocol contain an article on non-discrimination and should the protocoladdress transfer of LMOs between Parties and non-Parties. He said the concept of non-discrimination entailed that Parties are treated in the same manner and no discriminationis drawn between international and national activities. INDIA and MALAYSIA said theCBD is founded on principles of equity and objected to an article of this type within theprotocol. During the final Plenary, delegates accepted the Chair’s draft elements paper onmonitoring and compliance (UNEP/CBD/BSWG/2/CRP.14), which reflects the range ofproposals made during discussions.
In the final Plenary, delegates accepted the Chair’s draft report of the meeting(UNEP/CBD/BSWG/2/L.1) and reviewed and amended each of the Chair’s draftelements papers. The amended versions of these texts will be compiled into a Chair’ssummary of elements and attached to the report of the meeting. Delegates also acceptedan addendum on the future work of the BSWG (UNEP/CBD/BSWG/2/L.1/Add.3) anddetailed list of the Chair’s review of items that have been addressed by countrysubmissions (UNEP/CBD/BSWG/2/CRP.1/Rev.1).
The addendum notes, inter alia, governments were invited to submit legal texts onthe following issues: AIA; notification procedures; risk assessment and management;unintentional transboundary movements; handling, transportation, packaging and transitrequirements; competent authorities/focal points; information sharing/clearinghousemechanism; capacity-building; and public awareness/participation. Governments thathave already submitted texts were encouraged to revise them. Proposals must besubmitted by 1 August 1997.
The Secretariat will develop draft articles on: financial issues; institutional framework;scope of jurisdiction; relationship with other international agreements; and settlement ofdisputes. Delegates agreed that the Secretariat’s work programme for the next meetingshould include creation of an alphabetical list of terms requiring definition with countrysubmissions of definitions for each.
Regarding future studies, the document notes that Canada withdrew its proposal for astudy on criteria for confidential information and decided to convene an informalroundtable discussion on commodities at or before BSWG-3. The document also notesthat CAMEROON, on behalf of the G-77/CHINA, requested a study on socio-economicconsiderations. During the final Plenary, CAMEROON withdrew the request for thestudy and proposed a roundtable meeting at BSWG-3. Following a request from theCentral and Eastern European States, delegates agreed to a study on existinginternational, UNEP, UNIDO and OECD information-sharing systems for BSWG-3.
The Chair closed the meeting by thanking everyone for their cooperative work. The EUnoted its efforts to fund developing countries and encouraged other donor States to followsuit. CANADA, speaking informally for the JUSCANZ countries, congratulated theChair for his effective plan and accomplishments during BSWG-2. The Chair adjournedthe meeting at 2:00 pm on Friday, 16 May 1997.
A BRIEF ANALYSIS OF BSWG-2
Chair Veit Koester opened the second session of the Open-ended Ad Hoc WorkingGroup on Biosafety by urging delegates concentrate on core issues and identify theelements of a biosafety protocol for their next session. Under his guidance, delegatesdisplayed a cooperative spirit and agreed to a structure for discussions and theprogramme of work for this meeting as well as future meetings. After previous meetingscharacterized by some as “talk shops,” many BSWG-2 delegates left Montreal satisfiedthey had at last begun to move from generalities to specifics and taken substantial stepstoward a protocol. Despite this progress, some fundamental disparities of opinion,particularly regarding the scope of the protocol, remain, which threaten to derail theprocess when negotiations get underway.
If the initial questions raised at BSWG-2 on advanced informed agreement (AIA) aloneare indicative of negotiations to follow, delegates have a sizable task ahead of them.Delegates discussed whether AIA will be required for all LMO imports or only undercertain conditions, whether importing or exporting countries will be responsible forassessing and managing risks from LMOs, which party will be responsible for notifyingand taking action in case of unintended movements, whether there will be any legalrequirement for compensation or liability placed on producers or exporters of LMOs, andwhether LMO-containing commodities will be treated under this protocol at all. Equallylengthy debates are also looming over risk assessment and management, responsibilitiesfor unintended movements of LMOs, compensation and liability, and treatment ofcommodities produced with LMOs.
The developing countries’ insistence on addressing the impact of the movement of LMOson socio-economic conditions could prove to be the most troublesome. Many, but not all,developing countries and developing country NGOs expressed strong concerns about theramifications of LMO transfers, such as loss of employment and export markets,uncontrolled growth in the power of multinational corporations and an dangerousexpansion of the concept of patentability. In contrast to BSWG-1, which witnessed a riftamong developing countries, BSWG-2 saw a seemingly more unified G-77/China, atleast in their call for a study on socio-economic issues in response to a developed countrycall for a study on genetically-modified commodities. While both proposals for studieswere ultimately withdrawn in favor of roundtable discussions, the G-77/CHINA exhibiteda strong, if fleeting, unity on the issue. Some observers cautioned, however, that severaldeep-seated divergences of opinion remain unsettled and will likely emerge at futuremeetings.
Other position shifts were also apparent, most notably in the cooperative demeanor ofsome developed country delegations that were, as one observer noted, “obstructive” atBSWG-1. Some delegations that previously appeared adamantly opposed to thedevelopment of a protocol provided cautiously constructive interventions in Montreal.While it is far too early to assume an emerging consensus on a protocol or a successfuloutcome, the behavior of some delegations exhibited an acknowledgement of theimportance of being “at the table" as the negotiations unfold and consensus on itsnecessity emerges.
Failure to achieve that consensus would not bode well for the Convention or the state ofthe world’s biological resources. The Convention has devoted a considerable amount ofits time and energy to this issue, drawing criticism from some that there are a myriad ofmore urgent threats to biodiversity, such as habitat loss, overproduction and consumptionand increased population pressure. Given the fluctuations in country and regionalpositions, it is too early to speculate on successful outcome.
In the calculations of some, the likelihood of agreeing on a draft text is great. However,any adopted protocol must still be ratified. Because of the perceived threat of stronginternational oversight and difficulties with ratification, successfully completing aprotocol will be tempered by the fact that its effectiveness is limited if it is too restrictive.Nonetheless, a protocol lacking sufficient restrictions would prove equally ineffective-leaving delegates between an LMO and hard place. Biotechnology is expanding at anunprecedented rate and any unforeseen consequences may not wait on the adoption orratification of a protocol.
The Chair invited delegates, for the next meeting, to submit legal texts on some of theitems discussed and said the Secretariat will propose text as well, which will hopefullytake the process one step further toward a protocol. However, as the potentialcommitments become more focused, so too must the subjects to which they apply and, asseen at this meeting, consensus is anything but clear. There are a number of difficultquestions awaiting future BSWG meetings and the whether any or all of them emerge atthe next session meeting remains to be seen. Only one thing remains certain. Given themagnitude of the protocol’s possible implications, the urgency of the problem and therelatively short time frame for negotiations, some tough decisions will need to be takensoon. As one observer noted, these global negotiations in particular do not have “all thetime in the world.”
THINGS TO LOOK FOR
AD HOC GROUP ON BIOSAFETY: The third meeting of the Ad HocGroup on Biosafety (BSWG-3) is scheduled for 13-17 October 1997 in Montreal. DuringBSWG-2, delegates discussed the possibility of a fourth meeting to be heldFebruary/March 1998. They also considered a fifth meeting in late 1998. For moreinformation, contact the CBD Secretariat, 393 Saint Jacques St., Office 300, Montreal,Quebec, H2Y 1N9, Canada; tel: +1-514-288-2220; fax: +1-514-288-6588; e-mail:firstname.lastname@example.org.
CONVENTION ON BIOLOGICAL DIVERSITY: The third meeting of theSubsidiary Body on Scientific, Technical and Technological Advice (SBSTTA-3) will beheld in Montreal from 1-5 September 1997. The Fourth Meeting of the Conference of theParties (COP-4) will be held in Bratislava, Slovakia, from 4-15 May 1998. For moreinformation, contact the CBD Secretariat.
OTHER CBD MEETINGS: A meeting of the Liaison Group on ForestBiological Diversity will be held in Helsinki, Finland, from 25-28 May 1997. A LatinAmerican and Caribbean regional meeting on the Clearinghouse Mechanism is tentativelyscheduled for July in Colombia. A workshop on the implementation of Article 8(j)(traditional knowledge) is tentatively scheduled from 10-14 November 1997 in a venue tobe determined. For more information, contact the CBD Secretariat.
FIRST INTERNATIONAL CONFERENCE ON INTELLECTUAL PROPERTY OFINDIGENOUS PEOPLES FOR THE NEW MILLENNIUM: This conference,entitled “Conferencia Internacional: La Propiedad Intelectual de los Pueblos Indigenasante el Nuevo Milenio,” is scheduled for 2-6 June 1997 and will be hosted byWATU/Accion Indigena and Secretaria de Estado para la Cooperacion International ypara Iberoamerica. For information contact: Margrieth Nazareth Cortes, WATU/AccionIndigena, P. de la Chopera, Semisotano, 28045 Madrid, Spain; tel: +34 1 473 3031; fax:+34 1 473 2501; e-mail: email@example.com
INTELLECTUAL PROPERTY RIGHTS III: This conference, entitled“Intellectual Property Rights III — Global Genetic Resources: Access and PropertyRights Workshop,” will be held at the Holiday Inn Capitol, 550 C Street, SW,Washington DC, USA from 4-6 June 1997. The conference will review factors affectingglobal access to plant genetic resources and the effect of intellectual property rights onthe exchange of these materials. For further information contact: American Society ofAgronomy, 677 South Segoe Road, Madison, WI 53711, USA. To register via theInternet try http://www.agronomy.org/ipr/
INTERNATIONAL CONFERENCE ON MEDICINAL PLANTSCONSERVATION, UTILIZATION, TRADE AND BIOCULTURES: This meetingis scheduled from 16-20 February 1998 at the National Institute of Advanced Studies,Indian Institute of Science Campus, Bangalore, India. The meeting will focus on the issueof medicinal plants for survival. For further information contact the Foundation forRevitalisation of Local Health Traditions (FRLHT), No. 50, 2nd Stage, MSH Layout,Anandnagar, Bangalore 560 024, India; tel: +91 80 333 6909/0348; fax: +91 80 3334167; e-mail: firstname.lastname@example.org.
SPECIAL SESSION OF THE UN GENERAL ASSEMBLY: The SpecialSession of the UN General Assembly is scheduled for 23-27 June 1997. The session willconduct an overall review and appraisal of progress in implementing the UNCEDagreements since the 1992 Earth Summit. For more information, contact: AndreyVasilyev, UN Division for Sustainable Development, tel: +1-212-963-5949, fax: +1-212-963-4260, e-mail: email@example.com. Also visit the Home Page for the Special Session athttp://www.un.org/DPCSD/earthsummit/.