The Chair introduced an informal aide-memoire that presented a series of questions for consideration of procedures for specific transfers of LMOs. The text asks what procedures should be included in the protocol and states that the central question is whether protection requires explicit consent, implicit consent or both. Explicit consent, as seen in the Basel Convention procedure for Prior Informed Consent (PIC), implies that the absence of a reply from the importing country within a specified time frame does not constitute consent, but is instead a violation of the Protocol, which can be addressed according to the Protocols dispute settlement mechanism. Implicit consent implies that consent is deemed given if no reply from the importing country has been received within the specified time.
The EU noted two objectives: providing relevant information and giving importers the right to deny or accept movement of LMOs. Supported by SWITZERLAND, he stressed a choice of AIA (explicit consent) or simple notification (implicit consent). Response options could include consent with or without conditions, a request for additional information, a rejection of the application for movement or a notification of a need for more time for consideration. NORWAY favored explicit consent for all initial transfers of substances, but with an obligation for the importing country to respond within 90 days. For subsequent exports a notification procedure could be used. CANADA defined LMOs covered by specific AIA procedures as including only those with adverse effects and noted that explicit consent should be given in a timely fashion. Acknowledgement of receipt of application for movement should also be required. NEW ZEALAND favored both forms of consent, stressing flexibility and transparency as guiding principles. AUSTRALIA highlighted several components of AIA, including: the need for a system for notification of intent; a definition of the LMOs to be covered; and principles for risk assessment. The US said the decision of whether to apply implicit or explicit consent hinges on the type of LMO and that AIA explicit consent should only apply to the first shipment.
ZAMBIA, BRAZIL, the PHILIPPINES, SRI LANKA, CAMEROON and BANGLADESH stressed the need for explicit consent, stating that implicit consent at this stage is unacceptable as it could give importing countries an unfair responsibility arising from their different bureaucratic or communication conditions. COLOMBIA said AIA should be applied in every case and, with ZAIRE, called for a procedure requiring the exporter to notify a competent authority in the importing country of all potential risks and to wait for explicit consent from the importing country. INDONESIA noted that explicit consent systems would generate information-sharing opportunities. The GERMAN WORKING GROUP ON BIODIVERSITY and the THIRD WORLD NETWORK noted that the consequences of LMO movements may not be visible until later and that explicit consent for all movements allows an opportunity for revision.
PERU suggested that the decision of whether to apply explicit or implicit consent should lay with the importing country, which should mandate the standards for notification and importation. CHINA supported inclusion of both types of consent, but noted that the terms of implicit consent should be determined on a bilateral basis. MAURITIUS supported explicit consent but reserved judgement on a total ban on implicit consent. MALAYSIA noted that the decision of applying implicit or explicit consent should be made when LMOs have been determined. BRAZIL said a simplified procedure should be considered for subsequent transboundary movements of the same LMO. The MARSHALL ISLANDS, JAPAN and INDIA called for explicit consent, but in a manner different from that of the Basel Convention.
The aide-memoire also asked whether the applicable procedures for consent should be fixed within the protocol or left for the importing country to decide. ZAMBIA supported minimum information requirements to protect poorer countries. CANADA and NORWAY supported fixed criteria in order to provide predictability and consistency. SWITZERLAND and JAPAN said the protocol should provide for flexibility in procedures. INDIA said that importing countries should have the right to decide about their procedures.
On the question of which LMOs the procedures should apply to, many countries, including INDIA, BELARUS, SRI LANKA, ZAMBIA, PHILIPPINES, NEW ZEALAND, MAURITIUS, LESOTHO, MALAYSIA, CUBA and UGANDA, favored applying the AIA procedure to all transfers. BRAZIL noted that a simple procedure could provide maximum flexibility to importers and exporters. BANGLADESH and the CENTRAL AFRICAN REPUBLIC called for post-release monitoring activities. The EDMONDS INSTITUTE stated that even if an LMOs characteristics are known one cannot predict its effects in all environments.
BURKINA FASO specified coverage of LMOs that are the result of biotechnology. Other countries, including JAPAN, the EU, the US, CANADA, the REPUBLIC OF KOREA, NORWAY, THAILAND, CHINA and MYANMAR, specified LMOs that pose a possible risk for biodiversity and/or human health. JAPAN also favored excluding those LMOs not reproducible in the environment, covered under another international agreement, and for which risk has not been established. NORWAY noted this view is consistent with the CBD. THAILAND noted that products created from LMOs, such as vaccines and food products, might be covered under trade regulations. CHINA warned that dealing with LMOs according to type and use may not always be consistent under the protocol.
MALI asked how developing countries could know the risks they would run in accepting LMOs. TOGO, supported by the CENTRAL AFRICAN REPUBLIC, pointed out that the stability and behavior of many LMOs are still not ascertained, thus risks will continue to exist. AUSTRALIA, NIGER, MEXICO and CUBA advocated a flexible approach allowing an importing country to decide which LMOs needed an AIA, based on risk and other 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 applying AIA to LMOs for all intended uses. The PHILIPPINES favored flexibility on procedures depending on purpose, such as a simpler procedure for LMOs in transit. JAPAN stated that LMOs for research should not be restricted if there are adequate health and environmental safety measures. INDIA also said that LMOs for research could be treated differently from LMOs for commercial uses. CANADA, NORWAY and SWITZERLAND favored excluding LMOs intended for contained use. The US, supported by MYANMAR, specified applying AIA to LMOs intended for field testing or first growth in the importing country.
On the question of distinguishing between initial and subsequent transboundary movements of LMOs, INDIA, SRI LANKA, BANGLADESH, ZAMBIA, MAURITIUS, LESOTHO and the EDMONDS INSTITUTE favored making no distinction. The PHILIPPINES preferred AIA for all movements but said the procedure might differ depending on timing. NORWAY felt that notification with implicit consent might be used for subsequent movements. NEW ZEALAND, NIGER, MALAYSIA and the EU favored subsequent streamlining where there are no changes in use. UGANDA and AUSTRALIA proposed leaving this question to the importing party.
On whether there should be special provisions for LMOs for which commercialization has been prohibited within an exporting country, NORWAY said the protocol should not contain a ban on domestically prohibited products per se, but should provide a special procedure. Information about such prohibitions should be made available through the clearinghouse mechanism. MALAYSIA and BURKINA FASO said that no exports should be permitted for domestically prohibited products.
The US stated that the reasons for prohibiting an LMO domestically could hinge on its effects 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 exporter should provide complete information. CHINA, supported by NEW ZEALAND, cautioned that the inclusion of specific provisions within this protocol could lead to confusion where transfer of an LMO is already prohibited under another international agreement. INDIA supported information sharing on LMOs, but said the importing country should decide. The RUSSIAN FEDERATION said there should be no obligation on the exporter to provide information, but the importer should have the right to request and obtain information.
On whether there should be special provisions for transferring an LMO that is also produced in the country of import, a number of delegations noted that if the LMO in question was exactly the same as a domestically-produced LMO, the issue should be addressed under rules concerning non-discriminatory trade practices. INDIA, ETHIOPIA, GEORGIA and COLOMBIA warned of the difficulty involved in determining whether an LMO 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 and provided an example wherein rice genes were once imported and are now grown domestically. The Chair proposed noting that the issue would be addressed under provisions on non-discrimination.
Many delegations addressed the issue of whether the importing country, after receiving notification of a shipment, should have the opportunity to choose between a general or simplified procedure and whether there should be a general provision that permits unilateral or bilateral deviation from the general procedure, and the use of a simplified procedure or no procedure at all. COLOMBIA said the protocol should contain a high level of detail for AIA procedures. The US stated that the level of complexity was not as important as the act of notification itself. JAPAN called for flexibility in the protocol and highlighted the use of bilateral declarations. ETHIOPIA, ZAMBIA, NORWAY and INDIA noted that a decision regarding LMOs in one country could affect many in a region and called for agreed minimum standards and procedures. With ZAIRE, they noted that many countries need capacity-building assistance. MALAYSIA said the protocol should contain minimum standards and not allow for unilateral derogation. She supported using simplified procedures, provided that the specific terms are defined. NEW ZEALAND called for a case-by-case approach.
The US supported cooperative agreements that eliminate the need to apply AIA in all cases, provided they are concluded in a voluntary and non-discriminatory manner, and pointed to the PIC procedure for hazardous chemicals contained in the Basel Convention. ETHIOPIA noted the major differences between hazardous chemicals and biological materials and stated that careless decisions regarding LMOs could affect neighboring countries. He opposed the elimination of AIA. JAPAN said unilateral decision-making was not acceptable. ZAMBIA said the use of bilateral agreements regarding the transfer of LMOs defeats the purpose of the CBD. The COUNCIL FOR RESPONSIBLE GENETICS called for strong regulatory regimes in exporting countries.
The aide-memoire asked whether there should be one or more types of simplified procedures for cases in which the general procedures do not apply. It also notes that these simplified procedures could include implicit consent if the general procedure is defined as requiring explicit consent or a simple notification procedure with no possibility for the importing country to react. MALAYSIA noted that the protocol may define specific circumstances where general notification procedure requirements may not apply. AUSTRALIA said importing States should make decisions regarding the subsequent importation of the same LMO at the time of first import. The US called for a single simplified procedure, noting the administrative burden of establishing a shipment-by- shipment procedure. CAMEROON called for a simplified procedure incorporating explicit consent. CHINA sought flexibility for importing countries.
On who should trigger the procedure, the EU, the PHILIPPINES, COLOMBIA, NEW ZEALAND and JAPAN said the exporting country should trigger the procedure in the importing country. ZAMBIA and CAMEROON said the exporting country should notify the competent national authority in the importing country. CAMEROON added that the importing country should have sovereignty to designate its authorities. AUSTRALIA said the protocol should be flexible to allow notification to come from the entity that is most appropriate. THAILAND said the product-owner should trigger the procedure. BRAZIL said the importing State should trigger AIA.
On the kind of information to be provided, the PHILIPPINES and ETHIOPIA said the exporting country should notify the importing country regarding characteristics of the LMO, the venues of intended release and all potential risks. JAPAN stated it would be better to prepare the list later, once LMOs have been identified. NORWAY said risk assessment should be carried out prior to the first export of an LMO and submitted to the competent authority of the importing State. The EU called for the establishment of a technical annex and LMO-specific risk assessment guidelines. AUSTRALIA said risk assessment should begin with the initial exportation and include a description of the LMO, its biological characteristics, an assessment of the receiving environment, the method of transfer and the reproductive capacity of the LMO.
MALAYSIA urged that information be timely and complete to allow the importing country to make an informed decision. She sought inclusion of information regarding safe disposal in case of accidental release, intended uses of the LMO and its effects on human health and the environment. ZAMBIA supported the PHILIPPINES and said the exporting country should also be required to provide certification that release of the LMO is not banned in the country of origin. CHINA said the importing country should apply to its own government for importing procedures, as it is ultimately a government action.
The MARSHALL ISLANDS warned against restricting information for purposes of business confidentiality. Full risk assessment depends on capacity and risk assessment mechanisms. NEW ZEALAND listed categories of information from its own legislation and stressed an ongoing interchange of information, with allowances for confidentiality, as appropriate. COLOMBIA supported Malaysia and added that the competent national authority of the importing country should be able to ask for additional information. She said the protocol must have a clause on handling the confidential information given to the importing country. SRI LANKA called for the protocol to provide a system for scientific verification of information. CAMEROON noted that information should be provided in the official languages of the importing country, and should include a description of LMOs, safety requirements, mitigation measures in case of accidental release and risk assessment.
The REPUBLIC OF KOREA listed five information elements: specific regulations for safe handling and use; preliminary risk assessment; risk management procedures; practical information on transfer of the LMO; and assessment of socio-economic implications. The RUSSIAN FEDERATION called for information requirements to be based on OECD and other international regulations, with some flexibility. The THIRD WORLD NETWORK and the EDMONDS INSTITUTE called for information on insurance coverage for adverse effects in the host country.
On the prescribed period of time for a response from a competent authority regarding an LMO transfer, the EU called for time limits depending on various factors such as whether the competent authority has requested further information. JAPAN agreed, noting that the time limit should start from the date the applicant submits all necessary information. NEW ZEALAND, supported by AUSTRALIA, called for a reasonable but not infinite period, noting that the protocol creates a contractual arrangement giving balanced rights and obligations to all Parties.
NORWAY proposed a 90-day limit that would allow an importing country to ask for additional time. The RUSSIAN FEDERATION stated that any time limit would depend on the amount of information received and the countrys ability to digest it. INDIA, supported by MALAYSIA, SRI LANKA and MAURITIUS, opposed a time limit on response. Response is subject to factors such as capacity constraints and the adequacy of information provided. The PHILIPPINES and PAPUA NEW GUINEA stated that any time limit should be used only as a guideline, without consequences for failure to respond. CAMBODIA noted that developing countries lack the resources for studies to obtain adequate information, thus flexible and sufficiently long periods for response are needed. 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 more information. MALAYSIA said the types of action taken by an affected country are its prerogative and can include consent or prohibition, either absolutely, provisionally or conditionally. NORWAY noted that the importing country can consent specifically or provisionally provide an interim consent or decline. Where information is lacking, the burden of proof lies with the State of export. ETHIOPIA said that a non-response should never amount to implicit consent for import and neighboring countries should be informed of decisions. PERU recommended that each country develop domestic legislation assuring that they would respond within a reasonable amount of time.
Regarding a review mechanism on decisions taken by the importing country, NORWAY said if there is new information the importing country can alter the AIA. Duty to inform about new information should be shared with all importing States. An exporter of an LMO should be able to ask for review when new information emerges. Also, a third party or a neighboring country should be taken into account in environmental impact assessments. MALAYSIA said an affected country should trigger a review when new information arises. The exporting country could trigger it if the review is agreed jointly by both sides. The US said this is a decision for the exporting country and did not support an independent review body. The REPUBLIC OF KOREA suggested interested Parties or neighboring countries should be given the right of consultation during the review. The AUSTRALIAN GENE ETHICS NETWORK said that adjacent countries and citizens should have access to the appeal process and socio-economic consideration should be grounds for appeal.
On 14 May, the Chair presented his draft element paper on procedures for specific transfers of LMOs (UNEP/CBD/BSWG/2/ CRP.4). The Chair informed delegates this was not a negotiated document but should be viewed in conjunction with the Report of the Meeting and submissions from governments. The paper contains sections on notification, information that may be required, periods of time for response and review mechanisms. The paper also addresses the cases in which the procedures should apply and contains sections that allow for no deviations or exceptions, sections allowing deviations or exceptions under certain circumstances and sections addressing specific cases, such as banned chemicals. The paper also contains a range of options regarding simplified procedures and consent.
The section on the information that may be required contains a chapeau noting the channels through which information will flow, primarily competent authorities of States. The EU, the US and JAPAN all supported language noting that information may be communicated to the importing States competent authority directly from the private sector, rather than through the exporting States competent authority. The US also proposed noting the private sectors potential as a source for information. The EU proposed addressing AIA and simple notification procedures in separate sections and including 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 genetic modification; results of risk assessments and tests; and intended use of the transferred LMO. The EU and US proposed noting that the list is neither exhaustive nor agreed by all. INDONESIA proposed adding the status of the donor organism and the way and method of genetic modification. CANADA requested information on relevant previous notifications and decisions.
On the period of time allowed for response, the EU added a paragraph to prolong the time period if the organization is waiting for requested information. INDIA suggested having no time limit. On the review mechanism, NORWAY warned against implying that a mechanism should be established to overrule a States sovereign decision. The US opposed setting up a new review mechanism beyond that mentioned in Article 27 of the CBD on dispute settlement. The section was deleted.
Regarding exceptions and deviations from the consent procedure, the EU proposed noting that the simplified consent procedure should not pertain to an LMO bound for contained use. NORWAY proposed that all initial exports of an LMO shall be subject to an AIA procedure requiring explicit consent and notification shall apply to subsequent exports of LMOs requiring specific consent. The PHILIPPINES proposed replacing references to explicit consent with AIA procedures, but INDIA noted that the protocol applies to transfers other than shipments. The US proposed new paragraphs stating, inter alia, that the transfer of LMOs covered by other agreements should be governed by those agreements and detailing the procedures and coverage for AIA.
Regarding simplified procedures, the US called for provisions on cooperative agreements for imports and exports and allowing a Party to indicate that that the AIA procedures do not apply. INDIA added language noting that the protocol shall allow a single, explicit and standardized procedure in all cases. On consent, the EU proposed that a single notification and consent could cover several similar transboundary movements to the same party of import.
During the final Plenary, delegates accepted the Chairs draft element paper (UNEP/CBD/BSWG/2/CRP.4), which will reflect these amendments. They also accepted an addendum to the draft report of the meeting, which contains, inter alia, a summary of discussions on transfers of LMOs, including AIA (UNEP/CBD/BSWG/2/L.1/Add.1).
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