On 14 May, the Chair introduced UNEP/CBD/BSWG/2/CRP.5, an aide-memoire on risk assessment and risk management. Most speakers favored putting provisions for risk assessment in the protocol. SWITZERLAND and the US, however, did not fully agree. Most speakers favored provisions as the basis for decisions for transboundary movement, rather than just for information sharing. ETHIOPIA, supported by SOUTH AFRICA and the US, added that risk assessment is the basis for decision-making in general. SRI LANKA stressed risk assessment for the safe transfer, handling, and use of organisms that may have adverse effects. SWITZERLAND offered the alternative aim of guaranteeing a minimum level of harmonization in risk assessment.
ETHIOPIA, supported by NORWAY, SRI LANKA, INDIA and the US, stated that the protocol 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 make detailed standards that do not conflict with national laws.
ETHIOPIA, NORWAY, SRI LANKA and BANGLADESH called for the provisions to be legally-binding. SWITZERLAND preferred provisions as reference points only. NEW ZEALAND, supported by the US, favored leaving implementing methods to national competent authorities. ETHIOPIA, SRI LANKA, INDIA BANGLADESH, NEW ZEALAND and SOUTH AFRICA suggested that general provisions be included as an article of the protocol, with details possibly provided in an annex.
Numerous bases for risk assessment were proposed, including information about the relevant organism and the relevant receiving environment (NORWAY), available scientific information (SRI LANKA), information provided by the exporter or exporting country (INDIA, SOUTH AFRICA, COLOMBIA), environmental impact assessments, the clearinghouse mechanism and public participation (BANGLADESH), and any information the assessor considers relevant (SOUTH AFRICA).
Countries generally concurred that the sources for the provisions could include UNEP guidelines and other sources such as country submissions. Most speakers said competent authorities in the importing country should be responsible for risk assessment. To this were added: an institution accredited by the competent authority, or an applicant to export (SRI LANKA, SOUTH AFRICA) and focal points (BANGLADESH). The US said that the importer is ultimately responsible but risk assessment could be facilitated through third 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 and that competent authorities must have access to information relevant to risk assessment. General positions on risk assessment should be in the protocol and more detailed information in an annex. AUSTRALIA said the protocol should include general principles, not specific procedures, which should serve as guidelines only.
MALAYSIA supported incorporating specific requirements to provide information as the primary basis for decisions. Supported by most developing countries, she said decisions could also be based on socio-economic and ethical considerations. If they lack the technical capacity, specific provisions for assistance will be necessary. ZAMBIA, INDONESIA, CUBA, MALI and THAILAND called for general principles establishing that the Parties will perform risk assessments and adopt measures and said the protocol must have a detailed annex with the minimum standard of information that would be required for risk assessment.
Regarding who should perform the risk assessment, the EU said assessments are the responsibility of the importer and the exporter should provide information. MALAYSIA noted that the applicant should be responsible for the assessment and decisions should rest with national authorities. Financial responsibility lies with the country trying to undertake the transfer. NORWAY and INDONESIA noted that the exporting State bears responsibility for providing information and the importing State has the responsibility to analyze and decide on the risk assessment. The US stated that the risk assessment should be 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 responsibility for risk assessment lies with the importing State, but stressed that the exporter, company or State, must perform risk assessment and provide information. SAMOA and THAILAND said that risk assessment is the responsibility of authorities and governments.
The COUNCIL FOR RESPONSIBLE GENETICS said that risk assessment must consider the distribution of potential harms among different groups within a society. The AUSTRALIAN GENE ETHICS NETWORK, supported by ZAMBIA, stated that discussions should focus on assessment of risks versus benefits. Socio-economic elements should be included and given equal emphasis with other factors. The BIOTECHNOLOGY INDUSTRY ORGANIZATION, supported by SRI LANKA, stated that any risk assessment exercise needs to be focused and the first step is hazard identification.
Many delegations supported the inclusion of a provision for risk management in the protocol. CAMEROON, INDIA, BRAZIL, CHINA, NORWAY, NEW ZEALAND, BURKINA FASO and TOGO stated that Article 8(g) which states that each Party to the CBD shall establish or maintain means to regulate, manage or control the risks associated with the use and release of LMOs that are likely to have an adverse environmental impacts was relevant to the issue of risk management and should be referenced in the protocol. MALAYSIA noted the relevance of Article 8(g) but said it need not be included in the protocol as it already appears in the CBD. The US did not support 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 a basis for decisions on transboundary movement. CAMEROON and the BIOTECHNOLOGY WORKING GROUP sought recognition of the need to provide for liability, insurance and compensation. INDIA stated that the purpose of the risk management provision should also be to assign responsibilities in case of accidents. NORWAY and BURKINA FASO said the purpose of a risk management provision should be for information sharing and to provide a basis for decision making. SRI LANKA 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 manage the likely effects of movements of LMOs.
On the format of the risk management provision, INDIA, CHINA, MAURITIUS, the US and BURKINA FASO supported the use of general principles. MAURITIUS and BURKINA FASO also supported the use of detailed provisions in an annex. BRAZIL supported the use of detailed provisions. ZAMBIA called for the inclusion of detailed minimum standards. SRI LANKA supported the use of general principles, detailed provisions and minimum standards.
Regarding the enforcement capabilities in the risk management provisions, MALAYSIA, CAMEROON, CHINA, NORWAY, BURKINA FASO, TOGO and MAURITIUS supported legally-binding risk management provisions. AUSTRALIA and NEW ZEALAND disagreed. SRI LANKA sought liability compensation covered by national legislation.
As to the form of the provisions, MALAYSIA, NEW ZEALAND and BURKINA FASO called for the inclusion of risk management provisions in an article within the protocol. SRI LANKA, MAURITIUS and TOGO sought inclusion of risk management provisions in 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 other sources for the elaboration of provisions on risk management in the protocol. NEW ZEALAND, BURKINA FASO and TOGO said both the exporting and the importing country should share responsibility for risk management. ECOROPA recommended tapping the capacity in risk assessment and management of the insurance sector; this will depend on the final position taken on liability and compensation.
During the final Plenary, delegates accepted the Chairs draft elements paper on risk assessment and management (UNEP/CBD/BSWG/2/CRP.12). The paper contains proposals on whether to include risk assessment provisions and the level of specificity required. The paper also reflects delegates proposals on: the Party responsible for risk assessment, whether the provisions for risk assessment will be legally-binding; and overall aim and basis of risk assessment.
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