While the NBFs consist of policy, legal, administrative and technical instruments, the institutional responsibility for decision-making and for risk assessments of LMOs usually falls to Competent National Authorities (CNAs). According to the Cartagena Protocol, each Party is to designate one or more CNAs to perform the administrative functions required by the Protocol.
Additionally, according to the Protocol, it is a Party’s obligation to clearly indicate, though the Biosafety Clearing-House (BCH), any existing laws, regulations or guidelines for implementation of the Protocol, as well as the names and addresses of its CNA(s).
The NBFs usually set out competencies and procedures depending on the LMO (e.g. the type of LMO or its intended use). As such, risk assessments may be assigned to different CNAs within the same country.
The options chosen by countries for the institutional setup of CNAs in each NBF include (i) a single CNA receiving and processing all requests regarding LMOs, or (ii) more than one CNA, each with different responsibilities and with either a single or multiple routes for the submission of applications regarding LMOs.
In cases when a Party designates more than one CNA, information on their respective responsibilities should be clearly stated and made available to the BCH. This information may include, for instance, which CNA is responsible for which type of LMO. In most of the draft NBFs, developed by countries assisted by the UN Environment Programme (UNEP) as a GEF implementing agency, the responsibility of risk assessment has been assigned to the CNA(s) or the overall biosafety body, with or without advice from either an ad hoc scientific advisory body, or an established advisory committee.
