The Action Plan for building capacities in biosafety

The Action Plan for Building Capacities for the Effective Implementation of the Cartagena Protocol on Biosafety was adopted during the first meeting of the governing body of the Protocol (COP-MOP 1) with the Decision BS-I/5 - Annex I and was then revised by the Parties at their third meeting (COP-MOP 3) in Decision BS-III/3, Annex.

The objective of the Action Plan is to facilitate and promptly support the development and strengthening of capacities for the ratification and effective implementation of the Protocol at the national, sub regional, regional and global levels, including the provision of financial, technical and technological support to developing countries as well as to countries with economies in transition.

Biosafety

Biosafety means all measures, policies and procedures necessary to minimize the potential risks to the environment and to human health resulting from modern biotechnology

The Convention on Biological Diversity (CBD) recognizes that modern biotechnology is a relevant tool, also for the conservation and sustainable use of biological diversity (Article 16.1 and Article 19.1-2); on the other hand, the CBD seeks to ensure the development of appropriate procedures to improve its safety in order to reduce all potential threats to biological diversity, also taking into account risks to human health.

The international principles on biosafety are deal with in the Cartagena Protocol, one of the CBD protocols, which, referring to the precautionary principle, has the objective to protect the environment and human health from potential risks arising from transfer, manipulation and use of Living Modified Organisms obtained from modern biotechnologies.

The European Union (EU) and its Member States have adopted regulatory instruments to ensure the required levels of safety for the environment and human health as provided for in the Protocol.

In the EU Genetically Modified Organisms (GMOs) may only be authorized for the deliberate release into the environment for experimental purposes and for marketing after a rigorous risk assessment procedure to avoid any possible negative effects on the environment and human health. The principles and the methodology for risk assessment are dealt with by directive 2001/18/EC on the deliberate release into the environment of GMOs.

Based on the results of the risk assessment appropriate risk management measures are taken in each phase of manipulation and use of the GMOs, and post-marketing monitoring activities are carried out to observe the occurrence of any unexpected effects.

Risk assessment pursuant article 15 of the Cartagena Protocol

The aim of risk assessment is “to identify and evaluate the potential adverse effects of LMOs on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health" (from Annex III of the Cartagena Protocol) and it is used by the competent authorities to make informed decisions regarding living modified organisms (LMOs).

Risk assessment should be carried out in a scientifically sound and transparent manner, taking into account expert advices and guidelines developed by relevant international organizations.
Lack of knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk or the occurrence of an acceptable risk.
Risks associated with LMOs or derived products, namely LMOs processed materials containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered in relation to risks posed by the unmodified recipient or parental organisms in the environment that potentially could receive them.
Risk assessment should be carried out on a case by case basis. The nature and the level of details required for the requested information may vary from case to case depending on the living organism concerned, on its intended use and on the potential receiving environment.

According to Annex III of the Cartagena Protocol risk assessment includes the following steps:

  1. an identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking into account  risks to human health;
  2. an assessment of the likelihood of these adverse effects being realized, given the degree and type of exposure in the environment that could receive the living modified organism;
  3. an assessment of the possible consequences in case that these adverse effects occur;
  4. an estimation of the overall risk posed by the living modified organism on the basis of the evaluation of the probability that identified adverse effects and the relative negative consequences will occur;
  5. a recommendation indicating whether or not risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks;
  6. if there is uncertainty regarding the level of risk, it could be useful to request additional information on specific issues of concern, and apply appropriate strategies for risk management and / or monitoring the living modified organism in the receiving environment.

Tools for risk assessment