Risk Assessment and Management in Annex III

Risk Assessment and Risk Management

• Annex III specifies the scope of risk assessment in a scientific sound manner, with transparency, on a case-by-case basis.
• The absence or insufficiency of scientific knowledge or consensus does not indicate an absence of risk or an acceptable risk.
• Each party must establish and maintain mechanisms to regulate, manage, and control risks, and prevent unintentional transboundary movements of LMOs.

Handling, Transport, Packaging, and Identification

• Parties must require that LMOs are handled, packaged, and transported under conditions of safety.
• The Protocol sets minimal measures concerning documentation accompanying LMOs subject to transboundary movements.

Information Sharing and the Biosafety Clearing-House

• A clearing-house (BCH) facilitates the exchange of scientific, technical, environmental, and legal information and experience with LMOs.
• The BCH assists parties in implementing the Protocol and is open to all governments.
• The BCH is a distributed network composed of a Central Portal and national nodes or databases that are inter-operable with the Central Portal.

Capacity Building

• The Protocol promotes international cooperation to help developing countries and countries with economies in transition build human resources and institutional capacity in biosafety.

Public Awareness and Participation

• Parties are encouraged to promote and facilitate public awareness, education, and participation concerning the safe transfer and use of LMOs.
• Parties should ensure public access to information on LMOs that may be imported and consult the public in the decision-making process.

Egypt and International Agreements

• Egypt is a party to the Convention on Biological Diversity (CBD) since 1994 and the Cartagena Protocol on Biosafety since 2004.

National Biosafety Systems

• National Biosafety Systems vary from country to country but usually have common components such as a policy on biotechnology, a regulatory framework, a mechanism to handle notifications/requests for permits, enforcement and monitoring, and public information and participation.

Existing Biosafety Regulations in Egypt

• Decree number 85 (1995) establishes the National Biosafety Committee (NBC) with tasks such as setting regulations and guidelines, reviewing and deciding on applications, and contacting national and international organizations.
• Decree number 136 (1995) obliges obtaining a permit from the NBC for certain activities.
• Decree 1648 (1998) establishes a protocol for GM seed registration.
• Decree 767 (2006) establishes the National Competent Authority for the Cartagena Protocol on Biosafety.
• Decree 19 (2007) nominates new members of the NBC and establishes the Executive Secretariat of the NBC.

The Cartagena Protocol on Biosafety

• The Protocol is an international legally binding treaty that sets procedures and mechanisms for the transboundary movements of LMOs.
• The Protocol aims to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling, and use of LMOs, taking into account risks to human health and the conservation and sustainable use of biological diversity.