Risk Assessment and Management in Annex III
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Questions and Answers

What is the main objective of the Cartagena Protocol on Biosafety?

  • To ensure an adequate level of protection in the safe transfer, handling and use of LMOs (correct)
  • To ban the use of LMOs
  • To promote the development and commercialization of biotechnology
  • To regulate the import of non-LMOs
  • What type of organisms does the Cartagena Protocol on Biosafety apply to?

  • Only living modified organisms resulting from modern biotechnology (correct)
  • Only organisms used for food and feed
  • All types of organisms, including non-LMOs
  • Only genetically modified organisms
  • What is the purpose of the Biosafety Clearing-House?

  • To ban the use of LMOs
  • To regulate the use of biotechnology
  • To facilitate the export of LMOs
  • To share information on LMOs and promote public awareness (correct)
  • What is the focus of the Cartagena Protocol on Biosafety in terms of LMOs?

    <p>Transboundary movements of LMOs</p> Signup and view all the answers

    What is a key concept in the Cartagena Protocol on Biosafety?

    <p>Advance Informed Agreement Procedure</p> Signup and view all the answers

    What is the scope of the Cartagena Protocol on Biosafety?

    <p>Applicable to all LMOs that may have adverse effects on biodiversity and human health</p> Signup and view all the answers

    What is one of the key principles of the Cartagena Protocol on Biosafety?

    <p>Precautionary principle</p> Signup and view all the answers

    What is the purpose of capacity building in the Cartagena Protocol on Biosafety?

    <p>To enhance the ability of countries to make informed decisions about LMOs</p> Signup and view all the answers

    What is the primary purpose of the Biosafety Clearing-House?

    <p>To facilitate the exchange of scientific, technical, environmental and legal information and experience with LMOs</p> Signup and view all the answers

    What is the nature of the Biosafety Clearing-House?

    <p>A distributed network composed of a Central Portal and national nodes or databases</p> Signup and view all the answers

    What is the purpose of promoting public awareness, education, and participation concerning the safe transfer and use of LMOs?

    <p>To facilitate public participation in decision-making processes</p> Signup and view all the answers

    What is the primary function of the National Biosafety Committee (NBC) in Egypt?

    <p>To set regulations and guidelines for biosafety</p> Signup and view all the answers

    What is the role of the Management Centre in the Biosafety Clearing-House?

    <p>To control and manage information in the Biosafety Clearing-House</p> Signup and view all the answers

    What is the significance of the Cartagena Protocol on Biosafety in Egypt?

    <p>It established the National Competent Authority for Biosafety</p> Signup and view all the answers

    Who has access to the Biosafety Clearing-House?

    <p>All governments</p> Signup and view all the answers

    What is the purpose of Decree number 136 (1995)?

    <p>Obligation to obtain a permit from the NBC</p> Signup and view all the answers

    What is the purpose of the national nodes or databases in the Biosafety Clearing-House?

    <p>To facilitate the exchange of information on LMOs between governments</p> Signup and view all the answers

    What is the relationship between the Central Portal and the national nodes or databases in the Biosafety Clearing-House?

    <p>The Central Portal and national nodes or databases are inter-operable</p> Signup and view all the answers

    What is the significance of Decree 767 (June 2006)?

    <p>Establishment of the National Competent Authority for the Cartagena Protocol on Biosafety</p> Signup and view all the answers

    What is the purpose of the BCH National Focal Points?

    <p>To facilitate the exchange of information on LMOs</p> Signup and view all the answers

    What is the purpose of the Biosafety Clearing-House (BCH)?

    <p>To inform the public about the means of public access</p> Signup and view all the answers

    How can non-internet users access the Biosafety Clearing-House?

    <p>Upon request, through non-internet options</p> Signup and view all the answers

    What is the significance of Decree number 19 (January 2007)?

    <p>Nomination of new members of the NBC and establishment of the Executive Secretariat of the NBC</p> Signup and view all the answers

    What is the purpose of the National Biosafety Systems?

    <p>To regulate and monitor biosafety issues</p> Signup and view all the answers

    Study Notes

    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.

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    Description

    This quiz covers the scope of risk assessment and management in Annex III, including the principles of scientific soundness, transparency, and case-by-case evaluation. It also touches on the establishment of mechanisms to regulate and control risks and prevent unintentional transboundary movements of LMOs.

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