This document discusses biotechnology and its regulation. It defines biotechnology as techniques involving recombinant DNA and cell fusion beyond taxonomic families. The document outlines some benefits of biotechnology like increased efficiency and improved healthcare, but also potential dangers like invasive genetically modified organisms and impacts on non-target species. It describes key international agreements that regulate biotechnology - the Convention on Biological Diversity, the Cartagena Protocol on Biosafety, and the Nagoya Protocol on Access and Benefit-Sharing. These agreements aim to ensure safe use of biotechnology and fair sharing of benefits from genetic resources.

1. Biotechnology
• In vitro nucleic acid techniques,
including recombinant
deoxyribonucleic acid (DNA) and direct
injection of nucleic acid into cells or
organelles, or
• Fusion of cells beyond the taxonomic
family, that overcome natural
physiological reproductive or
recombination barriers and that are
not techniques used in traditional
breeding and selection

2. Some benefits of Biotechnology
• Increased agricultural efficiency, reducing the need for more
land, hence conservation of biodiversity
• Use of plants engineered to produce pesticides internally could
lead to reduced application of chemical pesticides
• Availability of products in bulk, such as hormones and
enzymes, that would have been so difficult to mass produce
• Improved health care, such as the application of gene therapy
• Resolution of genetic defects, such as infertility
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4. Potential dangers of Biotechnology
• Potential dispersal of genetically modified organisms in the
environment which may become invasive due enhanced
competitiveness
• Potential transfer of inserted genetic material (and related
characteristics) to other organisms, for example, through
cross-pollination
• Potential impacts on non-target species –crops modified to be
resistant to insect pests may also have adverse effects on
beneficial insects and birds
• Moral and ethical issues

5. Regulation of Biotechnology
• Potential hazards necessitates the need for biosafety measures
to protect human and ecosystem health
• The relevant regulatory frameworks in place consist of binding
instruments and non-binding policy documents
• The Convention on Biological Diversity, 1992
• The Cartagena Protocol, 2003
• The Nagoya Protocol, 2010

6. Convention on Biological Diversity (CBD)
• Main objectives are the
• Conservation of biodiversity
• Sustainable use of the components of biodiversity
• Fair and equitable sharing of the benefits arising out of the
utilization of genetic resources
• Signed by 150 governments in 1992 at the Rio Earth Summit

7. CBD cont’d
• The Convention establishes the standard institutional elements
of a modern environmental treaty: a governing body, the
Conference of the Parties (COP) a Secretariat; a scientific
advisory body; a clearing-house mechanism and a financial
mechanism
• Collectively, these translate the general commitments of the
Convention into binding norms or guidelines, and assist Parties
with implementation
• The principal function of the COP is to regularly review
implementation of the Convention and to steer its
development, including establishing subsidiary bodies as may
be required

8. CBD cont’d
• The principal functions of the Secretariat are to prepare for
and service meetings of the COP and other subsidiary bodies of
the Convention, and to coordinate with other relevant
international bodies
• The Secretariat is provided by UNEP and is located in
Montreal, Canada
• A clearing-house mechanism to promote and facilitate
technical and scientific cooperation

9. CBD cont’d
• A financial mechanism for the provision of resources to developing
countries for the purposes of the Convention
• The financial mechanism is operated by the Global Environment
Facility (GEF) and functions under the authority and guidance of,
and is accountable to, the COP
• GEF activities are implemented by the United Nations Development
Program (UNDP), UNEP and the World Bank
• Under the provisions of the Convention, developed country Parties
undertake to provide new and additional financial resources to
enable developing country Parties to meet the agreed full
incremental cost of implementing the obligations of the Convention
• Parties may also provide financial resources through bilateral and
multilateral channels

10. The Cartagena Protocol on Biosafety
• An international agreement whose objective is to ensure the safe
handling, transport and use of living modified organisms (LMOs)
resulting from modern biotechnology that may have adverse effects
on biological diversity, taking also into account risks to human
health
• Each Party shall take necessary and appropriate legal,
administrative and other measures to implement its obligations
under the Protocol
• Parties shall ensure that the development, handling, transport,
use, transfer and release of any living modified organisms are
undertaken in a manner that prevents or reduces the risks to
biological diversity, taking also into account risks to human health

11. The Cartagena Protocol on Biosafety
cont’d
• Protocol shall not affect the sovereignty of States over their territorial
sea established under international law, and the sovereign rights and the
jurisdiction which States have in their economic zones and continental
shelves, and the exercise by ships and aircraft of all States of
navigational rights and freedoms
• Protocol shall not be interpreted as restricting the right of a Party to
take action that is more protective of the conservation and sustainable
use of biological diversity than that called for in this Protocol, provided
that such action is consistent with the objective and the provisions of
this Protocol and is in accordance with that Party's other obligations
• The Parties are encouraged to take into account, as appropriate,
available expertise, instruments and work undertaken in international
forums with competence in the area of risks to human health

12. The Nagoya Protocol on Access and Benefit-
sharing
• A supplementary agreement to the CBD
• Provides a transparent legal framework for the effective
implementation of one of the three objectives of the CBD: the fair
and equitable sharing of benefits arising out of the utilization of
genetic resources
• An international agreement which aims at sharing the benefits
arising from the utilization of genetic resources in a fair and
equitable way
• Applies to genetic resources that are covered by the CBD, and to
the benefits arising from their utilization
• Also applies to traditional knowledge (TK) associated with genetic
resources that are covered by the CBD and the benefits arising
from its utilization