An Introduction to CPB and Importance of BCH to CPB Obligations

Biosafety and the Environment

What is Biosafety?

Biosafety: Efforts to reduce or eliminate potential risks resulting from modern biotechnology and its products

What is Biotechnology?

Bio: Life Technology: Any technique to produce new products or processes Biotechnology

Biotechnology: Any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or process for a specific use

Modern Biotechnology (CPB, Art.3(i)a) the application of:  in vitro nucleic acid techniques, including recombinant DNA and direct injection of nucleic acid into cells or organelles, or....

Modern Biotechnology (CPB, Art.3(i)b) the application of:  fusion of cells beyond the taxonomic family, that overcome natural physiological barriers and that are not techniques used in traditional breeding and selection

Why is Biosafety an Environmental issue?

Agenda 21, Rio Declaration on Environment and Development  Comprehensive action plan to be taken in every area in which humans impact on the environment  Adopted at UNCED, 1992

Chapter 16 of Agenda 21, “Environmentally Sound Management of Biotechnology” addresses biotechnology in 5 programme areas

Chapter 16 of Agenda 21, 2 of 5, biosafety-relevant areas:  Enhancing protection of the environment  Establishing enabling mechanisms for development & application of environmentally sound biotechnology

Agenda 21, Rio Declaration on Environment and Development  Action plan for 21 st century  Convention on Biological Diversity (CBD) and others

Convention on Biological Diversity  Adopted under auspices of UNEP (1992, Rio)  First global treaty to provide a comprehensive framework that addresses all aspects of biodiversity  188 ‘Parties’ to date

3 Goals of CBD:  Conservation of biodiversity  Sustainable use of the components of biodiversity  Fair and equitable sharing of benefits arising from the use of genetic resources

CBD Goals and Biotech: Governments recognized that modern biotechnology has the potential to contribute to achieving these 3 goals…

CBD Goals and Biotech: …as long as it is developed and used with adequate safety measures for the environment and human health.

Agenda 21/CBD (Rio 1992) COP 2 (Jakarta 1995) CPB (Montreal 2000) CPB in force (2003)

COP2 1995: Negotiations for a legally binding agreement on genetically modified organisms (GMOs)

Cartagena Protocol on Biosafety (CPB) Negotiations concluded on 29 Jan (Montreal) with adoption of the Cartagena Protocol on Biosafety within the framework of the Convention

Key Concepts of CPB :  biosafety (decision II/5 COP2)  precaution (Principle 15 Rio Declaration)

Objective of CPB (Art. 1) To contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of living modified organisms resulting from modern biotechnology......

Objective of CPB (Art.1).... that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health, and specifically focusing on transboundary movements.

Scope of CPB (Art. 4) … shall apply to the transboundary movement, transit, handling and use of all living modified organisms that may have an adverse effect on the conservation and sustainable use of biological diversity, taking also into account risks to human health

Biosafety CPB deals primarily with LMOs that are to be intentionally introduced into the environment or used for food, feed or further processing (LMOs-FFP) (Arts.7 & 11)

Biosafety and Precaution To promote biosafety, the Protocol reaffirms another fundamental concept known as the ‘precautionary approach’

Precautionary Approach (Principle 15 of 1992 Rio Declaration on Environment and Development)...”where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation”.

Biosafety and Precaution... This is the case even if there is insufficient scientific evidence about the GMO’s potential adverse effects. (Art. 10.6))

Biosafety and Precaution Governments may decide on basis of precaution not to permit a particular GMO to be imported across its borders....

Precaution & LMOs for FFP (Art.11.8) Lack of scientific certainty due to insufficient relevant information… shall not prevent that Party from taking a decision….with regard to import of that LMO-FFP….

The Protocol (CPB) applies precaution not just to potential risks to biodiversity, but also to human health.

Key Elements for Operation of CPB  Advance Informed Agreement (AIA) procedure (Art.7)  Special procedure for agricultural commodities (Art.11)  RA, RM & ERP (Arts. 15 & 16, Annex III)  BCH (Art.20)

Advance Informed Agreement (Art.7)  Applies to first intentional transboundary movement of LMO for intentional introduction into the environment of the Party of import

Advance Informed Agreement (Art.7)  Not applicable to TB movement of:  pharmaceuticals (Art.5)  transit & contained use (Art.6)  LMOs unlikely to have adverse effects (Art.7.4)

Advance Informed Agreement (Art.7) Intentional introduction to the environment not applicable to:  LMOs for FFP (Art.7.2)

LMOs for FFP (Art.11) A party that makes a final decision regarding domestic use including placing on the market,… LMOs for FFP shall, within 15 days of making that decision, inform the Parties, thru the BCH…. (Art.11.1)

LMOs for FFP (Art.11.5) Each party shall make available to the BCH copies of any national laws, regulations and guidelines applicable to the import of LMOs intended for FFP, if available.

LMOs for FFP (Art.11.6) … in the absence of domestic regulatory framework and in exercise of its domestic jurisdiction, declare to the BCH its decision, prior to the first import of LMO-FFP, will be taken according to:  Risk assessment  Decision within 270 days

BCH and Simplified Procedure (Art.13) A party of import …. specify in advance to the BCH:  Cases when TB movement occurs at same time as importing Party is notified  LMO imports exempted from AIA

Decision making and Timeframes  Party of import shall acknowledge receipt of notification… within 90 days (Arts.9.1)  Party of import shall communicate decision to the BCH and the notifier within 270 days of notification (Art. 10.3)

Socio-economics and Decision making (Art.26) Gives importing countries the right to take into account socio- economic concerns in making a decision on the import (provided they are “consistent with their international obligations”).

Socio-economic Considerations (Art. 26)... Such concerns could include the risk that GM foods may replace traditional crops, undermine local cultures and traditions or reduce the value of biodiversity to indigenous communities.

RA - Potential areas of concern about GMO release (Arts.15&16)  adverse effects on non-target species (e.g. beneficial insects) and ecosystems  potential for weediness, more invasive & possible gene transfer to wild relatives  stability of inserted gene

Governments cannot achieve biosafety on their own: they need the active involvement & cooperation of other stakeholders:  Policymakers & legislators  Biotech. researchers & companies  Civil society  Media

What is UNEP-GEF’s role in biotechnology and biosafety?

UNEP-GEF Projects for National Biosafety Frameworks Development Up to 130 country Projects on Development of NBF Implementation 8 country Demonstration Projects on Implementation of NBF BCH BCH Project (139) +

Review Questions What is biosafety and What is modern biotechnology? What is the CBD and what are its 3 Goals? What are the Key Concepts of CPB? What is the Objective of the CPB? What is the Scope of CPB? What are the Key Elements for Operation of the CPB?

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