Cartagena Protocol on Biosafety

Drew L. KershenUniversity of OklahomaCollege of LawEarl Sneed CentennialProfessor of Law Copyright 2005, all rights reserved

Background History

Protocol to the Convention on Biological Diversity (CBD) CBD opened for signature in 1992 and entered into force on 29

Dec 1993– Art. 8.g – “… as far as possible and as appropriate, establish or

maintain means to regulate, manage or control the risks … of biotechnology …”

– Art. 19.3 – “… shall consider the need for and modalities of a protocol setting out appropriate procedures … in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology …”

Cartagena BioSafety Protocol (CBSP) negotiated from 1996-2000; entered into force in Sept. 2003; over 100 Party Members; an international treaty.

Basic Concepts

Benefits and Risks of Biotechnology– Preamble – “Recognizing …great potential for human well-

being” – This is the only mention of benefits in the entire Protocol, in an non-binding preamble.

– Preamble and Article 1 – “Reaffirming” and Objective – “precautionary approach” – twice

– The Protocol uses the word “risk” or “risks” 67 times. Biosafety as the fundamental concept

– Precautionary approach is added above and beyond safety.

– Benefits are purposefully ignored.

Scope of Protocol

Article 4 – “…the transboundary movement, transit, handling and use of all living modified organisms (LMOs) …”

– Article 3 definitions (g), (h), and (i) must be read. Article 5 – “…this Protocol shall not apply to … (LMOs) which are

pharmaceuticals for humans …” Article 6

– Paragraph 1 – “… the advance informed agreement procedure shall not apply to (LMOs) in transit.”

– Paragraph 2 – “… shall not apply to (LMOs) destined for contained use undertaken in accordance with the standards of the Party of import.”

Example – transgenic yeast for food processing being sent from Spain to Guatemala but passing through Mexico.

Example – transgenic cassava sent from Colombia to Costa Rica for field trials

– Article 3 definition (b) must be read.

Living Modified OrganismsTransboundary Movement

Art. 7 – “… first intentional transboundary movement of (LMOs) for intentional introduction into the environment …”

– Art. 17 – unintentional transboundary movements Advance Informed Agreement Procedure

– Art. 8 – Notification through detailed written information to importing nation

– Art. 9 – Acknowledgement by importing nation 90 days to acknowledge receipt of notification Proceed to Art. 10 decision procedure; or Use domestic regulatory framework consistent with Protocol

Living Modified OrganismsTransboundary Movement

Art. 10 Decision Procedure– 270 days allowed to make decision– Failure to make decision does not constitute consent– Art. 15 on Risk Assessment and Art. 16 on Risk

Management must be used in making the decision Annex I on information required in notifications Annex III on risk assessment guidelines

– Precautionary approach– If Art. 10 decision procedure is used by a country,

transboundary movement may occur only when the country has given written consent

Direct Use as Food or Feed,or for Processing (FFP)

Art. 11 on the FFP Decision Procedure– Bulk commodities – Country of import may authorize entry of bulk commodities

By communicate decision to Biosafety Clearing House and obtaining information listed in Annex II

By domestic regulatory framework consistent with Protocol By procedure that mirrors the Art. 10 procedure in terms of timeframe,

risk assessment, and failure to meet the timeframe for decision Art. 18 on Handling, Transport, Packaging and Identification

– Amount of information and number of tests under Art. 18.2(a)– Art. 18.2(b) is for contained use; Art. 18.2(c) is for intentional

introduction into the environment – Costs and delays in trade escalate quickly the more information

and the greater number of tests required

Other Selected Provisionsof the Protocol

Art. 26 on Socio-Economic Considerations– “… may take into account, consistent with their international

obligations, socio-economic considerations …” Ethical and religious Impact of selected groups within society

Art. 27 on Liability and Redress– “… adopt a process with respect to the appropriate elaboration or

international rules and procedures in the field of liability and redress …”

Is there any need for international rules and procedures? What activities give rise to liability? Strict liability or fault? How broad the redress? For ethical concerns? For impacts on selected

groups within society? For environmental concerns? Example of the recently adopted German law

Other Selected Provisionsof the Protocol

Art. 24 on Non-Parties– “ Transboundary movement of (LMOs) between Parties and non-

Parties shall be consistent with the objectives of this Protocol.” Art. 1 requires “an adequate level of protection.” Art. 14 allows bilateral, regional, and multilateral agreements.

Relationship to other international treaties– Preamble clause “Emphasizing … shall not be interpreted as

implying a change ...”– Preamble clause “Understanding … not intended to subordinate

this Protocol …” International Plant Protection Convention World Trade Organization Codex Alimentarius Commission

Conclusion

What is the appropriate interpretive attitude toward the Protocol?

– Preventive or Precautionary toward biotechnology– Permissive or Promotional toward biotechnology– Both interpretive attitudes are plausible interpretations of

the Protocol.

The interpretive attitude adopted by nations responding to the Protocol will determine the future of biotechnology.