Precaution

1

• Precaution
• WTO Symposium, 6-7 July 2001
• Current issues facing the World Trading System
• SessionFood Safety and SPS
• D. TAEYMANS, Director
• Scientific Regulatory Affairs

2
Precaution Environment

• Rio Declaration
• Principle 15
• in order to protect the environment, the
  precautionary approach shall be widely applied by
  States according to their capability. 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

3
Precaution

• Should it be extended to other fields?
• Such as food safety?

4
WTO Agreement on the Application of SPS

• Article 2.2 states
• Members shall ensure that any SPS measure is
  based on scientific principles and is not
  maintained without scientific evidence, except as
  provided for in Article 5.7
• Scientific principles RISK ANALYSIS

5
Risk Analysis - Codex concepts

• Risk assessment
• Risk management
• Risk communication

6
Precaution Plant, Animal and Human Health

• WTO Agreement on SPS, Art 5.7
• In cases where relevant scientific evidence is
  insufficient, a Member may provisionally adopt
  sanitary or phytosanitary measures on the basis
  of available pertinent information, including
  that from relevant international organisations as
  well as from SPS measures applied by other
  Members. In such circumstances, Members shall
  seek to obtain the additional information
  necessary for a more objective assessment of
  risk and review the SPS measure accordingly
  within a reasonable period of time

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Precaution

• Precaution should be considered within a
  structured approach to risk analysis
• Precaution is particularly relevant to risk
  management
• Precaution, which is used by decision-makers in
  risk management, should not be confused with the
  element of caution (prudential approach) that
  scientists apply in their assessment of
  scientific data

8
Precaution

• For economic operators, precaution is not
  welcomed
• because it has the potential to create
  non-justified barriers to trade.
• But, in exceptional circumstances,
  decision-makers may need to take such measures to
  protect human health
• In such exceptional circumstances, the measures
  taken should comply with several criteria

9
Precautionary measures

• Exceptional
• Provisional
• Proportional
• Non-discriminatory
• Consistent
• Based on a cost/benefit analysis
• Assign burden of proof
• Allow consultation of stakeholders

10
Precaution - Codex discussions

• Codex develops Working Principles for Risk
  Analysis
• In the frame of this discussion, Codex discussed
  how to integrate precautionary approach in risk
  management possibly through definition of
  guidelines

11
Precaution - Codex recommendation

• When there is evidence that a risk to human
  health exists but that scientific data are
  insufficient or incomplete, the CAC should not
  proceed to elaborate a standard but should
  consider the need for a Codex related text, such
  as a code of practice, provided that such a text
  would be supported by the available scientific
  evidence
• CAC, July 2001

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Precaution - Conclusions

• Risk analysis
• Risk assessment
• Risk management
• Risk communication
• remains the rule
• Precautionary measures should remain the
  exception