The hormones beef case

Transcription

1 Lorenzo Boccoli University of Ferrara, Italy Anaёlle Chansay University of Nantes, France Patricia Daszewicz - University of Kozminski, Poland Allison Macé University of Nantes, France José Maria Casado Ruiz University of Jaen, Spain Agnese Sciotti University of Tuscia, Italy The hormones beef case

2 Introduction Recourse to the precautionary principle Comparison between US and EU approach Illustration : the hormones beef case

3 Health issues : spatial dimension, time-lag between the behaviour and the moment at which the problem caused by this behaviour becomes clear, irreversibility of some effects Problem : still scientific uncertainties => In all of these matters, the precautionary principle can be of help.

4 Environmental principle - 70 s : German policy => Vorsorgeprinzip - 80 s, 90 s : North-Sea Conferences : Bremen (1984), London (1987), The Hague (1990) and Esbjerg (1995) UNCED : Rio Declaration (1992) The precautionary principle is progressively asserted regarding possible scientific evidence harmful effects despite a lack of Reluctance of the US

5 European perspective - Treaty of Maastricht : precautionary principle added to the list of environmental principles (Art. 130 R Art.191 TFEU) - But its scope is wider and covers also consumer policy, European legislation concerning food and human, animal and plant health

6 - 90 s: the hormones beef case and the embargo on British beef products revived the discussion on the precautionary principle need of clarification - February 2000: Communication of the Commission regarding its doctrine on the precautionary principle Definition and conditions of application - April 2000: Codex Committee on General Principles answered US questions regarding this principle

7 - December 2000: Resolution of the European Council in Nice Annex III : 2. Considers that the precautionary principle applies to the policies and action of the Community and its Member States and concerns action by public authorities both at the level of the Community institutions and at that of Member States; that such authorities should endeavour to have that principle fully recognised by the relevant international fora; 3. Notes that the precautionary principle is gradually asserting itself as a principle of international law in the fields of environmental and health protection; 4. Considers that WTO rules do basically allow account to be taken of the precautionary principle; => Application to human health, as well as to the animal health and plant health sectors, principle of international law, compliance with WTO

8 Regulation (EC) No 178/2002 Art.1: assurance of a high level of protection of human health and consumers interest in relation to food ( ) Art. 7 : In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted ( )

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10 This principle is not acknowledged by every countries => some consider it as a mean of commercial protectionism or an obstacle to technical innovation and economic and social development WTO : - Art. XX GATT (exceptions) - Art. 5(7) SPS Agreement (procedure in the event of risk and insufficient scientific evidence) Also in other international texts (WHO, UNESCO)

11 Communication of the Commission of 2nd February 2000: The precautionary principle may be invoked when a phenomenon, product or process may have a dangerous effect, identified by a scientific and objective evaluation, if this evaluation does not allow the risk to be determined with sufficient certainty. Reg. (EC) No 178/2002. Art 3 What is risk? ( ) a function of the probability of an adverse health effect and the severity of that effect, Consequential to a hazard. Risk analysis: (Art.6) systematic methodology for the determination of effective, proportionate and targeted measures or other actions to protect health.

12 Risk analysis risk assessment: shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner risk management: shall take into acccount the results of risk, and in particular, the opinions of the European Food Safety Authority risk communication: interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, feed and food businesses, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions;

13 General principles of risk management: 1. proportionality between the measures taken and the chosen level of protection; 2. non-discrimination in application of the measures; 3. consistency of the measures with similar measures already taken in similar situations or using similar approaches; 4. examination of the benefits and costs of action or lack of action; 5. review of the measures in the light of scientific developments.

14 The precautionary principle shall be informed by three specific principles: a) the fullest possible scientific evaluation, the determination, as far as possible, of the degree of scientific uncertainty; b) a risk evaluation and an evaluation of the potential consequences of inaction; c) the participation of all interested parties in the study of precautionary measures, once the results of the scientific evaluation and/or the risk evaluation are available.

15 Art. 7 par. 2 «The measures shall be reviewed within a reasonable period of time depending on the nature risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.» legal acts, financing of research programmes, public information measures, etc. The burden of proof: in the case of an action being taken under the precautionary principle, the producer, manufacturer or importer may be required to prove the absence of danger. This possibility shall be examined on a case-by-case basis. It cannot be extended generally to all products and procedures placed on the market.

16 EU Precautionary principle USA Risk assessment Reg (EC) No 178/2002: ( ) where a risk to life or health exists but scientific uncertainty persists, the precautionary principle provides a mechanism for determining risk management measures or other actions in order to ensure the high level of health protection chosen in the Community. RISK -No political influences - technological development - no economic barriers Low level of risk High level of risk

17 EU Precautionary principle USA Risk assessment Uncertainty Science is a limited instrument that sometimes doesn t allow to have a satisfying answer. Time is also a limit to produce useful results. SCIENCE Trusted support Science is an available support. It produces helpful results to take decision in regulation. Scientifically based

18 The reality of precaution: comparing Approaches to risk and regulation (GSPA, EPC, DCES) 1st Dialogue: BSE GMO and nutrition Pharmaceutical product Phathalates 3rd Dialogue: Chemical treatment in breeding animals Health and safety of child Food Safety and acrylamide Violence in young people 2nd Dialogue: GMO and insects Nuclear energy Climate changin Atmospheric environment Tobacco 4th Dialogue: Marine environment Biodiversity Terrorism Ozone depletion

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20 Request for Consultations : 26 January 1996 The USA alleges that the European measures restrain the importation of meat and meat products from the US Panel Report : 18 August Appellate Body Report : 16 January 1998 Don t want to position themselves on that question

21 Article 191 TFEU (ex Article 174 TEC) : Union policy on the environment shall contribute to pursuit of the following objectives : - preserving, protecting and improving the quality of the environment, - protect human health, - prudent and rational utilisation of natural resources, - promoting measures at international level to deal with regional or worldwide environmental problems, and in particular combating climate change Communication of the European Commission, 2 February 2000 Paragraph 2 of art 191 of the Lisbon Treaty Union policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions on the Union. It shall be based on the precautionary principle and on the principles that preventive action should be taken

22 The Appellate body ruled in favor of the US but didn t adopt the same approach : they chose a more flexible approach The risk is not only studied in a scientific laboratory but also has to take into account social considerations The status of the precautionary principle is still open to debate

23 The essence of the principle : scientific uncertainty is not enough to justify an action The main differences of application : in terms of degree of uncertainty : - EU : accept a low level - US : require a much higher level

24 Important to prevent crises Important to reassure the population Important because of its global repercussions Conflicting rules SPS agreement : provisional measures and minimum standard protection

25 Evolution of the WTO s approach - Ecological awareness - Provisional and non provisional measures - States can choose the degree of protection

26 The main problem regarding the precautionary principle is not its definition but its application The main question : the degree of scientific uncertainty The solution : a more flexible approach?

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