Laws of fear or laws of reason? The precautionary principle and the law Geert Van Calster, KU Leuven blog: gavclaw.com

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Overview 3 Definitions? A Handbook on the precautionary principle? Case-law The bogeyman? The EU-US divide and conclusion

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Definition of the precautionary principle 5 Typically used for environment, OHS, and Public health Principle 15 of the Rio Declaration: o In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. 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. As many definitions as there are legal instruments making reference to the principle Typically pitched against the prevention principle Principle 2 of the Rio Declaration: o States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to exploit their own resources pursuant to their own environmental and developmental policies, and the responsibility to ensure that activities within their jurisdiction or control do not cause damage to the environment of other States or of areas beyond the limits of national jurisdiction.

Definition ctd 6 Cf. e.g. the 'no regrets' doctrine (Bush senior; Clinton /Gore The only uncontested definition is a negative one: lack of full certainty must not excuse inaction The main legal anchor for the principle therefore becomes not so much its definition, but rather its implementation. The legal straightjacket therefore is one of process, rather than outcome compliance: how the result is achieved, rather than what that result might be

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A 'handbook' of the precautionary principle 9 No definition is given Note the link with trade (DG Trade sponsored, not DG Env) Certainly NOT Sunstein's (The Law of Fears) reading: 'when in doubt' opt out', or 'when in doubt, don't do it' Rather: process-oriented approach, with 'marginal assessment' by the European Court of Justice

A 'handbook' ctd 10 Where action is deemed necessary, measures based on the precautionary principle should be, inter alia: proportional to the chosen level of protection, non-discriminatory in their application, consistent with similar measures already taken, based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis), subject to review, in the light of new scientific data, and capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.

A 'handbook' ctd 11 'Reversal of the burden of proof' often quoted as being part of the principle See e.g. REACH: no data, no market Cf review of cosmetics Directive

Case-law: EU 12 Various judgments by the ECJ with respect to ban on, or limited use of, pharmaceuticals, additives, pesticides etc. Clearly the Court prefers not to second-guess the science: there is no 'de novo' review of the scientific evidence Rather: could the Commission (often in co-operation with the Member States) reasonably come to its conclusion on the basis of a complete collection of facts

Case-law: EFTA 13 EFTA Court, Philip Morris v Norway (12 September 2011) o an assessment of whether the principle of proportionality (...) in the field of public health must take account of the fact that an EEA State has the power to determine the degree of protection that it wishes to afford to public health and the way in which that protection is to be achieved. o It follows that, where the EEA State concerned legitimately aims for a very high level of protection, it must be sufficient for the authorities to demonstrate that, even though there may be some scientific uncertainty as regards the suitability and necessity of the disputed measure, it was reasonable to assume that the measure would be able to contribute to the protection of human health.

Cf recently: New York 14 o Supreme Court of New York, 11 March 2013, New York Statewide Coalition of Hispanic Chambers of Commerce et al v New York City Department of Health and Mental Hygiene: o Is unconstitutional: the NY City Board of Health’s decision to limit the size of sugary soft drinks or ‘sodas’ sold in restaurants, movie theaters, stadiums and arenas at 16 ounces a cup. On the basis of separation of powers No assessment (yet) of the science (Tingling J: 'the judgment is not about the obesity epidemic, if any, and /or the contribution of soda drinks to same', although infringement of the separation of powers ‘(…) has the potential to be more troubling than sugar sweetened beverages

The bogyeman? : International trade 15 Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) General rule: all sanitary and phytosanitary measures must be based on scientific principles and should not be maintained without adequate scientific evidence Article 5(7): a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary 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 sanitary or phytosanitary measure accordingly within a reasonable period of time.

International trade ctd. 16 Other, less obvious Agreements are relevant, too: see the many fronts on which the current battle is fought against plain packaging regulations: Bilateral Investment Treaties; Intellectual Property; (national) constitutions

The bogyeman? : International trade 17 Quid ethical concerns? See current case EU Seal Pups See also proposal at EU level to allow ethical (including religious) objections at Member State level to lead to objections to GMO marketing

The EU-US divide 18 Different view on the risk analysis cycle Different legal context for 'regulatory agencies'

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Conclusion ctd. 20

21 Extracts from Chapter XXVIII 'In which Passepartout does not succeed in making anyone listen to reason' Passepartout found that he could not avoid telling his master what had occurred, and, with hanging head, he was turning towards the car, when the engineer, a true Yankee, named Forster called out, "Gentlemen, perhaps there is a way, after all, to get over." … "I know—I see," repeated Passepartout; "but it would be, if not more prudent, since that word displeases you, at least more natural—"

22 "Yes, all aboard!" repeated Passepartout (…) "But they can't prevent me from thinking that it would be more natural for us to cross the bridge on foot, and let the train come after!"

Laws of fear or laws of reason? The precautionary principle and the law Geert Van Calster, KU Leuven blog: gavclaw.com