1. The Precautionary Principle in the Sweden, the EU and the US Comparative Risk Regulation Workshop at University of California, Berkeley December 13 2012 Joakim Zander

2. 2 The scope of this presentation An outline of the precautionary principle in the respective systems Definition and role in the legal systems Examples of legislation built on the precautionary principle Practical examples and considerations Conclusion

3. Sweden

4. 4 The definition and role of the PP PP part of legal system since the 1960s Broadly defined in the Environmental Code Individual application Politically uncontroversial Strong public support for state intervention in the fields of health and environment

5. Environmental Code of 1999, Art. 2.3 “Persons who pursue an activity or take a measure, or intend to do so, shall implement protective measures, comply with restrictions and take any other precautions that are necessary in order to prevent, hinder or combat damage or detriment to human health or the environment as a result of the activity or measure. For the same reason, the best possible technology shall be used in connection with professional activities. Such precautions shall be taken as soon as there is cause to assume that an activity or measure may cause damage or detriment to human health or the environment.” 10/15/2015PUBLIC 5

6. Principle of substitution, Art. 2.4 ”Everyone who carries out an activity shall avoid using chemical products which can be suspected of entailing risks for human health or the environment, if they can be repleced with products that can be assumed to be less hazardous.” 10/15/2015PUBLIC 6

7. 7 Chemicals policy The Policy Objective “A Non-Toxic Environment”: The environment must be free from man-made or extracted compounds and metals that represent a threat to human health or biological diversity. The overall goal is that, one generation from now, the major environmental problems currently facing us will have been solved. Strong, hazard-based approach to reduction of the use of chemicals

8. 8 Policy on Radiation The Policy Objective “A Safe Radiation Environment”: Human health and biological diversity must be protected against the harmful effects of radiation Precautionary Principle does not apply to radiation from base stations for mobile phones (Gov’t Instruction) Upheld by Courts Considerably weaker position of the PP than in the field of chemicals…

9. 9 The PP in practice Swedish courts are formally strong… …but weak in practice Environmental Courts Bound by legislative intent Unlikely to overturn decisions by the Government Sparse case law involving the precautionary principle Human health and biological diversity must be protected against the harmful effects of radiation

10. 10 The EU

11. 11 The definition and role of the PP General reference included in Article 191 in the TFEU Applicable to fields of environment and health Interpreted by the European Commission in 2000 Further expanded on by EU Courts

12. 12 The PP underpins major EU legislation REACH Food Safety Legislation Various environmental legislation In principle, strong public and political support for a high level of environmental and health protection in the EU Legislative frameworks built on precaution often less problematic than individual decisions

13. 13 The Rhetoric of the EU courts Review limited to manifest error and ultra vires Risks may not be “hypothetical”… But rather “…adequately backed up by scientific data” (T-13/99 Pfizer) Zero-risk approach is not acceptable Scientific assessment must be “as thorough as possible” Costs and benefits should be balanced… …but impact assessments are not binding

14. 14 The Problematic Practice of the EU Courts Limited review Normally upheld, but not consistently… (Case T-229/05 Paraquat) Prevents Courts from making a full assessment of scientific evidence and limits assessments of costs and benefits The trigger for precautionary action Very low In practice uncertainty is enough… …and very low levels of uncertainty at that (C-343/09 Afton, T- 13/99 Pfizer, etc.) Costs and benefits Health concerns always takes precedence over economic concerns (T-13/99 Pfizer)

15. 15 The US

16. 16 Definition of Role of the PP No explicit place in US legislation But long history of de facto precautionary legislation The Clean Air Act of 1970 The Clean Water Act of 1972 Endangered Species Act of 1973 “The precautionary preference” of the US Congress?

17. 17 The Precautionary Principle in practice The “Partnership” between US Federal Agencies and activist Courts in the 1970s The Benzene ruling in 1980 Prevented the creation of requirements by Agencies and Courts Curtailed the “hard look doctrine” Threshold finding of “significant risk” necessary Risk assessment The “hard look doctrine” still shines through… Obligation to assess costs and benefits OMB oversight of regulation

18. 18 Conclusions

19. 19 Precautionary Legislation v. The Precautionary Principle A difference between precaution as an overriding concern and its application as a legal principle Framework legislation built on precaution: Built-in systems for risk assessment May contain institutionalised socio-economic analysis Clear and foreseeable requirements to subjects of legislation Legal guarantees

20. 20 Precautionary Legislation v. The Precautionary Principle Precaution as an independent legal principle comes with legal problems: Inconsistencies between fields of regulation (Sweden) Discretion of regulators? Triggers for regulation? Requirements on scientific assessment? Comparison of risks and benefits? Risk of arbitrariness and legal uncertainty Effective possibilities for redress for affected parties?

21. 21 How to increase legal certainty and effectiveness in the application of the PP Procedural rules Consistency requirement Rules on form and content of risk assessment Mandatory comparison of risks and benefits Mandatory evaluation of risk trade-offs Requirement to reason if rational criteria are not abided by Judicial review of the above

22. Thank you Joakim Zander joakim.zander@echa.europa.eu