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Symposium on Risk versus Hazard Symposium on Risk versus Hazard Risk versus Hazard – How to Regulate in the 21st Century Ragnar E. Lofstedt* In Europe, debate as to whether one should regulate chemicals based on intrinsic hazard or assessment of risk, or possibly a combination of both, has been gaining momentum. This article first provides a brief history of this risk versus hazard debate. Secondly, it ex-amines how European regulators are currently handling the regulation of two chemical compounds, namely Bisphenol A and Deca BDE (a brominated flame retardant), based on forty-five expert interviews with regulators, policy makers and industry representatives in eight Member States, as well as with European Commission officials. The paper shows that there is no clear consensus as to when risk or hazard considerations should be the basis for regulatory decision-making, with wide discrepancies between Member States (e.g. the UK is overall more risk based than Sweden) and between regulatory agencies within Member States. The penultimate section puts forward a series of recommendations to help regula-tors and policy makers develop more consistent and science based regulations for Europe. states, there has been a lively debate about how best to regulate chemicals, including metals, food Since the early 1970s with the formation of envi- additives and preservatives, as well as certain foods ronmental regulatory agencies in many European themselves1. Should regulations be based on a haz-ard classification (that is the potential for a sub- Professor Ragnar Lofstedt is the Director for the King's Centre stance, activity or process to cause harm or adverse for Risk Management, Department of Geography, King's College effect) or a risk (a combination of the likelihood and London. The author would like to thank the European regulators and stakeholders who agreed to be interviewed for this article the severity of a substance, activity or process to as well as the three anonymous reviewers for very helpful and cause harm) assessment23? In other words, should constructive comments. This article is based on research that has regulators ban substances that have an intrinsic abil- in part been funded by Afton, Bromine Science and Environmen- tal Forum, the Nickel Institute, the Swedish Emergency Manage- ity to cause harm, or should they examine whether ment Agency, the Swedish Government Agency for Innovation there is a real probability that these substances will Systems, the Swedish Maritime Administration, the Swedish Re- search Council, the Swedish Rescue Services Agency, the Swed- actually cause harm, in part based on exposure4? ish Road Administration, and the UK Department for Business To be clear hazard assessment and risk assessment Innovation and Skills.
are not mutually exclusive. In order to assess risks, J. McCormick, Environmental Policy in the European Union (Basingstoke, UK: Palgrave 2001); A. Alemanno, Trade in Food it is necessary to first understand the hazard, so – Regulatory and Judicial Approaches in the EU and the WTO advocates of risk-based regulation are dependent on (London: Cameron May 2007).
hazard classification taking place. The key compo- K. Nordlander, C. Simon, and H. Pearson, "Hazard vs Risk in EU Chemical Regulation", 1 European Journal of Risk Regulation nent of the debate centres around whether regula- (2010), pp. 239–250.
tory decision-making can/should be based on haz- UK Royal Society, Risk: Analysis, Perception, Management (Lon- ard classification alone, eschewing risk assessment. don: Royal Society 1992).
From an economics perspective, decision making This paper focuses specifically on approaches to regulation of in- dustrial chemicals rather than providing a broad brush approach on the basis of just hazard classification usually ig- examining European regulation.
nores impact assessment, which is a distinct factor For an in-depth historic account of how regulations are devel- and in so doing often contributes to poor regulatory oped in Europe please look at G. Majone (ed.), Regulating Eu- rope (London: Routledge 1996).
EJRR 2-2011 Inhalt.indd 149 20.05.2011 09:15:49 Symposium on Risk versus Hazard Some environmental non-governmental organi- Nations Food Agricultural Organisation (FAO) and sations (NGOs) and environmental lobby groups the World Health Organisation (WHO)11.
denounce risk assessments and argue for more haz- In other European nations, however, the use of ard-based controls. For example, the International hazard classifications has dominated the regulatory Chemical Secretariat, one such NGO based in Goth- discussions. Particularly interesting was the decision enburg, Sweden, argues against risk assessment not- to use hazard classifications in the formulation of Sweden's goal to develop a toxic-free society by the "The basis for risk assessment is the un-scientific belief year 202012, as it arguably served as a basis for the that risk can be foreseen and controlled. In an infinitely development of the European Union's (EU) Chemical complex system, such as chemicals, the risk is simply White Paper of 200113 14 15.
impossible to anticipate.6" The first significant use of risk assessment in the EU was associated with the 1993 Existing Substances It is clear that in Europe there has been a rather long, Regulation16. However, arguably it did not grow in and at times acrimonious discussion, as to the mer- popularity until the early part of this century follow- its of risk assessments for regulatory purposes es- ing the Commission's publication of its Communi- pecially with regard to chemical substances. Indeed cation on the precautionary principle17. This was in until the early 1990s neither risk assessment nor risk part due to the need to regain regulatory legitimacy management featured in European law7. In the case in Europe following considerable criticism18 19, as C-180/96 UK v. Commission in 1998, for example, well as to proactively address the call for harmonisa- there was no mention of the term risk assessment8. tion of this and related risk-based tools by the World During the 1980s and 1990s some Member States Trade Organisation's (WTO) Agreement on Sanitary eagerly adopted the risk assessment methodology. In and Phytosanitary Standards20. Indeed in that same 1995, for example, the Health Council of the Neth- year the European Commission published its path erlands took the view that risk assessment was an breaking study First Report on the Harmonisation of integral part of the policy-making process9. Risk as- Risk Assessment Procedures which had an aim to: sessment as a key policy-making tool was accepted "…promote an active debate on current practices for in the early 1980s in the UK and made more popular risk assessment used by the Scientific Committees of due to the seminal 1983 Royal Society study on the DG SANCO and to make proposals for developing con- topic10. Similarly, regulatory agencies in a number vergent approaches which will aid harmonisation21". of smaller Member States came to accept risk assess-ment methodologies and most of these now follow The use of risk assessments and science-based risk the risk assessment guidelines outlined by the United management tools began to gain further ground in International Chemical Secretariat, "Risk vs hazard", available on 14 R. Lofstedt, "Swedish Chemical Regulation: An Overview and the Internet at <www.chemsec.org/chemsec/the-toxic-issue/risk- Analysis", 23 Risk Analysis (2003), pp. 411–421.
vs-hazard> (last accessed on 31 March 2011).
15 I. Schorling, "The Green's Perspective on EU Chemicals Regu- European Council, "Council Regulation (EEC) no 793/93 of 13th lation and the White Paper", 23 Risk Analysis (2003), pp. 405– March 1993 on the evaluation and control of the risks of existing 16 European Council, "Council Regulation (EEC) no 793/93 of 13th E. Fisher, "Risk, Regulatory Concepts and the Law", in OECD March 1993 on the evaluation and control of the risks of existing (eds), Risk and Regulatory Policy: Improving the Governance of substances", supra note 7.
Risk (Paris: OECD 2010).
17 European Commission, "Communication from the Commis- Health Council of the Netherlands, Not All Risks are Equal, Pub- sion on the Precautionary Principle" (Brussels: COM 2000 1 lication No. 1995 06E, Committee on Risk Measures and Risk As- sessment (The Hague: Health Council of the Netherlands 1995).
10 UK Royal Society, Risk Assessment (London: The Royal Society 18 E. Fisher, "The Rise of the Risk Commonwealth and the Challenge for Administrative Law", 30 Public Law (2003), pp. 455–478.
Application of Risk Analysis to Food Standard Issues. 19 G. Majone, Dilemmas of European Integration: The Ambiguities Report of the Joint FAO/WHO Expert Consultation (Rome and and Pitfalls of Integration by Stealth (Oxford: Oxford University Geneva: FAO/WHO 1995).
Press 2005).
12 Swedish Cabinet Bill, Svenska Miljomal: Miljopolitik for ett hall- 20 European Commission, "Communication from the Commission bart Sverige [1997/1998 145] (Stockholm: Riksdagen 1997).
on the Precautionary Principle", supra note 17.
13 European Commission, White Paper: Strategy for a future chemi- 21 European Commission, "First Report on the Harmonisation of cals policy (Brussels: COM 2001 88 Final).
Risk Assessment Procedures" (Brussels: DG SANCO), p. 6.
EJRR 2-2011 Inhalt.indd 150 20.05.2011 09:15:50 Symposium on Risk versus Hazard 2002 with the growing popularity of the so-called sessment within the European food sector involving "Better Regulation Agenda" and with it the use of academics, stakeholders, regulators and industry26. regulatory impact assessments (RIAs). These were These discussions have not spread widely to other seen as mechanisms to reduce regulatory burdens regulatory domains, however. There has, for example, within the Commission and elsewhere22. In the same been limited case law discussing the use of risk as- year the Commission adopted the General Food Law sessment and management tools in setting regulation (GFL)23. The GFL followed the Commission's White in the non food sector, with the Pfizer, Alpha Pharma Paper on Food Safety, which in turn was prompt- and Gowan cases being notable exceptions27 28.
ed by a number of food scandals, most notably the spread of BSE (mad cow disease) in Europe. It called In Europe, many food, pharmaceutical and health for the separation of risk assessment from the risk- regulators as well as policy makers are concerned management process as a way to regain the trust of about basing regulations on hazard classifications European food consumers24. This risk assessment/ and implementing them via tools such as the pre- management separation led to the establishment of cautionary principle "better safe than sorry"29. As the European Food Safety Authority (EFSA). Since the House of Lords Select Committee on Economic 2002 this Authority has become the eminent scien- Affairs argued in 2006: tific risk-assessment authority for food policy issues "In our view, the use of ill-defined and ambiguous in Europe and has been involved in a number of con- terms in risk management and regulatory documents troversial issues ranging from genetically modified is generally unhelpful. There is a danger that they can foods to Bisphenol A25. As a result there has been induce an excessively cautious attitude to risk"30. a rich and far ranging discussion regarding risk as- Similarly the UK House of Commons Science and Technology Select Committee took the view: 22 For a useful discussion see R. Lofstedt, "The Swing of the Reg- "We believe that it is best to use the term precaution- ulatory Pendulum in Europe: From Precautionary Principle to ary approach, but with a consistent explanation of the (Regulatory) Impact Analysis", 28 Journal of Risk and Uncertainty (2004), pp. 237–260.
degree and nature of the risks, benefits and uncertainty 23 European Council, "Regulation (EC) No 2002/178 of the European and an explanation of the concept of proportionality. Parliament and the Council of 28th January 2002 laying down the It should never be considered a substitute for thorough general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in risk analysis which is always required when the science the matters of food safety" (Brussels: European Council 2002).
is uncertain and the risks serious"31. 24 E. Vos and F. Wendler, "Food Safety Regulation at the EU Level", in E. Vos and F. Wendler (eds), Food Safety Regulation in Europe German policy makers working in the food area also 25 M. van Asselt and E. Vos, "Wrestling with Uncertain Risks: EU view risk assessment as an integral part of the risk Regulation of GMOs and the Uncertainty Paradox", 11 Journal management process. As one policy maker noted: of Risk Research (2008), pp. 281–300.
"I have my doubts as to whether you can take informed 26 M. Dreyer and O. Renn, Food Safety Governance: Integrating Sci- management decisions if you don't have relevant ence, Precaution and Public Involvement (Berlin: Springer 2009).
knowledge, i.e. no competence in risk assessment … you 27 See, for example, E. Vos, "Antibiotics, the Precautionary Princi- ple, and the Court of First Instance", 11 Maastricht Journal (2004), just can't take management decisions without having sufficiently detailed knowledge on risk assessment.32" 28 The Pfizer and Alpharma judgments dealt with animal health is- sues while the Gowan judgment was triggered by the authoriza- tion process of a plant protection product.
Many environmental regulators and Green politi- 29 UK HM Treasury, Reducing Administrative Burdens: Effective cians, however, do not share this view. They see risk Inspections and Enforcements ((The Hampton Review) London: assessments as inherently complex, non scientific HM Treasury 2005).
and costly, and contend that regulations should be 30 UK House of Lords, Select Committee on Economic Affairs, Gov- ernment Policy on the Management of Risk, Volume 1 report based on hazard assessments and substitution prin- (London: The Stationary Office 2006), p. 25.
ciples. Inger Schorling, who for 10 years served as a 31 UK House of Commons, Science and Technology Committee, Swedish Green MEP has argued: Scientific Advice, Risk and Evidence Based Policy Making, Vol- ume 1 (London: The Stationary Office 2006), p. 83.
"The only reasonable goal is to make the environment 32 This quote can be found in M. Dressel, S. Bochen, M. Schneider, free from dangerous man-made chemicals and to try to W. Viehover, M. Wastian and F. Wendler, "Food Safety Regula- keep the levels of metals close to natural levels. When tion in Germany", in E. Vos and F. Wendler (eds), Food Safety Regulation in Europe (Antwerpen: Intersentia 2006), p. 318.
there is a risk, the precautionary principle should be EJRR 2-2011 Inhalt.indd 151 20.05.2011 09:15:50 Symposium on Risk versus Hazard used. This means that the chemicals industry also has This article attempts to answer these questions by ex- a special responsibility. They should stop producing amining in some detail two case studies namely: the persistent and bioaccumulating chemicals and try to phase-out of certain brominated flame retardants (in particular deca-BDE) and the partial ban of bisphenol A (BPA) first in Denmark and France and then in the EU as a whole from 2011. This study is based on 1. Why these differences? reviews of relevant academic articles on these three topics, a survey of the grey literature, most notably Food and pharmaceutical regulators have a much policy statements and background reports from the narrower mandate compared to their environmental European Chemicals Agency (ECHA), European counterparts who operate in a very broad domain Commission (in particular DG SANCO), European focusing on human and environmental risks in the Food Safety Authority (EFSA), the Swedish Chemi- air, water and land domains34.
cal Agency and the Swedish Food Administration as In terms of influence, budgets and policy interest well as interviews with regulators, academics, policy there have been historically huge differences between makers, politicians and other stakeholders in Berlin, these two areas. In Germany, for example, the state Brussels, Copenhagen, Helsinki, London, Madrid, established its first food regulator in 1876 (Kaiserli- Maastricht, Paris, and Stockholm. The majority of ches Gesundheitsamt) while the first national envi- the research was conducted in the period between ronment agency in that country did not come into April and November 2010. In total forty-five expert existence until 1971 following the passage of the interviews were conducted36.
German Environmental Programme35. In addition, food and pharma regulators have generally had much bigger operational and research and development II. Background – risk vs hazard
budgets than their environmental counterparts. In other words, quite rationally, people have preferred What are some of the criticisms of risk assessments spending funds on protecting human health from and hazard classifications and how long have they direct exposure to substances rather than making en- been used in influencing policy making? These ques- vironmental improvements. Is there any wonder that tions are addressed in this section environmental regulators with limited budgets and less political power overall will use the cheaper, and thereby more efficient, hazard classifications and the 1. A brief history of risk assessment precautionary principle as a basis to justify the ban-ning of certain chemicals, metals and other materials? The tools and ideas used in risk assessment have been around for millennia, determining everything to whether housing in Babylon was safe, to estimat- 2. Risk versus hazard: The key research This study tries to address the following issues: 33 I. Schorling, "This Book: The Only Planet", in I. Schorling and G. Lind, The Only Planet Guide to the Secrets of Chemicals Policy in a) How rigorously are the various European and na- the EU: REACH What happened and Why? (Brussels: European tional bodies using scientifically-based risk analy- Parliament, The Green/European Free Alliance 2004), p. 3.
34 In addition one could argue that assessing risks from substances that are directly ingested (via food or as a medicine) is less com- b) Which European regulators, either at the EU or plex than evaluating exposure to substances via the environment.
national level really favour risk assessments over 35 R. Wurzel, Environmental Policy Making in Britain, Germany and hazard classifications and what are the regulatory the European Union (Manchester: Manchester University Press trends in the environment and food area? 36 These interviews were not recorded but summarized after the c) Do these various regulatory bodies have differ- meeting in question. The information gleaned from them was ent views on the use of risk vis-à-vis hazard than primarily used to assist the author to gain a wider understanding of the regulatory environment in the country or agency in ques- politicians – Members of the European Parliament tion. When a regulatory or policy maker was quoted in the text or MPs and Ministers in the respective Member below, this was done so anonymously. Prior to scientific peer re- view the draft article was sent to the regulators and policy mak- ers who were interviewed to ensure factual correctness.
EJRR 2-2011 Inhalt.indd 152 20.05.2011 09:15:50 Symposium on Risk versus Hazard ing shipping loss in the middle-ages and understand- sifying and packaging dangerous substances and ing the probability of gambling37. It did not start to the 1973 Swedish Act on hazardous chemical prod- gain regulatory importance until the 1950s, however, ucts41. In recent years hazard classifications have when it was seen as a useful tool in predicting failure increased in popularity within the environmental of space bound vessels, as well as understanding the arena where it is used in some European Member safety of nuclear power stations and chemical plants, States as a reason to ban certain chemicals and met- work place safety, public health and environmental als on the basis that they are endocrine disruptive, hazards38. Today risk assessments, based on toxico- bio-accumulative or cause cancer. In this regard logical and or epidemiological data, are used as a ba- regulators find that hazard classifications are cost sis for many environmental and health regulations effective and efficient for banning entire lines of throughout the world39.
chemicals42. The Danish prohibition of Pentachlo-rophenol (PCP)43, the Swedish decision to aim for a toxic-free society by the year 202044, the Danish 2. History of hazard classification and French bans and the EU proposed ban of bis-phenol A from baby bottles are all based on hazard The use of hazard classifications for the setting of regulation has been around for several hundreds of years. It served as a basis for setting chemical con-trol laws in Sweden in 1756, for example40, and has 3. Confusing risk with hazard been increasingly used in Europe during the second half of the 20th century, including the 1967 Europe- What makes the discussion rather more complicat- an Council Directive (67/548/EEC) on labelling, clas- ed, however, is that the public and many stakehold-ers confuse the terms risk and hazard, particularly when applied to chemicals45. In a detailed study by Peter Wiedemann and his colleagues for the Ger- 37 P. Bernstein, Against the Gods: The Remarkable Story of Risk (New York: John Wiley and Sons 1996).
man Federal Risk Assessment Bureau, more than 38 For an in-depth discussion please see D. Paustenbach (ed.), Hu- 80 % of German respondents confused the terms46. man and Ecological Risk Assessment: Theory and Practice (New This is further complicated by the fact that most York: John Wiley and Sons 2002).
of the research done in the field of risk analysis is 39 US National Research Council, Science and Decisions: Advanc- ing Risk Assessment (Washington DC: National Academy Press primarily American in origin. Until recently, 90 % of all research in the risk field was carried out in the 40 M. Karlsson, "The Precautionary Principle, Swedish Chemicals United States for public and private bodies47. As a Policy and Sustainable Development", 9 Journal of Risk Research (2006), pp. 337–360.
result the whole language around risk assessment is 41 T. Christoforu, "The Precautionary Principle, Risk Assessment, grounded in English, where there is a clear linguis- and the Comparative Role of Science in the European Commu- tic distinction between risk and hazard. That cru- nity and the US Legal Systems", in N. Vig and M. Faure (eds), Green Giants: Environmental Policies in the United States and cial linguistic distinction is not the same in Dutch, the European Union (Cambridge, MA: MIT Press 2004).
German or in Swedish, for example, which leads to 42 Swedish Committee on New Guidelines on Chemicals Policy, greater confusion. As a case in point, the Swedish Non Hazardous Products: Proposals for Implementation of New language does not have an expression for hazard, Guidelines on Chemicals Policy [SOU 2000:53] (Stockholm: Fritzes 2000).
but rather the closest word is "fara" which means 43 96/211/EC, "Commission Decision of 26th February 1996 con- cerning prohibition of pentachlorophenol (PCP) notified by Den- mark", Official Journal LO 68,19/03/1996, 0032-0040.
44 Lofstedt, "Swedish Chemical Regulation: An Overview and Anal- ysis", supra note 14.
4. Criticisms of risk and hazard 45 M. Tyshenko, K. Pillips, M. Mehta, R. Poirer, and W. Leiss, "Risk Communication of Endocrine-Disrupting Chemicals: Improving One of the main problems with hazard classifica- Knowledge, Translation and Transfer", 11 Journal of Toxicology and Environmental Health Part B (2008), pp. 345–350.
tions are that they are only one initial part of the 46 E. Ulbig, R. Hertel and G. Bol (eds), Evaluation of Communica- risk analysis process. That is to say, policy makers tion on the Differences between "Risk" and "Hazard" (Berlin: can take the decision to ban certain chemicals and Federal Institute for Risk Assessment 2010).
metals on the assumption or idea that they may be 47 G. Majone, "Dilemmas of European Integration: The Ambiguities and Pitfalls of Integration by Stealth", supra note 19.
hazardous without testing whether this is actually EJRR 2-2011 Inhalt.indd 153 20.05.2011 09:15:50 Symposium on Risk versus Hazard the case48. Obviously, hazard assessments are quick- cialists interviewed will have a basic understand- er and cheaper to implement, but in the long term ing of the topic at hand? they can have significant consequences as they tend to ignore risk-risk tradeoffs49.
Based on these criteria the following case studies Risk assessment has its problems too. In effect were selected: Bisphenol A and the Brominated flame both risk assessments and risk management strategies retardant Deca-BDE. After an initial set of interviews limit the power of the administrator. By arguing for with the UK Food Standards Agency and the UK these tools, administrators establish de-facto scientific Health and Safety Executive (the UK competent boundaries for what they can and cannot regulate50. authority for REACH) it was clear that policy mak- In other words, policy makers may have less freedom ers and regulators felt comfortable discussing these to politically regulate in a world where risk assessment cases. Each case study is divided into three distinct and management tools are used. In addition, histori- sections: background, political and NGO attention cally risk assessments have been based on a wide array and risk or hazard issue? of different methodologies leading in turn to different outcomes, which decrease their usefulness in terms of predictability51. Other critics of the model feel that the narrowness of the focus, often limited to what can be measured quantitatively52, ensures that the is- sues that cannot be measured in this way (e.g. human values) are ignored53. Although risk assessments are Bisphenol A, or BPA, is a human-made chemical more comprehensive to their very nature than hazard used in the manufacture of plastics, that was first classifications, they are not always pure scientific af- developed in 189157. It was initially intended as a fairs. In cases when there are high levels of scientific useful synthetic oestrogen hormone to help women uncertainty, expert judgements are often used, which with a wide range of female sexual fertility issues58. in turn can at times be incorrect54. Finally, as risk as- By the early 1950s scientists were using BPA for sessment are often expensive and time consuming, critics argue that they can be open to abuse by exter-nal bodies who may benefit from delay – for example, 48 D. Paustenbach, "Human and Ecological Risk Assessment: The- by injecting some form of scientific uncertainty they ory and Practice", supra note 38.
can delay regulation yet further. This does not there- 49 J. Graham and J. Wiener, Risk vs Risk: Tradeoffs in Protecting Health and the Environment (Cambridge, MA: Harvard Univer- fore necessarily lead to better regulatory decisions55 56.
sity Press 1995).
50 J. Applegate, "A Beginning Not an End in Itself: The Role of Risk Assessment in Environmental Decision Making", 63 University III. The two case studies
of Cincinnati Law Review (1995), pp. 1643–1678.
51 P. Montague, "Reducing the Harms Associated with Risk Assess- ments", 24 Environmental Impact Assessment Review (2004), To address the question of how European and nation- pp. 733–748.
al authorities actually regulate risk, two case studies 52 W.K. Viscusi, Rational Risk Policy (New York: Oxford University were selected for examination following discussions Press 1998).
with policy makers and regulators in both Brussels 53 B. Ackerman and L. Heinzerling, Priceless: On Knowing the Price of Everything and the Value of Nothing (New York: The New Press and London. Selection was based on the following 54 D. Michaels, Doubt is Their Product: How Industry's Assault on a) Is the case in question "European" in scope? That Science Threatens your Health (New York: Oxford University Press 2008).
is has it been discussed in multiple Member States 55 T. McGarity and W. Wagner, Bending Science: How Special In- as well as within the European Commission? terests Corrupt Public Health Research (Cambridge, MA: Harvard b) Is it comparatively easy to get data on the case? Is University Press 2008).
there information in the public domain that can 56 W. Wagner, "The Science Charade in Toxic Risk Regulation", 95 Columbia Law Review, pp. 1613–1720.
be gathered and analysed? 57 For a good policy overview on BPA see A. Alemanno, "The Fab- c) Are policy makers, stakeholders and regulators ulous Destiny of Bisphenol A (BPA)", 1 European Journal of Risk willing to speak about the case in question? and Regulation (2010), pp. 397–400.
d) Have the selected case studies received at least 58 S.A. Vogel, "The Politics of Plastics: The Making and Unmaking of Bisphenol A ‘Safety'", 99 American Journal of Public Health, some media attention, ensuring that the non spe- S3, pp. 559–566.
EJRR 2-2011 Inhalt.indd 154 20.05.2011 09:15:50 Symposium on Risk versus Hazard the manufacture of epoxy resins. These resins were findings. His first paper on the topic, published in turned into long lasting and durable coatings found 1997, indicated higher than anticipated oestrogen re- on anything from steel drums to false teeth. By 1957 sponses63. Since this initial study, Dr. vom Saal and chemists were using BPA in the manufacturing of his colleagues at the University of Missouri have car- hard, transparent, and rather heat resistant plastic ried out a number of small scale studies on mice (and material called polycarbonate to replace glass con- more recently in-vitro) examining how they respond tainers for food and electronic products, including to low doses of BPA. To date the majority of these baby bottles59. The epoxy resins found in packaging studies have not been replicated by other research- materials serve a variety of purposes. They act as a ers64. Most of these studies were carried out on a protective lining on the inside of metal-based food small number of mice and did not therefore meet and beverage cans, halting the corrosion of cans and the Organisation for Economic Cooperation and De- limiting the contamination of foods. When used in velopment (OECD) defined Good Laboratory Practice bottles polycarbonate can increase heat resistance (GLP). However, they indicate that very low levels of and durability. Most studies indicate that BPA in exposure to BPA, via injection into the blood stream food packaging provides high level of food safety of mice or (less often) given to them orally, may have and value to food supply60.
significant health effects including reproductive ab- The controversy surrounding BPA began in the normalities, obesity, breast and prostate cancer and early 1990s when a number of researchers at Stan- neurobehavioral problems in mice65 66.
ford University in the United States realised that the The studies by vom Saal and his colleagues did not chemical was migrating from the plastic (polycarbon- initially change the regulatory policy climate regard- ate) laboratory bottles into the water that they were ing the safety of BPA. Regulators in the US (the FDA using61. This sparked concern that BPA might be mi- in particular) and elsewhere (e.g. the European Food grating from packaging used for consumer products Safety Authority (EFSA) examined the research find- and that BPA, similar to other artificial and natural ings but viewed them as somewhat unreliable67. They hormones (e.g. female birth-control pills), might also suffered from a combination of lack of reproducibil- be an endocrine disrupter. At this time, endocrine ity and small sample sizes. The studies focused on disruption was starting to be much discussed in both low doses and primarily addressed injection into the the US and Europe by policy makers, regulators and blood stream rather than oral administration, which academics following the publication of a number of may have better reflected real-world consumption68. books and articles, most notably Our Stolen Future62. The supposed level of BPA uptake is significantly dif- One researcher who is highly active in the field of ferent depending on the method of administration. endocrine disruption is Dr. Frederic vom Saal of the For example, after reviewing the research conducted University of Missouri, who began testing artificial by vom Saal and his colleagues, EFSA's BPA 2008 oestrogens, including BPA, following the Stanford panel took the view that BPA is safer than initially 59 K. Aschenberger, P. Castello, E. Hoekstra, S. Karakitsios, S. Munn, guidelines requiring appropriate positive controls in endocrine dis- S. Pakalin, and D. Sarigiannis, Bisphenol A and Baby Bottles: Chal- ruption research' by vom Saal", 115 Toxicological Sciences (2010), lenges and Perspectives (Ispra: European Commission, Joint Re- pp. 614–620.
search Centre 2010).
65 Vogel, "The Politics of Plastics: The Making and Unmaking of Bi- 60 For a good review see K. Aschenberger et al., Bisphenol A and sphenol A ‘Safety'", supra note 58.
Baby Bottles: Challenges and Perspectives, supra note 59.
66 F. vom Saal and C. Huges, "An Extensive New Literature Concern- 61 A. Krishnan, P. Strathis, S. Permuth, L. Tikes, and D. Feldman, "Bis- ing Low-Dose Effects of Bisphenol A shows the Need for a New phenol A: An Estrogenic Substance is Released from Polycarbonate Risk Assessment", 113 Environmental Health Perspectives (2005), Flasks during Autoclaving", 132 Endocrinology (1993), pp. 2279–2286.
pp. 926–933.
62 T. Colborn, D. Dumanoski and J. Myers, Our Stolen Future (New 67 EFSA examined the research findings surrounding Bisphenol A on York: Penguin Books 1996).
three separate occasions, most recently in 2010, eg., EFSA, "Sci- 63 S. Nagel, F. vom Saal, K. Thayer, M. Boechler and W. Welshons, entific opinion of Bisphenol A; Evaluation of a study investigating "Relative Binding Affinity: Serum Modified Access (RBA-SMA) As- its neurodevelopmental toxicity, review of recent scientific litera- say Predicts the Relative in Vivo Bioactivity of the Xenoestrogens ture on its toxicity and advice on the Danish risk assessment of Bisphenol A and Octylphenol", 105 Environmental Health Perspec- Bisphenol A", 1829 EFSA Journal (2010), pp.1–110.
tives (1997), pp. 70–76.
68 T. Butterworth, Science Suppressed: How America Became Ob- 64 See, for example, L. Gray jr., B. Ryan, A. Hotchkiss and K. Croft- sessed with BPA (Washington DC: George Mason University's on, "Rebuttal of ‘flawed experimental design reveals the need for Center for Health and Risk Communication STATS 2009).
EJRR 2-2011 Inhalt.indd 155 20.05.2011 09:15:50 Symposium on Risk versus Hazard thought and suggested increasing the daily safety ratory studies75. Prior to the EFSA ruling, a letter threshold of consumption by a factor of five69.
authored by vom Saal and Breast Cancer UK, and Similarly two large studies, including one from signed by 60 scientists and international environ- Harvard University, question the validity of vom ment, health, and women's organisations to the EFSA Saal's findings. They note that they are inconsistent on the 23rd June 2010, asked the Agency to push for and there are therefore doubts as to whether there a ban of the chemical noting: are any real functional or physical impairments "action is necessary to reduce the levels of Bisphenol-A caused by BPA administered to mice70 71. Vom Saal exposure, particularly in groups at highest risk, namely and Hughes have in turn questioned these find- young infants and pregnant mothers76. Environmental groups and a number of academ- The issue is complicated by the fact that the oppo- ics have taken the view that vom Saal's findings are nents to BPA continue to attack scientific findings correct and that the findings of other academics, in- that do not agree with the earlier low dose findings, dustry, and the regulators are simply wrong. This ar- taking the view that regulatory agencies base their gument became cemented in 2006 when 38 experts decisions on outdated guidelines that were estab- working on endocrine disrupters, led by vom Saal, lished 50 years ago77.
met in Chapel Hill, North Carolina and put forward In addition, in 2010 there was a heated debate in a consensus statement arguing that the levels of BPA the journal Toxicological Sciences regarding the ef- at concentrations found in the human body corre- fects of BPA as an endocrine disrupter in rats. One three-year study showed that feeding pregnant rats "organisational changes in prostate, breast, testis, BPA at doses 4000 times higher than the maximum mammary glands, body size, brain structure and exposure to humans produced no adverse effects; chemistry, and behaviour of laboratory animals.73" while the positive control group of pregnant rats fed with the synthetic oestrogen used in birth controls This consensus statement combined with vom Saal's active media work and outcries from some environ-mental groups started to change the nature of the 69 EFSA, "Scientific opinion of the panel on food additives, flavour- debate regarding the safety of BPA.
ings, processing aids and materials in contact with food (AFC) re- By mid 2008, several policy makers responding to lated to toxicokinetics of Bisphenol A. Question EFSA –Q-2008- 382", 759 EFSA Journal (2008), pp. 1–10.
expressions of public concern and media pressures, 70 J. Goodman, E. McConnell, I. Sipes et al., "An Updated Weight began arguing for local and country-wide bans of of the Evidence Evaluation of Reproductive and Developmental BPA-containing plastics. In October 2008, following Effects of Low Doses of Bisphenol A", 26 Critical Review of Toxi- cology 2006, pp. 387–457.
a number of critical BPA articles in the Toronto Globe and Mail referencing the work of vom Saal and oth- 71 G. Gray, J. Cohen, G. Cunha et al., "Weight of the Evidence Eval- uation of Low-Dose Reproductive and Developmental Effects ers, Health Canada (the Canadian food and health of Bisphenol A", 10 Human Ecological Risk Assessment (2004), regulator) took the ground breaking decision to ban pp. 875–921.
BPA from baby bottles citing the precautionary prin- 72 Vom Saal and Hughes, "An Extensive New Literature Concern- ing Low-Dose Effects of Bisphenol A shows the Need for a New Risk Assessment", supra note 66.
Following the baby bottle ban in Canada, in- 73 F. vom Saal, B. Akingbemi, S. Belcher et al., "Chapel Hill Bisphe- creased pressure was put on the European bodies to nol A Expert Panel Consensus Statement: Integration of Mecha- nisms, Effects in Animals and Potential to Impact Human Health at ban BPA-containing plastic containers used by small Current Levels of Exposure", 24 Reproductive Toxicology, p. 134.
children as well. Due in part to the international pres- 74 Health Canada, "Government of Canada protects families with sure there have been five scientific evaluations of the bisphenol A regulations", Press release from Health Canada on safety of BPA in Europe all indicating that the dan- 75 See, for example, Vogel, "The Politics of Plastics: The Making gers of BPA leaching out from baby bottles and other and Unmaking of Bisphenol A ‘safety'", supra note 58.
mechanisms have been overstated.
76 A. Carterbow, "Joint action of NGOs and scientists to call for This, however, has not stopped critics from ques- a reduction of BPA exposure, especially for children and preg- nant women" (Brussels: Women in Europe for a Common Future tioning the EFSA's findings. They argue, for example, that they do not take into account the low dose (non 77 F. vom Saal, B. Akingbemi, S. Belcher et al., "Flawed Experimental GLP) studies carried out by vom Saal that appear to Design Reveals the Need for Guidelines Requiring Appropriate Positive Controls in Endocrine Disruption Research", 115 Toxi- show that BPA can have effects on rodents in labo- cological Sciences (2010), pp. 612–613.
EJRR 2-2011 Inhalt.indd 156 20.05.2011 09:15:51 Symposium on Risk versus Hazard did78. This study was attacked by vom Saal et al for were the same that led Denmark to impose the above having a flawed study design – the rats were insen- mentioned temporary ban on BPA in food contact sitive to low dose oestrogens79. The study authors materials for children ages 0–3 years of age. On the challenged this, noting that science is about replicat- 30th September 2010, the EFSA published its evalua- ing studies in order to verify them, and if this is not tion of these studies and concluded that no research possible then the original science was incorrect80.
could be identified that would lead to a revision of In spring 2010 Denmark put forward a temporary the current tolerable daily intake (TDI) levels based national ban on BPA in materials that are in contact on a No-Observed-Adverse-Effect-Level (NOAEL) of with food for children aged 0–3 years of age. The ban 0,05 mg/kg b.w./day from a multi-generational repro- came into effect on July 1st 2010. In France on the 25th ductive study carried out on rats82. This opinion was March 2010, the Senate forwarded a draft law to the questioned by both stakeholders and representatives National Assembly prohibiting the manufacture, im- from Denmark and France who noted that their bans portation or exportation of baby bottles, which was would remain in place. Per Rosander of the Interna- approved in May 2010. In the summer of 2010 the tional Chemical Secretariat argued: Swedish Environmental Minister, Andreas Carlgren, "The EFSA decision is very unsatisfactory. There are asked the Swedish Chemicals Agency to develop a a large number of studies showing health risks with proposal on how to best design a ban on BPA in baby BPA.83". bottles and other plastic products noting that:"It is unacceptable that young children are exposed to Following the EFSA decision, the EU risk manage- the risks that have been proven to be associated with ment authority for food and consumer affairs (DG bisphenol A, especially when changing to alternative SANCO) instigated a discussion with EU Member materials is easy. This is why we are now making the States on how to best minimise exposure of infants first move by preparing a national ban.81" to BPA focusing on the possibility of a ban. On the 26th November the Standing Committee on the Food This Swedish analysis will be completed no later Chain and Animal Health voted in favour of the than 31st of March 2011. In 2009 the EFSA was asked Commission's proposal for a Directive that would once again to re-evaluate the safety of BPA, follow- ban BPA from plastic infant feeding bottles. This ban ing a number of studies, notably Stump et al 2009, will go in effect as of mid 2011with Commissioner which examined a link between BPA in diets and Dalli justifying it by arguing: development of neurotoxicity in rats. These studies "… In the view of the recent opinion of EFSA, I had stressed that there were areas of uncertainty, deriv-ing from new studies, which showed that BPA might 78 B. Ryan, A. Hotchkiss, K. Crifton and L. Gray Jr., "In Utero and have an effect on the development, immune response Lactational Exposure to Bisphenol A, in Contrast to Ethinyl Estra- or tumour promotion. The decision taken today is good diol, does not alter Sexually Dimporphic Behaviour, Fertility, and Anatomy of female LE Rats", 115 Toxicological Sciences (2010), news for European parents who can be sure that as of pp. 133–148.
mid -2011 plastic infant feeding bottles will not contain 79 Vom Saal et al., "Flawed Experimental Design Reveals the Need BPA84. (Dalli in European Commission 2010) for Guidelines Requiring Appropriate Positive Controls in Endo- crine Disruption Research", supra note 77.
et al., "Rebuttal of ‘Flawed Experimental Design Reveals the Need for Guidelines Requiring Appropriate Positive Design Controls in Endocrine Disruption Research' by vom Saal", supra b. Political and public outcry 81 Quote from Andreas Carlgren comes from a press release issued In Europe BPA is a "hot" political topic, although the by the Swedish Ministry for the Environment, "Government pre- extent varies across Member States. Clearly the topic paring a national ban on bisphenol A in baby bottles", 29 July is hotter in Denmark than in the UK, for example, 82 EFSA, "Scientific opinion on bisphenol A", supra note 67.
even though Breast Cancer UK is trying to widen its 83 Quote from Per Rosander comes from a press release issued by campaigning credentials by pushing for an anti BPA the International Chemical Secretariat, "EFSA fails to lower EU platform. And one of the main drivers for national limit on BPA and protect the health of EU's citizens", 8 October bans on BPA is politics. In Denmark, for example, it 84 Quote from Commissioner Dalli is taken from a press release is- was the far right People's Party (Dansk Folkeparti) sued by the European Commission, "Bisphenol A: Commission that helped to hold up the centre-right coalition and welcomes ban in baby bottles by Member States", 26th Novem- pushed for a ban on BPA in baby bottles in order EJRR 2-2011 Inhalt.indd 157 20.05.2011 09:15:51 Symposium on Risk versus Hazard to attract votes85. Similarly in Sweden, Carlgren's these substances (plastics for example are mostly pet- announcement on the 29th July occurred in the run rol-based products) in combination with the fact that up to a national election (19th September 2010). In they are often located near or part of heat and elec- France the discussion surrounding BPA is the brain tricity sources (e.g. televisions and computers) there child of the French politician Yvonne Collin, of the has been a significant amount of legislation introduc- Parti Radical de Gauche. Surprisingly, the debate sur- ing ever stricter fire safety requirements associated rounding BPA has not received much EU-wide media with the use of these appliances and other products. attention. There was a series of "scare" articles in the One of the most popular ways to satisfy these re- UK Independent in May 2010 attempting to get BPA quirements is through the use of flame retardants, on the national policy agenda, but these were not and of these brominated types account for 32 % of picked up by the other more influential media and all those used88. The popularity of brominated flame soon fizzled out. Similarly the debate on BPA in Scan- retardants (BFRs) is down to their inherent thermal dinavia has been largely muted. As one Swedish food stability, overall strong performance (compared to the alternatives) and cost effectiveness89.
"This has been a political rather than a media issue. As modern day flame retardants are found in a The main newspapers have been rather quiet about wide array of products, both in homes and busi- BPA, and it was only one of the tabloids that ran a nesses, they are widely dispersed. Because they can front page cover story in August regarding the high be removed through leaching, abrasion or volatilisa- levels of BPA found on shopping receipts." (Swedish tion, and are inherently stable – they are designed to Food regulator, September 2010). last for the life time of a product, they can, albeit in small amounts, be found more or less anywhere90. To make matters worse, some flame retardants are c. Risk versus hazard and BPA bio-accumulative91. As a result there are health and environmental concerns regarding the use of flame The discussions surrounding how to best regulate retardants, particularly brominated ones. These are BPA have been largely based on a debate around particularly stable and have a high affinity for fats whether to use risk or hazard classifications. Some compared to other flame retardants, tending towards regulators that have established controls based on a greater degree of bio-accumulation92. These con- data produced by small non-GLP studies86, rather cerns have led to generalisations made about bromi- than large conclusive ones, using the argument that the substance is an endocrine disruptor and there-fore can cause a hazard. This hazard classification 85 Please see press release from the Dansk Folkeparti, "DF sikrer forbud mod Bisphenol A I sutteflasker", 26th March, 2010.
is in their view sufficient for a ban. However, other regulators, most notably the EFSA and the UK Food 86 For an illuminating discussion on the pros and cons of GLP, please see R. Alcock, B. MacGillivray and J. Busby, "Understanding the Standards Agency, rely on the large studies that are Mismatch Between Demands of Risk Assessment and Practice of available and also take into account exposure to Scientists – The Case of Deca-BDE", Environment International, make the judgement that current safety standards 87 P. Fisk, A. Girling, and R. Wildey, Prioritisation of Flame Retard- ants for Environmental Risk Assessment (Wallingford, UK: UK Environment Agency 2004).
88 UK Royal Society for Chemistry, Environmental Health and Safety Committee Note on: Why do we worry about brominated flame 2. Brominated flame retardants – retardants? (London: Royal Society for Chemistry 2008).
The case of Deca-BDE et al., "Prioritisation of Flame Retardants for Environmental Risk Assessment", supra note 87.
et al., "Understanding the Mismatch Between Demands of Risk Assessment and Practice of Scientists – The Case of De- ca-BDE", supra note 86.
Over the last hundred years there have been moves 91 See, for example, M. Ikonomou, S. Rayne, and R. Addison, "Ex- away from wood and metal products to synthetic car- ponential Increases of Brominated Flame Retardants and Poly- brominated Diphenyl Ethers in the Canadian Arctic from 1981 bon-based polymers with high fuel values, including to 2000", 36 Environmental Science and Technology (2002), automotive parts, textiles, furniture fabrics and hous- pp. 1886–1892.
ings for electronic equipment and surface coatings of 92 International Chemicals Secretariat, Electronics Without Bromi- nated Flame Retardants and PVC – A Market Review (Gothen- other materials87. Because of the high fuel values of burg: International Chemicals Secretariat 2010).
EJRR 2-2011 Inhalt.indd 158 20.05.2011 09:15:51 Symposium on Risk versus Hazard nated flame retardants (BFR) (which number some In 2002 the European Union passed the so-called 75 commercialised substances) and the even broader Restriction of the use of certain Hazardous Substanc- one of the halogenated flame retardants (i. e. includ- es (RoHS) Directive which calls for a restriction on ing chlorinated substances).
the use of a number of hazardous substances found A number of national regulators have called for in electrical and electronic equipment, including bans or substitutions of several brominated flame re- some flame retardants. When the Directive passed, tardants (BFRs). For example, the Swedish Chemical's however, it required a review of the substances pend- Agency recommended a ban of two BFRs in 199993, ing restriction in order to take into account any EU while in the same year the Danish Environmental risk assessments98 that had been conducted before Protection Agency published a study reviewing their the RoHS came into effect in 2006. When this review marketing, properties and uses94. In Germany the was completed, the European Commission concluded Environmental Ministry published a multi-volume that Deca-BDE should be exempted from the RoHS study assessing the hazards of BFRs95. BFRs, how- Directive because there were no human or environ- ever, are not identical and therefore should not be mental risks justifying a restriction99. In 2008, how- treated as such. In Europe, the penta- and octabro- ever, following complaints from the European Parlia- modiphenyl ethers have more or less been taken off ment and Denmark, supported by Finland, Portugal, the market, while the most widely use BFR, deca-Bro- Norway, and Sweden, the European Court of Justice minated Diphenyl Ether (deca-BDE) has less hazard- decided to annul it100. This led to a ban on the use ous properties96. A number of studies over the past of Deca-BDE in electrical and electronic equipment 15 years have shown that deca-BDE does not pose from 1st July 2008. The annulment, however, was not human and environmental health risks and therefore based on scientific grounds but on procedural issues does not need to be further regulated97.
concerning how Deca-BDE became exempt outside of the purview of the European Parliament101.
The debate regarding Deca-BDE stems from vari- 93 Swedish Chemicals Agency, Phase-out of PBDEs and PBBs: Report on a Governmental Commission (Sundbyberg: Swedish Chemi- ations in fire safety requirements across the EU due cals Agency 1999). in large part to divergent perceptions regarding its 94 Danish Environment Agency, Brominated Flame Retardants: Sub- benefits. The UK, for example, has particularly strict stance Flow Analysis and Assessment of Alternatives (Copenha- gen: Danish Environment Agency 1999).
fire standards, especially related to furnishings as a 95 German Environment Ministry, Substituting Environmentally Rel- consequence of observed rises of fires in dwellings evant Flame Retardants: Assessment and Fundamentals (Bonn: in the 1960s and 1970s with deaths peaking at 865 German Environment Ministry 2000).
in 1979. A large number of these fatalities involved 96 R. Alcock and J. Busby, "Risk Mitigation and Scientific Advice: The Case of Flame Retardant Compounds", 26 Risk Analysis (2006), foam-filled furniture (furniture accounted for 7.5 % pp. 369–382.
of the fires but 35 % of the deaths)102 leading to the 97 See, for example, US National Academy of Sciences, Toxicologi- introduction of the 1988 Furniture and Furnishings cal Risks of Selected Flame-Retardant Chemicals (Washington, DC: National Academy Press 2000).
Fire Safety Regulations (FFRs), which are above the 98 European Commission, "European Commission Risk Assessment European fire safety standards. Results of the FFR Report Bis (pentabromophenyl) ether" (Luxembourg: Office of regulations indicate, that accounting for fire alarms the Official Publications of the European Communities 2002).
and more educated publics, that in the period of 99 European Commission, "Commission Decision 2005/717/EC- 1988-1997 approximately 710 lives had been saved exemption of DecaBDE from the prohibition of use" (Brussels: and in the period 2002-2007 the FFR regulations 100 B. MacGillivray, R. Alcock, and J. Bussby, "Is Risk-Based Regula- have led to an additional 54 fewer deaths and 1065 tion Feasible? The Case of Polybrominated Diphenyl Ethers (PB- fewer fires each year103. Based on the UK concerns DEs)", 31 Risk Analysis (2011), pp. 266–281.
with regard to fire safety it is not surprising that the 101 Case C-14/06 and C-295/06, Parliament v. Commission [2008] ECR p. I-1649.
UK was the only member State country supporting 102 University of Surrey, The Effectiveness of the Furniture and Fur- the European Commission over its exemption of De- nishings (Fire)(Safety) Regulations 1988 (London: Department ca-BDE in the European Court of Justice 2008 court of Trade and Industry 2000).
case. Many others, such as Denmark and Germany, 103 Greenstreet Berman, A Statistical Report to Investigate the Ef- fectiveness of the Furniture and Furnishings (Fire) (Safety) Regu- have much weaker fire safety standards, while oth- lations 1988 (London: Department of Business, Innovation and ers do not have any fire safety requirements on cer- Skills 2009).
tain products104. As there is no consensus about how 104 Fisk et al., "Prioritisation of Flame Retardants for Environmental Risk Assessment", supra note 87.
tough fire safety standards should be, it will be dif- EJRR 2-2011 Inhalt.indd 159 20.05.2011 09:15:51 Symposium on Risk versus Hazard ficult to get a consensus on whether flame retardants certain hazardous properties as discussed previously, such as Deca-BDE should be used. As one anonymous and research shows high levels of public concern to- Danish regulator noted: wards these type of chemicals110 111.
"The Brits are much more worried about fire safety than us. They want to use even more flame retardants than are presently used today, rather than following 3. Risk and hazard assessment – our example of trying to minimise the risk in the first Is it predictable? place, such as, by asking our stereo manufacturers to move all combustible materials far away from the heat In both of these case studies hazard was advocated source." (Interview September 2010). to justify bans. Both cases carry a strong Scandina-vian flavour – that is to say that either Denmark and/or Sweden were heavily involved for pushing for the b. Political and public outcry ban of both chemicals. These nations are not always in favour of hazard assessments and bans. When There has been a considerable amount of pressure the substances concerned impact on the economies from NGOs, policy makers and regulators to ban and or heritage of these nations they, like other Member substitute BFRs, because of the bio-accumulation is- States, will base their regulatory decisions on risk as- sue. This pressure has been particularly strong in the sessments. One example of this is the Finnish and Nordic countries where there have been a number of Swedish temporary exemption (needs to be renewed leading research institutions looking into the hazards every 5 years) on Baltic herring and salmon containing of BFRs105, and strong support from environmental high levels of PCBs and dioxin within their Member NGOs, regulators (such as the Swedish Chemical States. In 2001 the Commission put forward a regula- Agency) and other bodies. BFRs have also received a tion that set maximum levels of contaminants includ- significant amount of media attention following the ing dioxins and furans in food stuffs, including fish112. World Wildlife Fund (WWF) bio-monitoring (blood) campaigns which show that we have some BFRs in our bodies, leading to further media amplification 105 P. Eriksson, E. Jakobsson, and A. Frederiksson, "Brominated Flame and rising public concern106. These concerns are Retardants: A Novel Class of Developmental Neurotoxicants in our Environment?, 109 Environmental Health Perspectives (2001), based on the hazard as opposed to any calculation pp. 903–908.
of the actual risk.
106 J. Busby, R. Alcock, and B. MacGillivray, "Interrupting the Social Amplification of Risk Process: A Case Study in Collective Emis- sions Reduction", 10 Environmental Science and Policy (2009), pp. 297–308.
c. Risk versus hazard 107 J. Flynn, P. Slovic and H. Kunreuther (eds), Risk, Media and Stig- ma: Understanding Public Challenges to Modern Science and BFRs, and in particular Deca-BDEs, have been regu- Technology (London: Earthscan 2001).
lated in Europe based on a hazard. Arguably Deca- 108 R. Gregory, J. Flynn and P. Slovic, "Technological Stigma", 83 American Scientist (1995), pp. 220–223.
BDE has been banned from electronic goods and 109 A. Williamns and J. DeSesso, "The Potential of Selected Bromi- products based on the so-called class stigmatisation nated Flame Retardants to Affect Neurological Development", effect107. In a classic article on the topic, Gregory et 13 Journal of Toxicology and Environmental Health Part B (2010), pp. 411–448.
al. argue that the initial cause of technological stigma 110 P. Slovic, "Perception of Risk", 236 Science (1987), pp. 280–285.
is some form of event or occurrence that becomes 111 Not all EU institutions are supportive of precautionary decisions amplified by the media, sending a strong signal of against brominated flame retardants. In a recent decision by the abnormal risk. Stigmatised products usually have European Parliament and the EU Council of Ministers regarding the Restriction of Hazardous Substances in electrical and elec- highly hazardous properties and are perceived nega- tronic equipment (RoHS Directive) the Green MEP rapporteur, tively by the public108. Deca-BDE ticked all of these Jill Evans, proposed a total ban of all brominated flame retard- ants which was refused as was her compromise position to list boxes. There have been a multitude of scientific stud- all brominated and chlorinated flame retardants in an annex as ies, most of them based on small samples and drawn priority substances for review. Such an approach would have employed a precautionary hazard approach by targeting these up in laboratory facilities rather than actual field ex- substances as leading candidates for future restriction (Chemical ercises and making in some cases allegedly unsub- Watch 2010).
stantiated claims109. In addition Deca-BDE is often 112 EC 2375/2001 of 29th November 2001 amending Commission Regulation 466/2001 setting the maximum levels for dioxin and clumped together with the other BFRs that do have furans (Brussels: European Commission).
EJRR 2-2011 Inhalt.indd 160 20.05.2011 09:15:51 Symposium on Risk versus Hazard Finland and Sweden, backed by risk assessments not- 1. The pushers and pul ers for chemical ing that the benefits of eating contaminated fish (e.g., and environmental regulation Omega 3s) outweighed the risks113, initially received an exemption until 2006 initially, and subsequently Although Europe is now seen as the leading environ- extended till 2011114. As one Swedish regulator inter- mental regulator in the world115 all European Mem- viewed for this study candidly noted: ber States do not agree with the regulations put for- "It is in a way odd that we have double standards. ward by the European authorities. Rather it is more We will use science based risk assessments to defend the case that some nations attempt to win green cred- products that we care about and which have direct it by attempting to ban certain chemical substances. impact on our economy such as forest products, but for As these nations are members of the wider European products that have no notable impacts on our economy Union, it makes no sense to push only for a domes- but which we as regulators or as members of the public tic ban, as there is always the legal threat that the are concerned about we invoke hazard classifications European Union could call for a ban to be revoked to ensure that they are banned" (Swedish regulator (as was the case with Sweden putting forward an September 2010). unilateral ban on Deca-BDE a few years ago). Rather these Member States try to win over their domestic audiences by pushing through European-wide bans. IV. Discussion and analysis
For example, the Swedish socialist MEP, Asa West-lund, argued as part of her re-election campaign that The two case studies show significant inconsisten- she was helping the Swedes from being inundated by cies in the application of risk and hazard assess- dangerous chemicals by her political efforts in the ments for regulation setting throughout Europe. EU European Parliament116. Indeed, Danish and Swed- Member States have different concerns about risk ish regulatory authorities are widely regarded as the topics. UK authorities, for example, worry about pioneers of present day EU chemical regulation117 118. fires while Swedish policy makers are concerned These Member States have also put forward Euro- by man-made chemicals. What are the reasons for pean legislation to ban Deca-BDE (Denmark led the these differentiating cultural views on regulations, effort in getting the Deca-BDE exemption revoked), and what are the consequences of them? Is more the phase-out of antibiotics in animal feed119, as well dialogue between regulators and policy makers as a host of other chemicals (e.g., paraquat)120. The reason why these Scandinavian regulatory bodies have been so successful in their European banning efforts is a combination of three distinct factors.
113 O. Leino, M. Tainio, and J. Tuomisto, "Comparative Risk Analysis of Dioxins in Fish and Fine Particles from Heavy-Duty Vehicles", 28 Risk Analysis (2008), pp. 127–140.
a. The rise of the post-trust society 114 I. Anderson and M. Aune, Redovisning av uppdrag rorande grans- varden for langlivade miljoforengar I fisk fran Ostersjoomradet (Uppsala: Swedish Food Administration 2010).
Regulators who are seen to be tough on industry, such as the Swedish Chemicals Agency (KemI), have 115 M. Schapiro, Exposed: The Toxic Chemistry of Everyday Products and What's at Stake for American Power (White River Junction, a high level of public credibility, as they are viewed VT: Chelsea Green Publishing 2007).
to have the public's best interest at heart121. Therefore 116 Naturskyddsforeningen, Rapport: Miljoloften for Europa (Stock- the decisions they make, some based on good science holm: Swedish Society for Nature Conservation 2009).
and others based on weak science, are not questioned 117 Danish Environmental Ministry, Kemikalie-Handlingsplan 2010– 2013. Sikkerhed i Danmark-samarbejde internationalt (Copenha- by policy makers, academics or other stakeholders. gen: Danish Environmental Ministry 2010).
Some regulators, on the other hand, who are seen to 118 D. Liefferink and M. Andersen, "Strategies of the ‘green' Mem- be influenced by industry are viewed by the public ber States in EU Environmental Policy Making", 5 Journal of Eu- ropean Policy (1998), pp. 254–270.
and stakeholders as weak, are less trusted and are 119 Vos, "Antibiotics, the Precautionary Principle and the Court of increasingly marginalised. Similarly, policies and sci- First Instance", supra note 27.
entific arguments put forward by "low-trust" bodies, 120 J. Zander, The Application of the Precautionary Principle in Prac- such as the chemical industry and its consultants, tice (Cambridge: Cambridge University Press 2010).
even though they may be based on stronger scientific 121 R. Lofstedt, Risk Management in Post Trust Societies (Basingstoke: Palgrave/MacMillan 2005) evidence than those made by the Scandinavian reg- EJRR 2-2011 Inhalt.indd 161 20.05.2011 09:15:51 Symposium on Risk versus Hazard ulators, are increasingly being questioned by stake- push forward tougher environmental regulation. The holders, academics and other bodies122. Industry can Centre right parliamentarians do not have a similar no longer be trusted as they have vested interests in spokesperson to counter these arguments.
the product being questioned, and increasingly in-dustry funding is seen as biased123.
Industry's credibility has not been helped by the c. The politics of regulation fact that a number of industry bodies have misused science to delay the regulation of hazardous sub- Politicians will push for bans or fight for certain stances such as tobacco, a fact that has only became environmental/chemical/ energy issues which do widely known over the past fifteen years or so124. not affect the economic well being of their country. Finally the accusers, that is primarily academics and Sweden has strong positions on phasing out chemi- stakeholders, have been gaining public and political cals which it can afford to do as it has only a small credibility following a number of European scandals chemical industry129. Similarly, Austria richly en- ranging from BSE (mad cow disease) to dioxin in Bel- dowed with hydropower, has a strong anti-nuclear gian chickens and tainted blood in France125. This is policy. Its Eastern neighbours, Czech Republic and a profound shift compared to just over 30 years ago, Slovakia, do not have the Alps and are therefore to when the public more or less expected a close work- a greater extent reliant on nuclear power130. At the ing relationship between regulators and industry126.
same time Sweden would not dream of having tough Due to these three reasons it has become easier controls on mobile telephone base stations as one of for nations such as Denmark and Sweden to push the world's largest mobile telephone systems provid- through regulation as they are trusted, while their ers, Ericsson, is based there131. In other words, it is industry counterparts are not. In addition these easy for Denmark and Sweden to take strong Anti- Scandinavian regulators have been, and continue to BPA and Anti-Deca-BDE positions at the European be, ably assisted by stakeholders and academics who level as there are no economic consequences for their are also trusted. Following the passing of the Lisbon domestic markets in doing so, and at the same time Treaty granting increased power to the European Par- they gain domestic "green" credentials. An example liament, it is likely that it will be even easier to push of this political game playing is one Swedish EPP through tough hazard-based regulations.
122 It is interesting to note that EFSA was specifically set up to pro- b. Lack of interest in environmental regulatory vide credible scientific advice, yet government and EU agencies issues on the centre right feel comfortable over ruling EFSA's scientific opinions as was the case of Bisphenol A. 123 Vom Saal and Hughes, "An Extensive New Literature Concern- Setting Scandinavian countries aside, the call for ing Low-Dose Effects of Bisphenol A Shows the Need for a New tougher European chemical and environmental reg- Risk Assessment", supra note 66.
ulations is coming unsurprisingly primarily from 124 See, for example, N. Oreskes and E. Conway, Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues politicians that are from the centre left, left and the from Tobacco Smoke to Global Warming (New York: Bloomsbury greens127. The Greens, for example, have one main platform, that of promoting tougher environmental 125 R. Lofstedt, F. Bouder, J. Wardman and S. Chakraborty, "The regulation, while the EPP parliamentarians spend a Changing Nature of Communication and Regulation in Europe", Forthcoming Journal of Risk Research.
large amount of their time focusing on a number of 126 J. Hayward and R. Berki, State and Society in Contemporary Eu- economically-based platforms, be it internal markets, rope (Oxford: Robertson 1979).
competition or trade policy128. There are a number 127 Schorling, "The Green's Perspective on EU Chemicals Regula- of examples of this. The rapporteur for the European tion and the White Paper", supra note 15.
Parliament's report on the European Commission's 128 McCormick, "Environmental Policy in the European Union", su- pra note 1.
2001 Chemical White Paper was a Swedish Green 129 Lofstedt, "Swedish Chemical Regulation: An Overview and Anal- MEP, Inger Schorling, while the rapporteur on the ysis", supra note 14.
REACH Regulation was Guido Sacconi, an Italian 130 R. Lofstedt, "Are Renewables an Alternative to Nuclear Power? Socialist MEP. Similarly, the European Greens have An Analysis of the Austria/Slovakia Discussions", 36 Energy Pol- icy (2008), pp. 2226–2233.
a political spokesperson (a former director of Green- 131 Zander,"The Application of the Precautionary Principle in Prac- peace Germany) whose role is to debate, lobby and tice", supra note 120.
EJRR 2-2011 Inhalt.indd 162 20.05.2011 09:15:52 Symposium on Risk versus Hazard MEP who put forward a parliamentary question on 2. Ignoring the risk-risk trade-off the 27th May 2010 asking how the Commission will safeguard against imports of BPA material to the EU The so-called risk-risk trade-off occurs when a reg- (following the Swedish agenda on chemicals). On ulator focuses on decreasing one specific risk (e.g., 3rd September she put forward a question on how chlorinating drinking water to make it safer) and un- the Commission will safeguard an important part intentionally increases a risk elsewhere (e.g., human of Swedish heritage, namely the fermented Baltic cancers caused by substances being generated dur- herring, by extending the exemption past 2011, ac- ing the chlorination). The concept builds on risk-risk knowledging in her question the fact that the herring analysis put forward by Lester Lave135 and, according contains higher levels of dioxin than the European to Graham and Wiener who popularised the concept, Union allows132. requires regulators and policy makers to systemati- When politicians push for these types of bans (or exemptions from a ban) on the European stage the "Evaluate in weighing the comparative importance of economic consequences are significant. The chemi- target risks and countervailing risk when hard choices cal industry, for example, is Europe's fourth largest must be made136". industrial sector and is particularly significant for Germany. It accounts for 11 % of Europe's manufac- Over the years risk-risk tradeoffs have been and are turing capacity, and employs 1.6 million individu- frequently ignored by regulators, be they based in als133. Strong opposition from those nations who are Europe, North America or elsewhere. This is despite affected by these bans and regulations would be ex- the fact that over the years there have been a number pected, but in many cases this has not been the case. of studies from authorative sources stating that they Denmark, for example, was able to push through the need to be properly and systematically addressed in annulment of the Deca-BDE exemption in the face the making of regulations137.
of UK opposition, Sweden was able to drive through Both the case studies discussed above are riddled the ban of the pesticide paraquat, and REACH was with risk-risk tradeoffs. With regard to the ban on passed following modest policy changes on the part Deca-BDE two issues stand out. The ban is being put of the Germans134.
in place because of environmental and public con-cerns associated with other BFRs, yet to date there appears to have been no studies demonstrating the consequences of the ban in terms of increased appli- 132 The 2 parliamentary questions from A. Corazza-Bildt (MEP-EPP) ance fires. Similarly, it is not the case that Deca-BDE were "Ban on bisphenol A (BPA) in infant feeding bottles" – Par- can be simply substituted for safer and better proven liamentary question 27th May 2010 and "Fermented Baltic her- ring" – Parliamentary question 3rd September 2010. retardants138. Deca BDE is one of the world's most 133 K. Geiser and J. Tickner, New Directions in European Chemicals studied flame retardants, yet the alternatives being Policies: Drivers, Scope and Status (Lowell MA: Lowell Center promoted, such as phosphorous-based compounds for Sustainable Production 2003).
have not been equally studied. Would it not be wise 134 Zander, "The Application of the Precautionary Principle in Prac- tice", supra note 120.
to do more in-depth studies examining the possible environmental and health risks associated with those 135 L. Lave, The Strategy of Social Regulation: Decision Frameworks for Policy (Washington DC: Brookings 1981).
phosphorus-based flame retardants before the substi- 136 Graham and Wiener, "Risk vs Risk: Tradeoffs in Protecting Health tution principle can be activated139? With regard to and the Environment", supra note 49, p. 19.
BPA, aside from replacing BPA plastic baby bottles 137 See, for example, F. Cross, "Paradoxical Perils of the Precau- with glass ones (and resulting problems associated tionary Principle", 53 Washington and Lee Law Review (1996), pp. 851–921.
with consequences of breakage) manufacturers have 138 Busby et al., "Interrupting the Social Amplification of Risk Pro- in many cases struggled to find suitable alternatives. cess: A Case Study in Collective Emissions Reduction", supra In addition, these alternatives have not been tested and researched to the same degree as BPA, and may 139 Alcock and Busby, "Risk Mitigation and Scientific Advance: The Case of Flame Retardant Compounds", supra note 96.
in fact be riskier for human health and the environ- 140 Ryan et al., "In Utero and Lactational Exposure to Bisphenol A, ment140. The causes of these unintentional risk-risk in Contrast to Ethinyl Estradiol, Does Not Altersexually Dimpor- tradeoffs are two fold. Firstly, special interest groups phic Behaviour, Fertility and Anatomy of Female LE Rats", supra focused on single source pollution end points rather 141 Viscusi, "Rational Risk Policy", supra note 52.
than the broader environmental problem at hand141. EJRR 2-2011 Inhalt.indd 163 20.05.2011 09:15:52 Symposium on Risk versus Hazard Secondly, the risk-risk trade-offs were in these two study also showed that there was a lack of coordina- cases products of incomplete, and to a certain de- tion on the use and type of risk assessments with gree unscientific, decision making. Regulations were regard to BPA or Deca-BDE, be the regulators based driven too quickly without taking into account all the in Denmark, Finland, Germany, Sweden or the UK. possible unintended consequences, by political, me- The regulators did not know what their counterparts dia and stakeholder concerns rather than evidence- were doing on these issues.
based policy making – sometimes referred to as the "risk of the month concern"142. As a result, the so called substitution principle is not a risk free solution 5. The stigmatisation of products as some regulators imply143.
A number of environmental regulators, environ-mental stakeholders and academics are attempting 3. The many cultures of Europe to stigmatise particular products, such as Deca-BDE and BPA. These groups do two things. Firstly they Europe is not one entity, but the European Union is attempt to make a general link between BPA or De- made up of 27 Member States populated with indi- ca-BDE with environmental effects or human health viduals who have different values and ideas. This in issues. For example the International Chemical Sec- turn complicates matters for the making of consist- retariat argued that: ent environmental chemical regulations. Be it with "…brominated flame retardants tend to be particu- regard to environmental issues or food concerns, larly able to bio-accumulate and to be persistent. This there is not one united Europe144. The Swedes, for means they stay in the environment for a long time example, are more concerned about the welfare of and accumulate in animals and humans. Many bro- farmed animals than the Hungarians; while the Lat- minated flame retardants are also toxic.147" vians are much more worried about the freshness of food than the Dutch. Similarly, the Portuguese worry Frederic vom Saal argues with regard to BPA: more about genetically modified food than the Brit- "The science is clear and the findings are not just scary, ish do145. These types of cultural differences will im- they are horrific. Why (would) you feed a baby out of pact on regulation.
a clear, hard plastic bottle – it's like giving a baby a birth control pill.148" 4. The silo effect of regulatory agencies At the same time these and other campaigners argue that there are much safer alternatives available, and Research for this study has identified a problematic lack of communication between domestic regula-tors working on similar issues and between member 142 L. Lave and E. Males, "At Risk: The Framework for Regulating State regulators targeting similar issues. With regard Substances", 23 Environmental Science and Technology (1989), pp. 386–391.
to BPA, the Swedish Chemical Agency (KemI) had a 143 For an excellent historical discussion on the substitution princi- different perspective on how this chemical should be ple please see A. Nilsson, Att byta ut skadliga kemikalier: Substi- regulated to their counterparts at the Swedish Food tutionprincipen-en miljorattslig analys (Stockholm:Nerenius and Santerus forlag 1997).
Agency (SLV). The KemI wants to regulate based on 144 Eurobarometer, "Special Eurobarometer 354: Food-Related Risks" a hazard classifications and the precautionary prin- (Brussels: TNS Opinion and Social 2010).
ciple, while the SLV wants to use a risk assessment 145 Eurobarometer, "Special Eurobarometer 354: Food-Related Risks", and risk management approach. If the precaution- supra note 144.
ary principle is to be used, the SLV is insisting on a 146 European Council, "Regulation (EC) No 2002/178 of the Euro- pean Parliament and of the Council of 28th January 2002 laying EU-agreed definition that includes a clause for cost down the general principles and requirements of food law, es- effectiveness, which would require some sort of risk tablishing the European Food Safety Authority and laying down procedures in matters of food safety", supra note 23.
assessment146, while the KemI did not have a defini- 147 International Chemical Secretariat, Electronics Without Bromi- tion as such. The same split with regard to BPA oc- nated Flame Retardants and PVC – A Market Review, supra note curred in Denmark where the Danish Food Agency was forced to call for a temporary ban for political 148 The quote from Frederick vom Saal can be found in R. Sharpe, "Let Common Sense Guide you in the Saga of Bisphenol A", In- rather than scientific (risk analysis) reasons. The dependent, 13 April 2010, p. 39.
EJRR 2-2011 Inhalt.indd 164 20.05.2011 09:15:52 Symposium on Risk versus Hazard hence these substances can simply be substituted complicated by environmental campaigners, academ- for something better. They do not go into any detail ics and journalists. They have launched controversial about the possible negative environmental and pub- and highly publicised campaigns against chemicals in- lic health consequences of the substitute products. In cluding BPA and Deca-BDE, through bio-monitoring so doing they put pressure on corporations to shift schemes (be it blood or breast milk) to gain yet further from one chemical compound to another, as dem- media attention155. Is it therefore any wonder that the onstrated by the International Chemical Secretariat public is fearful of BPA and Deca BDE, which in turn overview of electronics without brominated flame justifies the environmental groups' campaigns? retardants149. These campaigns are increasingly suc-cessful. The plastic's industry in Europe, for exam-ple, has been removing BPA from baby bottles as it anticipated a European wide ban on the chemical150.
As seen in the two case studies, there is no such thing as uniform European-wide science-based risk 6. Public perceptions of chemicals regulation. Rather there are multiple actors at differ-ent member state and European levels pushing their Over the past 40 years there has been much social own views and opinions of how regulations should science research discussing why the public perceives be formed, resulting in the passing of bans/directives some risks differently to others151. This research and regulations that are at times hazard based and shows, for example, that the public is more concerned at other times risk based. What is needed to ensure about involuntary risks than voluntary ones, it fears greater consistency in the European regulatory pro- technological hazards more than natural ones, and cess? What is needed to ensure greater science- and that it is more frightened of unfamiliar than familiar risk-based regulatory thinking? This final section risks152. Chemicals tick all these boxes: they are in- will address these questions.
voluntary, technical and highly unfamiliar, with most members of the public not having much information on, or understanding the use of, the chemical in ques- 1. Importance of education tion. In addition, science shows that these types of unfamiliar, technological and involuntary risks are of- If European regulators are to be successful in increas- ten socially amplified by the media153 154. As a result ingly basing environmental and health regulations on the public is on the whole worried about the effects of risk assessments then there is a need for the public and chemicals. The whole situation has been made more stakeholders to actually understand what risk assess-ment is, something that is clearly not the case at the present time. One way around this would be to push 149 International Chemical Secretariat, "Electronics Without Bromi- for the introduction of risk assessment as part of the nated Flame Retardants and PVC – A Market Review", supra note science curriculum in the final years of school (last two years of high school/gymnasium) as well as by encour- 150 One could also argue that another form of stigmatisation is related aging European universities to teach risk assessment to the so called REACH "Candidate List of potential substances for substitution" which is nothing more than a "blacklisting" as as part of the undergraduate or graduate curriculums, chemicals put onto that list are almost impossible to take off.
something that the Commission is also actively pro- 151 Slovic, "Perception of Risk", supra note 110.
moting156. At the present time there is little teaching 152 See, for example, B. Fischhoff, P. Slovic, S. Lichtenstein, S. Read activity on this topic with just a handful of universities and B. Combs, "How Safe is Safe Enough? A Psychometric Study Towards Technological Risk and Benefits", 9 Policy Studies (1978), teaching risk assessment. What is interesting is that pp. 127–152.
there is clearly a demand for such courses. Because of 153 R. Kasperson, O. Renn and P. Slovic et al., "The Social Amplifi- new regulations such as REACH, there are more risk cation of Risk: A Conceptual Framework", 8 Risk Analysis (1988), pp. 177–187.
assessments than ever before being performed in Eu- 154 N. Pidgeon, R. Kasperson, and P. Slovic (eds), The Social Ampli- rope. To generate funding in the risk assessment area it fication of Risk (Cambridge: Cambridge University Press 2003).
would be good for a number of academic institutions to 155 Alcock and Busby, "Risk Mitigation and Scientific Advance: The encourage the Commission's DG Research and Innova- Case of Flame Retardant Compounds", supra note 96.
tion to host a workshop on this topic to see what such a 156 European Commission, Maximising the Contribution of Science to European Health and Safety (Brussels: DG SANCO 2005).
proposed funding stream in this area would look like. EJRR 2-2011 Inhalt.indd 165 20.05.2011 09:15:52 Symposium on Risk versus Hazard 2. Scientific peer review of risk undue media attention and amplification of risks assessments used for regulations which could be better and more responsibly com-municated159. Was it ethically correct, for example, One way to ensure that the risk assessments being for the Independent to publish a series of alarmist ar- put forward by regulators remain of the highest qual- ticles on the supposed dangers of BPA in April 2010? ity (and therefore cannot be undermined by stake- The articles were not scientifically balanced and were holders and special interest groups) is to ensure that arguably designed to put pressure on the UK FSA the risk assessments and other underlying scientific to regulate it. Other examples of unnecessary media arguments used as the foundations for the environ- amplification include the mishandling of the mea- mental and health regulations are based on appropri- sles, mumps and rubella (MMR) vaccine scare in the ate peer review. Such a peer review could be based on UK160 and the communication of the Y2K or millen- the US Office of Information and Regulatory Affairs nium computer bug161. Effective media amplification (OIRA) within the Office of Management and Budget in such cases is often undermined by poor handling (OMB) 2004 "Final Information Quality Bulletin for of science, not helped by the fact that due to recent Peer Review". This bulletin: budget cuts there are less and less broadsheet science "… establishes government wide guidance aimed at en- editors than ever before.
hancing the practice of peer review of government sci- One way of addressing poor communication would ence documents …. Peer review can increase the quality be through the development of reporting guidelines, and credibility of the scientific information generated similar to those agreed by the BBC in 2003162 and by across the federal government. This Bulletin is one as- Harvard and IFIC163 that would help journalists to pect of a larger OMB effort to improve the quality of become more attuned to communication pitfalls164. the scientific information upon which policy decisions Another way to do so would be to use more science- media forums to encourage greater critical dialogue between scientists and journalists on topics such as The then Administrator of OIRA, Professor John Gra- the intricacies of risk assessment, such as those pro- ham, was concerned about the varying quality of the moted by the European Science Forum.
underlying science used in the development of regula-tions and felt that by having a peer review system in place, the overall policy decisions could be improved. 4. Improving risk communication capacity The Bulletin was signed into law in December 2004, after having benefited from extensive agency, stake-holder and public comments on two prior drafts. One of the main reasons why regulators and politi- The idea is probably worth introducing in Europe, as cians are under pressure to regulate based on hazard long as the peer review guidelines are developed in tandem with a number of key regulatory agencies so they have some ownership of the project and are not 157 US Office of Management and Budget-Office of Information and merely dictated to by a central oversight authority. Regulatory Affairs, Final Information Quality Bulletin for Peer Re- view (Washington, DC: OMB-OIRA 2004).
One way to proceed with the introduction of an EU 158 D. Taverne, The March of Unreason: Science, Democracy and the wide peer review bulletin would be to bring together New Fundamentalism (Oxford: Oxford University Press 2005).
a number of key EU risk assessment institutions such 159 Kasperson et al., "The Social Amplification of Risk: A Conceptual as the EFSA, the German Federal Institute for Risk Framework", supra note 153.
Assessment, the UK Food Standards Advisory Board 160 R. Horton, MMR Science and Fiction: Exploring the Vaccine Cri- sis (London: Granta 2004).
(COT) and DG SANCO to discuss the proposal.
161 N. Davies, Flat Earth News (London: Chatto and Windus 2008).
162 R. Harrabin, A. Coote and J. Allen, Health in the News: Risk Re- porting and Media Influence (London: King's Fund 2003).
3. Media guidelines 163 H. Fineburg and S. Rowe, "Improving Public Understanding: Guidelines for Communicating Emerging Science on Nutrition, Food Safety, and Health", 90 Journal of the National Cancer In- The European public does not need to be "educated" stitute (1998), pp. 194–199.
in the way that many policy makers seem to be- 164 For an in-depth discussion on media communication guidelines lieve158. Rather many public outcries or alarms that please see: R.Lofstedt, "Risk communication guidelines for Eu- rope: A modest proposition", 13 Journal of Risk Research (2010), are prevalent in today's Europe are perpetuated by EJRR 2-2011 Inhalt.indd 166 20.05.2011 09:15:52 Symposium on Risk versus Hazard rather than risk is the simple fact that the promoters and concise messages needed for the modern media. of hazard classifications are better communicators of To address this problem, regulators could either be the potentially resulting risk in question165. In ad- encouraged to participate in existing continuing edu- dition it should be noted that hazard classification cation risk communication courses for professionals is easier to communicate than risk assessment, as such as those developed by Harvard University, or because it is less complicated, as given that elements by developing customised risk-communication and of uncertainty (in particular linked to exposure) are risk-analysis guidelines, something that the EFSA is not discussed. These stakeholders are in many cases presently doing169.
professional public relations machines that excel in courting media attention and framing public opin-ion, debate and controversy. By being fast and nimble 5. Establish a scientific advisory board for they can consistently engage in proactive risk com- the European Parliament munication attuned to the demands of a 24-hour news cycle, and they understand that the public per- There is a need to increase the scientific competency ceives some risks more than others166. What makes of the European Parliament. Based on the interviews them even more effective is that in many cases they with European Commission officials, European par- are more trusted than the regulators and the risk im- liamentarians and senior officials in the Member posers (usually industry)167.
States, there is a clear growing concern that in line Regulators and policy makers, on the other hand, with increased parliamentarian power, there needs are generally poor communicators. Indeed, apart to be an increased understanding of the science un- from anything else, they are often too slow to com- derlying the amendments, laws and suggestions that municate, because in many cases held back by the parliamentarians are making. One key way of help- vast bureaucratic machinery that makes up most gov- ing parliamentarians gaining this competence would ernment departments. By being slow in their com- be through the establishment of a neutral/independ- munication strategies officials spend more time fire- ent scientific advisory board that would produce fighting and engaging in reactive communications. opinions and suggestions on the various proposed The problem with this strategy is that reactive risk directives and regulations made by the Commission. communication destroys public trust whereas proac- This advisory board could work in close collaboration tive risk communication gains public trust168. This is with the Science and Technology Options Assess- complicated by the fact that many regulatory bodies ment (STOA) panel within the European Parliament.
do not understand the importance of risk perception and staff has not been trained in risk communication. They therefore often find it difficult to convey clear 6. Properly interpreting and implementing the Commission's communication on the precautionary principle 165 For a discussion see: Lofstedt et al, "The changing nature of com- munication and regulation in Europe", supra note 125. The seminal European Commission Communication 166 G.Jordan, Shell, Greenpeace and the Brent Spar (Basingstoke: on the precautionary paper needs to be properly inter- preted and implemented. When it was published the 167 UK House of Lords, Select Committee on Science and Technol- Commission noted that the Communication should ogy: Science and Society (London: House of Lords 2000).
be seen as an "input into the ongoing debate"170 rath- 168 B.Fischhoff, "Risk perception and communication unplugged: Twenty years of research", 15 Risk Analysis (1995), pp. 137-145.
er than the definitive statement on the topic. Since 169 EFSA, Draft Risk Communication guidelines (Parma: EFSA 2010).
that time there have been multiple studies evaluat- 170 European Commission, "Communication from the Commission ing the usefulness of the Communication171 and on the Precautionary Principle", supra note 17, p. 3.
whether the Commission is actually following the 171 See, for example, J. Graham and S. Hsia, "Europe's Precaution- Communication172. One of the key provisos was that ary Principle: Promise and Pitfalls", 5 Journal of Risk Research (2002), pp. 371–390.
any invocation of the precautionary principle must 172 G. Marchant and K. Mossman, Arbitrary and Capricious: The Pre- be preceded by a risk assessment173. These published cautionary Principle in the European Courts (Washington, DC: studies, along with the case studies discussed above indicate that the Communication is in many cases be- 173 European Commission, "Communication from the Commission on the Precautionary Principle", supra note 17.
ing ignored. Different guidelines and legal cases are EJRR 2-2011 Inhalt.indd 167 20.05.2011 09:15:52 Symposium on Risk versus Hazard being agreed on without a clear coherent policy as to holders could discuss, both formally and informally, when the Commission should be using risk assess- the latest issues impacting on the risk analysis field.
ments let alone the precautionary principle. To ad-dress these ambiguities, there is a need to form an in-dependent academic expert group that would discuss and describe how the Communication should best be interpreted and implemented. The outcome of such The regulation of chemicals and food is never easy, an independent study would need to be launched in particularly when regulators and policy makers are the European Parliament with the backing of senior increasingly distrusted by the public175. It is much parliamentarians and Commission officials.174 more complicated when chemical and food regula-tions become politicised. In this time of greater regu-latory uncertainty, there is a need to examine the in- 7. Establishing a chapter of the Society for consistencies that are prevalent in Europe to see what Risk Analysis in Scandinavia can best be done to address them. It is hoped that this paper, highlighting two complex cases of BPA and In the interviews that were conducted with risk- Deca BDE, and by putting forward a series of policy based policy makers and regulators in Scandinavia it relevant recommendations ranging from educating was clear that they needed a meeting place to discuss the public in risk assessment, to using scientific peer the present developments in the risk analysis field. review of risk assessments, to promoting European- The Germans, for example, did not know what the wide media guidelines, to improving the risk com- Danes and the Swedes were doing in this area and munication capacity and competencies of regulators vice versa. Similarly, because of the so called "silo" in Europe, will assist in the making of more scientific mentality there was little communication between and risk-based European-wide policy making. the representatives of the Swedish Food Administra-tion and the Swedish Chemical Agency with regard to what types of risk analyses should be used for 174 An alternative approach would be to clarify the scope and ap- BPA. Finally, the Finns were looking for guidance on plicability of the precautionary principle by way of legislation. current best practice within the risk analysis field. Indeed, there is an increasing body of case law defining the pro- cedural and factual boundaries of having recourse to that princi- The establishment of a Scandinavian chapter of the ple. Marchant and Mossman's book, "Arbitrary and Capricious", SRA with an annual meeting in one of the Nordic supra note 172, is one such attempt in examining how the Euro- pean Courts have interpreted the principle. capitals would help form some type of peer group 175 M. Hamburg, "Advancing Regulatory Science", 331 Science (25 where interested regulators, academics and stake- February 2011), p. 987.
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Source: http://risksummit.eu/wp-content/uploads/2013/06/Risk-Versus-Hazard-Prof.-Ragnar-Lofsted.pdf

Empirical calibration

Empirical calibration Martijn J. Schuemie, Marc A. Suchard In observational studies, there is always the possibility that an effect size estimate is biased. This can betrue even for advanced, well thought out study designs, because of unmeasured or unmodeled confounding.Negative controls (test-hypotheses where the exposure is not believed to cause the outcome) can be usedto detect the potential for bias in a study, and with enough negative controls we can start to estimatethe systematic error distribution inherent in an observational analysis. We can then use this estimateddistribution to compute a calibrated p-value, which reflects the probability of observing an effect size estimate