Precautionary Principle A Balance of Science and Politics
Precautionary Principle A Balance of Science and “Politics” Paul Leonard BASF SE 2/24/2012 INTERNAL
Precautionary Principle n Origins n Use n Hazard based legislation, the ultimate form of Precaution n Case law? n Innovation n Trade n Risk-Risk trade-offs & substitution n Conclusions
Origins and Evolution Principle 15 of the 1992 Rio Declaration: "Where there are threats of serious or irreversible damage, lack of scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. " â The PP was designed to address situations where political action is required, but science is not clear or readily available.
The EU Policy Treadmill It´s a complex & lengthy process NGOs & Public Opinion Media Revision Regulation Elections • 27 Member States • NGOs • Lobbyists • Think tanks • Chambers of commerce • Journalists Political Compromise Members of European Parliament Opinions Commission Drafts Legislation Parliament amends legislation Council Reaction â Precaution is faster, more decisive, less complex to administer & can be justified by Scientific Uncertainty
What Is Scientific Uncertainty? n Lack of scientific certainty should not prevent regulatory action n A statistical probability of 95% is also equivalent to 5% scientific uncertainty â Science is built on uncertainty, but this can be missused
What About Scientific Risk Assessment? n Traditional basis for regulation of uncertainty, n Hazard X Exposure potential = Risk n Management of risk and uncertainty by application safety factors n EFSA and Risk Assessment are increasingly criticised by NGOs and politicians as, “An unreliable practice of guessing without adequate knowledge” â The Precautinary Principle is Promoted as a Responsible Solution
Guidance on Interpretation of the Precautionary Principle 2/24/2012 INTERNAL
COM(2000) 1 COMMUNICATION FROM THE COMMISSION on the precautionary principle “The implementation of an approach based on the precautionary principle should start with a scientific evaluation, as complete as possible, and where possible, identifying at each stage the degree of scientific uncertainty. Where action is deemed necessary, measures based on the precautionary principle should be, inter alia: • proportional to the chosen level of protection…. . ”
2001, European Environment Agency’s “Late lessons from early warnings: the precautionary principle 1896– 2000” Important shifts: n Stress alternatives in cases of uncertainty n Scrutinise claimed benefits n Importance of lay knowledge (including public domain science) n Reverse the burden of proof n Precaution – as an environmental policy management tool
Lisbon Treaty December 2007 Paragraph 2 of article 191 of the Lisbon Treaty, "Union policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay. "
Legislative Guidance on PP? There are: n Guidelines for risk assessments, risk management & impact assessments n Several pieces of relevant legislation, and semi-legislative texts, relating to the precautionary principle n Case law n Academic and public debate & eminent opinions Would a surgeon practice new invasive procedures without reference to tried and tested medical guidelines? â No single comprehensice legislation laying down rules for its use
How is the Precautionary Principle Being Used?
Media deaths e e b o t d e k n li ticides Call to ban pes ent Editor m n o ir v n E y h t Car By Michael Mc 1 21 January 201 “Speaking at the event, ALDE deputy Chris Davies called on the EU to invoke the precautionary principle in relation to certain pesticides, which could result in their withdrawal from the market were they found to constitute a health risk. ” ir food e h t d n i f 't ees can Forgetful b 2011 h c r a M 0 1 r Ben Webste â EU and National policy makers were put under pressure to ban neonicotinoid insecticides – without substantiated evidence
Hazard Based Legislation, the Ultimate form of Precaution
Hazard criteria Plant Protection & Biocides Ground Water Protection 0. 1 ppb Cut Off A political decision in 1980 to use 0. 1 ppb as a surrogate for zero tolerance - Not a health-based standard = one drop in an Olympic-sized swimming pool! = 1 stem in 111, 000 hay bales, or = 1 baked bean in 21 million cans â The Ultimamte Precaution - “Better don´t do it at all”
Hazard criteria Plant Protection & Biocides 1107/2009 & New Biocide Regul. CMR category 1 a & 1 b Endocrine disruptors POP*/PBT/v. Pv. B Cut-off No Registration Market Removal â Exposure no longer relevant - Removal from the European market
Regulation 1107/2009 Endocrine Disruption Annex II, 3. 6. 5 prevents regulation of active ingredients which are, “considered to have endocrine disrupting properties” n What is an endocrine disruptor? n Which level of ED should trigger in a ban? Triazole fungicides are associated with endocrine “activity”, by virtue of their aromatase mode of action (*) – Also used as medication for fungal infections Endocrine activity is NOT the same as Endocrine Disruption * http: //ec. europa. eu/environment/endocrine/documents/bkh_report. pdf#page=1 http: //ec. europa. eu/environment/docum/pdf/bkh_main. pdf and http: //www 2. mst. dk/common/Udgivramme/Frame. asp? http: //www 2. mst. dk/Udgiv/publications/2007/978 -87 -7052 -538 -1/html/default. htm
Endocrine Disruption n Potential impact for a wide range of chemicals: n phthalates, parabenes, alkylphenols, BPA, synthetic hormones, various pesticides including triazoles, n EU Commission must define criteria for endocrine disruption by end of 2013, for the Biocide Regulation n Industry argues that potency and exposure should be taken into account by the EU Commission, when defining criteria for the ED definition â ED criteria are not just relevant for plant protection and biocides
Economic importance of Azoles in European Agriculture: Wheat Case Study n With azoles, estimated wheat production to increase by 13% in 2020, but the class is potentially under threat from EU Regulations n Removal of azoles would: n reduce EU wheat production by 7% in 2013 and by 12% n Loss of 2, 4 billion euros in 2013 and 4, 6 billion in 2020 n Cultivated area would need to increase by 7, 5 % and 13, 9 % respectively, to maintain EU´s wheat self sufficiency n Without increased cultivation, EU would become a net importer n Uncertainty concerning global food security would further increase n Prices would continue to rise The assessment of the economic importance of Azoles in European agriculture: wheat case study, Nomisma, Sept. 2012 19
New Biocide Regulation June 2009 n Hazard-based cut-off criteria, copied & pasted from the Plant Protection Regulation 1107/2009 n EU Commission Proposed Article 5. 1(c) n No chance of derogation for product types 4 and 14 to 19 Ø This would have resulted in removal of anticoagulant rodenticides, with no viable alternative and no chance of derogation â EU Commission was Persuaded to Remove Article 5. 1(c)
Hazard criteria under REACH, Plant Protection & Biocide Regulations 1107/2009 & New Biocide Regul. REACH CMR category 1 a & 1 b Endocrine disruptors POP*/PBT/v. Pv. B POP/PBT/v. Pv. B Cut-off No Registration Market Removal Substances of very high concern (SVHC) Authorisation • Risk Assessment • Socioeconomic assessment No limitation Mitigation Use restriction Substitution â Similar Hazard Criteria for REACH, Diffferent Regulatory & Market Consequences
Case Law?
Paraquat Sweden challenged Comm’s view that non-GLP studies were irrelevant, raised “scientific uncertainty” & invoked use of the PP. The Court of First Instance (CFI) ruled against the Commission. Source, 2009, http: //www. papers. ssrn. com/so 13/papers. cfm? abstract_id=1325770, and Hudig, The European Risk Forum Study, The Precautionary Principle Application and Way Forward
EU Case Law* Artegon (marketing of certain pharmaceuticals), The CFI and the Eu Court of Justice confirmed that: n economic and financial considerations do not take precedence over risk to public health, even if uncertain, & n perception of risk may lead to differences in scientific opinion, even arising from the same scientific evidence! *Alemanno, 2009, http: //www. papers. ssrn. com/so 13/papers. cfm? abstract_id=1325770, and Hudig, The European Risk Forum Study, The Precautionary Principle Application and Way Forward
EU Case Law* Pfizer / Alpharma (virginiamycin and bacitracin) n CFI imposed that “a public institution can be required to act even before any adverse effects have become apparent” n Implying that EU institutions may be obliged to apply the PP. n CFI also signalled that precautionary measures can not be based on hypothetical risks, but must be based on scientific studies available at the time, even if inconclusive *Alemanno, 2009, http: //www. papers. ssrn. com/so 13/papers. cfm? abstract_id=1325770, and Hudig, The European Risk Forum Study, The Precautionary Principle Application and Way Forward â Interpretatin of the Precautionary Principle is increasingly being defined by public concern, through EU Law Courts
Bisphenol A (BPA) EU Ban of use in Baby Bottles n Adopted under comitology procedure, no impact assessment was conducted, n Data on alternatives was limited or non-existent n Results on “risk-risk trade-off” were not taken into account n No evidence that alternative materials are safer than BPA. â EU Comm´s 2000 Guidance Was Not Followed
BPA – EU Commission n Overruling EFSA's opinion and presenting the EU Directive to ban BPA use in baby bottles, Commissioner Dalli stated the ban, "represents a landmark in our efforts to protect better the health of EU citizens, in particular when it comes to our children, following the precautionary principle“ â Public concern appeared to have greater influence on DG SANCO than EFSA´s expert and independent scientific opinion
Innovation is one of the 3 key priorities of the European Commission Europe 2020 Strategy. It also plays a key role in the Horizon 2020 framework programme for Research and Innovation and is recognised as a key enabling technology. Source: COM(2011) 808; COM(2012) 341.
“Risk” Perception EU Member State GMO Interest/Concern Positive to GM Negative to GM Wavering Bre. Br etag nene Picardie re oioi al L Poitou. Charen tes Cen Ce ntre Bourgo og gne Lorraine Fra nchhe nc e Co m te sdee ysd P ay Alsace Ile-de-Fra Frannce ce Chaamp Adrrdmpagne enne NNoo HHaut rrmm auet an andd ei No N orrd d-Pas Calais e Ca dde Basse -Norm a and ie ndie Limousi usinn Auverg ne Rhône-Al pes Aquit aine Midii-P Pyrenees Provence-Al -Alpes. Cote-d‘A zur Crr s c do doc nguue ng La n silol ssill -Rou Source: Europa. Bio è Profound Differences in Risk Perception, within the EU
Professor Anne Glover Eu. Comm. Chief Scientific Advisor “There is no substantiated case of any adverse impact on human health, animal health or environmental health, so that’s pretty robust evidence, and I would be confident in saying that there is no more risk in eating GMO food than eating conventionally farmed food, ” http: //m. euractiv. com/details. php? aid=514072 n stating that, as a result the precautionary principle no longer applies! â What is a sufficient level of evidence to overturn precaution?
Public Perception of Chemicals Public are: n More concerned about involuntary Risks than voluntary ones n Fear technological hazards more than natural ones, & are n More frightened of unfamiliar risks than familiar risks* *Fishhoff et. Al. “How safe is safe enough” **Ragnor E. Lofstedt, “Risk v Hazard – How to Regulate in the 21 st Century” â Chemicals tend to be involuntary, technplogical and unfamiliar
Re-Registration, under Directive 91/414/EEC “Re-Registration” Directive 91/414/EEC Regulation 1107/2009 Hazard Criteria & Comparative Assessment Prepared by the European Crop Protection Association â The Tool Box has been reduced by more than 70%
Cost of Bringing a New Product to Market $m Total $256 m. Total $184 m. Total $152 m. Development 146 Development 67 Research 72 Development 79 Research 94 Research 85 Results of 2010 Study undertaken for ECPA and Crop. Life America â Cost of compliance has increased © Phillips. Mc. Dougall
Rate of Product Introductions and R&D by Crop Number of new Active Ingredients Herbicides Insecticides Fungicides Cereals Soybean Maize Rice F&V Other Total F&V Rice Cotton Others Total F&V Cereals Rice Others Total Average annual rate of introduction 1980/1989 15 11 2 10 51 11 5 9 4 29 13 14 9 0 36 7 1 23 12. 3 1990/1999 12 10 10 19 1 5 57 16 2 12 7 37 9 16 5 0 30 3 127 12. 7 Results of 2010 Study undertaken for ECPA and Crop. Life America Time period 2000/2009 12 1 9 14 0 2 38 15 3 3 5 26 17 8 7 0 32 5 101 10. 1 In R&D 3 0 1 4 1 1 10 6 3 13 6 8 3 1 18 1 42 8. 4 © Phillips. Mc. Dougall â Innovation can not always keep pace with precaution â Why should industry invest if it is not possible to demonstrate safe use?
Trade
Trans. Atlantic Perspective • 1960 and 1990, US health, safety, and environmental regulations were more stringent, risk averse, comprehensive, and innovative than those adopted in Europe. • Since around 1990, Europe has increasingly taken a leading regulatory position. • EU policymakers have grown more willing to regulate risks on precautionary grounds, while American policymakers have called for higher levels of scientific certainty before imposing additional regulatory controls on business. Professor, Haas School of Business & the Department of Political Science at the University of California, Berkeley. â Why has Europe become more risk averse while American policy makers are calling for greater levels of scientific evidence?
EU USA Trade Implications n June 4, 2008, following an 11 year precautionary ban on marketing of poultry washed in chlorinated water, the EU Commission proposed to permit marketing with labelling for consumer choice. n The EU Council described the proposed compromise solution as “onerous”. n The EU Parliament objected n The US Poultry & Egg Export Council attacked the EU position as “pure and simple protectionism”. n EU´s Interpretation of the precautionary principle was contested by Washington è Use of the precautionary principle can result in trade disputes
Risk-Risk Trade-Offs & Substitution
Regulation 1107/2009 Non-Chemical V Traditional Pest Control 10 X references to Non-chemical pest control: n Definition 8: n "Non-chemical methods means alternative methods to chemical pesticides for plant protection and pest management, based on agronomic techniques such as those referred to in point 1 of Annex III* to Directive 2009/…/EC +, or physical, mechanical or biological pest control methods” *ANNEX III. General principles of integrated pest management â General Principle for IPM, non-chemical MUST be preferred
Introduced “natural enemies” The harlequin ladybird Harmonia axyridis Source: National Biodiversity Network n Introduced to North America in 1988, n Already invaded much of northwest Europe, n Now the most widespread ladybird n Arrived in Britain in summer 2004 – now species on the continent. widespread â Risk-risk trade-offs were not taken into account â Non-Chemical Solution Resulted in Serious and Irreversible Environmental Damage
Weed control - Flames n Fire hazard? n Air pollution? n Carbon footprint? n Selectivity to non-target species? n Impact on biodiversity? â Risk-risk trade-offs not taken into account
Impact of Ploughing on Earthworms? Aspects of Applied Biology 47 (1996), Rotations and cropping systems. The influence of crop management systems and rotation on earthworm populations 19901994. J A Hutcheon and D R Iles â It can take up to 6 years for earthworms to recover from deep furrow ploughing
Organic V Conventional Agriculture? May 2001 Been shoots produced according to organic guidelines infected more than 4000 people, of which 53 died. About 500 became seriously ill, and were treated in hospital. â What would have happened if 53 people died as a result of chemical contamination?
Quality of Science and Precaution? The European Food Safety Authority concluded that Séralini et al´s paper which raised international concerns about the potential toxicity of genetically modified (GM) maize NK 603 and of a herbicide containing glyphosate, “is of insufficient scientific quality to be considered as valid for risk assessment. ” EFSA initial review on GM maize and herbicide study Press Release 4 October 2012 â How good does scientific evidence need to be to trigger precaution?
Risk-Risk Analysis? “bisphenol A, phthalate, PVC and polycarbonate free” http: //www. makeuwell. com. au/glass-baby-bottle-240 ml-bpa-free. html â What about other risks which may be associated with use of glass baby bottles? 2/24/2012 INTERNAL
What about other risks associated with Glass Baby Bottles? “Avoid heating glass baby bottles. These bottles absorb microwave energy rapidly, which may result in the bottle cracking or exploding. ” http: //www. ext. nodak. edu/food/factsheet/warming. pdf â Where is the evidence that it really is safer to use glass baby bottles? 2/24/2012 INTERNAL
Failure to account of risk-risk trade-offs can result in replacing known and mitigated risks with unknown and unmitigated risks â Precaution is not risk free
Conclusions n The Precautionary Principle is valuable, when intrepretted according to EU Commission´s 2000 Guidance Document, but this guidance is not always followed n Policy makers are under increasing pressure to be “precautionary”, fuelled by media´s focus on potential hazards n Hazard-based legislation can be viewed as an extreme interpretation of the “precautionary” approach n Scientific risk assessment and EFSA are increasingly challenged as a basis for regulation by the precautionary principle n Precautionary legislation can result in known and mitigated risks being replaced by unknown and unmitigated risks n Use of the precautionary principle can result in trade disputes â Out of context use of the precautionary principle, can remove valuable technologies, increase cost and prevent innovation
Is precaution out of balance in the EU?
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