INTERNAL2/24/2012

Precautionary Principle

A Balance of Science and “Politics”

Paul LeonardBASF SE

Precautionary Principle

Origins

Use

Hazard based legislation, the ultimate form of Precaution

Case law?

Innovation

Trade

Risk-Risk trade-offs & substitution

Conclusions

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."

The PP was designed to address situations where political action is required, but science is not clear or readily available.

Origins and Evolution

The EU Policy Treadmill

NGOs & Public Opinion

Media

ElectionsMembers of European Parliament

Opinions

Commission Drafts Legislation

Parliament amends legislation

Council Reaction

Political Compromise

Regulation

Revision

•27 Member States•NGOs•Lobbyists•Think tanks•Chambers of commerce•Journalists

It´s a complex & lengthy process

Precaution is faster, more decisive, less complex to administer & can be justified by Scientific Uncertainty

Science is built on uncertainty, but this can be missused

What Is Scientific Uncertainty?

Lack of scientific certainty should not prevent regulatory action

A statistical probability of 95% is also equivalent to 5% scientific uncertainty

The Precautinary Principle is Promoted as a Responsible Solution

What About Scientific Risk Assessment?

Traditional basis for regulation of uncertainty,

Hazard X Exposure potential = Risk

Management of risk and uncertainty by application safety factors

EFSA and Risk Assessment are increasingly criticised by NGOs and politicians as,

“An unreliable practice of guessing without adequate knowledge”

INTERNAL2/24/2012

Guidance on Interpretation of the Precautionary Principle

COM(2000) 1COMMUNICATION FROM THE COMMISSIONon 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:

Stress alternatives in cases of uncertainty

Scrutinise claimed benefits

Importance of lay knowledge (including public domain science)

Reverse the burden of proof

Precaution – as an environmental policy management tool

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."

Lisbon Treaty

December 2007

Legislative Guidance on PP?

There are:

Guidelines for risk assessments, risk management & impact assessments

Several pieces of relevant legislation, and semi-legislative texts, relating to the precautionary principle

Case law

Academic and public debate & eminent opinions

No single comprehensice legislation laying down rules for its use

Would a surgeon practice new

invasive procedures

without reference to tried and tested

medical guidelines?

How is the Precautionary Principle Being Used?

Forgetful bees can't find

their food

Ben Webster 10 March 2011

Call to ban pesticides linked to bee deaths

By Michael McCarthy Environment Editor

21 January 2011

Media

EU and National policy makers were put under pressure to ban neonicotinoid insecticides – without substantiated evidence

“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.”

Hazard Based Legislation,

the Ultimate form of Precaution

Hazard criteria Plant Protection & Biocides

The Ultimamte Precaution - “Better don´t do it at all”

Ground Water Protection0.1ppb 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

Hazard criteria Plant Protection & Biocides

CMR category 1a & 1b

Endocrine disruptors

POP*/PBT/vPvB

1107/2009 &New Biocide Regul.

Cut-offNo RegistrationMarket Removal

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”

What is an endocrine disruptor?

Which level of ED should trigger in a ban?

* http://ec.europa.eu/environment/endocrine/documents/bkh_report.pdf#page=1 http://ec.europa.eu/environment/docum/pdf/bkh_main.pdf and

http://www2.mst.dk/common/Udgivramme/Frame.asp?http://www2.mst.dk/Udgiv/publications/2007/978-87-7052-538-1/html/default.htm

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

Endocrine Disruption

Potential impact for a wide range of chemicals:

phthalates, parabenes, alkylphenols, BPA, synthetic hormones, various pesticides including triazoles,

EU Commission must define criteria for endocrine disruption by end of 2013, for the Biocide Regulation

Industry argues that potency and exposure should be taken into account by the EU Commission, when defining criteria for the ED definition

ED criteria are not just relevant for plant protection and biocides

Economic importance of Azoles in European Agriculture: Wheat Case Study

With azoles, estimated wheat production to increase by 13% in 2020, but the class is potentially under threat from EU Regulations

Removal of azoles would:

reduce EU wheat production by 7% in 2013 and by 12%

Loss of 2,4 billion euros in 2013 and 4,6 billion in 2020

Cultivated area would need to increase by 7,5 % and13,9 % respectively, to maintain EU´s wheat self sufficiency

Without increased cultivation, EU would become a net importer

Uncertainty concerning global food security would further increase

Prices would continue to rise

19

The assessment of the economic importance of Azoles in European agriculture: wheat case study, Nomisma, Sept. 2012

New Biocide Regulation

June 2009

Hazard-based cut-off criteria, copied & pasted from the Plant Protection Regulation 1107/2009

EU Commission Proposed Article 5.1(c) No chance of derogation for product types 4

and 14 to 19

This would have resulted in removal of anticoagulant rodenticides, with no viable alternative and no chance of derogation

EU Commission was Persuaded to Remove Article 5.1(c)

Hazard criteria under REACH, Plant Protection & Biocide Regulations

CMR category 1a & 1b

Endocrine disruptors

POP/PBT/vPvB

Authorisation •Risk Assessment

•Socioeconomic assessment

REACH

Substances of very high concern(SVHC)

No limitation Mitigation

Use restrictionSubstitution

CMR category 1a & 1b

Endocrine disruptors

POP*/PBT/vPvB

1107/2009 &New Biocide Regul.

Cut-offNo RegistrationMarket Removal

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/so13/papers.cfm?abstract_id=1325770, andHudig, 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:

economic and financial considerations do not take precedence over risk to public health, even if uncertain, &

perception of risk may lead to differences in scientific opinion, even arising from the same scientific evidence!*Alemanno, 2009, http://www.papers.ssrn.com/so13/papers.cfm?abstract_id=1325770, andHudig, The European Risk Forum Study, The Precautionary Principle Application and Way Forward

EU Case Law*

Pfizer / Alpharma (virginiamycin and bacitracin)

CFI imposed that “a public institution can be required to act even before any adverse effects have become apparent”

Implying that EU institutions may be obliged to apply the PP.

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/so13/papers.cfm?abstract_id=1325770, andHudig, The European Risk Forum Study, The Precautionary Principle Application and Way Forward

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

Adopted under comitology procedure, no impact assessment was conducted,

Data on alternatives was limited or non-existent

Results on “risk-risk trade-off” were not taken into account

No evidence that alternative materials are safer than BPA.

EU Comm´s 2000 Guidance Was Not Followed

BPA – EU Commission

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“

Public concern appeared to have greater influence on DG SANCO than EFSA´s expert and independent scientific opinion

Innovation

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.

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EU Member State GMO Interest/Concern

Country VoteGermany 29France 29UK 29Italy 29Spain 27Poland 27Romania 14Netherlands 13Portugal 12Belgium 12

Czech 12Hungary 12Greece 12Sweden 10Austria 10Bulgaria 10Slovakia 7Finland 7Denmark 7Ireland 7Lithuania 7Latvia 4Slovenia 4

Luxemburg 4Cyprus 4Estonia 4Malta 3

Positive to GM

Negative to GM

Wavering

Profound Differences in Risk Perception, within the EU

Source:EuropaBio

“Risk” Perception

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

stating that, as a result the precautionary principle no longer applies!

What is a sufficient level of evidence to overturn precaution?

Public Perception of Chemicals

Public are:

More concerned about involuntary Risks than voluntary ones

Fear technological hazards more than natural ones, & are

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 21st Century”

Chemicals tend to be involuntary, technplogical and unfamiliar

Re-Registration, under Directive 91/414/EEC

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100

200

300

400

500

600

700

800

900

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New AS

Existing AS

Prepared by the European Crop Protection Association

The Tool Box has been reduced by more than 70%

“Re-Registration”

Directive 91/414/EEC

Regulation 1107/2009

Hazard Criteria &

Comparative Assessment

Cost of Bringing a New Product to Market

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Environmental Chemistry

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Field Trials

Chemistry

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Chemistry

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Research 72

Research 85

Research 94

Development 67

Development 146

Development 79

Total $152 m.

Total $256 m.

Total $184 m.

Results of 2010 Study undertaken for ECPA and CropLife America © PhillipsMcDougall

Cost of compliance has increased

Number of new Active Ingredients Time period 1980/1989 1990/1999 2000/2009 In R&D Herbicides Cereals 15 12 12 3

Soybean 11 10 1 0 Maize 2 10 9 1 Rice 11 19 14 4 F&V 2 1 0 1 Other 10 5 2 1 Total 51 57 38 10

Insecticides F&V 11 16 15 6 Rice 5 2 3 3 Cotton 9 12 3 1 Others 4 7 5 3 Total 29 37 26 13

Fungicides F&V 13 9 17 6 Cereals 14 16 8 8 Rice 9 5 7 3 Others 0 0 0 1 Total 36 30 32 18

Others 7 3 5 1 Total 1 23 127 101 42 Average annual rate of introduction 12.3 12.7 10.1 8.4

Rate of Product Introductions and R&D by Crop

© PhillipsMcDougall

Innovation can not always keep pace with precaution Why should industry invest if it is not possible to demonstrate safe use?

Results of 2010 Study undertaken for ECPA and CropLife America

Trade

TransAtlantic Perspective

Professor, Haas School of Business & the Department of Political Science at the University of California, Berkeley.

• 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.

Why has Europe become more risk averse while American policy makers are calling for greater levels of scientific evidence?

EU USA Trade Implications

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.

The EU Council described the proposed compromise solution as “onerous”.

The EU Parliament objected

The US Poultry & Egg Export Council attacked the EU position as “pure and simple protectionism”.

EU´s Interpretation of the precautionary principle was contested by Washington

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:

Definition 8:

"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

General Principle for IPM, non-chemical MUST be preferred

Introduced “natural enemies”

Source: National Biodiversity Network

Introduced to North America in 1988, Now the most widespread ladybird

species on the continent.

The harlequin ladybirdHarmonia axyridis

Already invaded much of northwest Europe, Arrived in Britain in summer 2004 – now

widespread

Risk-risk trade-offs were not taken into account Non-Chemical Solution Resulted in Serious and Irreversible Environmental Damage

Weed control - Flames

Fire hazard?

Air pollution?

Carbon footprint?

Selectivity to non-target species?

Impact on biodiversity?

Risk-risk trade-offs not taken into account

Impact of Ploughing on Earthworms?

It can take up to 6 years for earthworms to recover from deep furrow ploughing

Aspects of Applied Biology 47 (1996), Rotations and cropping systems. The influence of crop management systems and rotation on earthworm populations 1990-1994. J A Hutcheon and D R Iles

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.

What would have happened if 53 people died as a result of chemical contamination?

Organic V Conventional Agriculture?

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 NK603 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

How good does scientific evidence need to be to trigger precaution?

Quality of Science and Precaution?

Risk-Risk Analysis?

“bisphenol A, phthalate, PVC and polycarbonate free”

http://www.makeuwell.com.au/glass-baby-bottle-240ml-bpa-free.html

INTERNAL2/24/2012

What about other risks which may be associated with use of glass baby bottles?

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

INTERNAL2/24/2012

Where is the evidence that it really is safer to use glass baby bottles?

Failure to account of risk-risk trade-offs can result in replacing known and mitigated risks

with unknown and unmitigated risks

Precaution is not risk free

Conclusions

The Precautionary Principle is valuable, when intrepretted according to EU Commission´s 2000 Guidance Document, but this guidance is not always followed

Policy makers are under increasing pressure to be “precautionary”, fuelled by media´s focus on potential hazards

Hazard-based legislation can be viewed as an extreme interpretation of the “precautionary” approach

Scientific risk assessment and EFSA are increasingly challenged as a basis for regulation by the precautionary principle

Precautionary legislation can result in known and mitigated risks being replaced by unknown and unmitigated risks

Use of the precautionary principle can result in trade disputes

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?