Precautionary Principle
A Balance of Science and “Politics”
Paul Leonard
BASF SE
2/24/2012
INTERNAL
Precautionary Principle
 Origins
 Use
 Hazard based legislation, the ultimate form of Precaution
 Case law?
 Innovation
 Trade
 Risk-Risk trade-offs & substitution
 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."
 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
 Precaution is faster, more decisive, less complex to administer & can be justified
by Scientific Uncertainty
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
 Science is built on uncertainty, but this can be missused
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”
 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:
 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
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:
 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
Would a surgeon
practice new
invasive
procedures
without reference
to tried and tested
medical
guidelines?
 No single comprehensice legislation laying down rules for its use
How is the Precautionary
Principle Being Used?
Media
“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.”
 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
0.1ppb 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
 The Ultimamte Precaution - “Better don´t do it at all”
Hazard criteria
Plant Protection & Biocides
1107/2009 &
New Biocide Regul.
CMR category 1a & 1b
Endocrine disruptors
POP*/PBT/vPvB
Cut-off
No Registration
Market 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?
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://www2.mst.dk/common/Udgivramme/Frame.asp?http://www2.mst.dk/Udgiv/publications/2007/978-87-7052-538-1/html/default.htm
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
The assessment of the economic importance of
Azoles in European agriculture: wheat case study,
Nomisma, Sept. 2012
19
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
1107/2009 &
New Biocide Regul.
CMR category 1a & 1b
REACH
CMR category 1a & 1b
Endocrine disruptors
Endocrine disruptors
POP*/PBT/vPvB
POP/PBT/vPvB
Cut-off
No Registration
Market Removal
Substances of very high concern
(SVHC)
Authorisation
•Risk Assessment
•Socioeconomic assessment
No limitation
Mitigation
Use restriction
Substitution
 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, 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:
 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, and
Hudig, 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, and
Hudig, 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.
“Risk” Perception
EU Member State GMO Interest/Concern
Country
Germany
France
UK
Italy
Spain
Poland
Romania
Netherlands
Portugal
Belgium
Czech
Hungary
Greece
Sweden
Austria
Bulgaria
Slovakia
Finland
Denmark
Ireland
Lithuania
Latvia
Slovenia
Luxemburg
Cyprus
Estonia
Malta
Vote
29
29
29
29
27
27
14
13
12
12
12
12
12
10
10
10
7
7
7
7
7
4
4
4
4
4
3
Positive to GM
Negative to GM
Wavering
Source:
EuropaBio
 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
 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
1000
“Re-Registration”
Directive
91/414/EEC
900
800
700
600
500
New AS
400
Existing AS
300
Regulation
1107/2009
200
100
Hazard Criteria
&
Prepared by the European Crop Protection Association
 The Tool Box has been reduced by more than 70%
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
0
Comparative
Assessment
Cost of Bringing a New Product to Market
Registration
$m
300
Environmental
Chemistry
Total $256 m.
250
Total $184 m.
200
150
100
24
Field Trials
32
Total $152 m.
13
13
18
18
11
16
18
Development
67
18
10
50
Toxicology
25
30
25
54
Development
146
Development
79
20
9
Tox/Env Chemistry
36
11
44
Research
72
Chemistry
Research
94
32
32
41
42
1995
2000
2005-8
Research
85
Biology
Chemistry
0
Results of 2010 Study undertaken for ECPA and CropLife America
 Cost of compliance has increased
© PhillipsMcDougall
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
Others
Total
Average annual rate of introduction
1980/1989
15
11
2
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 CropLife 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
1
3
13
6
8
3
1
18
1
42
8.4
© PhillipsMcDougall
 Innovation can not always keep pace with precaution
 Why should industry invest if it is not possible to demonstrate safe use?
Trade
TransAtlantic 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.
 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”
The harlequin ladybird
Harmonia axyridis
Source: National Biodiversity Network
 Introduced to North America in 1988,  Already invaded much of northwest Europe,
 Now the most widespread ladybird  Arrived in Britain in summer 2004 – now
species on the continent.
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?
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
 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.
 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 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?
Risk-Risk Analysis?
“bisphenol A, phthalate, PVC and
polycarbonate free”
http://www.makeuwell.com.au/glass-baby-bottle-240ml-bpa-free.html
 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
 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
 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?