VZCZCXRO1539
RR RUEHAG RUEHDF RUEHIK RUEHLZ RUEHPOD RUEHROV RUEHSR
DE RUEHBS #0521/01 0971245
ZNR UUUUU ZZH
R 071245Z APR 09
FM USEU BRUSSELS
TO RUEHC/SECSTATE WASHDC
INFO RUCNMEU/EU INTEREST COLLECTIVE
RUCNMEM/EU MEMBER STATES COLLECTIVE
RUEHRC/DEPT OF AGRICULTURE WASHDC
RUCPDOC/DEPT OF COMMERCE WASHDC

UNCLAS SECTION 01 OF 03 BRUSSELS 000521 
 
SIPDIS 
 
STATE FOR EUR/ERA KESSLER 
STATE PASS TO USTR CHRIS WILSON 
STATE PASS TO OMB BECK, MANCINI 
STATE PASS TO CPSC O'BRIEN 
 
E.O. 12958: N/A 
TAGS: EAGR ECON EFIN EFTA ETRD EU
SUBJECT: PRECAUTIONARY PRINCIPLE: SENTENCE FIRST, VERDICT 
SECOND 
 
 ¶1. (U) SUMMARY.  At its quarterly meeting in Brussels March 
31, the European Risk Forum focused its roundtable discussion 
on the precautionary principle, with Commission and European 
agency officials, private sector representatives, academics 
and others weighing in.  The discussion, which was less a 
debate about the merits of the principle and more about its 
proper use, was highlighted by robust exchanges which led to 
general conclusions that the EU had gone far enough in its 
use of precaution, that benefits needed greater consideration 
in impact assessments, and that prudent caution need not lead 
to bans of products if other options are available and if 
there is not yet compelling evidence that demands drastic 
measures.  Indeed, there was general agreement that excessive 
use of the precautionary principle should be avoided, lest it 
stifle innovation, but with health and environmental concerns 
paramount in the decision-making process.  END SUMMARY. 
 
Background 
---------- 
 
¶2. (U) The European Risk Forum (ERF) convened its first 
quarterly meeting of 2009 on March 31 in Brussels.  ERF is a 
Brussels-based think tank well known to Mission and 
Washington risk managers and analysts as an objective 
promoter of high quality risk assessment and management, a 
vigorous interlocutor with EU institutions and officials, and 
a strong supporter of science and fact-based policy making. 
 
¶3. (U) In addition to the precautionary principle, other 
items on the March 31 agenda included a review of ERF's 2009 
work plan, a discussion of emerging trends in risk management 
at the EU level, and a presentation on risk communication. 
The signal event of the meeting, however, was the roundtable 
on the precautionary principle, the risk-focused principle 
used by EU regulators to guide their assessment and 
management of risk.  While not a spirited debate per se, the 
conversation was quite robust, focused more on the proper 
uses of the principle in the guidance of crafting policy 
rather than whether or not a precautionary approach should be 
in the toolbox at all. 
 
Definition 
---------- 
 
¶4. (U) Harrie van Dijk from the Dutch Health Council opened 
the roundtable and offered two definitions of the 
precautionary principle.  He said the definition accepted in 
European jurisprudence is the following: where there is 
uncertainty as to the existence or extent of risks to human 
health or the environment, the institutions may take 
protective measures without having to wait until the reality 
and seriousness of those risks become fully apparent.  To put 
it more simply, said van Dijk, the precautionary principle is 
the anticipatory exercise of caution with a view to 
preventing something undesirable. 
 
¶5. (U) Van Dijk suggested the principle was more a process 
than a decision rule, and said the key to applying it was to 
find balance between caution and progress.  He cited cell 
phones as a good example:  despite some evidence linking cell 
phone use to some cancers, the EU would never think to ban 
them unless a strong and irrefutable link was established. 
Risk managers will continue to monitor the situation, van 
Dijk said, in a cautionary, rather than a precautionary 
manner.  But in general, he said, the ultimate challenge was 
to produce a fair distribution of cost and benefits across EU 
citizenry and future generations while ensuring that risks to 
health and environment never outweigh the benefits.  He 
suggested the principle be regarded as a strategy for dealing 
with uncertainties, and, as such, should  be applied to all 
health related issues and to issues with considerable 
uncertainty.  Returning to the need for balance, he warned 
against the undesirable consequences of both excessive and 
insufficient caution and suggested that banning and/or 
exclusion of products or substances should be seen as last 
resorts. 
 
Jurisprudence 
------------- 
 
¶6. (U) Alberto Alemanno, Associate Professor of Law at the 
Ecole des Hautes Etudes Commerciales (HEC) in Paris, 
presented the first of two views on jurisprudence and the 
principle.  Alemanno said the BSE crisis of the 90s shaped 
 
BRUSSELS 00000521  002 OF 003 
 
 
earlier decisions regarding the principle in European 
Community courts, prompting the courts to err on the side of 
caution in cases regarding risk management and awareness.  A 
key ruling issued in 2002 by the EU Court of First Instance 
in the case of Pfizer-Alpharma reinforced the EU's legal 
framework for applying the principle, reaffirming that 
precautionary action can be justified in appropriate 
circumstances and clearly defined the conditions triggering 
its application.  He said that as agencies such as the 
European Food Safety Agency (EFSA) and the European Chemicals 
Agency (ECHA) have been established, the Commission has taken 
the lead in risk; nonetheless, courts have also ruled there 
is clearly no supremacy of "Euro science" over national 
science and when there are uncertainties in scientific 
research, member states can "decide what degree of protection 
. . . they intend to ensure."  But Alemanno stressed that 
courts have also ruled that the principle of proportionality 
must be applied as well, and that a member state measure will 
be considered disproportionate "if it is manifestly 
inappropriate or when it may be shown that other, less 
onerous measures" are available. 
 
¶7. (U) Commenting on a study of the principle and EU case 
law, Michael Rogers, from the International Council of Amino 
Acid Science, said the results are mixed in terms of how and 
when the principle should be applied.  According to his 
study, 140 cases involving the principle were heard from 
1995-2008, half of which the study deemed significant.  Those 
decisions said that the principle should be 
non-discriminatory, applied consistently, take into account 
both costs and benefits, and should be subject to review in 
the face of new evidence.  On disproportionality, he said, 
one case was decided in favor of member state competence, 
another in support of the Commission's lead.  But in a 1999 
case, the European Court of Justice (ECJ) ruled that a member 
state was not obliged to give its consent to allowing the 
sales or cultivation of genetically modified organism (GMO) 
products if it had new information regarding risk.  On the 
other hand, he said, a European court has never asked a 
member state to go back and do more risk assessments before 
applying the principle.  Rogers said the Commission should 
issue a new Communication regarding the principle, one that 
might encourage alternate approaches to risk management that 
fall short of keeping products from the market.  Regardless, 
Rogers thought the major consequence of strictly applying the 
precautionary principle - sentence first, verdict second - 
was vulnerable to modification in the courts in the long run, 
adding that an expected high number of cases due to the new 
REACH regulation may well provide such a test. 
 
¶8. (U) The roundtable concluded with a presentation from 
Bjorn Hansen, DG Environment.  (Note: Hansen is the new chair 
of the OECD's Working Party on Manufactured Nanomaterials and 
is former director of the European Chemicals Agency. End 
Note)  Hansen cited two case studies, both involving flame 
retardants, as examples of how the principle, correctly, was 
and was not invoked.  In one study, the EU had conducted risk 
assessments that suggested five to ten years were needed to 
generate enough data to accurately assess the safety of the 
chemicals.  Based on the risk assessments and invoking the 
precautionary principle, the EU decided to ban at once and 
not wait for further evidence.  On the other hand, said 
Hansen, was the risk assessment for another flame retardant, 
which could not conclude that there were any risks to health, 
but suggested another 10 years would be needed to prove 
long-term safety.  In this case, said Hansen, the Commission 
did not invoke the principle, and the product was approved 
for sale.  He said, on balance, the EU has not gone too far 
in its invocation of the principle, but has gone far enough. 
 
Comment 
------- 
 
¶9. (U) While not a debate per se, the roundtable illustrated 
the varied perspectives on the precautionary principle within 
Europe.  It is clear that while some EU regulators strive to 
find a balance between caution and precaution, legislation 
such as REACH and other similar measures (the Toy Safety 
Directive, the Novel Foods Directive) that are firmly 
grounded in the precautionary principle may provide future 
judicial grist to modify use of the principle and ensure its 
proportionate application.  Nonetheless, the precautionary 
principle is here in Europe to stay, and with hot-button 
issues such as GMOs, nanotechnology, and cloning still under 
 
BRUSSELS 00000521  003 OF 003 
 
 
discussion and vulnerable to guilt by association, continued 
USG efforts to encourage a process in which evidence-based 
science leads to a fair verdict on risk before a sentence is 
pronounced remain vital. 
.