VZCZCXRO9970
RR RUEHAG RUEHDF RUEHHM RUEHIK RUEHLN RUEHLZ RUEHMA RUEHPB RUEHPOD
RUEHRN RUEHROV
DE RUEHBS #0184/01 0361653
ZNR UUUUU ZZH
R 051653Z FEB 08
FM USEU BRUSSELS
TO RUEHC/SECSTATE WASHDC
INFO RUEHZN/ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE
RUCNMEU/EU INTEREST COLLECTIVE
RUCNMEM/EU MEMBER STATES COLLECTIVE
RUEHSS/OECD POSTS COLLECTIVE
RUCPDOC/DEPT OF COMMERCE WASHDC
RHMFIUU/DEPT OF ENERGY WASHINGTON DC
RUEHRC/DEPT OF AGRICULTURE WASHDC

UNCLAS SECTION 01 OF 05 BRUSSELS 000184 
 
SIPDIS 
 
SENSITIVE 
SIPDIS 
 
STATE FOR EUR/ERA, OES/SAT 
STATE PASS TO EPA 
STATE PASS TO FDA 
STATE PASS TO NSF 
STATE PASS TO OSTP 
STATE PASS TO USTR 
 
E.O. 12958: N/A 
TAGS: ECON EIND EUN TPHY TSPL
SUBJECT: NANOTECHNOLOGY: EUROPEAN UNION VIEWPOINTS AND U.S. 
OPPORTUNITIES FOR COLLABORATION 
 
 
¶1.  (SBU) Summary:  The European Commission wants to continue 
cooperation with the U.S. in nanotechnology research and 
regulation to avoid divergent policies which could harm 
transatlantic cooperation and trade.  Given the Community's 
possible influence over global approaches to nanotechnology, 
USEU recommends we significantly increase our cooperation 
with the EU on this issue, considering that: 
 
  -- The Commission is divided on nanotechnology regulation, 
with DG Enterprise believing existing regulation probably is 
sufficient to deal with new products as they approach the 
marketplace, whereas DG Environment favors new regulation, 
possibly to include labeling or moratoria on the release of 
new products until further information is available; 
  -- while the OECD will remain the primary forum in which to 
address existing information gaps without dampening the 
investment climate, we need to influence the EU and member 
state views in Brussels, Paris and other capitals; 
  -- we should capitalize on the Slovene Presidency's 
enthusiasm for nanotechnology by promoting cooperative 
scientific efforts and come to resolution on key areas of 
concern through venues such as the Transatlantic Economic 
Council. 
 
¶2.  (SBU) Bilateral engagement in the near future is crucial 
to ensure U.S. leadership of, and a coordinated transatlantic 
approach to, the development of a measured approach to 
nanotechnology regulation and policy.  As a first step, USEU 
recommends we arrange for a USG interagency team to meet with 
key Commission Directorates General in Brussels on the 
margins of the March International Dialogue on Nanotechnology 
Research. OECD,s two Working Parties dealing with 
nanotechnology also present opportunities. End summary 
 
----------------------------------------- 
USEU Perceptions of Commission Nano-think 
----------------------------------------- 
 
¶3.  (SBU) The European Community and member states place a 
very high priority on nanotechnology research and 
development.  For the period 2007-2013, the European 
Commission has allocated over EUR 3.5 billion to 
nanotechnology related projects in addition to the individual 
member state funding of over EUR 650 million per year 
combined - Germany alone contributes EUR 330 million per 
year. These figures are comparable with those of the U.S. and 
Japan, the other two largest contributors to nanotechnology 
research worldwide.  This concentration throughout Europe 
will lead to an increased role worldwide in determining 
global nanotechnology regulation.  Though no final decisions 
have been made, possible avenues the EU could choose range 
from simply using the regulation which currently exists as it 
applies to sectors affected by nanotechnology to moratoria on 
research and development of nanotechnology and 
nano-containing products within certain sectors, which could 
include limitations or prevention of imports in these 
sectors.  Intermediate steps include placing no additional 
limitations on release to market so long as all 
nano-containing products include mandatory labeling or 
requiring detailed life-cycle studies before a product can 
come to market.  The decisions the EU takes in the coming 
years could have very dramatic effects on the global 
nanotechnology industry. 
 
¶4. (SBU) Indeed, the Commission is increasingly absorbed with 
debates about how it should best regulate the technology, 
with a tendency toward a more politically-correct 
"precautionary" approach, in part because the Commission 
often focuses on Eurobarometer studies of European public 
opinion to guide policy formulation rather than taking it as 
a signal that more public debate and communication may be 
necessary.  This comes through most clearly in the 
Commission's September 2007 Communication on Nanosciences and 
Nanotechnologies, when the Commission states that "The 
Commission's role as a policy making body is to take account 
of people's expectations and concerns" and that there "should 
also be public consensus on their overall impact."  Even in 
 
BRUSSELS 00000184  002 OF 005 
 
 
the area of medical technologies, where the Community tends 
to take more of a risk-based approach, the Commission's 
European Group on Ethics in Science and New Technologies said 
in its January 2007 opinion on nanomedicine that the EU needs 
more research on safety and ethics, and recommends the 
setting up of a European network on the ethics of 
nanomedicine.  The Commission does recognize that presenting 
accurate information on expected benefits and potential 
risks, and presenting opportunities for public debate, is 
crucial to the public's formulation of an independent view. 
 
¶5. (SBU) Based on numerous meetings with Commission 
officials, diverging perspectives on regulation are apparent. 
 DG Enterprise maintains the European Commission lead on 
regulatory review of nanotechnology and holds a position most 
similar to that of most USG agencies; however DGs SANCO 
(Health and Consumer Protection), Research, and Environment, 
which all have regulatory influence, appear to have diverging 
views.  DG Enterprise believes existing regulation is 
sufficient for the vast majority of new products, though this 
regulation should be reviewed periodically to verify that it 
accounts for all new products.  Cornelius Brekelmans from DG 
Enterprise provided the "EU Perspective on Policy and 
Regulatory Issues" during DG SANCO's October 2007 First 
Annual Safety for Success meeting, which brought together 
European and U.S. government officials, experts from the 
research and industry communities, and NGOs to discuss the 
current state of nanotechnology and understanding of risk 
assessment and risk management, (See 
http://www.conf-sanco.eu/ for the program and presentations 
of the conference.)  Brekelmans defined the EU perspective as 
a "safe, integrated, and responsible approach," explaining 
that health, safety, and environmental aspects of 
nanotechnology are covered by current EU regulatory 
framework; and that he expects most future EU action to occur 
at the level of additional supporting documents that more 
clearly define the existing framework using scientific 
findings, legal guidance, and other external inputs. 
 
¶6. (SBU) DG SANCO under Director General Robert Madelin 
generally shares the DG Enterprise outlook and often 
collaborates with DG Enterprise in supporting a pragmatic 
risk-based approach to nanotechnology development.  DG SANCO 
has a robust ongoing dialogue with FDA, and has been 
increasing contact with CPSC.  FDA,s presentation given by 
Dr. Richard Canady during the Safety for Success meeting 
explaining current FDA regulatory approaches and the 
reasoning behind why certain decisions are being made was 
very well received by both the Commission and the public.  It 
appeared that while some in the audience - notably from the 
NGO community - still do not agree with FDA's approach, they 
appreciated the method by which the process was explained and 
the reasons for which FDA has made some of its regulatory 
decisions. 
 
¶7. (SBU) DG Environment generally focuses on the effect on 
the environment throughout the lifecycle of a product, from 
manufacturing to disposal.  This approach provides DG 
Environment with a tendency toward "precaution" and multiple 
opportunities to call for regulation.  Eva Hellsten, now the 
scientific advisor to the Director General of DG Environment 
covering several topics, including nanotechnology, has 
indicated during meetings with USEU Econ officers that her DG 
leans in favor of blanket regulation on all nanotechnology 
products, possibly to include full labeling, limitations on 
the types of products released to market, or moratoria on 
products released to market until all properties are known 
fully.  (Note: Ms. Hellsten prides herself on being one of 
the founding authors of REACH, the chemical regulation regime 
used by the EU that operationalizes the precautionary 
principle to the detriment of a pragmatic scientifically 
based approach. Additionally, she was co-author on an 
encyclopedia of chemicals regulation in Sweden, including 
indicating a preference toward labeling.  She appears to be 
continuing this line of reasoning on nanotechnology 
regulation, including stricter efforts to prevent possible 
negative effects of products on the market. End note.) 
 
BRUSSELS 00000184  003 OF 005 
 
 
Follow-up meetings with Henrik Laursen, the new DG 
Environment desk officer for nanotechnology, support the idea 
that DG Environment is in favor overall of the precautionary 
principle.  In meetings with USEU officials, Mr Laursen has 
explained that he believes the U.S. will see the "beauty" of 
REACH and will develop a similar regulatory strategy, and 
this thinking probably will drive DG Environment's position 
on nanotechnology. 
 
¶8. (SBU) Somewhere between DGs Enterprise and SANCO and DG 
Environment is DG Research, which has no regulatory 
authority, but a substantial amount of influence within the 
Commission.  It generally is in favor of innovation, having 
committed over EUR 2 billion to research, but at the same 
time, has released the guidelines for a voluntary code of 
conduct on research. DG Research recently hosted a 
conference, "Towards a Code of Conduct for Responsible 
Nanosciences and Nanotechnologies Research," which focused on 
European efforts, specifically those by DG Research, to 
implement a voluntary code of conduct on nanotechnology 
research and those by industry to implement a similar measure 
within the commercial sector. (See 
ec.europa.eu/research/consultations/list en.html for the full 
text.)  Peteris Zilgavis, the Head of Unit for Ethics in DG 
Research, led the discussion for the Commission.  He 
explained that nanotechnology present substantial benefits, 
but the DG decided on a code of conduct in response to a 
demand and expectation from civil society to guarantee the 
safe, ethical, and efficient development of nanotechnology. 
(Note: DG Research may be highlighting some of the possible 
risks of nanotechnology in part to attract more funding for 
research efforts to answer the knowledge gaps. End note.) 
 
¶9. (SBU)  Not surprisingly, this divergence among the 
Commission Directorates-General is reflected in the European 
public debate on nanotechnology.  DG Enterprise is influenced 
by industrial comments and views; while NGOs such as 
Greenpeace, Friends of the Earth, and Which? appear to drive 
actions by both DG Research and DG Environment. 
Specifically, industry wants a more hands off approach, 
explaining that existing regulation is sufficient to cover 
new products coming to market, and that industry inherently 
self-regulates to guarantee its products can remain on the 
market.  Large NGOs such as Greenpeace and Friends of the 
Earth are driving for further regulation and more input as to 
government decision making, often contributing to Commission 
conferences such as those organized by DGs SANCO and 
Research.  Frequent themes are the public's right to define 
"no-go" areas in research and consumer products, the use of 
the precautionary principle when faced with a lack of 
information, and providing further information to the 
consumer, preferably through the use of labeling.  During DG 
Research's code of conduct meeting, these NGOs argued 
strongly that there should be restrictions on research 
activities according to public opinion; whereas industry and 
the majority of researchers preferred freedom to investigate 
any areas or applications. 
 
¶10. (SBU) These internal differences have limited EU decision 
making on the way forward for regulating nanotechnology.  The 
Commission was expected to release a communication last fall 
detailing the current state of nanotechnology related 
regulation in Europe and paths forward.  However, this 
document has been delayed indefinitely, although we now 
expect to see the paper before the end of February.  DG 
Environment,s Laursen explained that the Communication has 
been downgraded to a Staff Working Paper, a document 
providing current thinking by the Commission on a topic, but 
not a binding position paper.  He explained that Commissioner 
Guenter Verheugen was the driver for the change, wanting to 
"test the waters" before coming to a committed stance. 
 
--------------------------------------------- 
Existing Cooperation and Future Opportunities 
--------------------------------------------- 
 
¶11. (SBU) Despite the differences on regulatory approach, 
 
BRUSSELS 00000184  004 OF 005 
 
 
separate meetings between USEU Econ officers and all four DGs 
indicate that the Commission is in favor of further 
cooperation with the U.S. on a broad number of nanotechnology 
related issues.  The topic has high-level political backing 
here, with references "to foster the exchange of information 
on nanotechnology" both in the 2007 U.S.-EU Summit 
declarations and the November 2007 Transatlantic Economic 
Council meeting, which contribute to the priority status of 
the issue within the Commission.  Several DG Research 
officers explained that their work-plan in relation to the 
U.S. is driven almost entirely by these declarations and a 
need to produce concrete results. 
 
¶12. (SBU) Furthermore, the Slovenian Presidency, which will 
have the Council presidency seat during both the Summit and 
Transatlantic Economic Council meeting in the first semester 
of 2008, has identified nanotechnology research as a priority 
- in part to promote the Josef Stefan Institute, which is one 
of the few nanotechnology doctoral programs worldwide.  Dr. 
Vito Turk, the President of the Institute, explained to 
Embassy Ljubljana and a visiting USEU officer that he is 
strongly in favor of cooperation with the U.S., and he would 
like to expand collaborative efforts to include researcher 
and student exchanges.  We can build on this interest to 
promote nanotechnology in the TEC meeting and further 
scientific collaboration with Europe during the Presidency. 
 
¶13. (SBU) Renzo Tomellini, Head of Unit for Nanotechnology in 
DG Research has indicated during meetings with USEU Econ 
officers that he would be receptive to further efforts to 
perform joint research projects - the 7th Framework Program 
gives priority to research cooperation with an international 
dimension - or to joint workshops in which experts share 
their results and projects.  Priority topics for the 
Commission are in environmental, health, and safety issues, 
and DG Research often references toxicology and risk 
assessment as opportunities for cooperation, both in the OECD 
and as new bilateral efforts.  Additionally, both DG Research 
and DG Enterprise would be receptive to efforts to develop 
new methodologies and standards for nanomaterials testing for 
use in these assessments. 
 
-------------------------- 
Comment and Recommendation 
-------------------------- 
 
¶14. (SBU) USEU shares the concern that many, particularly in 
industry, have shared with us that the Community may adopt an 
overly "cautious" regulatory approach to nanotechnology, as 
it has done in the area of agricultural biotechnology.  The 
divisions within the Commission provide us an opportunity now 
to try to influence the outcome of the policy debate, but we 
will only succeed in doing so if we aggressively engage 
Commission policy makers now. 
 
¶15. (SBU) To some extent, we are doing this now in the OECD, 
where the USG, the European Commission, and European Union 
member states are actively engaged in efforts to develop 
research strategies, communicate research efforts, define 
safety test guidelines and collaborate on nanomaterials 
testing through the Working Party on Nanotechnology and the 
Working Party on Manufactured Nanomaterials. It is very much 
in our interest to expand and highlight the collaborative 
work being done in these fora (which also involve the private 
sector and other NGOs), as the momentum gathering in them can 
be used to build confidence among Europeans that we are 
appropriately addressing concerns, thereby limiting appeals 
for application of the precautionary principle and a need to 
regulate to fill remaining gaps. 
 
¶16. (SBU) But even as we build confidence in the OECD and 
member states for our processes and efforts to fill 
information gaps, we need to find opportunities to lessen the 
impact in the EU of NGO opposition to fully open research and 
innovation.  We need to reinforce those in the Commission 
that are comfortable using science-based approaches as 
opposed to the precautionary principle if we are to have more 
 
BRUSSELS 00000184  005 OF 005 
 
 
influence over the Commission's regulatory stance.  This 
should also help us reinforce Commission efforts to 
communicate to the European public our shared methods and 
reasoning for using existing regulation to cover the vast 
majority of products and what we are doing collaboratively to 
fill what gaps remain. 
 
¶17. (SBU) The 3rd International Dialogue on Research and 
Development of Nanotechnology will be held in Brussels in 
March. This meeting will bring together government 
decision-makers on nanotechnology research from all countries 
with robust nanotechnology research programs.  We recommend 
arranging a meeting on the margins of the International 
Dialogue to bring together representatives from USG agency 
stakeholders in nanotechnology with counterparts from DGs 
Enterprise, Research, SANCO, and Environment.  USEU believes 
this meeting could approach key topics of interest of 
nanotechnology, including discussions of our efforts in OECD, 
how we can approach future bilateral research programs, and 
our current stances on nanotechnology regulation. 
Specifically, these discussions should focus on 
environmental, health, and safety efforts which are most 
likely to drive future regulatory actions in higher priority 
sectors such as chemicals, medicines, food, and cosmetics. 
Although some uncertainties about our own approach remain, 
the USG has a much more coherent position than the 
Commission, and, as Dr. Canady,s presentation for FDA at the 
DG SANCO conference demonstrates, the USG can help drive how 
the Commission approaches nanotechnology over the coming 
years by presenting a compelling case that our approach is 
effective and that they must ensure future regulatory efforts 
are not divergent.   We should also use this occasion to 
focus on the importance of public education, and our sense of 
the most effective approaches to this, for this is one area 
where the Commission, and the Community more generally, are 
seriously deficient. 
 
¶18. (SBU) In that regard, we should use the presence of our 
policy makers at the International Dialogue to engage NGOs - 
in Brussels and elsewhere in Europe - on this issue.  While 
these organizations tend to be dogmatic, there are areas 
where they may be willing to be more flexible, specifically 
on certain sectors where nanotechnology is applied and on 
labeling.  During DG Research's Code of Conduct conference, 
for instance, the Greenpeace representative acknowledged that 
the risks of nanotechnology are very different depending upon 
the sector, and that inevitably, these discussions need to 
take place on a sector specific basis, and not generically on 
nanotechnology.  On labeling, it appears the concern is more 
about information to the consumer, and labeling is one 
obvious method to address this concern.  However, NGO reps 
seem amenable to presentation of other methods of providing 
information that proves there is no attempt to hide 
information.  USEU and the EUR PD Hub in Brussels have 
facilities to help our policymakers reach the European media 
and the European NGO community; we should take advantage of 
this. 
 
MURRAY 
.