The combination of technological promises, speculation about safety, and lack of public awareness of the consequences of nanotechnologies can easily lead to mistrust and opposition. The debate on the risks and opportunities of nanotechnologies has been going on for more than a decade, but has been limited to a small circle of specialists and institutions. Therefore, few people understand what nanotechnologies are, or even know that nano materials are already used in consumer products. In March 2009 the Dutch government decided to stimulate societal dialogue on nanotechnologies and implemented a broad discussion in which viewpoints and opinions could be expressed by all kinds of stakeholders and publics. Dutch people perceive the innovation potential of nanotechnologies as positive provided there is an adequate system for risk research, assigning permits, and nano oversight. In this respect reliability and responsibility of nano actors (risk assessors, regulators and innovators) will be decisive. Responsible nano innovation will be strongly influenced by both public perceptions of the promises and risks of nanotechnologies, and the expectation that there are responsible parties addressing remaining uncertainties. Nano actors require insight into what information is pivotal to determine whether a nano material is safe. Meanwhile, the interaction between nano actors, stakeholders and publics should be improved in order to allow discussions on safety and wider issues to keep better pace with the innovation processes. We are in need of approaches ensuring safe and responsible use of nanotechnologies that enable open routes to addressing risk and wider issues - whether these are technological, social, economic or political. Two concepts are further discussed: Safe-by-Design and Societal Incubator. Responsible nano innovation will largely depend on the willingness of nano actors to define responsibility wider than just regulating risks.

1. Assessing Nanotechnologies
Integrating RATA into
responsible nano innovations
NanoCity 2015, Amersfoort, October 5th
© Lucien Hanssen
Deining Societal Communication & Governance
L.hanssen@fo.nl

2. Topics
 Societal dialogue nanotechnologies
 Follow up in Dutch policy-making
 Challenges for Risk and Technology Assessment
 New approaches: Safe-by-design, Societal Incubator
 Towards responsible nano innovations
2

3. Societal Dialogue 3
The Dutch government decided to stimulate a
societal dialogue on nanotechnologies (SDN) and
implemented a broad discussion in which viewpoints
and opinions could be expressed by all kinds of
stakeholders and publics (2009 - 2011)
(www.nanopodium.nl)

4. Societal Dialogue
Discourses Top 10 Issues N
Risk Health risks
Environmental risks
Labelling
26
17
12
Innovation Sustainability
Opportunities
18
18
Socio-ethics Ethics
Privacy
21
15
Governance Good governance
Legislation
Public information
19
18
15
4
N = number of projects (out of 32) in which an issue was discussed
(Hanssen et al. 2013, Tijdschrift Comwet 41, 122-135)

5. Societal Dialogue 5
In a nut shell:
public perceptions of nanotechnologies would be
positive if there is an adequate system for:
 risk assessment and risk management,
 public information about nano products,
 nano oversight (regulation and legislation)

6. Societal Dialogue 6
A reflection:
‘One may conclude that that the general public
is more fearful of authorities that hide the potential
risks of nanotechnologies than the actual risks
themselves - when monitored and understood well’
(Wiebe Bijker 2011)

7. Follow up in Dutch policy-making
 To fill the knowledge gap on nano risks and wider issues the
government has allocated about 15 % of the budget in
NanoNextNL to risk assessment & technology assessment (RATA)
 Regulatory issues preferable EU-level: definition of nanoparticles,
REACH nano annexes, nano labelling, nano register is covered
through mobilisation of relevant national institutions and
participation in EU FPs (NANoREG), SCs (SCENHIR), WGs (OECD)
 Public information is provided by governmental and agency web
portals such as KIR nano (RIVM) and Kennislink (NCWT);
broader public dissemination is left to initiatives of industries
(position paper), CSO’s (website), EU FPs (NanoDiode)
7

8. Follow up in Dutch policy-making
Where are we standing in 2015 ?
 Safety
 Regulation
 Governance
 Engagement
8

9. 2015: Lagging risk research 9
 Risk research not informed enough by
exposure data of (novel) nanomaterials
 To develop models and tools for general
approaches (overarching principles)
 There’s still a lack of information on the use
of nanomaterials in products (CPI: 1600+)
 To formulate directives for addressing
nanomaterials safety that do not hamper
innovation potential
RIVM report 2014 - 0157

10. 2015: Regulatory waiting games
 Nano actors: risk assessors, regulators, entrepreneurial
innovators, are in need of insight into which information is
pivotal to address the question whether a nanomaterial or
nanotech application is safe
 The interaction between innovators and regulators should
be improved - in continued consultation - in order to allow
discussions on safety and wider issue to keep better pace
with innovation processes
10

11. 2015: Nano governance
 Responsible Nano-Code (2008 !)
 Guidance for safe working (OHS), company level,
use reference values that act as exposure limits
 Oversight (EHS), national / EU level, hampered by
sharing of confidential business information
 Public right to know: limited transparency
11

12. 2015: Nano governance
EU (slow political processes):
 recommendation on the definition of nanomaterials; EU consultation;
no distinction natural, incidental, manufactured; change during LC
 adaptation of REACH regulation to include the generation of data
and subsequent assessment of risks (data gap: volumes < 1 ton/year)
 number of EU product regulations include labelling obligation
(cosmetics, food, biocides)
 some member states developed national initiatives for a register of
consumer products containing nanomaterials (EU consultation)
12

13. 2015: Engagement
Public engagement exercises allow members of
the public articulating their preferences which
may be taken up in decision making as
additional strategic intelligence
In codes of conduct there is an assumption that
there will be CSOs willing and able to call actors
into account, but these CSO’s may not be able
or willing to spend time and effort on this
13

14. 2015: Engagement
Traditional CSOs effort and influence hinges on two
factors:
 decision makers readiness to reconsider policy
orientations (political and institutional uptake)
 broader public response
In the end: critical public opinion constitutes the only
incentive to make concessions (GM did, Nano not)
14

15. 2015: Engagement fatigue
Only 4 CSO’s in SDN, most were spin-offs of GM debate
 New type CSO’s use different approach:
‘Using law as a tool for societal change’
BEUC ‘defender EU consumer’s interests’
CIEL, Client Earth ‘activist lawyers committed to a healthy earth’
(Urgenda: forcing the government to adopt stringent climate policies)
15

16. Challenges RATA
Risk Assessment:
 Smart approaches in nano risk research
for breaking the regulatory deadlock
Technology Assessment:
 Keeping pace with nano innovations and
society’s ability to affirm this innovations
16

17. Challenge for RA 17
Smart approaches in nano risk research
for breaking the regulatory deadlock
Safe-by-Design approach

18. Safe-by-Design approach 18
Why ? Regulators urge nano businesses to invest
in safe-by-design, whereas industry request clarity
on data requirements to demonstrate safety
How? The approach combines activities on
safe-by-design with activities to timely regulatory
preparedness, based on the stage-gate model
Stage-gating splits R&D into discrete stages; decision-gates use
certain criteria for progression through the successive stages

19. Stage-gating in geoengineering 19
SPICE:
Stratospheric
Particle (S2, H2S)
Injection for
Climate
Engineering
technology to reflect
the Sun’s rays to keep
the Earth cool (SRM)
could one day provide
a radical fix for climate
change
© MacNaghten & Owen 2011, Nature 479, 293
Aerosol

20. Stage-gating in geoengineering 20
Decision-gate was constructed for the SPICE project to include
a set of responsible innovation criteria:
(Stilgoe et al. , 2013, Res Pol 42, 1568-1580)
1. Risks identified and managed
2. Compliant with regulation
3. Clear communication of nature and purpose project
4. Applications and impacts described and review put in place
5. Mechanisms to understand public and stakeholder views

21. Stage-gating in geoengineering 21
Stage-gate panel evaluated SPICE team’s response:
1. Testbed deployment was save and principal risks identified ●
2. Testbed deployment was compliant with relevant regulation ●
3. Develop a revised communication plan to inform public debate ●
4. Review risks & uncertainties of solar radiation management: SEPTEL ●
5. Organize a thorough process of engagement with stakeholders ●
In the end the SPICE team decided to cancel the testbed project due
to lack of good governance for geoengineering and a patent
application representing a ‘potentially conflict of interest’

22. Future of geoengineering 22
 For geoengineering technology to progress, its
developers must be mindful of wider impacts from
the outset; and it must proceed under robust
governance mechanisms
 Geoengineering patents of any kind could give
companies a vested interest in the continuation of
climate change. It seems conceptually wrong to
create conditions for enterprises that would
institutionally benefit from a stressed climate

23. Challenge for TA 23
Keeping pace with nano innovations and
society’s ability to affirm this innovations
Societal Incubator

24. Societal Incubator 24
Could act as a solution to ‘waiting games’.
Here the aim is not to develop a specific
product or a specific business, but to create a
space to assess and develop nano applications,
products and businesses. It provides:
(1) resources,
(2) protected space,
(3) collective coaching
(Van Lente 2015, S.NET Book series)

25. Protected Space 25
DuPont and Environmental Defend Fund (EDF)
developed a joint nano risk framework. In other to
stimulate interactivity they created a protected
space (2006-2009)
EDF had to sign a non-disclosure agreement
(other industries or CSOs couldn’t join the discussions)
A closed-confidential beginning or a safe house
could provide a productive space for interaction
and this is crucial for building mutual trust

26. Societal Interface Group 26
To inform CBSG’s governance practice and
strategy by an interactive learning process that
facilities the inclusion of societal concerns and
needs into plant genomics innovations
At the same time enable plant genomics actors
to search for more societal aims, meanings and
starting points s for their research agendas
(Hanssen & Gremmen 2013, PUS 22, 718-729)

27. Societal Interface Group 27
Issues discussed:
 Using genomics tools in breeding for organic and
other low-input farming systems
 IP, open-source and the public nature of science
and scientists in a public-private partnership
 Food and space: metropolitan agriculture, urban
farming
 Connected value development in supply chain
(new partnerships, MSP food security)

28. SIG Lessons learned 28
1. Issues are not limited to risk & safety
2. Developing trust and a common language
takes time
3. Explicit attention to societal embedding plant
genomics R&D results from the outset
4. Institutional uptake of outcomes deliberative
engagements is not obvious

29. Responsible nano innovations 29
A definition:
‘A transparent interactive process by which societal
actors and innovators become mutually responsive
to each other with a view to the acceptability,
sustainability and societal desirability of the
innovation process and its marketable products’
(René Von Schomberg 2011)

30. Responsible nano innovations 30
A reflection:
‘This perspective assumes too much harmony.
There are not only tensions and conflicting
interests, but there is also a basic political
problem in the whole notion of ‘responsible’
(Arie Rip 2015)

31. Responsible nano innovations 31
Everyday practice:

32. Responsible nano innovations ? 32
 We need approaches ensuring responsible use of
nanotechnologies that enable open routes to
addressing risk and wider issues (SEPTEL)
 Responsible nano innovations will largely depend
on the willingness of nano actors to define
‘responsibility’ wider than just regulating risks

33. Responsible nano innovations ? 33
 How can responsibility be built in into the
innovation process without it stymieing the very
innovations it sets out to enable ?
Responsible nano-code has the potential to bridge
the gap between the concept of responsible
innovation and the practicalities of translating nano
research into business ventures
(Maynard 2015, Nat Nan 10, 199)

34. Principles of Responsible Nano-Code 34
1. Board Accountability
2. Stakeholder Involvement
3. Occupational Heath & Safety
4. Public and Environmental Health & Safety
5. Wider Societal Issues
6. Engaging Businesses in Supply Chain
7. Transparency and Disclosure

35. Responsible nano innovations 35
Principles of Nano-Code: Safe by Design Societal Incubator
1. Board Accountability +
2. Stakeholder Involvement +
3. Occupational Heath & Safety +
4. Public and Environmental H & S +
5. Wider Societal Issues +
6. Engaging Businesses in Supply Chain +
7. Transparency and Disclosure +
+ strength of approach or instrument

36. Assessing Nanotechnologies
Integrating RATA into
responsible nano innovations
NanoCity 2015, Amersfoort, October 5th
© Lucien Hanssen
Deining Societal Communication & Governance
L.hanssen@fo.nl