Plenary session 3

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PLEANARY Session 3
Governance: what are the responsibilities of the various
players? The challenge of governance in regards to
nanotechnology
Ne3LS Network International Conference
Montreal
A Suggestion on Nanotechnology Governance
Roland Hosein PhD
Chair, Standards Council Canada Mirror Committee (SMC)
for ISO TC 229, Nanotechnology
November 2 2012

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Regulatory Governance
• A “Smart” approach to business regulation involves:
– Focus on regulatory outcomes, not process
– Regulate when necessary, but don’t necessarily regulate (are there other
regulations, standards, market checks, or incentives that can be employed?)
– Understanding competitive and cumulative impacts of regulatory compliance
requirements and adjusting accordingly
– Science-based risk analysis
– Focus on high risk not all risk
– Simplified and less costly compliance requirements
– Identify and eliminate unnecessary regulatory differences across jurisdictions
– Adopt internationally competitive service standards
– Lean regulatory and approval processes within government
– Ensure consistent, timely, efficient & effective regulatory management within
government
– Depends on seeing business as a partner in developing effective regulations

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Regulating Nano
• What does a “Smart” approach entail?
– Clear focus on health, safety, environment, consumer protection
– Are existing regulations, product and process standards adequate? Canadian
approach to work within existing regulatory framework – supported by
practices of other jurisdictions
– Need a rapid response system to deal with fast pace of technological change
– Science-based risk analysis
– Focus on high risk not all risk
– Simplified and less costly compliance requirements
– Work across departments, governments, regulating agencies internationally
– Adopt internationally competitive service standards – don’t repeat the
disjointed, confusing, duplicative, costly approach taken in biotechnology
– Ensure consistent, timely, efficient & effective regulatory management within
government
– Depends on seeing business as a partner in developing effective regulations

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Managing Risk & Uncertainty
• A critical issue for Nanotechnology
– Risk assessment and management are key
– There are “Knowns”, “Known Unknowns” and “Unknown Unkowns”
– Each require a different approach to risk management and regulation
– Existing regulatory approaches to deal with Known risk
– Identify “Unknown” risks that we know to exist and assess applicability of
existing regulations – new regulations if necessary
– Fast assessment and diagnosis of “Unknowns” as they become known
– Public confidence and effective enforcement is key to sustaining a risk
management approach to regulation – depends on:
• Good science
• Transparency
• Communications
• A cost competitive approach to compliance that puts the emphasis on
desired outcomes not on how to get there

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Regulatory Cooperation
• Regulatory Cooperation initiative – launched by PM Harper &
President Obama in December 2011
• US and Canada will work to align regulations & regulatory
approaches
• Integral part of effort to improve competitiveness & create
jobs
• RCC Joint Action Plan – 29 initiatives including Nano
• Objective is to resolve current regulatory misalignment &
unnecessary differences and establish lasting mechanisms for
ongoing regulatory alignment involving the development of
new regulations

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Regulatory Cooperation
• Systemic Alignment Mechanisms:
– Standards
– Reliance on regulatory outcomes achieved in other jurisdictions
– Managing third country import risks
– Product approvals and review
• Benefits in fewer unnecessary differences, greater efficiencies,
lower costs, more effective enforcement & compliance
• Currently reviewing regulatory approaches and benefit analysis
for aligning regulatory approaches for nanotechnology
• Status report expected before end of year

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Governance: Context 1
• Some attempts at international governance on complex big issues with
limited success (food safety, GMO, trans-border wastes..)– a top-down
approach
• Social, cultural, ethical and ideological differences between regions have
generated unique regional and national standards with limited attempts at
harmonization
• Although many are science based, interpretation of science varies
• Some initiatives at international level on nanotechnology standardization
– OECD, ISO, CEN, BSI, IEC, ASTM, IEEE (Lead taken by ISO, IEC,OECD)

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Governance: Context 2
• More openness, transparency, and social media tools may
help with some common developments
• But because of economic weaknesses, some fickleness
abound today
• More recent focus on product stewardship, and life cycle
analyses and management may encourage movement

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Governance: Context 3
• Nanotechnology is too big for any region to do well because
of gaps in knowledge; uncertainty in science, ethics, trade and
knowledge on how to regulate
• Chemical standards and regulations developments have
evolved over time; in many cases becoming more stringent
with better science and risk assessments, and broader
involvement
• A dynamic tension exist in sectors between technology
benefits and harm prevention

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Governance: Context 4
• With nanotechnology, regions are slow to move as
they are uncertain about how to do it – many are
using classical methods and principles when a nano-
specific one may be needed
• Getting it perfect first time may not be the approach,
but evolution over time may be the way to start

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Risk Value Assessment
 Some consumer
 Construction
Low goods
 Composites
 Over the counter
nanomaterials
Value to
Society
 Pharmaceutical
 Coatings
High  Medical
 Concrete
 Electronics
Low High
Risk

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An Aspect of Governance for Nanotechnology (1)
Bottoms-Up
• ISO, IEC, and OECD have taken the lead globally on developing
voluntary nano standards
• The participation and work items processes are transparent
and open for participation by member states
• Best global brains participate in contributing to international
standards (IS), technical reports (TR), and technical
specifications (TS)

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An Aspect of Governance for Nanotechnology (2)
• No country/region can replicate the quality, depth and democratic process
necessary for good standards as these organizations
• Adoption and adaptation by regions of the ISO/IEC/OECD published tools
may be good for harmonization and ease of trade
• Some signs of progress in Canada and Asian countries (Asia Nano Forum)

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An Aspect of Governance for Nanotechnology (3)
• At the international tables, delegates must be encouraged to
“sell” the tools/definitions to their respective nations/regions
– Some evidence it has started
• Trade Associations, as CME, has a major job in “selling” to
partner global trade associations the adoption of voluntary
international standards to reduce paper burden
• In this way, there in the beginning of harmonization without
international governance models

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Summary
• Attempts at global governance in specific areas have not worked well for
lack of agreement between regions
• At international standards development tables, the process is robust,
transparent, attracts the best global brains, and voted upon by experts
and regions
• Suggest two ‘bottoms-up’ approaches based on this:
- nations adopt or adapt the agreed upon international standards
- participating expert delegates discourage major diversion by their
home region from the standards
• This approach results in harmonized standards to help international trade
and reduce paper burden without the need for a global governance model