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PLEANARY Session 3Governance: 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 PhDChair, Standards Council Canada Mirror Committee (SMC) for ISO TC 229, NanotechnologyNovember 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

Construction Composites

Some consumer goods

Over the counter nanomaterials

Pharmaceutical Medical Electronics

Coatings Concrete

Low

Low

High

High

Value to Society

Risk

www.cme-mec.caAn 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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• 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)

An Aspect of Governance for Nanotechnology (2)

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• 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

An Aspect of Governance for Nanotechnology (3)

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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