Managing Risks and Uncertainties

Challenges

Regulation often struggles to keep up with development of new products and technologies.  As the speed of development of nanomaterials increases and their properties become more advanced, the challenges will also increase.  While the UK is seeking to adapt the existing regulatory framework to enable proportionate and appropriate control of nanotechnologies, we have the opportunity to lead the world in the exploration of new and better ways of managing risks.  Please help us to shape the way in which we manage or avoid risks in the future.

What has been done so far?

In very simplistic terms, the traditional approach has been for academics and businesses to carry out research and develop new products and technologies while Government has taken responsibility for identifying and regulating any possible harms.

Nano-products and applications will encompass many product sectors, from materials to medicine to energy.  Their development, production, marketing, use and disposal are covered by existing legislation in areas as diverse as environmental protection, health and safety, and the safety of food, medicines, medical devices, cosmetics and consumer products.  In many areas, there is a requirement for the manufacturer to carry out risk assessments to determine whether new products can be made safely and are safe to be placed on the market.  The legislation also enables prompt action to be taken if products pose a risk to health, safety or the environment.  For example, when evidence became available to suggest that carbon nanotubes might cause health problems, in a similar way to asbestos, the regulators were able to act promptly to ensure appropriate controls were in place to manage the risks.

The UK Government and the European Commission have commissioned several studies of current legislation affecting the development and marketing of nanomaterials.  These have found that the existing regulatory framework is broadly adequate but that some changes are needed and there may be some regulatory gaps.  Although progress is being made in improving our understanding of potential risks from nanomaterials, our knowledge in many areas is not yet sufficient to enable us to determine if there are real regulatory gaps or how they should be remedied.  In addition, our understanding has still to reach the stage at which we can be confident that methods of identifying hazards and evaluating risks are adequate, and thus that businesses are able to carry out reliable risk assessments of new products.

The Government is committed to ensuring that legislation is proportionate and evidence- and risk-based and focused on the specific properties and functionalities of nanomaterials as well as their size.  The regulatory issues are not unique to the UK and the Government is working with -

• The OECD to share information and agree priorities for regulation; and

• The EU to ensure that EU legislation is amended in a timely and appropriate manner, where necessary following advice from the relevant EU scientific advisory committees.

Hilary Benn, the Secretary of State for Environment, Food and Rural Affairs wrote to the European Commission in 2008 to encourage it to expedite actions to update its legislation.  Since then -

• Agreement has been reached on updating and amending the EU Cosmetics Directive to take account of nanomaterials.  It will require prior notification and labelling of products containing nanomaterials;

• Negotiations have begun on a proposal to update the Novel Foods Regulation and make it clear that nanomaterials fall within its scope; and

• A working group has been established that is considering the applicability of the new EU Chemicals regime, the REACH Regulation, to nanomaterials.  For example, it will consider the need for different weight thresholds for nanotechnologies.  In addition, methods for identifying hazards and evaluating risks of substances at the nano-scale need to be further refined over the next few years.

Enforcement
In many cases, local authorities are responsible for enforcement of the legislation.  In others, the enforcement role rests with the relevant Government department or agency.  As yet, enforcement bodies are unlikely to have had much, if any, experience of enforcing controls relating to products containing nanomaterials.  However, this situation will change as the number of products containing nanoparticles increases and legislation is amended to take account of nanotechnologies.  It is recognised that the regulators will need to develop expertise and, in due course, enforcement bodies will need guidance and access to relevant expertise and facilities.  The Government will work with its agencies, LACORS and the Local Government Association as necessary when legislative changes are made.

Future prospects – adaptive management

Although progress is being made to update the legislation to accommodate nanotechnologies, such changes will take a long time to take effect.  For example, the changes to the Chemicals regime, REACH, are unlikely to be adopted before 2012.  There will also be greater challenges in adapting legislation to the more advanced nanomaterials that will be developed in the future.  But these challenges also offer an opportunity for the UK to lead the way in finding new, better ways of managing risks and uncertainties.  A robust and adaptive approach could also deliver benefits to business by ensuring a stable regulatory environment and consumer confidence.

As the Royal Commission on Environmental Pollution (RCEP) pointed out in its report on novel materials in the environment, the speed of development presents considerable challenges as regulatory mechanisms alone cannot be flexible or responsive enough to provide effective control.  RCEP suggested that more “adaptive management” systems will be needed, to respond quickly and effectively as new information becomes available.  These systems should look beyond traditional regulation for more imaginative solutions and involve a greater number of stakeholders than is usual.

RCEP pointed to the need to pay greater regard to public aspirations and concerns, and highlighted that the common themes from public dialogue in the UK and USA are -

• an expectation that nanotechnologies will deliver benefits;

• anxiety about the management of unforeseen risks;
• concern that innovation would not be directed towards appropriate social goals;
• a desire for science and technology policy to be more open to public involvement.

The RCEP suggested that more responsive and flexible governance structures are needed, to bring together -

• social and ethical intelligence;
• early information on nanomaterials under development and their potential implications; and
• the results from a robust monitoring system.

Possible measures include -

• embedding anticipatory risk management approaches within the organisations and businesses that fund research and development projects, so that the innovation and its responsible development are considered alongside one another.  For example, in the Research Councils’ Grand Challenge call on nanotechnologies for carbon capture and utilisation, applicants are being asked to identify any potential environmental, health, safety, ethical or other impacts or concerns that may result from the innovation process and to assess the risk and uncertainty around each.  These can then be managed through further research where necessary.  The Technology Strategy Board is also seeking to achieve similar outcomes with the projects it supports.  The outcomes of such upstream risk uncertainty analysis might also inform programmes of research such as the Environmental Nanoscience Initiative;

• wider adoption of voluntary measures such as Corporate Social Responsibility or Codes of Conduct that encourage researchers, businesses and funding organisations to adopt practices that go beyond compliance with the legislation;

• provision of advice and expertise to help researchers and businesses undertake life cycle analyses or undertake proactive identification and management of risks;

• a simple “checklist” for researchers and businesses to alert Government of the potential uses and implications of novel nanomaterials or nanotechnologies;

• a more detailed submission of this information, perhaps as a means of complying with changes to REACH with reference to nanotechnologies.

Governance structures and coordination

Currently Government activities are coordinated and given strategic direction by a Ministerial group on nanotechnologies, which is supported by policy and research coordination groups.  Stakeholder views inform decisions through the Nanotechnology Stakeholder Forum and the contacts that individual departments and agencies have with stakeholders.  Public dialogue has also informed decisions.  However, if we are to move to more innovative approaches to managing nanotechnologies, alternative structures might be more appropriate.

Your views

We would welcome your views on how the UK can manage the implications (health, safety, environmental, social, ethical) of developments in nanotechnologies at the earliest stage.  The SWOT analysis below summarises Government understanding, from discussion with stakeholders, of the major strengths, weaknesses, opportunities and threats facing the UK in this area. This (and the questions to the right hand side) is intended to help you think about the issues and steer future actions and shape the UK nano environment.