National Workshop on Nanosafety and Regulatory Aspects of Nanotechnology

Transcription

1 National Workshop on Nanosafety and Regulatory Aspects of Nanotechnology October 2014 Shah Alam, Malaysia Key Components/Considerations of a Draft Framework for Nano Safety Roadmap Satyabrata Sahu, Ph.D. Asian and Pacific Centre for Transfer of Technology (APCTT) of the United Nations Economic and Social Commission for Asia and the Pacific (UN-ESCAP)

2 Outline 1. APCTT s nanotechnology programme 2. Nanotechnology risks and safety concerns 3. Nanotechnology risk governance 4. Regulatory approach to nanotechnology risk governance 5. Nano safety research needs and priorities 6. Standardization and metrology primary considerations 7. The way forward

3 APCTT s Nanotechnology capacity building programme Regional consultations Promoting innovation in nanotechnology and fostering its industrial application: an Asia-Pacific perspective, 2-3 Dec 2009, Colombo, Sri Lanka Expert Group Meeting on Networking of R&D institutions in the asia-pacific to strengthen capacity of R&D management and innovation in the field of nanotechnology, 7-8 Dec 2011, Bangkok, Thailand (Recommended to focus on Nanosafety, standardization and certification of nanoproducts for R&D management capacity building of Member Country stakeholders) Expert Group Meeting on testing, standardization and certification of nanomaterial and nanoproducts, 23 July 2014, Manila, Philippines National capacity building workshops Indonesia (June 2013) Malaysia (December 2013) Islamic Republic of Iran (February 2014) Philippines (July 2014) Tools and resources Manual on Critical Issues in Nanotechnology R&D Management: An Asia-Pacific Perspective Asia-Pacific Nanotechnology R&D Management Network website - Databases of nanotechnology R&D institutions, technologies, researchers Normative and analytical studies

4 Nanotechnology applications Agriculture Automotive industry Food and beverage, packaging Textiles Personal care and hygiene Medicine, therapeutics Structural materials, coatings and industrial applications Electronics and computing Environmental applications water purification, waste treatment, etc Others!

5 Understanding the risks of nanotechnology Being a new and emerging technology, Nanotechnology offers: Promise of new opportunities Threat of new and potential risks Pertinent questions : What are the risks that nanotechnology may pose? Human health, Environment How can the risks be adequately dealt with? Regulatory, Management, Research How can we avoid unproductive controversies surrounding nanotechnology? Risk communication, Multi-stakeholder engagement, Public awareness

6 Safety concerns of nanotechnology Mass production of engineered nanomaterials (ENM) will increase the exposure of workers (in the laboratory and industry) as well as consumers Increasing societal and public debate about the safety of ENMs and associated nano-enabled applications will increase consumer pressure on the government, researchers and industry The EHS concerns of nanomaterials include: (1) research safety, (2) manufacturing (occupational) safety, (3) consumer (product) safety, and (4) environmental impacts throughout the life cycle until final disposal

7 Socio-ethical risks of nanotechnology There are challenges with regard to: Risk-benefit evaluation - Uncertainties associated with nanotechnology pose a challenge in risk benefit evaluation Access, Equity and Justice - Nanotechnology-enabled products are generally expected to be expensive, mostly reaching affluent and betteroff; poor people are less likely to be the principal beneficiaries Regulation, Responsibility, Accountability, Rights and Entitlements Public Participation/Engagement Source: Capabilities and Governance of Nanotechnology in the Developing World (2013), The Energy and Resources Institute (TERI), New Delhi, India

8 Governing risks of nanotechnology Issues and challenges R&D advancements and commercialization of nanotechnology is evolving rapidly whereas understanding on potential environmental and health impacts has been slow. Under-emphasis on research and management of the potential risks Knowledge gaps on safety implications of existing nanomaterials and nanoapplications Flexibility and ability to converge with other technologies Appropriate tools for detecting and measuring nanomaterials are still largely in development, as well as expensive or inaccessible, especially in developing countries. Challenges in developing nomenclature and definitions, metrics and standards for nanotechnologies, and also for arriving at standardized methodologies for risk evaluations

9 Nanotechnology risk governance Three basic dimensions Risk governance Risk governance goes beyond the scope of risk assessment and risk management Includes policy, regulatory, monitoring and enforcement, etc Risk management Risk management refers to the decision-making process regarding acceptable levels of risk. Risk assessment Decision-making process relies heavily on technical evidence obtained through science-based risk assessments.

10 Nanotechnology risk governance Feasibility of a top-down approach!!! In general, nanotechnology risk governance only through a top-down regulatory approach is not recommended because of two reasons: Nanotechnology is multi-disciplinary, horizontal technology, cuts across many industrial sectors, wide array of consumers, complexities in terms of applications Thus cannot be governed only by legislative approaches Involves multiple actors, stakeholders and institutions thus making it difficult to govern only by regulatory tools and mechanisms

11 Structure of nanotechnology risk governance A comprehensive, well-functioning risk governance structure may include: Regulatory framework coupled with standardization, testing and certification systems Institutional mechanisms and processes Nano safety research - EHS data generation Training and HR capacity building Stakeholder engagement - Consumer awareness; Communication and dialogue; Dissemination of reliable information on nanosafety International collaboration; Global dialogue

12 Guiding principles of nanotechnology regulatory governance 1. The regulatory response should be coordinated among different agencies responsible for monitoring, management and regulatory enforcement 2. Regulatory approaches to nanotechnology should be flexible and adaptive. 3. Information gathering efforts should offer incentives for participation, and should involve both industry and researchers. 4. Risk management approaches should be comprehensive, by incorporating a lifecycle approach to govern the potential risks of nanotechnology. 5. Risk management approaches should strive for balance and proportionality between the costs and benefits of regulating. 6. Understanding of the profile of beneficiaries of nanotechnology for fixing accountability - Stakeholder engagement and transparency of regulatory systems Source:

13 Nanotechnology regulatory governance Possible approach(es) Regulatory pyramid approach consists of: Command regulation Regulations, rules, registration, evaluation and authorization of nanomaterials; Monitoring and enforcement mechanisms Enforced self-regulation Tools for information gathering, databases of nanomaterial properties, and guideines play an important role in applying external pressure. Government registration Nanomaterial users to register their activities and provide some basic information about those activities. Self-regulation Voluntary approach to facilitate the responsible development of nanomaterials by companies, as well as private and public research institutions Sources: Igor Linkov & F. Kyle Satterstrom, Nanomaterial Risk Assessment and Risk Management: Review of Regulatory Frameworks, Real time and deliberative decision making (Igor Linkov et al. eds.) (2008). Ian Ayres & John Braithwaite, Responsive Reg.: Transcending the deregulation debate (1992).

14 IRGC framework of risk governance The existing IRGC framework Pre-assessment Risk appraisal Risk characterization and evaluation Risk management and decision making Communication IRGC recommendations for nanotechnology risk governance Improve the knowledge base Strengthen risk management structures and processes (e.g. policy, regulatory and institutional mechanisms Promote stakeholder communication and participation Ensure social benefits and acceptance Collaboration between stakeholders and nations Source: International Risk Governance Council (IRGC)

15 Nano safety research needs and priorities The emergence of nanotechnology products has occurred much faster than the generation of corresponding EHS data. Research needs and priorities: Nanomaterial identification and classification Nanomaterial exposure, transformation and life cycle assessment Hazard mechanisms related to effects on human health and environment Tools for risk prediction, assessment and management Databases; Epidemiological/health studies Source: Nanosafety in Europe : Towards Safe and Sustainable Nanomaterials and Nanotechnology Innovations (2013), Finnish Institute of Occupational Health

16 Nanotechnology standardization and metrology Standardization: The roadmap broadly comprises: Terminology Characterization of nanomaterials Safety and health aspects Product performance Metrology Nano dimensional metrology - Dimensional measurement at nanoscale Nano mechanical metrology - Mechanical properties, performance and characterization Source:

17 The EU NanoSafety cluster approach The EU NanoSafety cluster approach identifies a number of cross-cutting issues: The regulatory framework for ENM and nanotechnologies, coupled with standardization to promote good practice and to facilitate communication; The innovation/value chain for environmental health and safety and innovation and means to unblock the value chain; The development of infrastructures for nanosafety to promote research, education and innovation; International collaboration and global dialogue, with a view towards a global research area in nanosafety; Communication and dissemination of research to key stakeholders beyond the research community, including industry, regulatory bodies and others. Source: Nanosafety in Europe : Towards Safe and Sustainable Nanomaterials and Nanotechnology Innovations (2013), Finnish Institute of Occupational Health

18 Nano safety and risk governance a recap Establish policy (e.g. guidelines, frameworks) and regulations Strengthen institutional arrangements for monitoring and enforcement Ensure standardization, testing and certification Conduct nano safety research - EHS data generation Develop/adopt tools for risk characterization, evaluation and assessment (Databases, Epidemiological/health studies, etc) Strengthen risk management and decision making structures and processes (e.g. safety guidelines for researchers, R&D institutions, industry, consumers; compliance system and procedure, etc) Training and HR capacity building Promote stakeholder engagement, communication and consumer awareness Forster international collaborations Participate in global dialogue

19 The way forward A comprehensive national nano safety roadmap should include all necessary and relevant components Various policy and programmatic elements/components with timelines could be designed and specified under each of the major components The roadmap needs to be flexible enough to accommodate new and emerging dimensions of safety and risk aspects of nanotechnology The nano safety roadmap should be able to conceive and shape pragmatic policies, strategy and programmes for nanotechnology risk governance. The process of developing a draft nano safety roadmap needs to have wider consultations with all relevant stakeholders associated with regulatory/governance systems, nanotechnology research community, industry, civil society organizations and public at large.

20 Thank you For more information, contact Satyabrata Sahu, Ph.D. UNESCAP-APCTT P.O. Box 4575, C-2, Qutab Institutional Area, New Delhi , India Tel : Fax : sahus@un.org Website : nanotech.apctt.org,