National Workshop on Nanosafety and Regulatory Aspects of Nanotechnology. Drafting Nano Safety Roadmap for Malaysia Lessons from Other Countries

Transcription

1 National Workshop on Nanosafety and Regulatory Aspects of Nanotechnology October 2014 Shah Alam, Malaysia Drafting Nano Safety Roadmap for Malaysia Lessons from Other Countries Dr. Krishnan S Raghavan Ph.D. Coordinator, Technology Transfer 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. Introduction 2. Drafting Nano Safety Roadmap for Malaysia Key Issues for Consideration 3. Experiences of a few selected countries / regions related to drafting Nano Safety guidelines 4. Way Forward

3 Nano Safety Guidelines Document Introduction From studies conducted so far, that some materials manufactured at nanoscale may show significant deviations in physicochemical properties, interaction with biological systems, and/or effects, compared to conventional equivalents (Source: Scientific Committee on Consumer Safety, European Commission) While in some cases these unique characteristics of nano-materials are advantageous (E.g. Treatment of neurodegenerative disorders and diseases, such as Alzheimer's and Parkinson's), it can also cause potential health hazards (It can result in increased production of reactive oxygen species (ROS), including free radicals which may result in oxidative stress, inflammation, and consequent damage to proteins, membranes and DNA (Source: Nel, Andre; et al. (3 February 2006). "Toxic Potential of Materials at the Nanolevel". Science 311 (5761): 622 7) As our understanding on Nano Safety and risk assessment is still evolving, the Nano Safety Guidelines document is envisaged to provide guidance to the practitioners in this field based on the existing knowledge on this topic. The guidance may need to be revised in the light of new scientific knowledge in the future.

4 Drafting Nano Safety Roadmap for Malaysia Key Issues for Consideration Whether a product would be considered to be a nanomaterial or representing an application of nanotechnology also depends on available definitions applied by regulators. Criteria I: An altered or new dimension at nanoscale Criteria II: Concurrent change of properties due to the change of dimension. The FAO/WHO Draft Report on Nanotechnologies used in food and agriculture and their risk assessment defines true nanomaterial that requires the attention of regulators and a specific risk assessment would need to meet both criteria. The size dimension of the particle in question and change of properties resulting from this new size dimension (nano scale) could be among the important safety assessment criteria that could be included in Malaysia s Nano Safety Roadmap. Besides, Malaysia could compare various Nano safety regulations developed by countries around the world and identify critical elements based on its national priorities. Some of the international examples are included in the scope of this presentation.

5 Nano Safety Guidelines from OECD (1) The Working Party on Nanotechnology (2) The Working Party on Manufactured Nanomaterials Working Party on Nanotechnology: Creating and maintaining inventories that will include information regarding: current regulatory frameworks, current legislative regimes relevant to regulatory frameworks in place for regulating the use of nanotechnology; and government-supported research institutions related to nanotechnology. The inventories will assist the Working Party on Nanotechnology in identifying areas of shared interest and highlight opportunities for enhancing communication related to regulation and applications of nanotechnology. Working Party on Manufactured Nanomaterials: concentrates on the human health and environmental safety implications of manufactured nanomaterials, mainly with regard to the chemicals sector. The Working Party on Manufactured Nanomaterials aims to ensure that the approach to hazard, exposure and risk assessment is of a high, science-based and internationally harmonized standard. Its programme seeks to promote international cooperation on the human health and environmental safety of manufactured nanomaterials and involves the safety testing 605 and risk assessment of manufactured nanomaterials

6 National / Regional Experiences Food Standards Australia New Zealand (FSANZ): The primary focus is NOT on the size of the material per se, but on materials likely to exhibit physicochemical and/or biological novelty. FSANZ differentiates between nanoscale materials that undergo dissolution in water or oil in the final food or in the gastrointestinal tract and nanoscale or microscale materials that are insoluble in water and oil and nonbiodegradable, particularly those that may not be readily excreted. The latter type of material may require additional regulatory examination due to its particulate nature. Any new food substances manufactured using nanotechnologies that may present safety concerns will have to undergo a comprehensive scientific safety assessment under the appropriate standard before they can be legally supplied in Australia and New Zealand.

7 National / Regional Experiences Canada Health Canada helps protect and promote health by using existing legislative and regulatory frameworks to mitigate the potential health risks of nanomaterials and to help realize their health benefits. Health Canada considers any manufactured substance or product and any component material, ingredient, device or structure to be a nanomaterial if it is at or within the nanoscale in at least one external dimension or has internal or surface structure at the nanoscale; or it is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena Health Canada encourages stakeholders to communicate with the responsible regulatory authority early in the development process, especially for combination products that are, contain or make use of nanomaterials. In order to identify and assess potential risks and benefits of nanotechnology-based health and food products, Health Canada encourages manufacturers to request a presubmission meeting with the responsible regulatory authority to discuss the type of information that may be required for their product s safety assessment.

8 National / Regional Experiences European Union Nanomaterial means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm 100 nm. The European Commission recommends that this definition, which is complemented by further definitions for terms used, such as aggregate, be used as a reference to determine whether a material is considered as a nanomaterial for legislative and policy purposes in the European Union Japan Nanotechnology was specified as one of the priority research targets in the third Science and Technology Basic Plan for by the Japanese government (Government of Japan Council for Science and Technology Policy, 2006). The Food Safety Commission, the Japanese organization that undertakes risk assessment, published a survey report on the use of nanotechnology in the food sector in March 2010 (FSC, 2010). From the replies to the questionnaire by the domestic industry on the use of engineered nanomaterial, it was concluded that there was no need for specific nanomaterial regulation at present. However, the report also concluded that there were questions on the classification of nanotechnology-using food products as well as significant data gaps, which precluded the drawing of firm conclusions. If any regulation needed to be introduced, safety assessment methods would need to be established first.

9 The way forward There is no One size fits all approach for developing a comprehensive Nano Safety roadmap Malaysia has to evolve a strategy taking into consideration its national priorities The nano safety roadmap should be able to address the needs and concerns of all relevant stakeholders including producers and consumers. Nano safety is still an evolving field and there is a need for the government to play the role of a facilitator to bring all stakeholders together in a consultative process. Government must encourage multi-disciplinary approach for testing and characterization of nano materials and this requires collaboration on equal footing from multiple players. Government alone has the will, mandate and resources to make this happen.

10 Thank you For more information, contact Krishnan S Raghavan, Ph.D. UNESCAP-APCTT P.O. Box 4575, C-2, Qutab Institutional Area, New Delhi , India Tel : Fax : srinivasaraghavan@un.org Website :