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It is a fact that there are no organizations in Asia like the European Union, Af- rican Unity or Organizations of American States (OAS). Nevertheless, the Asian countries are members of some regional and international organizations like the United Nations and its specialized agencies like Food and Agriculture Organiza-

WLRQ)$2:RUOG+HDOWK2UJDQL]DWLRQ:+2,/22(&'$VLD3DFL¿F(FR- nomic Cooperation (APEC), ISO, etc. All these organizations have been working to develop different frameworks and guidelines relating to nanotechnology.

Ten economies of South East Asia are members of the ASEAN, a regional economic community in South East Asia. The ASEAN countries have already adopted some directives, e.g. on cosmetic97 and medical devices,98 which can be used in this regard and all the members of ASEAN have to follow the provisions of these directives after incorporating the provisions in their municipal law. Some of the ASEAN countries have already adopted national legislation by way of statutory law or in the form of guidelines by giving effect to the ASEAN Direc- tives.99 Furthermore, there are also guidelines like ASEAN Guidelines on Good Industrial Relations Practices, the Agreement on the ASEAN Harmonized Cos- metic Regulatory Scheme, which was signed at Phnom Penh, Cambodia on Sep- tember 2, 2003 and was entreated into force on the same date. The Agreement on the ASEAN Harmonized Electrical and Electronic Equipment (EEE) Regulatory Regime, signed at Kuala Lumpur in December 9, 2005; and the ASEAN Sectoral Mutual Recognition Arrangement for Good Manufacturing Practice (GMP) In- spection of Manufacturers of Medicinal Products, 2009 was signed and entered into force on April 10, 2009. All these ASEAN legal instruments have, to some

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through signature in international forum.

Concurrently, many of the Asian countries and nanotech leaders are members of APEC, a leading forum to promote trade and economic cooperation. APEC has

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was adopted to promote and enforce information privacy and to maintain the

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partners.100 APEC has established a Product Safety Incidents Information Sharing System to build capacity among developing APEC economies on safety incident information management, develop a product safety incident information sharing

97. Agreement on the ASEAN Harmonised Cosmetic Regulatory Scheme, Sept. 2, 2003.

98. ASEAN Medical Device Directive (AMDD), 2014.

99. For example, the Health Sciences Authority (HSA) of Singapore has implemented the ASEAN Cosmetic Directive (ACD) since January 1, 2008.

100. ASIA-PACIFIC ECONOMIC COOPERATION, Preamble to The APEC PRIVACY FRAMEWORK 2005 (2005), available at http://www.apec.org/Groups/Committee-on-Trade-and- Investment/~/media/Files/Groups/ECSG/05_ecsg_privacyframewk.ashx.

web portal and guideline document on product safety incident information shar- ing. This initiative can play a crucial role and is anticipated that if it is successful, many concerns relating to nanomaterials can be overcome. Such an initiative can be compared to the similar initiative of developing a product register at the Euro- pean level.

Some of the Asian countries are members to the working groups of the OECD, i.e. Working Party on Manufactured Nanomaterials (WPMN) and OECD Work- ing Party on Nanotechnology (WPN).101 These working parties have been work- ing towards regulation of nanomaterials. Out of thirteen nanomaterials, three Asian countries, i.e. China, Japan and South Korea, have been sponsoring the

WHVWLQJRI¿YHPDQXIDFWXUHGQDQRPDWHULDOV: iron nanoparticles [China], fullerenes (C60), single-walled carbon nanotubes (SWCNTs), multi-walled carbon nano- tubes (MWCNTs) [Japan], and silver nanoparticles [South Korea].

Some of the Asian countries are members to the ISO Technical Committee on Nanotechnology (ISO/TC 229 on Nanotechnologies)102 and International Electro- technical Commission Technical Committee on Nanotechnology Standardization for Electrical and Electronic Products and System (IEC/TC 113). Under the ISO/ TC 229, four Working Groups were established and two Asian nanotech giants convened two groups: Japan convened Working Group 2 on Measurement and CharacterizDWLRQDQG&KLQDFRQYHQHG:RUNLQJ*URXSRQ0DWHULDOV6SHFL¿FD- tion. Pertinent to mention here that some of the member countries have already adopted national standards on nanotechnology which are in line with the ISO standards on nanotechnology. For example, Malaysia so far has adopted three Ma- laysian Standards relating to carbon nanotube, i.e. test methods for measurement of electrical properties of carbon nanotubes (IEC 62624:2009, IDT) [MS IEC 62624:2011], Nanotechnologies - Characterization of single-wall carbon nano- tubes using near infrared photoluminescence spectroscopy (ISO/TS 10867:2010, IDT) [MS ISO/TS 10867:2012], Nanotechnologies - Characterization of volatile components in single-wall carbon nanotube samples using evolved gas analysis/ gas chromatograph-mass spectrometry (ISO/TS 11251:2010, IDT) [MS ISO/TS 11251:2012 ]. All these standards are adopted at the municipal level to give effect to the provisions of the corresponding ISO and IEC standards.

101. From among the Asian countries Japan and South Korea are members and China, Singapore and Thailand are observers in the WPMN.

102. Asian countries like China, India, Indonesia, Iran, Japan, South Korea, Malaysia and Singapore are participating countries and Hong Kong, Mongolia, Sri Lanka and Thailand are observing countries in this ISO/TC 229 on Nanotechnologies.

Similarly, the Standardization Administration of China has already published and implemented seven national standards, which are voluntary in nature: (a) GB/T 19619-2004 on Terminology for nanomaterials, (b) GB/T 13221-2004 on nanometer powder-determination of particle size distributions-small angle X-ray scattering method, (c) GB/T 19578-2004 on dHWHUPLQDWLRQRIWKHVSHFL¿FVXUIDFH area of solids by gas adsorption using the BET method, (d) GB/T 19588-2004 on nano-nickel powder, (e) GB/T 19589-2004 on nano-zinc powder, (f) GB/T 19590-2004 on nano-calcium carbonate, (g) GB/T 19591-2004 on nano-titanium dioxide.103

Important to reiterate here that the ISO standards are voluntary in nature104 and perhaps for this reason all these Malaysian standards explicitly mention that “compliance with a Malaysian Standard does not of itself confer immunity from legal obligations.”105 Furthermore, there are few arguments against the role of the ISO as the organization is a member-dues-paying NGO and it is believed that this Organization has been representing the interest of its members which are national standard bodies.106 Though participation in ISO is open for any country, effective participation is a challenge for many countries.107 There is no voice of the con- sumers in the organization and therefore, the interest and need of the consumers

103. In between 2004-2009, China adopted more than twenty standards on nanomaterials or nanoparticles. See Darryl Stuart Jarvis & Richmond Noah, Regulation and Governance of Nanotechnology in China: Regulatory Challenges and Effectiveness, 2 Eur, J.L. & Tech. (2011). For a list of nine new technical published standards, see

TSUNG-TSAN SU, A LIST OF NINE NEW TECHNICAL PUBLISHED STANDARDS OF CHINA,

available at http://www.asia-anf.org/admin/upload/¿OHV/general/News172_16.pdf. 104. So far ISO has published a total of 42 standards relating to ISO/TC 229. For a

list of standards, seeStandards Catalogue, INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, http://www.iso.org/iso/home/store/catalogue_tc/catalogue_tc_ browse.htm?commid=381983&published=on&includesc=true (last visited Aug. 5, 2014).

105. See, e.g., DRAFT MALAYSIAN STANDARDS, Foreword to FRESH DOKONG –

SPECIFICATION (2014), available at http://www.sirim.my/srmc/documents/Aug-Sept- 2014/11A012R0_PC.pdf.

106. For a discussion on how decisions are taken and made in ISO, see JOHN MILES, INTERNATIONAL HANDBOOK ON REGULATING NANOTECHNOLOGIES 88 (Graeme A., Hodge, Diana M. Bowman & Andrew D. Maynard eds., 2010).

107. STEPHANIE HOWARD & KATHY JO WETTER, NANOTECHNOLOGY AND GLOBAL SUSTAINABILITY 95 (Donald Maclurcan & Natalia Radywyl eds., 2011).

may not get priority.

Apart from such tensions, the main legal question which will arise in relation to the different guidelines, standards and regulations is the legal implications of these guidelines or regulations. Another possible future concern will be the obli- gations and responsibilities of the countries which are members of more than one

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