Regulating Safety of Nanotechnology in Food: The Legal Case for Malaysia

Insufficient scientific evidence and uncertain risks are typically thought to be the principal barriers to regulating new and emerging technologies. In the case of nanotechnology, they result in different ways of treating nanomaterials as a regulatory category. This paper contributes to the study of (technological) risk regulation by assessing the role of pre-existing legal order in the formation and development of nanotechnology safety in Malaysia, particular in the field of nanotechnologies in food. It addresses a central question: would the legal order provide a robust mechanism in promoting safe and responsible approach? To answer this question, it sets out how debate over safe uses of nanotechnology is gradually becoming a concern among regulatory community in Malaysia. This is built upon two arguments: firstly, regulatory response should be tailored to the perceived risk-profile presented by the technology; and secondly, safety of nanomaterials should be reflected in good investing practice, development and commercialisation of nanotechnology. The paper shows how Malaysia’s approach is consistent with three familiar assumptions in the global mainstream debates over nanotechnology regulation: First, it sheds light on why most nations – Malaysia included - are inclined to apply pre-existing legal framework. Second, it shows that the legal framework is incomplete and questions the claims that uncertainties hinder the process of creating appropriate regulation for nanotechnology. Third, the analysis highlights that using product approach is sufficiently precautionary in managing risks arising from nanotechnology products. Semi-structures interviews with relevant regulatory agencies and industry experts are also sought to demonstrate how safe and responsible approach is being materialised on the ground and what are the potential regulatory implications of utilising the current laws to capture this platform technology. It finds that the mapping of Malaysia’s regulatory approaches to managing products of nanotechnology are being aligned to the normative yardstick of law applied to the existing regulation of classic industries. Given the rising deployment of several types of nanomaterials in the products (and process), regulatory authorities are considering a separate treatment of the materials should this gives rise to wider legal, trade and public health implications. It concludes by reiterating that responsible approach to regulating nanotechnology should be aimed at identifying ‘tolerable risk’ of nanomaterials and protecting human health as a core value deserving the highest legal protection.