Nanotechnology and the Products of Inherited Regulation

Abstract

New technologies do not always elicit new regulatory responses. More often than not, policymakers deal with new technologies by deferring to existing regulatory regimes. This article argues that there are often overlooked consequences of grafting a new technological area, displaying different types of risks and uncertainties, onto an existing regulatory framework. Not only can it entail the application of ill‐suited rules and standards, but it can also involve the reproduction of deeply ingrained traditions and assumptions which, under the weight of history, makes scrutiny extremely difficult. As is shown here, nanotechnology‐enhanced products inherit a raft of consumer protection rules as well as a regulatory predisposition to internal market facilitation. So entrenched is the focus on market opening that making ad hoc changes to existing regulations to incorporate the broader concerns around nano‐products cannot escape the reach of a very powerful market context.

Special Treatment? Flexibilities in the Politics of Regenerative Medicine’s Gatekeeping Regimes in the UK

“…This leads us to ask: In what sense might regenerative medicine or cell therapy be framed and constructed in market regulation and healthcare system innovation as a special sector or zone deserving of its own gatekeeping conventions, its own gateways to markets and health system/clinical adoption, and support systems? How do regenerative therapy movements counter and influence the systemic standardisation embedded in existing, 'inherited' (Stokes, 2012) regulatory regimes?…”

Regulating Emerging and Future Technologies in the Present

“…This model of Binherited regulation,^according to Stokes [42], occurs when an explicit or implicit choice is made to maintain the regulatory status quo, where products and processes of an emerging technology fall under a pre-existing umbrella of legislative and regulatory instruments and regimes.…”

The EU Regulation of Nanomaterials

“…Because traditional risk assessment focuses on acceptable level of harm, it assesses potential risks on their own merits. 49 A related consequence is to ask whether the harm is necessary in the first place. 42e43].…”

“…Do we consider short-term harms defined narrowly in terms of death or illness, or do we also want to address longer term harms including cumulative harm from multiple and diverse impacts, cultural and social harm (including questions of distributive justice on who benefits and in what ways and conversely), or indirect "ripple effects"? 49 A concrete example of this search for alternatives is embodied in Article 55 of REACH, which explicitly states that substances of very high concern should be "progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. It is because we want to avoid harm that we switch our attention to possible alternatives, to other types of balancing methods between risks and benefits, and more importantly to the quality of the knowledge produced ("what are the assumptions underlying the knowledge and models mobilized, how can we reduce blind spots, what other type of knowledge is relevant?").…”