The Case for Regulating Nanotechnologies: International, European and National Perspectives

• Published date: 01 July 2013
• DOI: http://doi.org/10.1111/reel.12029
• Author: Sekai Ngarize,Ricardo Pereira,Karen E. Makuch
• Date: 01 July 2013

The Case for Regulating Nanotechnologies:

International, European and National Perspectives

Sekai Ngarize, Karen E. Makuch and Ricardo Pereira

Governments in leading industrialized countries are

currently primarily relying on existing regulatory

frameworks for environmental, health and safety

regulation to cover nanotechnology risks. European

and national regulators have generally concluded that

any risks posed by nanomaterials can be addressed

using existing frameworks, with minor adjustments

to specific regulations. Identifying appropriate

responses to uncertain risks is a difficult task for

policy makers and regulatory agencies, as they are

faced with a high degree of scientific uncertainty, the

need to balance the costs and benefits of regulation,

and the need to find a reasonable compromise

between scientific freedom, technological innovation,

consumer safety and environmental protection. As

nanotechnologies are arguably only recently gaining

public prominence, and their regulation is still in its

infancy, this article examines some of the issues faced

by regulators, offers insights into potential methods

for regulation, and critiques the current state of inter-

national, European and national law and policy. The

article concludes that to address the current regula-

tory gaps and environmental and health safety con-

cerns surrounding nanomaterials, nanospecific

regulation establishing product specification, notifica-

tion, public disclosure and risk assessment require-

ments is necessary.

INTRODUCTION

The debate concerning the regulation of nanomaterials

(NMs)1has focused on whether they could harm the

environment and human health, much along the lines

of the biotechnology debate of the 1990s and early

2000s.2Yet, concerted regulation in this area is still

lacking. A key issue in the regulation of nanotechnolo-

gies is that the deliberate exploitation of properties at

nanoscale is central to their application and may cause

NMs to exhibit very different properties from their con-

ventional bulk substances. Potential benefits of these

technologies include vast product, industrial and tech-

nological applications, wealth generation, job creation

and other societal advances.3Conversely, risks associ-

ated with these technologies include potentially serious

harm to human health and the environment,4as NMs

may be discharged directly into rivers or the atmo-

sphere by industry or escape when products are used or

disposed of in the environment. However, at this stage,

the effects of NMs and their toxicological impacts on

human health and the environment are not yet fully

understood.5

Rapid commercialization of NMs suggests that the

potential for human and environmental exposure will

increase dramatically.6However, the pace of regulatory

progress lags behind the speed at which NMs are being

introduced in the market.7Arguably, regulatory chal-

lenges are related to uncertainties regarding the devel-

opment and commercial applications of NMs, hazards

and exposure pathways, the speed of technolo-

gical change and effectiveness of existing regulatory

1In the absence of a generally accepted def‌inition, the term ‘nano-

materials’ is used in this article to cover commonly used terminology

such as manufactured (or engineered) nano-sized and nanostruc-

tured nanomaterials.

2See also L. Boisson de Chazournes and U.P. Thomas (eds.),

WTO Law, Science and Risk Communication (special issue), 3 Eco-

Lomic Policy and Law (2006), found at: <http://www.ecolomics-

international.org/epal_2006_special_edition_wto_law_science_and

_risk_communication.pdf>; and L. Boisson de Chazournes and M.M.

Mbengue, ‘GMOs and Trade: Issues at Stake in the EC Biotech

Dispute’, 13:3 Review of European Community and International

Environmental Law (2005), 289.

3For example, NMs are used to create very f‌ine membranes, which

act as effective f‌ilters, and magnetic nanoparticles remove heavy

metal contaminants from waste water. Nanotechnologies have also

revolutionized manufacturing processes in the consumer sector, cre-

ating a new generation of NM products such as resistant glass, water

repellents and anti-odour, crease-free fabrics. Nanotechnology is a

multi-billion dollar industry expected to grow to US$1 trillion by 2015.

See Q. Chaudhry, A. Boxall, R. Aitken and M. Hull, A Scoping Study

into the Manufacture and Use of Nanomaterials in the UK (Central

Science Laboratory, 2005).

4NMs covering relatively large surface areas are potentially more

reactive and toxic compared to their conventional bulk substances.

See K. Thomas et al., ‘Research Strategies for Safety Evaluation of

Nanomaterials, Part VIII: International Efforts to Develop Risk-based

Safety Evaluations for Nanomaterials’, 92:1 Toxicological Sciences

(2006), 23.

5See, e.g., Organization for Economic Co-operation and Develop-

ment (OECD), Current Developments in Delegations on the Safety of

Manufactured Nanomaterials – Tour de Table (OECD, 2013); M.

Kendall and S. Holgate, ‘Health Impact and Toxicological Effects of

Nanomaterials in the Lung’ 17:5 Respirology (2012), 739.

6K. Floroni, S. Walsh, J.M. Balbus and R. Denson, ‘Nanotechnology:

Getting it Right the First Time’, 6:3 Sustainable Development Law and

Policy (2006), 46.

7Ibid.

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Review of European Community & International Environmental Law

RECIEL 22 (2) 2013. ISSN 0962-8797

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