II. Mandatory Nano-specific Regulations
Current legislation provides inadequate oversight of nanomaterials. A modified or sui generis, nano-specific regulatory regime must be an integral aspect of the development of nanotechnologies. Considering the already advanced and rapidly expanding development and commercialization of nanomaterials, a governmental assessment of current oversight mechanisms is urgently needed, taking into account the novel properties exhibited by nanomaterials.
Even where legal authority exists, substantial regulatory changes in existing laws are likely to be necessary in order to adequately and effectively address the fundamentally different properties of nanomaterials and new challenges that nanomaterials present.[8] Current laws are even less equipped to oversee products and processes such as active nano-systems and nano-structures that are currently under development.[9] Government agencies thus far have failed to use their existing regulatory authority.[10] Current regulatory systems must be adjusted and applied to nanomaterials as a temporary response, until nano-specific oversight mechanisms can be formulated and put into place.[11] Regulatory actions should retroactively cover all nanomaterial products already on the market.
The adverse effects of nanomaterials cannot be reliably predicted from the known toxicity of the bulk material.[12] Some experts recommend that up to sixteen physicochemical parameters be evaluated – a “far cry from the two or three [parameters] usually measured” for bulk materials.[13] Because of their novel properties and the associated risks, nanomaterials must be classified as new substances for assessment and regulatory purposes.[14].
Voluntary initiatives are wholly inadequate to oversee nanotechnology. Voluntary programs lack incentives for “bad actors” or those with risky products to participate, thus leaving out the entities most in need of regulation. [15] Under voluntary initiatives, companies may lack motivation to test for long-term or chronic health and environmental effects.[16] Voluntary initiatives often delay or weaken essential regulation, forestall public involvement, and limit public access to vital environmental safety and health data. For these reasons, the public overwhelmingly prefers mandatory governmental oversight to voluntary initiatives.[17] Because of their novel properties and the associated risks, nanomaterials must be classified as new substances for assessment and regulatory purposes.
8 J. Clarence Davies, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Managing the Effects of Nanotechnology (2006); J. Clarence Davies, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, EPA and Nanotechnology: Oversight for the 21st Century, (2007); Michael Taylor, Woodrow Wilson International Center. for Scholars, Project on Emerging Nanotechnologies, Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs? (2006); American Bar Association, Section of Environment, Energy, and Resources, Nanotechnology Project, at http://www.abanet.org/environ/nanotech/; George Kimbrell, The Environmental Hazards of Nanotechnology and the Applicability of Existing Law, in Nanoscale: Issues and Perspectives for the Nano Century, (Nigel Cameron, ed. 2007); George Kimbrell, Nanomaterial Consumer Products and FDA Regulation: Regulatory Challenges and Necessary Amendments, 3 Nano L. & Bus. 329 (2006); Steffen Hansen et al., Limits and prospects of the “incremental approach” and the European legislation on the management of risks relating to nanomaterials, 48 Regulatory Toxicology and Pharmacology 171-83 (2007).
9 See generally Mihail C. Roco, National Science Foundation and National Nanotechnology Initiative, Presentation at Science and Technology for Human Future, April 28, 2006; M. C. Roco, Nanotechnology’s Future, Scientific American Aug. 2006.
10 J. Clarence Davies, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, EPA and Nanotechnology: Oversight for the 21st Century 32 (2007) (“What I have described in this section is the entire experience that EPA has reported to date with regulating nano. One would not guess, based on this experience, that nano is a major new technology being commercialized at a very rapid pace. … Rather, it reflects the rapidly widening gap between the adoption of the technology in the private sector and the government’s lagging attempts to understand nano and to ensure that it does not harm humans and the environment.”); George Kimbrell, Nanomaterial Consumer Products and FDA Regulation: Regulatory Challenges and Necessary Amendments, 3 Nano L. & Bus. 329 (2006).
12 The Allianz Group and the Organisation for Economic Co-operation and Development, Small Sizes that Matter: Opportunities and risks of Nanotechnologies, § 6.4 (2005) (“Experts are overwhelmingly of the opinion that the adverse effects of nanoparticles cannot be reliably predicted or derived from the known toxicity of the bulk material.”); European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Opinion on the appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies, 6 (2005) (“Experts are of the unanimous opinion that the adverse effects of nanoparticles cannot be predicted (or derived) from the known toxicity of material of macroscopic size, which obey the laws of classical physics.”); Royal Society Report, supra note 6 at 49 (“Free particles in the nanometre size range do raise health, environmental, and safety concerns and their toxicology cannot be inferred from that of particles of the same chemical at a larger size.”); Tran et al., A Scoping Study to Identify Hazard Data Needs For Addressing The Risks Presented By Nanoparticles and Nanotubes, Institute of Occupational Medicine 34 (2005), at 34 (“Because of their size and the ways they are used, [engineered nanomaterials] have specific physical-chemical properties and therefore may behave differently from their parent materials when released and interact differently with living systems. It is accepted, therefore, that it is not possible to infer the safety of nanomaterials by using information derived from the bulk parent material.”).
13 Andrew Maynard, Nanotechnology: The Next Big Thing, or Much Ado about Nothing?, 51 Annals of Occupational Hygiene 1, 7 (2006); Nel et al., supra note 6; Oberdörster et al., Principles for Characterizing the Potential Human Health Effects From Exposure to Nanomaterials: Elements of a Screening Strategy, 2 Particle and Fibre Toxicology 8, 1.0 (2005). Additional tests should include testing for pharmacological properties; absorption, distribution, metabolism, excretion studies; genotoxicity; effects on the development of embryonic and fetal organisms, immunotoxicity, and carcinogenicity. Physico-chemical properties additional to size, including shape, surface structure, polarity etc, influence the toxicity of nanomaterials and therefore must also be assessed. Exposure metrics must include surface area, number and concentration of particles not just mass. Jaydee Hanson, Nano Matters: Environmental and Safety Concerns, Speech to Nanotechnology and Biotechnology in Society Conference, (Mar. 29, 2006). Physico-chemical properties additional to size, including shape, surface structure, polarity etc, influence the toxicity of nanomaterials and therefore must also be assessed. Exposure metrics must include surface area, number and concentration of particles not just mass.
14 See, e.g., The Royal Society and the Royal Academy of Engineering, Nanoscience and nanotechnologies: Opportunities and uncertainties 6, 43, 73, 83 (2004); NRDC et al., Comments to EPA, Re: EPA Proposal to regulate nanomaterials through a voluntary pilot program, Docket ID: OPPT-2004-0122, July 5, 2005; ICTA et al., Petition to FDA on Regulation of Nanomaterial Products, FDA Docket 2006P- 0210/CP1, May 2006, at http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf
15 See, e.g., British Department for Environment, Food, and Rural Affairs, http://www.defra. gov.uk/environmental/nanotech (voluntary program launched in September 2006, and as of April 2007, has received only six submissions).
16 J. Clarence Davies, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, EPA and Nanotechnology: Oversight for the 21st Century 18 (2007) (“It is hard to see what will motivate manufacturers to carry out chronic and environmental testing if regulation does not require it.”).
17 Jane Macoubrie, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Informed Public Perceptions of Nanotechnology and Trust In Government 14 (2005).