I. A Precautionary Foundation

The Precautionary Principle,[2] already integrated into many international conventions,[3] has been described as follows: “When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.”[4] Such an approach requires preventative action in the face of uncertainty, assigns the burden of protection to those responsible for the potentially harmful activities, considers all alternatives to new activities and processes, and insists on public participation in decision-making. This would include prohibiting the marketing of untested or unsafe uses of nanomaterials and requiring product manufacturers and distributors to bear the burden of proof. Simply put, ‘no health and safety data, no market.’ Adequate lifecycle assessment of nanomaterials should be defined and the assessment conducted before commercialization. Adequate resources should be dedicated to discerning and using the safest possible feedstock, processes and products.

The Precautionary Principle must be applied to nanotechnologies because scientific research to-date suggests that exposure to at least some nanomaterials, nanodevices, or the products of nanobiotechnology is likely to result in serious harm to human health and the environment. The small size of engineered nanomaterials can imbue them with novel physical, chemical, and biological properties that that are potentially useful; however, the comparatively high reactivity, mobility, and other properties that come with small size are also likely to impart novel toxicity.[5] Existing research on the impacts of nanomaterials on human health and the environment have raised red flags that warrant precautionary action and further study.[6] Because the potential toxicity of nano-scale materials cannot be reliably predicted from their toxicity profile in bulk (non-nano) form, regulations must require rigorous, accurate and comprehensive pre-market safety assessments that take into consideration the unique properties of nanomaterials. Regulations underpinned by a precautionary approach are critical for new technological developments where long-term health and environmental impacts are unknown, inadequately studied, and/or unpredictable.[7] Lack of data or evidence of specific harm cannot substitute for a reasonable certainty of safety.

2 See generally Perspectives on the Precautionary Principle (Ronnie Harding & Elizabeth Fisher, eds., 1999).

3 See, e.g., Rio Declaration on Environment and Development, June 14, 1992, 31 I.L.M. 874, 879 (“Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.”); Cartagena Protocol on Biosafety, Jan. 29, 2000, 39 I.L.M. 1027 Art. 10(6) (“Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Part of import, taking also into account risks to human health, shall not prevent that party from taking a decision, as appropriate, with regard to the import of the living modified organism in question . . . in order to avoid or minimize such potential adverse effects.”); U.N. Framework Convention on Climate Change, May 9, 1992, 21 I.L.M. 849, (“The Parties should take precautionary measures to anticipate, prevent or minimize the cause of climate change and mitigate its adverse effects. Where there are threats of serious or irreversible damage, lack of full scientific certainty should not be used as a reason for postponing such measures.”); The World Charter on Nature, G.A. Res. 37/7, ¶ 11, U.N. Doc. A/RES/37/7 (Oct. 28, 1982) (“Activities which might have an impact on nature shall be controlled, and the best available technologies that minimize significant risks to nature or other adverse effects shall be used.”); The London Convention on the Prevention of Marine Pollution by Dumping Wastes and Other Matter, 1996 Protocol to the Prevention of Marine Pollution by Dumping of Wastes and Other Matter, Mar. 24, 2006, art. 3, para. 1 (“Appropriate preventative measures are [to be] taken when there is reason to believe that wastes or other matter introduced into the marine environment are likely to cause harm even when there is no conclusive evidence to provide a causal relation between inputs and their effects.”); Agreement for the Implementation of the Provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 Relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks, G. A. 164/37, art. 6, U.N. Doc. A/CONF164/37 (“States shall apply the precautionary approach widely to conservation . . . .”).

4 Wingspread Statement on the Precautionary Principle, January 1998; see also Nancy Myers, Anne Rabe & Katie Silberman, Louisville Charter for Safer Chemicals: Background Paper for Reform No. 4 (2005) available at www.louisvillecharter.org/paper.foresight.shtml

5 See, e.g., Andre Nel et al., Toxic Potential of Materials at the Nanolevel, 311 Science 622-27, 622, 623 Fig. 1 (2006).

6 See, e.g., The Royal Society and the Royal Academy of Engineering, Nanoscience and Nanotechnologies: Opportunities and Uncertainties (2004); Andre Nel et al., Toxic Potential of Materials at the Nanolevel, 311 Science 622, 622-23 (2006); Holsapple et al., Research Strategies for Safety Evaluation of Nanomaterials, Part II: Toxicological and Safety Evaluation of Nanomaterials, Current Challenges and Data Needs, 88 Toxicological Sciences 12 (2005); Oberdörster et al., Nanotoxicology: an Emerging Discipline from Studies of Ultrafine Particles, 113 Environmental Health Perspectives 823 (2005); Tran et al., Institute of Occupational Medicine, A Scoping Study to Identify Hazard Data Needs For Addressing The Risks Presented By Nanoparticles and Nanotubes (2005); 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); Andrew Maynard, Nanotechnology: The Next Big Thing, or Much Ado about Nothing?, 51 Annals of Occupational Hygiene 1, 4-7 (2006); J. Sass, Natural Resources Defense Council, Nanotechnology’s Invisible Threat, (2007); Friends of the Earth, Nanomaterials, Sunscreens and Cosmetics: Small Ingredients, Big Risks (2006).

7 The European Union plans to apply the precautionary principle to issues that may have “potentially dangerous effects on the environment, human, animal or plant health.” European Commission, Communication from the Commission on the Precautionary Principle (2000).