The Third International Nano Regulation Conference took place on September 12-13, 2007 in
St. Gallen, Switzerland The conference was sponsored by The Innovation Society, and was focused on the "Regulation of Nanotechnology in Consumer Products." Several presentations at the conference are well-worth summarizing from the written post-conference materials published by The Innovation Society:
Dr. Georg Karlaganis, Federal Office for the Environment, Switzerland, presented "Nanomaterials — Challenges and opportunities for Switzerland." He described a Spring 2006 Swiss action plan on "synthetic nanomaterials" that was undertaken by the Swiss Federal Office for the Environment and the Federal Office of Public Health. The Swiss government designed the plan to coordinate nano-EHS research efforts with OECD, ISU, and the EU. The group published its first basic report in July 2007 in which it concluded that there is a current lack of scientific knowledge that prevents conclusive risk assessment for synthetic nanoparticles. The report also concluded that definitions, standardization methods, and testing guidelines are largely absent from the scientific literature, but are a necessary prerequisite to any detailed nano-EHS analysis. The group also suggested the development of a Swiss legislative framework to make sure laws adequately cover synthetic nanoparticles, and concluded that legislative uncertainty leads to both EHS risk as well as business development and innovation risks.
Peter van der Zandt of the European Commission presented "Nanomaterials in EU chemicals legislation: REACH & Co." He indicated the EU has an action plan to inventory existing legislation that may be applicable to nanotechnology EHS issues, and to improve its scientific knowledge base surrounding these issues. He took the position that potential EHS presented by nanomaterials are in principal covered by existing EU regulatory frameworks, however, the implementation of those frameworks remains difficult due to scientific knowledge gaps and the fast evolving market for products. Mr. van der Zandt also indicated that the EU may need to make regulatory changes in light of new science, and the new EU REACH requirements apply to nanomaterials (even though REACH does not contain specific provisions for nanomaterials). Finally, he advocated continuing to watch nano-related EHS issues as the science develops, and possibly modify existing EU laws as needed.
Dr. Treye A. Thomas, of the US Consumer Product Safety Commission presented an overview of existing regulatory framework for nanoscale materials used in consumer products in the United States. Dr. Thomas began by noting that any potential EHS-risk associated with nanomaterials, as with other compounds, incorporated into consumer products, can be adequately assessed under existing CPSC statutes, regulations, and guidelines. Dr. Thomas explained that premarket registration or approval of consumer products is not required under US law, and that "CPSC would evaluate a product’s potential risk to the public" after its been distributed in commerce. In the absence of express regulations, Dr. Thomas explained CPSC will look to see whether a nano-product "creates a substantial risk of injury to the public because of, among other factors, the pattern of any defect, the number of defective products distributed in commerce, and the severity of the risk." Dr. Thomas concluded his presentation by noting that CPSC’s "[a]pproach to regulatory products with nanomaterials will likely be similarly to approach used to regulate products containing other chemicals."
Dr. Gerhard Nohynek, L’Oreal Research and Development, France, presented "Grey Goo on the Skin?" Dr. Nohynek explained that nanosized components of modern cosmetics and sunscreens do not penetrate human skin beyond the superficial layers of the stratum corneum and that they "may" enhance or reduce penetration within that narrow layer, "albeit at a limited order of magnitude." He also explained that TiO2 and ZnO nanoparticles do not penetrate into or through compromised human skin. As for the apparent concerns rauised by the comparison of cosmetics containing nanoscale materials to nano-transdermal drugs, Dr. Nohynek explained "[t]he experience of transdermal drug delivery research has shown that significant passive skin penetration may only be achieved for substances combining a low molecular weight, melting point and a favorable lofPo/w which excludes insoluble nanoparticles, " and "[t]here is little evidence supporting a general rule that effects of particles to the skin or other tissues increase with smaller particle size, or produce novel toxicities when compared with those of micro sized materials." Dr. Nohynel concluded by stating that "[o]verall, the weight of current scientific evidence suggest that the use of nano-sized cosmetic or sunscreen ingredients poses no or negligible potential risk to human health."
Dr. Martin Kuster, MD MOH, Novartis International AG, Switzerland, presented "Nanoparticles in drug delivery: potential avenues and issues." Dr. Kuster explained one "issue with nanoparticles is the unknown toxicology especially of the non-biodegradable ones." He indicated that even innocuous substances scaled down to nanosize may develop caustic properties, lead to oxidative stress in tissues, and also to acute and chronic inflammation most often combined with scar formation in the target organ. Dr. Kuster took the position that "[t]he different properties of nanoparticles mandate new sets of test, as the classical toxicological tests are bound not to deliver meaningful results." Finally, he theorized that "biodegradable [nanoscale] substances should not elicit any [adverse EHS] effects, but [should be useful for the] desired transport of a [drug] substance."
Dr. Gerhard Schmidt, Munich Re, Germany, presented "Insuring nano-Perspective of Munich Re." Dr. Schmidt’s presentation stated that "[t]he application of nanotechnology products and processes could bring about a whole new dimension In personal injury, property damages and pure financial losses as well as third-party liability risks, for instance in product, environmental and third-party liability." He believes that "[i]n particular, product liability is the key question today and could take on new dimensions in view of the complexity of the potential applications of nanotechnology products and processes." He closed by indicating that because product recalls are not typically covered under product liability policies, insurance companies can expect an increasing demand for product recall policies.
Monika Büning, Federation of German Consumer Organizations, presented "Buying nano: What consumers want to know." The Federation of German Consumer Organizations is an NGO that acts as an umbrella for 40 German consumer associations. Ms. Büning took the position that "[c]onsumers are buying products labeled ‘nano’ but in fact it does not mean that there is nano inside." She further indicated that whether products truly contain nanoscale materials is important to consumers so they can decide whether or not to buy the product. She said there is a need for a clear definition of nanomaterials and an obligation for manufacturers to declare when a product contains nanoparticles. Ms. Büning finally indicated that "[i]n cosmetics, a short notice would be enough," while "on food, it could be like it is on food containing GMO."
Del Stark, European Nanotechnology Trade Association (ENTA), United Kingdom, presented "Selling Nano." ENTA acts as industry voice for nanotechnology in Europe. It is aimed at promoting the potential benefits and mitigating any reputational and regulatory risk associated with the development of nanotechnology . Mr. Stark presented a balanced view of nanotechnology research and development. He explained his view that safety is a necessity; industry is being responsible; current regulations are working; any new laws and amendments must be based on scientific evidence and must be proportionate; and industry wants open discussion with NGOs on nano-related issues in Europe.
David Rejeski, Woodrow Wilson International Center for Scholars, did not attend the conference, but submitted the presentation "Building a new social contract for 21st Century products." Mr. Rejeski’s presentation explained that 70-80% of Americans have heard nothing or very little about nanotechnology, prompting him to take the position that "[n]ano is an invisible technology with big impacts that nobody is talking about." He then noted what he called some "generic deficiencies" in regulations covering nanoscale materials: (i) they do not address size and/or novel properties, (ii) there are no reliable and inexpensive emissions monitoring devices; (iii) they are typically based on mass-based standards and thresholds; (iv) there are reporting exemptions for manufacturing facilities with small production quantities; and (v) technologies for pollution control (BAT) are not available. Regarding US laws, Mr. Rejeski’s presentation claimed there are gaps in FDA’s and EPA’s authority to regulate nanoscale materials; a lack of financial and human resources to regulate the materials; and that public trust in government and industry to accomplish these tasks is weak. At the same time, Mr. Rejeski noted there is little public support for a on moratorium of industry self-regulation on nanotechnology research and development. His presentation conclude by recommending: greater transparency in the regulatory process; more pre-market testing of products employing nanoscale materials, as well as additional third-party testing and research.
Carolina Kranz, BASF AG, Germany, presented "Code of Conduct: A suitable tool for the sustainable development of nanotechnologies – the BASF experience." Dr Kranz explained that "[i]n 2006, BASF introduced its Code of Conduct and Nanotechnology. [It is a] [s]et of rules outlining the responsibility to protect employees, customers and business partners, to participate in safety research, to communicate openly, and to strive for a public dialogue." Dr. Kranz stated that in some instances excess regulation prevents innovation and progress. She also believes regional limited regulations may restrict competitiveness, and that to-date toxicological results do not substantiate the need for nano-specific regulation. She concluded her presentation by explaining "A code of conduct is the tool of choice, that maintains the necessary framework conditions for innovation and competitiveness. It is an option, where regulation is not possible and a commitment that makes a company accountable towards society and politics."
Thorsten Weidl, TÜV SÜD Industrie Service GmbH, Germany, presented "CENARIOS© – A nano risk management system as a business and safety opportunity." He explained his company’s new product — CENARIOS — is not a product certificate, but rather it is a certificate for a risk management system and workplace monitoring system for nanotechnology. He further explained that CENARIOS "does not reinvent the wheel," but rather employs all the well-known steps of basis risk-management systems: (i) Risk and Hazard Assessment/Risk Evaluation; (ii) Risk Monitoring System; (iii) Management and Communication; (iv) certification requiring the updating of the risk report at least twice a year; and (v) continuous monitoring (at least every three months) of possible workplace exposures.
Of final note, Dr. John M. Balbus, MD, MPH, Environmental Defense presented "A framework for Responsible Nanotechnology Development" in a workshop format in which he explained the new EID/DuPont Nano Risk Framework that has received much public and press attention of late.
