Nanotechnology Law Report October 2007 Porter Wright Morris & Arthur LLP Inside this issue: Regulation of Nanotech- 111-1---3333 Regulation of Nanotechnology in Consumer nology in Consumer Prod- ucts Products NIOSH Urges EPA to Treat 333 Nanoscale Materials as The Third International the existing regulatory framework for nanoscale New Chemical Sub- stances Under TSCA Nano Regulation Conference materials used in consumer products in the US. took place on September 12- Dr. Thomas began by noting any potential EHS- EPA's Nanoscale Material 333 Stewardship Program 13, 2007 in St. Gallen, Swit- risk associated with nanomaterials, as with other zerland. The conference was compounds incorporated into consumer products, Nanotube Production 444 sponsored by The Innovation can be adequately assessed under existing CPSC Pollution? Society, and focused on the statutes, regulations, and guidelines. Dr. Tho- New Woodrow Wilson 444 "Regulation of Nanotechnol- mas explained premarket registration or approval Public Opinion Poll ogy in Consumer Products." Several presenta- of consumer products is not required under US Andrew Maynard Starts 444 tions at the conference are well-worth summariz- law, and "CPSC would evaluate a product's po- New Nanoblog ing from the written post-conference materials. tential risk to the public" after it has been distrib- uted in commerce. In the absence of express Brownian Motion 444 Peter van der Zandt of the regulations, Dr. Thomas explained CPSC will Report: Evaluating the 555 European Commission pre- look to see whether a nano-product "creates a Case for More Regulation sented "Nanomaterials in EU substantial risk of injury to the public because of, chemicals legislation: REACH The Rise of “Nanoethics” 555 among other factors, the pattern of any defect, & Co." He indicated the EU the number of defective products distributed in Nano-implants Predicted 555 has an action plan to inventory existing legisla- to Monitor Health Status commerce, and the severity of the risk." Dr. tion applicable to nanotechnology EHS issues Thomas’ presentation concluded by noting that Nobel Charitable Trust 666 and to improve its scientific knowledge base sur- Foundation Responds CPSC's "[a]pproach to regulatory products with rounding these issues. He took the position po- nanomaterials will likely be similarly to the ap- Nano App Summit a Great 666 tential EHS presented by nanomaterials are in proach used to regulate products containing Success principal covered by existing EU regulatory other chemicals." Back to School: Nano- 777 frameworks, however, the implementation of style those frameworks remains difficult due to scien- Dr. Gerhard Nohynek of Diversity of Nanoparticles 777 tific knowledge gaps and the fast evolving mar- L'Oreal Research and De- Complicates EHS- ket for products. Mr. van der Zandt also indi- velopment, France, pre- Predictions cated the EU may need to make regulatory sented "Grey Goo on the Anti-Oxidant Coating Im- 777 changes in light of new science, and the new EU Skin?" Dr. Nohynek ex- pedes TiO2 Dermal Pene- REACH requirements apply to nanomaterials plained nanosized components of modern cosmet- tration (even though REACH does not contain nano- ics and sunscreens do not penetrate human skin Fantastic Voyage 888 specific provisions). Finally, he advocated con- beyond the superficial layers of the stratum Porter Wright Client Re- 888 tinuing to watch nano-related EHS issues as corneum and "may" enhance or reduce penetra- solves Largest Environ- science develops, and possibly modify existing tion within that narrow layer, "albeit at a limited mental Case in US History EU laws as needed. order of magnitude." He also explained TiO2 NIOSH to Publish Medical 888 and ZnO nanoparticles do not penetrate compro- Dr. Treye A. Thomas of the US Consumer Prod- Monitoring Guidance mised human skin. As for apparent concerns uct Safety Commission presented an overview of Events and Publications 999 raised by the comparison of cosmetics containing NanoLawReport © 2007 Porter Wright Morris & Arthur LLP Regulation of Nanotechnology in Consumer Products (cont.) nanoscale materials to nano-transdermal drugs, Dr. Nohynek Monika Büning of the Federation of German Consumer Organi- explained "[t]he experience of transdermal drug delivery re- zations, presented "Buying nano: What consumers want to search has shown that significant passive skin penetration may know." The Federation of German Consumer Organizations is only be achieved for substances combining a low molecular an NGO that acts as an umbrella for 40 German consumer asso- weight and melting point which excludes insoluble nanoparti- ciations. Ms. Büning took the position that "[c]onsumers are cles," and "[t]here is little evidence supporting a general rule buying products labeled 'nano' but in fact it does not mean that that effects of particles to the skin or other tissues increase with there is nano inside." She further indicated that whether prod- smaller particle size, or produce novel toxicities when compared ucts truly contain nanoscale materials is important to consumers with those of micro sized materials." Dr. Nohynel concluded that so they can decide whether or not to buy the product. She said "[o]verall, the weight of current scientific evidence suggest that there is a need for a clear definition of nanomaterials and an obli- the use of nano-sized cosmetic or sunscreen ingredients poses no gation for manufacturers to declare when a product contains or negligible potential risk to human health." nanoparticles. Ms. Büning finally indicated that "[i]n cosmetics, a short notice would be enough," while "on food, it could be like it Dr. Martin Kuster, MD MOH of Novartis International AG, is on food containing GMO." Switzerland, presented "Nanoparticles in drug delivery: potential avenues and issues." Dr. Kuster explained one "issue with Del Stark of the European Nanotechnology Trade Association nanoparticles is the unknown toxicology especially of the non- (ENTA), United Kingdom, presented "Selling Nano." ENTA biodegradable ones." He indicated that even innocuous sub- acts as industry voice for nanotechnology in Europe. It promotes stances scaled down to nanosize may develop caustic properties, the potential benefits and the mitigation of any reputational and lead to oxidative stress in tissues and also to acute and chronic regulatory risk associated with the development of nanotechnol- inflammation most often combined with scar formation in the ogy. Mr. Stark presented a balanced view of nanotechnology target organ. Dr. Kuster took the position that "[t]he different research and development. He explained his view that safety is a properties of nanoparticles mandate new sets of test, as the classi- necessity; industry is being responsible; current regulations are cal toxicological tests are bound not to deliver meaningful re- working; any new laws and amendments must be based on scien- sults." Finally, he theorized that "biodegradable [nanoscale] tific evidence and must be proportionate; and industry wants substances should not elicit any [adverse EHS] effects, but open discussion with NGOs on nano-related issues in Europe. [should be useful for the] desired transport of a [drug] sub- David Rejeski of the Woodrow Wilson International Center for stance." Scholars, did not attend the conference, but submitted the presen- Dr. Gerhard Schmidt of Munich Re, tation "Building a new social contract for 21st Century products." Germany, presented "Insuring Mr. Rejeski's presentation explained 70-80% of Americans have Nano: Perspective of Munich Re." heard nothing or very little about nanotechnology, prompting Dr. Schmidt's presentation stated him to take the position "[n]ano is an invisible technology with that "[t]he application of nanotech- big impacts that nobody is talking about." He then noted what he nology products and processes could called some "generic deficiencies" in regulations covering nano- bring about a whole new dimension scale materials: (i) they do not address size and/or novel proper- in personal injury, property damages and pure financial losses as ties, (ii) there are no reliable and inexpensive emissions monitor- well as third-party liability risks, for instance in product, environ- ing devices; (iii) they are typically based on mass-based standards mental and third-party liability." He believes that "[i]n particu- and thresholds; (iv) there are reporting exemptions for manufac- lar, product liability is the key question today and could take on turing facilities with small production quantities; and (v) tech- new dimensions in view of the complexity of the potential appli- nologies for pollution control are not available. Regarding US cations of nanotechnology products and processes." He closed by laws, Mr. Rejeski's presentation claimed there are gaps in FDA's indicating that because product recalls are not typically covered and EPA's authority to regulate nanoscale materials; a lack of under product liability policies, insurance companies can expect financial and human resources to regulate the materials; and that an increasing demand for product recall policies. public trust in government and industry to accomplish these Page 2 October 2007 © 2007 Porter Wright Morris & Arthur LLP Regulation of Nanotechnology in Consumer Products (cont.) tasks is weak. At the same time, Mr. Rejeski noted there is little prevents innovation and progress. She also believes regionally public support for a moratorium on nanotechnology research or limited regulations