Nanotechnology Regulation: A Proposed Roadmap

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1 Nanotechnology Regulation: A Proposed Roadmap Lloyd L. Tran President, International Association of Nanotechnology Director California Institute of Nanotechnology

2 What is Nanotechnology? Nanotechnology deals with the manipulation of materials on an atomic or molecular scale measured in billionths of a meter (nanometers). One nanometer is about 100,000 times smaller than the diameter of a human hair. This ability to design and manipulate materials at the molecular level, atom per atom can result in changing the composition of materials and how the products are manufactured in a radical ways.

3 Why is nanoscale so important? 3 The wavelike properties of electrons inside matter are influenced by variations on the nanometer scale. By patterning matter on the nanometer length scale, it is possible to vary fundamental properties of materials (for instance, melting temperature, magnetization, charge capacity) without changing the chemical composition. STM Manipulation single atoms 2 Angstroms = 0.2 nm Standing Electron Waves

4 Nanotechnology R&D Funding by Agency 4 4

5 Investment in Nanotechnology

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7 Nanotech Consumer Products New nanotechnology consumer products are coming on the market at the rate of 3-4 per week, a finding based on the latest update to the nanotechnology consumer product inventory maintained by the Project on Emerging Nanotechnologies (PEN). As of April 24, 2008, the number of consumer products using nanotechnology has grown from 212 to 609 since PEN launched the world s first online inventory of manufactureridentified nanotech goods in March 2006

8 Early Nanotechnology Applications No Spots 8 The clothing industry uses nanotech to make stain-repellent fabrics. A chemical process during manufacture forces liquids to bead up when spilled on a garment for easy wiping away. Socks that are made with nano-silver particles give anti-microbial protection, preventing bacteria and fungus that cause itchiness and smells. building_from_the_bottom_up/html/2.stm

9 9 Early Nanotechnology Applications Little bits The cosmetics industry already puts nano-particles in lotions, creams and shampoos. Nano-sized zinc oxide particles are used in sun creams. The particles are particularly good at absorbing ultra-violet rays, but make the lotion transparent and smooth instead of sticky and white. building_from_the_bottom_up/html/2.stm

10 Single Wall Carbon Nanotube contains Redox-Active Iron Source: Valerie E. Kagan, Dept. Environmental & Occupational Health, University of Pittsburgh

11 Examples of Nanotoxicity 1. Researchers in the University of Texas found that carbon nanotubes squirted into the trachea of mice caused serious inflammation of the lungs and granulomas (tumour-like nodules of bloated white blood cells in the lining of the lungs), and five of the nine mice treated with the higher dose died. 2. In a similar experiment carried out at the National Institute of Occupational Safety and Health (NIOSH) in Morgantown, West Virginia, researchers not only found granulomas in the lungs, but also damage to mitochondrial DNA in the heart and the aortic artery, and substantial oxidative damage, both foreshadowing atherosclerosis. 3. In another similar experiment in Tottori University, Japan, researchers showed that within a minute of contacting the mice s tiniest airways, carbon nanotubes began to burrow through gaps between the surface lining cells and into the blood capillaries, where the negatively charged nanoparticles latched onto the normally positively charged red blood cells surface, thereby potentially causing the red blood cells to clump and the blood to clot. 11

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13 Examples of Nanotoxicity 4. Researchers from the University of Rochester, New York, reported an increased susceptibility to clotting in rabbits that had inhaled buckyballs. 5. Buckballs present in water at 0.5 parts per million were taken up by largemouth bass, which suffered severe brain damage 48 hours later, the extent of damage being 17 times greater than that seen in controls. 6. Carbon Nanotubes in the lungs are translocated to the circulatory system and from there throughout the body, accumulating in the liver, spleen, and bone marrow. Carbon Nanotubes inhaled through the nose and air passages are translocated to the brain through the olfactory nerves, and accumulate in the brain. 13

14 14 Sources: Friends of the Earth

15 15 CTA Petitions on FDA's Failure to Regulate Health Threats from Nanomaterials May 16, 2006

16 The International Association of Nanotechnology Roadmap for the beneficial applications of Nanobiotechnology

17 The International Association of Nanotechnology NanoBio Roadmap Road map # 1: Foster advanced scientific research & business collaboration worldwide CREATE COLLABORATE

18 The International Association of Nanotechnology NanoBio Roadmap Roadmap # 2: Develop international nomenclature and standards 1. Metrology and test methods: 2. Properties and characteristics of nanomaterials 3. Risk assessment and management 4. Toxicology study 5. Environmental impact

19 Actions by Standards Organizations Nomenclature Metrology ASTM E , Terminology for Nanotechnology ASTM E2456 ISO Technical Committee (TC) 229 OECD WPMN Environmental Health Safety: International Council of Nanotechnology (ICON) EH&S database Nanotechnology Characterization Laboratory (NCL) NIOSH Voluntary Frameworks

20 The International Association of Nanotechnology NanoBio Roadmap Road Map # 3: Study the health and safety of nanomaterials. Ensure quality assurance of nano-manufacturing processes and products

21 Nanoparticle Safety What are the nanoparticle pathways inside the human body? How long do the nanoparticles remain in the tissues and how are they cleared? What effects do nanoparticles have on cellular and tissue functions? Can nanoparticles gain access to the systemic circulation from dermal exposure? If nanoparticles enter skin cells, is there an effect on cellular functions? What are unanticipated reactions in vivo?

22 From the ATSDR Public Health Assessment Guidance Manual, January 2005

23 The International Association of Nanotechnology NanoBio Roadmap Road Map # 4: Develop Nanotechnology education and workforce training Economists predict a $1.5 trillion dollars global multi-industry market for nanotech products in 10 years Nanotechnology could create as many as 2 million jobs by 2015 in the USA. An urgent need to train a new workforce that are equipped with the knowledge relating to environmental health and safety aspects of nanomaterials.

24 The International Association of Nanotechnology NanoBio Roadmap Road Map # 5: Provide adequate funding to study health & safety and environmental aspects of nanomaterials

25 25 More funding for EHS required At a House Science Committee hearing Nov. 17, 2006 environmental and industry representatives alike said federal spending on environmental, health and safety implications of nanotechnology should be $100 million to $200 million a year, or about 10 percent to 20 percent of the government's $1.2 billion nanotech development budget for fiscal The Science Board Subcommittee in February 2008 recommended a double budget for the FDA to tackle the challenges facing the agency

26 The International Association of Nanotechnology NanoBio Roadmap Road map # 6: Outreach to stake-holders and upstream public engagement

27 Public Engagement? Public Trust Ethical Societal Environmental Health Safety Nomenclature Methodology Measurement Peer Reviews Standards Intellectual Property Workforce Development Economic Value Investment

28 The International Association of Nanotechnology NanoBio Roadmap Road map # 7 Developing a framework of regulation that is fair, equitable, transparent to protect the consumers, while foster innovation

29 29 Nano Regulation in Berkeley Nanotechnology regulations imposed by the Berkeley City Council took effect on December 18, The council decided to amend its hazardous materials law to include nanoparticles, making Berkeley the nation's only local government to regulate nanotechnology. The unanimous action compels researchers and manufacturers to report what nanotechnology materials they are working with and how they are handling them.

30 Summary and Perspective Nanotechnology has a wide spectrum of applications with significant impact to industries, business, government, and society at large International Standards are in the developmental stage Education and workforce training urgently needed for the emerging industry Health safety, environmental, and societal implications to be addressed Regulation of novel nanomaterials are needed provided that it is fair, equitable and transparent to protect the consumers while foster innovation. 30

31 Thank You! Lloyd L. Tran President, International Association of Nanotechnology Director California Institute of Nanotechnology Tel