CTA is a Washington, D.C.-based non-profit, bi- partisan organization committed to providing the public with full assessments and analyses of technolo

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1 Nanotechnology: A Risky Future? George A. Kimbrell The International Center for Technology Assessment Harris Martin s Cutting Edge Toxic Tort Conference December 11, 2006 Scottsdale, AZ

2 CTA is a Washington, D.C.-based non-profit, bi- partisan organization committed to providing the public with full assessments and analyses of technological impacts on society. CTA explores the environmental, human health, economic, ethical, social and political impacts that can result from the applications of technology or technological systems.

3 What Is Nanotechnology? Nanotechnology involves the manipulation of materials and the creation of structures and systems that exist at the scale of atoms and molecules, nanometer (nm) scale. Engineered/manufactured nanoparticle: A particle <100 nm engineered or manufactured with a specific physicochemical ca composition o and structure u to exploit properties and functions associated with its dimensions and exhibits new or enhanced size-dependent properties compared with larger particles of the same material. A nanometer (nm) = one billionth of a meter. Hair strand=80,000 nm; Red blood cell= 7,000 nm; DNA=2.5 nm.

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5 Measures of Nanotechnology s Maturation R&D surging: global nanotech R&D= $9 billion, with $1 trillion estimated for 2015 (Lux Research 2006) Term nano approaches ubiquitous status in U.S. society and media (>18,000 citations in U.S. media in 2005) The gold rush for nano-patents continues- over 4,000 U.S. patents issued to date (Lux Research 2006) Perhaps most importantly, nanotechnology commercialization is moving forward at a rapid rate

6 Nanomaterials in Consumer Products: The Future is Now (Photo by David Hawxhurst-Woodrow Wilson International Center for Scholars.)

7 Nanomaterials in Consumer Products Lux Research s 2006 Nanotechnology Report: : more than $32 billion in nano-products sold in 2005, 2X the total of Wilson Center s Project on Emerging Nanotechnologies 2006 Consumer Product Database: more than 300 self-identified ifi d nano-products now on U.S. market shelves. Products include paints, coatings, sporting goods, sunscreens, cosmetics, personal care products, stain- resistant clothing, cleaning products, and light emitting diodes d used in computers, cell phones, and digital it cameras.

8 US Leads in Nanotechnology Companies

9 No Where Are Nanomaterials Reaching the Consumer Faster than in Personal Care Products Wilson Center s Product Datebase largest single category (125 products) Friends of the Earth Report: 116 cosmetics, sunscreens, and personal care products containing nanomaterials commercially available free nanoparticles, not fixed in product matrix; used daily and directly on the skin; they may be inhaled and are often ingested. Photo by David Hawxhurst-Woodrow Wilson International Center for Scholars.)

10 Report Findings: Companies Using Nanomaterial Ingredients Almay Barney s NY Chanel Clinique Estee Lauder Johnson & Johnson L Oreal Lancôme Revlon And many others

11 Size Matters Materials engineered or manufactured to the nano-scale can exhibit different fundamental physical, biological, and chemical properties Quantum physics effects Exponentially increased surface area These new properties ( nano-ness ) ness ) can create unique and unpredictable human health and environmental risks

12 Unprecedented mobility: Human Health Risks Entry through inhalation or ingestion; the jury still out on ease of skin penetration. Due to size, nanoparticles more easily taken up by the human body and can cross biological membranes, cells, tissues and organs more efficiently than larger particles. Once in the blood stream, nanomaterials can be transported around the body and can be taken up by organs and tissues including the brain, heart, liver, kidneys, spleen, bone marrow and nervous system.

13 Human Health Risks Increased reactivity: Increased surface area creates increased reactivity and enhanced intrinsic toxicity. Some nanoparticles shown to cause DNA mutation, structural damage to mitochondria and cell death. Conventional risk assessments and toxicity tests are insufficient Nanotoxicology: new paradigms of toxicity testing -- up to 16 physiochemical parameters should be evaluated a far cry from the 2 or 3 usually measured (Oberdorster et al., Part Fiber Toxicol,, 2005) Industry commenter: Some scientists believe that under current conditions determining the true safety of such products is a lottery for consumers. Simon Pittman, CosmeticsDesign.com (10/27/06)

14 Environmental Impacts: A new class of manufactured non-biodegradable pollutants. Pathways to the environment: during manufacturing, transport, use, or disposal Risks Mobility Transportation Reactivity it Durability Bioaccumulation Management Challenges: Testing, Detection and Removal??

15 Case study: carbon fullerenes Fullerenes (Carbon 60 ) known as buckyballs, used in some face and anti- aging creams Environmental impacts Adverse impacts on aquatic species: cause brain damage in fish, kill water fleas, and have bactericidal properties. Human Health impacts low levels have been found to be toxic to human liver cells.

16 Case study: nano-sunscreens Engineered nanoparticles make them transparent or cosmetically clear, rather than white. legally patented for their novelty. Widely-available and used, free particles; placed directly on skin. Nanoparticles of titanium dioxide and zinc oxide shown to be photoactive in some studies, producing free radicals and causing DNA damage to human skin cells when exposed to UV light. As with nano-cosmetics cosmetics, jury is still out on ease of skin penetration

17 Case study: nano-silver products A universe of products containing (or purporting to contain) silver nanoparticles: food storage, washing machine, refrigerator lining, shoe lining, air filters and fresheners, drywall, paint, medical coatings, and wide range of other products Inserted for their nano anti- microbial properties; but the same enhanced properties are harmful to microorganisms and ecosystems (NACWA letters) Nano-silver products=pesticides? (see infra)

18 Case study: nanotubes- the new asbestos? Familiar needle-like like shape of nanotubes, nanowires, and nanofibers NASA Study: effects of nanotubes on the lungs of rats produced more toxic response than quartz dust. "The message is clear. People should take precautions. Nanotubes can be highly toxic. - Dr. Robert Hunter (NASA researcher) Fiber-shaped nanomaterials possibly represent a unique inhalation hazard, and their pulmonary toxicity should be evaluated as a matter of urgency. -Maynard et al., Nature, 2006)

19 Regulatory Action (or Inaction) FDA: CTA Petition- First-ever Legal Action On Risks Of Nanotechnology On nanomaterial consumer products Comprehensive nanomaterial-specific regs New paradigms of nano-specific toxicity testing Classification of nanomaterials as new substances Labeling NEPA compliance Recall nano-sunscreens until reviewed as new drug products FDA held ed first-ever e public meeting (Oct 2006) but not yet responded otherwise

20 Regulatory Action (or Inaction) Continued EPA FIFRA/Nano-Silver (Nov 2006) first federal restriction to focus largely on nanotechnology ; test case (Wash Post 11/23/06) (proposed rule forthcoming) TSCA: Voluntary Nano-chemicals Pilot Program (expected 2007) NIOSH In the Federal vacuum- local regulation Berkeley, CA proposed p city ordinance/disclosure reqs

21 Putting Nano in Toxic Tort Terms Some possible issues: Potential plaintiffs and defendants? Exposure to harmful substances or products? Causation/uncertainty questions? Latency between exposure to the substance and manifestation of adverse impacts? Strict t liability: design defect or failure to warn? Some possible indications from potential defendants: A lack of transparency/cbi on safety evidence? Internal/public statement inconsistencies? Responsive to agency and public?

22 Conclusions Much More EHS Research (and EHS Funding): Existing studies raise red flags, underscoring the urgent need for further study. Adequate, publicly l available, independent, peer-reviewed reviewed safety studies on the environmental and health impacts of nanomaterials. seminal Nature article: 14 experts urged nano-safety "grand challenges" that must be tackled in the near future, including develop air and water detection/tracking, develop methods to evaluate nano-toxicity, and develop systems for evaluating and models for predicting health and environmental impacts over product lifecycle. (Maynard et al., Nature, 11/16/06) FY06 NNI Budget: only 4% of $1 Billion goes to Environmental Health and Safety (EHS) research

23 Conclusions Learning from the past: regulators must act quickly if they hope to avoid repeating the mistakes of past regulatory failures (e.g., asbestos, DDT, PCBs) Only the first or passive phase: increased nano-engineering capabilities are expected to lead to more sophisticated and heterogeneous materials and devices (active nanostructures) (M. Roco, 2004) Adequate Oversight: A regulatory framework is needed that protects workers, the general public and the environment from the impacts of nanomaterials

24 For More Information George A. Kimbrell International Center for Technology Assessment 3 Nanotechnology L. & Bus. 329 (Fall 2006)