PRODUCT SAFETY IN NANOTECHNOLOGY

1. PRODUCT SAFETY IN NANOTECHNOLOGY EIN 5322 Project Fall 2007 Jonathan Rivera

2. INTRODUCTION • Overview- A look at the role product safety is playing in the development of nanotechnology, including initiatives by government, private, and international sectors to address safety concerns and challenges. • Why is this topic important? – nanotechnology affects a wide range of people and industries; addressing product safety helps ensure technology reaches its full potential; regulation is forthcoming; protection of public health and safety and the environment is essential in engineering ethics

3. INTRODUCTION OUTLINE • Development of Nanotechnology • Relation of Product Safety to Engineering Ethics • Product Safety Concerns in Nanotechnology • Current Governance Initiatives • Challenges in Addressing Product Safety • Summary

4. What is nanotechnology? “…the creation and utilization of materials, devices, and systems through the control of matter on the nanometer-length scale—at the level of atoms, molecules, and supra-molecular structures.” – National Science and Technology Council “The science and technology of controlling matter at the nanoscale” – Environmental Law Institute & WWISC “…the processing of, separation, consolidation, and deformation of materials by one atom or by one molecule…” – Norio Taniguchi, Professor, Tokyo Science University, 1974 DEVELOPMENT OF NANOTECHNOLOGY

5. DEVELOPMENT OF NANOTECHNOLOGY What is nanotechnology? No official definition; generally accepted definition by National Nanotechnology Initiative: 1. Research and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1 - 100 nanometers 2. Creating and using structures, devices and systems that have novel properties and functions because of their small and/or intermediate sizes, and 3. Ability to be controlled or manipulated on the atomic scale

6. DEVELOPMENT OF NANOTECHNOLOGY What is nanotechnology?

7. DEVELOPMENT OF NANOTECHNOLOGY What is nanotechnology? • A multi-disciplinary field extending existing science into the nanoscale size • Manipulating materials at the nanoscale can change the electronic, magnetic, mechanical, chemical, optical, structural, and functional properties of a substance, producing unique phenomena that can be applied in novel and ground-breaking ways

8. DEVELOPMENT OF NANOTECHNOLOGY What is nanotechnology? • Identifying what constitutes a nanomaterial is the subject of substantial debate in the scientific, regulatory, and standards communities • Several terms used to describe nanomaterials depending on shape and structure, such as nanoparticles, nanocrystals, nanotubes, nanowires, nanopores, fullerenes, dendrimers, andnanoshels

9. DEVELOPMENT OF NANOTECHNOLOGY History • 1959 – speech by physicist Richard Feynman at Caltech - “There's Plenty of Room at the Bottom” – introduced idea of manipulating individual atoms and molecules • 1980s – advances in microscopy enabled developments in nanotechnology • 1985 – discovery of fullerene by Robert F. Curl, Jr., Sir Harold W. Kroto, and Richard E. Smalley (Noble Prize in Chemistry 1996)

10. DEVELOPMENT OF NANOTECHNOLOGY History • 1991 - discovery of the nanotube by Sumio Iijima (NEC Corporation) - “jumbotron lamp” in athletic stadiums • 2000 - first nano-structured coating for gears of air conditioning units on U.S. Navy ships – DOD estimates $20 million reduction in maintenance costs over 10 years

11. DEVELOPMENT OF NANOTECHNOLOGY Wide range of impacted industries and products, including: Automobile Electronics Building & Household Products Medicine Consumer Products

12. DEVELOPMENT OF NANOTECHNOLOGY Existing and near term applications

13. Temperature controlling fabrics Hearing aid implants Cancer tagging mechanisms Temperature dependent smart roofs Advanced water filtration systems Breakdown of biological warfare agents Precise surgical tools Groundwater remediation Breakdown of manufacturing waste DEVELOPMENT OF NANOTECHNOLOGY Other applications:

14. DEVELOPMENT OF NANOTECHNOLOGY

15. DEVELOPMENT OF NANOTECHNOLOGY The market today • Over 700 nano-based products (including consumer products) currently available in U.S. • Over 1600 companies producing and selling nano-based products in U.S.; ½ small businesses • In 2005, U.S. government invested $1.6 billion in research and development; U.S. based corporations invested $1.7 billion • In 2004, state and local governments invested over $400 million in research, facilities, and business incubation programs

16. DEVELOPMENT OF NANOTECHNOLOGY The market today • In 1990, approx. 200 patent applications filed (worldwide); by 2002 over 1900 patent applications • Number of consumer products (worldwide) using nanotechnology more than doubled since March 2006, from 212 to 475; clothing and cosmetics top the list (77 and 75 products, respectively); others include bedding, jewelry, sporting goods, and nutritional and personal care; over $30 billion in manufactured goods; U.S. leads with 247 products – 58% increase from 2000

17. DEVELOPMENT OF NANOTECHNOLOGY The market today • One of the top research priorities of the U.S. government today; Japan, China, Korea, as well as several European countries have made leadership in nanotechnology national priorities • Interesting fact: Over 80% of general public knows very little or nothing about nanotechnology

18. DEVELOPMENT OF NANOTECHNOLOGY

19. DEVELOPMENT OF NANOTECHNOLOGY

20. DEVELOPMENT OF NANOTECHNOLOGY

21. DEVELOPMENT OF NANOTECHNOLOGY The future market • By the year 2015: • Nano-based products could constitute over 15% of the global manufacturing output • Revenues from nano-based products could total over $2.6 trillion • Nanotechnology could surpass the impact of the Industrial Revolution

22. DEVELOPMENT OF NANOTECHNOLOGY The future market Nanotechnology is one of three areas of substantial investment[for General Electric]…potential for helping develop high-heat resistant blades for gas turbine engines, more efficient MRI contrast agents, and high-strength lightweight components for a variety of products. • Jeffrey Immelt, General Electric Nanotechnology will form the foundation for revolutionary discoveries and advancements in the decades to come. It will profoundly influence the competitiveness of companies in every relevant industry. - Herbert Riemenschneider, Degussa Corporation

23. PRODUCT SAFETY RELATION TO ENGINEERING ETHICS • Engineering ethics – applying ethical principles to the engineering profession, where engineers are obligated to uphold certain standards of conduct in the interest of the public, clients, employers, and the profession as a whole • All engineers faced with similar ethical issues (e.g., whistle blowing, product liability, quality, legal compliance, conflict of interests, bribery, treatment of confidential or proprietary information, outside employment)

24. PRODUCT SAFETY RELATION TO ENGINEERING ETHICS • During the rise of the engineering profession in the 19th century, professional societies were developed, such as ASCE (1851) and AIEE (1884) • With significant structural failures, such as Tay Bridge Disaster (1979) and Quebec bridge collapse (1907), formal codes of ethics where established

25. PRODUCT SAFETY RELATION TO ENGINEERING ETHICS • No single, uniform system, or standard, of ethical conduct across entire engineering profession, however codes of ethics established by engineering professional societies (BMES, IEEE, ASCE, ASME, NSPE, International: ICE in UK, several societies in Canada)

26. National Society of Professional Engineers (NSPE) extends licensing and code of ethics in the U.S. Licensed engineers subject to ethics laws; code of ethics written into law in most states Many similarities between codes of ethics across professional engineering societies PRODUCT SAFETY RELATION TO ENGINEERING ETHICS

27. PRODUCT SAFETY RELATION TO ENGINEERING ETHICS Core concepts present in engineering code of ethics: • Public Interest – protection and enhancement of the health, safety, welfare, and quality of life of the public • Truth, Honesty, and Fairness – being honest and impartial; communicating consequences of work; maintaining confidential information; acting as a faithful agent or trustee; avoiding conflicts of interest; basing decisions on merit, competence, and knowledge without biases; not giving or accepting bribes; being truthful in discussions, reports, and actions

28. PRODUCT SAFETY RELATION TO ENGINEERING ETHICS Core concepts present in engineering code of ethics: • Professional Performance – possessing competence in work undertaken, and striving to continually improve on competence; extending knowledge to others; accepting responsibility for actions; giving appropriate credit to others

29. PRODUCT SAFETY RELATION TO ENGINEERING ETHICS Core ethic: safety, health, and wellness of the public "A practitioner shall, regard the practitioner's duty to public welfare as paramount." – Professional Engineers Ontario (PEO) "We, the members of the IEEE…do hereby commit ourselves to the highest ethical and professional conduct and agree…to accept responsibility in making decisions consistent with the safety, health and welfare of the public, and to disclose promptly factors that might endanger the public or the environment;" – Institute of Electrical and Electronics Engineers (IEEE) "Engineers, in the fulfillment of their professional duties, shall: Hold paramount the safety, health, and welfare of the public.“ – National Society of Professional Engineers (NSPE)

30. PRODUCT SAFETY CONCERNS IN NANOTECHNOLOGY Overall Concern Nanomaterials, because of their unique properties, may behave differently than the same material in bulk form, having the potential to be toxic to humans and the environment

31. PRODUCT SAFETY CONCERNS IN NANOTECHNOLOGY Initial studies have indicated that nanomaterials: • can penetrate individual cells • deposit in organ systems • trigger inflammatory responses • affect biological behavior at the cellular, sub-cellular, and protein levels

32. PRODUCT SAFETY CONCERNS IN NANOTECHNOLOGY Studies in 2004 • Brain tissue in bass inflamed and damaged as a result of exposure to aqueous fullerenes (Eva Orberdorster, Southern Methodist University, Journal: Environmental Health Perspectives, Vol. 112) • Immune cells gather around clumps of nanotubes in rats’ lungs (David Warheit, researcher, Dupont, Journal: Toxicological Sciences, Vol. 77)

33. PRODUCT SAFETY CONCERNS IN NANOTECHNOLOGY Studies are inconclusive • Research on possible effects on human health and the environment at its early stages; a lot of speculation, but no hard evidence • Little is known about the risk associated with the life cycle of nanoproducts (manufacture, use, and disposal) • Over 81,000 peer-reviewed journal articles on toxicology since 2000 - 0.6% talked about nanomaterials compared to 12% for polymers

34. PRODUCT SAFETY CONCERNS IN NANOTECHNOLOGY Other concerns • No current health and safety governance structure specifically for nanotechnology • Rate of development far exceeding rate of knowledge acquisition on hazardous effects • Disposal of nano-based products has already begun

35. CURRENT GOVERNANCE INITIATIVES “Securing the Promise of Nanotechnology: Is U.S. Environmental Law Up to the Job” (Conference) May 25 – 26, 2005 Washington, DC • Dialogue convened by Woodrow Wilson International Center for Scholars (WWICS) Project on Emerging Nanotechnologies and the Environmental Law Institute (ELI) • Purpose was to examine how U.S. laws and regulations, and other means of governance, can address environmental, health, and safety (EHS) implications on nanotechnologies

36. CURRENT GOVERNANCE INITIATIVES Conference • Forty representatives from private companies, research institutions, law firms, and federal government agencies. • Most frequently cited challenges: rapid rate of nanotechnology development, limited EHS-related data, lack of specific laws and regulations, and the influence of public perception • Helped define framework for governance structure

37. CURRENT GOVERNANCE INITIATIVES Conference • Rate of development: • Pressure for governance structure in a timely manner • Workers and consumers already being exposed, and nanomaterials already being discharged into the environment • As rate of production increases, need for EHS protection will increase

38. CURRENT GOVERNANCE INITIATIVES Conference • Limited data: • The “science is way behind” – may not be available for 10 to 15 years; need for short term action • Cost-efficient methods for monitoring and cleanup not readily available • Little known about nanomaterials in the workplace • Inadequacy of federal funding for EHS research

39. CURRENT GOVERNANCE INITIATIVES Conference • Lack of specific laws and regulations: • Need to evaluate and adapt current laws and regulations; new legislation unlikely in near term • Jurisdiction lies under a diverse spread of federal and state agencies (EPA, state departments of environment, CPSC, FDA, DOD, and others) • Sound EHS data needed for new legislation

40. CURRENT GOVERNANCE INITIATIVES Conference • Possible uses of current regulatory authorities: • Toxic Substances Control Act (TSCA) most apt vehicle, but not optimal; multi-statute approach may be most appropriate • Clean Air Act • Clean Water Act • Resource Conservation and Recovery Act (RCRA) • Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund Law)

41. CURRENT GOVERNANCE INITIATIVES Conference • Influence of public perception: • Controversies can impede development and deployment of nanotechnologies • Importance of communication of risk and safety information; lack of information could lead to misperceptions and unfound fears • Readiness for “first public scare”

42. Restrict dispersive uses Prioritize substances of concern Conduct health surveillance Conduct exposure monitoring Assume toxicity until shown otherwise Treat wastes as hazardous materials Train workers in personal protective equipment and hygiene CURRENT GOVERNANCE INITIATIVES Conference Short-Term Recommendations

43. CURRENT GOVERNANCE INITIATIVES U.S. Government • The National Nanotechnology Initiative (NNI) • Started FY 2001 • Consists of 24 federal agencies • Nanoscale Science Engineering and Technology (NSET) Subcommittee appointed by the President • Coordinates multi-agency efforts, provide funding for university laboratories, and support U.S. companies • Supports responsible development of nanotechnology for protection of health and safety

44. CURRENT GOVERNANCE INITIATIVES U.S. Government • Environmental Protection Agency (EPA) • Has taken leadership role in planning research directions for the environmental applications and implications of nanotechnology • Twelve recently selected research projects focus on studying the possible harmful effects of manufactured nanomaterials, i.e., toxicity, fate, transport and transformation, and exposure and bioaccumulation

45. CURRENT GOVERNANCE INITIATIVES U.S. Government • Environmental Protection Agency (EPA) • White Paper (February 2007) – what EPA should do about implications of nanotechnology

46. CURRENT GOVERNANCE INITIATIVES U.S. Government • National Science Foundation • Solicitation for proposal (due March 17, 2008) to develop Center for the Environmental Implications of Nanotechnology (CEIN) - to conduct fundamental research and education on the implications of nanotechnology for the environment and living systems at all scales

47. CURRENT GOVERNANCE INITIATIVES U.S. Government • Food and Drug Administration (FDA) • Nanotechnology Task Force • Formed August 2006 • Identifies and recommends ways to address any knowledge or policy gaps that exist so as to better enable the agency to evaluate possible adverse health effects from FDA-regulated products that use nanotechnology materials • Task Force Report – July 25, 2007

48. CURRENT GOVERNANCE INITIATIVES U.S. Government • National Institute for Occupational Safety and Health (NIOSH) • Leading federal agency conducting research and providing guidance on the occupational safety and health implications and applications of nanotechnology • “Approaches to Safe Nanotechnology” – October 2005 document describing what is currently known about toxicity and control, and request to occupational safety and health practitioners, researchers, product innovators and manufacturers, employers, workers, interest group members, and the general public to exchange information

49. CURRENT GOVERNANCE INITIATIVES Private Sector • Nanoparticle Benchmarking Occupational Health Safety and Environment Program – consortium of companies to address analytical needs to measure airborne concentrations and particle sizes, and to assess effectiveness of controls • Design and development of portable workplace monitoring instrumentation; and • Development and testing of protective clothing fabrics as a barrier to an aerosol of nanoparticles

50. CURRENT GOVERNANCE INITIATIVES Non-profit Organizations • Woodrow Wilson International Center for Scholars (WWICS) – Project on Emerging Nanotechnology – bring together leaders from industry, government, research, and other sectors to take a long-term view of what is known and unknown about potential health and environmental challenges posed by emerging nanotechnologies, and develop recommendations to manage them