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PRODUCT SAFETY IN NANOTECHNOLOGY

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PRODUCT SAFETY IN NANOTECHNOLOGY EIN 5322 Project Fall 2007 Jonathan Rivera INTRODUCTION Overview - A look at the role product safety is playing in the development of ... – PowerPoint PPT presentation

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Title: 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
DEVELOPMENT OF NANOTECHNOLOGY
  • What is nanotechnology?
  • the creation and utilization of materials,
    devices, and systems through the control of
    matter on the nanometer-length scaleat 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

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, and
    nanoshels

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
DEVELOPMENT OF NANOTECHNOLOGY
Other applications
  • 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

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 Electricpotential 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
PRODUCT SAFETY RELATION TO ENGINEERING ETHICS
  • 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

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 IEEEdo hereby commit
ourselves to the highest ethical and professional
conduct and agreeto 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
CURRENT GOVERNANCE INITIATIVES
Conference
Short-Term Recommendations
  • 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

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

51
CURRENT GOVERNANCE INITIATIVES
  • Non-profit Organizations
  • Environmental Defense work with government to
    develop nanotechnology responsibly calls for
    increase in federal funding to research potential
    risks of nanomaterials

52
CURRENT GOVERNANCE INITIATIVES
  • Other Organizations
  • Environmental Law Institute Nanotechnology
    Initiative - seeks to respond to the urgent need
    to develop an effective environmental, health,
    and safety governance structure for
    nanotechnologies

53
CURRENT GOVERNANCE INITIATIVES
  • International Standards
  • ASTM International
  • Established Committee E56 in January 2005 to
    develop standards and guidelines for
    nanotechnology, which includes a subcommittee on
    Environmental Occupational Health Safety
  • WK8985 under development - New Standard Guide
    For Handling Unbound Engineered Nanoparticles in
    Occupational Settings

54
CURRENT GOVERNANCE INITIATIVES
  • International Standards
  • International Organization for Standardization
    (ISO)
  • Technical Committee TC 146 (Air Quality)
    developed ISO/TR 276282007 - contains guidelines
    on characterizing occupational nanoaerosol
    exposures

55
CURRENT GOVERNANCE INITIATIVES
  • National Standards
  • American National Standards Institute (ANSI)
    established Nanotechnology Standards Panel in
    August 2004 to develop and adopt voluntary
    standards in terminology, materials properties,
    and procedures for testing, measurement, and
    characterization

56
CHALLENGES IN ADDRESSING PRODUCT SAFETY
  • Pace of development bringing health and safety
    knowledge up to speed with a rapidly developing
    technology
  • Research funding allocating the appropriate
    amount of resources to health and safety research
  • Regulation how to effectively regulate by
    balancing traditional regulation with promotion
    of good practices

57
CHALLENGES IN ADDRESSING PRODUCT SAFETY
  • Information dissemination how and when to
    disseminate information to the public
  • Public perception maintaining legitimacy in
    light of the likelihood that mistakes will be
    made
  • International framework coordinating approaches
    with other nations, using such models as the
    United Nations Framework Convention on Climate
    Change
  • Innovation flexibility in performance standards
    so as to not hinder the development of the
    technology

58
CHALLENGES IN ADDRESSING PRODUCT SAFETY
  • Prioritization assessment of products to
    establish degree of danger or hazard
  • Data gathering producing, screening, managing,
    and maintaining information on health and safety,
    and risk
  • Standardization establishment of safety
    standards to harmonize governance structures
    between companies, governments, and nations
  • Liability establishing a balance between a
    preventative and an after-the-fact liability
    system

59
CHALLENGES IN ADDRESSING PRODUCT SAFETY
  • Proprietary Information balancing information
    dissemination with the need to protect private
    information
  • Benefits vs. risk balancing the benefits the
    technology provides with the potential health and
    safety risks
  • EHS/Regulatory costs understanding the
    financial impacts governance of health and safety
    will have
  • Risk management developing approaches to
    mitigating risk in light of limited EHS data

60
CHALLENGES IN ADDRESSING PRODUCT SAFETY
  • Timeliness management of time in developing
    governance approaches, even in the event of a
    catastrophic EHS problem
  • Stakeholder involvement fostering involvement
    to understand stakeholder preconceptions and
    provide information that could address related
    concerns

61
SUMMARY
  • Nanotechnology is a rapidly developing technology
    with beneficial applications across several
    industries
  • Potential for adverse health and environmental
    effects
  • Studies are inconclusive governance structure
    lacking
  • Currently several governance initiatives by
    government, private, and international sectors
    regulation forthcoming
  • Scientific, regulatory, and financial challenges
    ahead

62
WEBSITE REFERENCES
  • http//www2.eli.org/research/nanotech.htm
  • http//www.technologyreview.com
  • http//es.epa.gov/ncer/nano/index.html
  • http//www.fda.gov/nanotechnology
  • http//www.cdc.gov/niosh/topics/nanotech/default.h
    tml
  • http//www.nano.gov
  • http//nano.foe.org.au/node/78
  • http//www.wilsoncenter.org/nano
  • http//ethics.iit.edu/codes/engineer.html
  • http//en.wikipedia.org/wiki/Engineering_ethics
  • http//www.nsf.gov
  • http//www.ceg.org/industryreports/Nanotechnology
    20executive20summary.pdf
  • http//www.nsti.org/NanoInvestor2006/slides/TYadav
    .pdf
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