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					Addressing the Issue of SH&E Management and

                         Managing Uncertainty

 Presented by Robert C. Adams, MS, CIH, CSP
 ENVIRON International Corporation
 Princeton NJ
Managing Uncertainty

  Nanotechnology Background
  The Media and Nanotechnology
  The Good News
  The (Potential) Bad News
  Regulatory Status
  Considerations for Best Management Practices

                       Nanotechnology Background
Managing Uncertainty

  Nanotechnology
        Nanotechnology is the understanding and control of matter at
         dimensions of roughly 1 to 100 nanometers
        In perspective; a nanometer is to a meter what a dime is to planet
        Nanotechnology involves imaging, measuring, modeling, and
         manipulating matter in this scale

  Nanomaterial
        Any material that has some dimension in the nanoscale (< 100 nm)
        Examples:
          •   Nanoparticles
          •   Nanowire and Nanotubes
          •   Nanocoating and Nanolayers
          •   Quantum Dots
          •   Nanoshells

                       Nanotechnology Background
Managing Uncertainty

                       Nanotechnology Background
Managing Uncertainty

  Nanoparticles follow the laws of quantum physics
      The physics of the incredibly small
      The classical laws of physics breakdown at this scale

      Quantum physics describes how these materials can assume
       different physical, optical, electrical or magnetic properties

  Engineered nanoparticles are intentionally produced
  Natural nanoparticles exist as a result of combustion
      Welding or diesel fume are two examples
      Mechanical processes are not able to produce particles in this
                       Nanotechnology Background
Managing Uncertainty

  Macro particles have physical properties that are well known and
  At the nanoscale this is generally not the case – the properties are
   different and that gives rise to the interest in these materials
        Copper nanoparticles smaller than 50 nm are considered super hard
         materials that do not exhibit the same malleability and ductility as
         larger forms of copper.

  Nanoparticles have greater ratio of surface area to mass
        Greater reactivity and more adsorption capacity than with macro
          • In environmental remediation, increased adsorption capacity of
            nanomaterials for some volatile organic compounds such as toluene has
            been demonstrated

Managing Uncertainty
                       The Media and Nanotechnology

        Nanotechnology Regulation Needed, Critics Say
        December 5, 2005

        Study Raises Concerns About Carbon Particles
        March 29, 2004
        ASSESSING RISKS; Technology's Future: A Look at the Dark Side
        May 17, 2006

        The promise and perils of the nanotech revolution;
        Possibilities range from disaster to advances in medicine, space
        July 26, 2004
        Solar Energy Nanotechnology Can Replace Fossil Fuels
        July 11, 2005
Managing Uncertainty
                       The Media and Nanotechnology

  “Magic Nano”
      Aerosol spray treatment to make glass/ceramic
       water and dirt repellent
      Around 100 consumers reported respiratory
      TUV Sued stamp "Production Inspected,
       Safety Approved” used on product without
      Product withdrawn from marketplace

      Implications

          • Galvanizes groups opposed to nanotechnology
          • Hurts small business and startup sectors of

Managing Uncertainty
                       THE GOOD NEWS!

  The immense economic impact:
      NSF estimates a $1 Trillion market by 2015
      Lux Research estimates a $1 Trillion market by 2011-2012 for
       nanotechnology-enabled products
      Rand estimates that revenues have already surpassed $10

  The potential for the development of advanced products
   that will have a remarkable impact on everyday life:
      Improved optics, electronics, and optoelectronics
      New medical imaging and treatment technologies

      Production of advanced materials for high-efficiency energy
       storage and generation
Managing Uncertainty
                       Nanotechnology Facts

  National Nanotechnology Initiative (NNI) was started in
   2000 by President Clinton
  Since 2000, the federal government has allocated over
   $2 billion for nanotechnology research
  $480 million of venture capital went into
   nanotechnology startups in 2005
         United Press International

Managing Uncertainty
                       Predicted Growth

                                $15 billion annual investment
                                 predicted within 10 years
                                50% of all products produced will
                                 be influenced by nano within 10
                                Employment in the
                                 nanotechnology sector is
                                 expected to grow to 2 million
                                 workers within the next decade
                                 (US Department of Labor)

Managing Uncertainty
                       Applications for Nanoparticles

  Nanotechnology is still in the “pre-competitive” stage but…
         Nanoparticle research continues to receive intense scientific study,
          due to a wide variety of potential applications in biomedical, optical,
          and electronic fields
         New material discoveries will spur further growth
  Nanoparticles are here now!
         Bumpers on cars
         Paints and coatings
         Stain-free clothing and mattresses
         Burn and wound dressings
         Ink
         Protective and glare-reducing coatings for eyeglasses and
         Metal-cutting tools
         Sunscreens and cosmetics
         Longer-lasting tennis balls and light-weight, stronger tennis racquets
                       Consumer Benefit
Managing Uncertainty

       One current application is the use of silver
        nanoparticles which can kill micro-organisms
          • Used on refrigerators and washing machines
          • Helps to ensure food will stay fresh for a very long time
            and clothes are cleaned thoroughly

                       Nanotechnology and the Battle Against
Managing Uncertainty   Cancer

  Nanoscale devices can
   serve as customizable,
   targeted drug delivery
   vehicles capable of sending
   large doses of anticancer
   agents into malignant cells
   without harming healthy
  Overcome the many
   barriers that the body uses
   against traditional

        National Cancer Institute
                       First Two Generations of
Managing Uncertainty   Nanoproducts
  Passive nanomaterials (most current)
       Constant properties/functions
       Products are components (wires, nanotubes, etc.)

       Examples include coatings, dispersions, patterns and bulk

  Active nanomaterials (today to 10-years)
       Changes states during operation
       Products are devices (molecular machines, targeted drugs,
        transistors, etc.)
       Examples include sensors, energy storage devices,
        nanoelectromechanical systems

  Nanosystems (multiple interactive structures – future!)
Managing Uncertainty
                       The (Potential) Bad News

  Do engineered nanomaterials pose unique work-related health
  In what ways might employees be exposed to nanomaterials in
   manufacture and use?
  In what ways might nanomaterials enter the body during those
  Once in the body, where would the nanomaterials travel, and how
   would they interact physiologically and chemically with the body‟s
  Will those interactions be harmless, or could they cause acute or
   chronic adverse effects?
  What are appropriate methods for measuring and controlling
   exposures to nanometer-diameter particles and nanomaterials in
   the workplace?
 16                    NIOSH Position Statement on Nanotechnology
Managing Uncertainty
                       The (Potential) Bad News

  NGOs like ETC Group continue to call for a moratorium on the
   use of nanotechnology in products until more research is available
   on the safety and toxicity of these materials
  October 17, 2005, RAND Corporation meeting with stakeholders
   identifies concerns among industry, government, labor and
         Knowledge gaps related to health risks may create liabilities that
          could stymie the development of beneficial new nanomaterials
         Efforts to address the occupational risks are being impeded by
          shortfalls in fundamental scientific knowledge
         Resources allocated to occupational health and environmental risks
          are not keeping pace with development of new nanomaterials
         Cooperation between the public and private sectors is needed

Managing Uncertainty
                       Ethics in Nanotechnology

  The difficulty is that the potential toxicity of nano-engineered
   particles is subject to scientific uncertainty in a very fundamental
   way. Indeed the very definition of the toxicity of these particles is
   problematic. Furthermore, there are no clear views on how this
   toxicity, if defined, could be scientifically and indisputably tested.
   Finally, there are no scientific studies on the toxicity of many
   particles. One of the issues could be that such a toxicity may be
   slow to manifest itself, as was the case for asbestos. Therefore,
   the question of the applicability of the precautionary principle
   would need to be studied and discussed, and scientific uncertainty
   should not lead to skip the necessary debate. In this connection,
   issues of risk analysis and standardization require in-depth
   ethical, and not only scientific, consideration.
                 Outline of a Policy Advice on Nanotechnologies and Ethics
                 UNESCO 6-7 December 2005
Managing Uncertainty
                       Managing Uncertainty

                        The Bottom Line Remains
      Can we achieve the promises of nanotechnology
                while minimizing potential risks?
                      But we must also ask
      Will nanotechnology development be permitted to
               go forward amid the calls to halt its
          Will we be able to manage the ethical and
            scientific issues that nanotechnology will

Managing Uncertainty
                       Health Risks

  “Nanotechnology is an emerging field. As such,
   there are many uncertainties as to whether the
   unique properties of engineered nanomaterials
   (which underpin their commercial potential) also
   pose occupational health risks.”

Managing Uncertainty
                       Potential Exposures to Nanoparticles

  The exposure route of primary interest remains
         Where the nanoparticles deposit in the lung will be a significant
          factor in the development of health effects

  Ingestion of nanoparticles is also a concern
         Little is known about possible adverse effects from the
          ingestion of nanoparticles

  The potential for direct penetration through the skin has
   been reported
         Some laboratory studies have suggested that carbon
          nanotubes can be absorbed and deposited in skin cells and
          potentially induce cellular toxicity

Managing Uncertainty
                       Effect of Particle Size
         Equivalent dose of smaller particles presents
          a much larger surface area for reactions to take place
         Potential for generation of free oxygen radicals
          DNA damage          inflammation         tissue damage

                                            100 g Iron:
                                            diameter = 50 nm
                                            Surface area = 1,500 m2
      100 g Iron:
      diameter = 3.0 cm
      Surface area = 26 cm2
Managing Uncertainty
                       Other Factors Affecting Toxicity

  Coatings
         Hydrophilic surface coating on TiO2 induced greater
          inflammatory response than hydrophobic coating

  Chemistry
       Certain nanomaterials may contain varying types and levels of
        metals used as catalysts
       Differences in toxicity of various nanotubes that have different
        metal contents

  Structure or shape
         C60 Fullerenes are more reactive than carbon particles or
          carbon nanotubes

Managing Uncertainty
                       Direct Transport to Brain?

                              Viruses, UF Gold. Mn
       Human                                              Latex Microspheres,
      Mn Fume?                                              UF carbon, Mn,
        Drugs                                                 but not Iron

                                         Mn, Fullerenes

Managing Uncertainty
                       Dermal Penetration?

                                         Lack of dermal penetration for
                                          nano TiO2; few studies report
                                          dermal penetration
                                         Penetration of 0.5-1.0 µM-
                                          sized fluorospheres and Be
                                          sensitization in human skin –
                                          flexing experiments
                                         Oxidative stress, toxicity, and
                                          loss of viability of human skin
                                          cells - HaCaT cells - carbon
                                         Reactivity with sunlight?

Managing Uncertainty
                       The Bottom Line

  Existing toxicity information can provide a baseline for
   anticipating the possible adverse health effects that
   may occur from exposure to nanoparticles
  Not possible to set health protective limits without
   assumptions about toxicity relative to that of the same
   macro-scale material

Managing Uncertainty
                       Toxicity Data Gaps Remain

  No studies greater than 3 months duration
  Absorption, Distribution, Metabolism & Excretion
   (ADME) studies very limited
  No dose-response data
  No developmental/reproductive studies
  No chronic bioassays
  More research needed to address the uncertainty

Managing Uncertainty

  "New technologies introduce new occupational health
   and safety hazards, and nanotechnology is no
   exception. Materials and devices are under
   development are so far from our current understanding
   that we can not easily apply existing paradigms to
   protecting workers.” – Dr. John Howard (NIOSH

Managing Uncertainty
                       Exposures to Nanoparticles

  There are still very few studies of occupational
   exposures to nanoparticles
  Largely due to the lack of available monitoring
   equipment and lack of exposure metrics for comparison
  Most studies that are available are being conducted in
   research settings and not in industrial facilities under
   actual working conditions
         Most SHE professionals are not equipped to conduct the
          monitoring that would be needed

Managing Uncertainty
                       Exposures to Nanoparticles

  Situations that are likely to create significant exposures include:
         Working with nanomaterials without adequate protection
         Working with nanomaterials during pouring or mixing operations,
         Working with nanomaterials where there is a high degree of agitation
         Generating nanoparticles in the gas phase in non-enclosed systems
         Handling nanostructured powders could increase aerosolization
         Maintenance of equipment and processes used to produce or
          fabricate nanomaterials
         Cleaning of dust collection systems can pose a potential for both skin
          and inhalation exposure

  These situations are not unlike the types of situations
   encountered in industry that historically create significant

Managing Uncertainty
                       Lack of Exposure Metrics Remains

  Nanoparticles may not be suitable for comparison to „traditional‟
   exposure metrics
         Mass based metrics may understate exposures
         Larger particles will mask nanoparticles

  Mass and bulk chemistry are believed to be less important
  Particle size, particle number and/or surface area (or reactivity)
   metrics are still considered to be more reliable indicators of
  Research is still ongoing but there is still no definite answer
  Metric to be used will depend on availability of sampling
   equipment or instruments

Managing Uncertainty
                       Exposure Monitoring

  “Until more information is available on the
  mechanisms underlying nanoparticle toxicity, it is
  uncertain as to what measurement technique
  should be used to monitor exposures in the

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                       Exposure Monitoring

  There are limited air sampling methods or instruments
       Real time particle counters / particle sizers
       Size-fractionated aerosol sampling with impactors in the
        nanoparticle range
       High resolution TEM

       Surface area estimation

  NIOSH is funding research on air sampling techniques
  Many instruments that are available are still limited to
   research (i.e.; not portable)

Managing Uncertainty

 Three stage nanoparticle
 cascade impactor capable
 of proving three particle
 size fractions - 32, 18
 and 10 nm.                  Condensation particle counter
                             capable of measuring particles to
 Source: MSP Corporation     10 nm.
                             Source: TSI
Managing Uncertainty
                        Exposure Control

  Prudent practice suggests that in the absence of
   available toxicity data, exposures to nanomaterials
   must be minimized
  Nanoparticle behavior
       Behave         more like gases
          • migrate from areas of highest concentration
       Tend  to agglomerate
       Gravitational settling slower than macro particles

       Will widely disperse

       Can be re-suspended easily

Managing Uncertainty
                       Exposure Control

  In general, control
   techniques such as source
   enclosure and local exhaust
   ventilation systems are
   considered to be effective
   for capturing airborne

Managing Uncertainty
                       Exposure Control

  Challenges still remain:
         Effectiveness of filtration is still not confirmed
           • NIOSH is conducting research to validate the efficiency of HEPA
             filter media
         Design of hoods and enclosures have not been specified for
           • Apply current ACGIH design criteria for the control of fine
             particulate matter
         Capture and transport velocities have not been specified
           • Again, ACGIH criteria are expected to be sufficient for nanoparticle

Managing Uncertainty
                        Exposure Control

  Respiratory protection research continues
         There have been no specific recommendations on the types of
          respirators applicable for exposure to nanoparticles
           • Respirators are tested against particles around 300 nm
           • In theory, a respirator filter that is effective for larger particles
             should be effective for the smaller scale particle
                – NIOSH is still undertaking studies to validate this
         Nanoparticles still present the following challenges
           •   Criticality of facial seal for negative pressure respirators
           •   Effectiveness of positive pressure respirators
           •   Appropriateness of fit factors or protection factors
           •   Fit testing methods may require further improvements

Managing Uncertainty
                       Exposure Control

  Dermal protection
       There are no current recommendations on types of clothing
        that will be effective for prevention of dermal absorption
       No dermal exposure standards

       Small sized particles may penetrate traditional knit clothing

          • Penetration efficiencies for nanoparticles have not been studied
          • Existing ASTM standards incorporate testing with nanometer-sized
       Modern PPE materials of construction will likely provide some
        protection but the efficacy of that protection is still unclear
       Ocular protection still presents some additional challenges and
        may represent the more significant risk

Managing Uncertainty
                       Exposure Control

  Good work practices can help minimize worker
   exposure to nanomaterials
         Efforts should focus on:
           • Good housekeeping and maintenance programs
           • Good hygiene and sanitation
              – Restrictions on the consumption of food and beverages in work areas
              – Facilities for hand and face washing
              – Facilities for showering and changing clothes

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                       Safety Issues

  Fire / Explosion/Catalytic Hazards
       There has been little research on the potential safety hazards
        of nanoparticles
       From current information, concerns most likely involve catalytic
        effects or fire and explosion hazards
       Nanoscale powders or combustible material could present a
        higher risk than a similar quantity of coarser material
           • Increased surface area = more easily ignited?
              – Nanoscale Al/MoO3 thermites ignite more than 300 times faster than
                corresponding micrometer-scale material
         Can nanomaterials initiate catalytic reactions that would not
          otherwise be anticipated from their chemical composition

                       Will Nanomaterials Behave the Same as
Managing Uncertainty   Common Environmental Pollutants?
   Likely but additional research is ongoing due to unique
    chemical/physical properties of nanomaterials
   Fate and transport of nanomaterial releases and wastes
          Mobility of nanoparticles in the air, soil and water
          Surface chemistry of mineral oxide and carbon nanoparticles
          Degradation of materials containing nanoparticles
          Mechanisms of nanoparticle degradation
          Nanoparticle bioaccumulation

   Applicability of technologies to control nanoparticle
    releases and to treat nanoparticle wastes

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                       Regulatory Framework

  A realistic regulatory framework will ultimately be
  NIOSH is currently in the forefront on workforce matters
       “NIOSH is pursuing strategic, multidisciplinary research that will
        help practitioners, with greater certainty, to apply the well-
        established principles of occupational safety and health to
        workplace exposures involving nanomaterials.”
       “NIOSH is evaluating the unique benefits that nanotechnology
        may bring to improving occupational safety and health.”

Managing Uncertainty
                       NIOSH Activities on Nanotechnology

  NIOSH is currently investigating the following areas (FY
       Survey of uses and workers involved on nanotechnology
       Measurement studies of nanoparticles in the workplace

       Evaluate control banding options to reduce worker exposures

       Analyses of filter efficiency for nanomaterials

  Nanoparticle Information Library
         Solicits and disseminates information on all types of
          nanoparticles in products

Managing Uncertainty
                       Regulatory Framework

  EPA
       TSCA is one of the statutes under which commercial
        applications will likely be regulated
       Key question - Is a nanoparticle of a chemical which is
        intended to impart new chemical and/or physical properties, to
        be considered:
          •   a new chemical;
          •   a significant new use of an existing chemical;
          •   a modified but not significant new use of an existing chemical; or
          •   none of the above?

Managing Uncertainty
                       Regulatory Framework

  Most likely, TSCA will apply at some level
       EPA probably will not treat nanoparticles as “new chemical
       EPA probably will treat each new category of nanoparticles as
        a “significant new use”

  Recent White Paper (December 2, 2005)
         Important recommendations include:
           •   Pollution Prevention, Stewardship, and Sustainability
           •   Research
           •   Risk Assessment
           •   Collaboration and Leadership
           •   Cross-Agency Workgroup
           •   Training

Managing Uncertainty
                       Recent Developments in TSCA

  Natural Resources Defense Council
         Has frequently commented to the EPA that it must consider all
          nanomaterials as “new” substances

  Outcome of Public Meetings on Nanotechnology and
         Being converted into Nanoscale Materials Stewardship

  Some nanomaterials have already been approved
         Carbon nanotubes have been issued a LoREx exemption
Managing Uncertainty
                       OSHA Position on Nanotechnology

  No change since last year
  Reliant on present set of regulations to answer
       Hazard communication – 1910.1200
       Occupational exposure to hazardous chemicals in laboratories
        - 1910.1450
       Respiratory protection – 1910.134

       Personal protective equipment – 1910.132

  New OSHA Head has commented on need to address
Managing Uncertainty
                       OSHA Position on Nanotechnology

  “…OSHA is participating in initiatives led by the White
   House to address issues related to nanotechnology,
   such as risk assessment and safety and health
   research. As information becomes available, OSHA
   plans to develop guidance for employers and
   employees engaged in operations involving
   nanomaterials, and OSHA is also working with NIOSH
   as they conduct research in this area.”
                       Edwin G. Foulke Jr. (Assistant Secretary of
                       Labor for Occupational Safety and Health)

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                       ASTM E56

  Formed in 2005
  Addresses issues related to standards and guidance
   materials for nanotechnology & nanomaterials,
  Includes subcommittees on “Environmental &
   Occupational Health & Safety” and “Standards of
   Care/Product Stewardship”
  No specific work products have been produced

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                       A Concept for Best Management

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                       Best Management Practices

  Development of standard operating procedures and
   best management practices
       Development of work procedures that emphasize the
        prevention of inadvertent exposures
       Use of job safety analysis and other risk assessment
        techniques to identify potential exposures routes and identify
        control approaches
       Reduce unnecessary exposures (consider the use of controlled
        access areas)

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                       Best Management Practices

  Development of standard operating procedures and
   best management practices (cont)
       Develop standards for construction of nanomaterials work
       Develop procedures for responding to unexpected releases or
       Provide up to date hazard information to the workforce
        including MSDS and other substance specific information
       Develop a process to identify the workers that would have
        potential for exposures to nanomaterials

Managing Uncertainty
                       Application of Control Banding

  Control banding is a technique for managing materials
   where there is uncertainty as to the risks posed by the
         Establish a minimum level of containment based on the
          potential for exposures, volume of material used and potential
          hazard of the material
           • Lowest level would involve the use of standard safe handling
             practices and general ventilation
           • Highest level would involve the use of state of the art containment
             systems that would eliminate any direct contact with the material
             (100% closed system)

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                       Application of Control Banding

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                       Application of Control Banding

  NIOSH has been investigating the potential for the
   application of control banding methods to
  The technique has promise as a control approach for
   addressing the potential risks that might be present until
   such time as better toxicity data becomes available

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                       The Future

  There is still much work to be done in the area of
   nanotechnology and SH&E
  Limited available science will not deter development of
   effective safeguards
       Build on existing models (JSA; control banding; ALARA; or
        potent compounds)
       Utilize safe handling practices and minimize potential for
        contact (think BMP)
       Use prudent precautions for protection of the workforce -- Err

  Multidisciplinary approaches will be needed
Managing Uncertainty

  Regulations will lag but continuing efforts are underway,
   particularly at EPA, that will have an impact
  Toxicology and epidemiology continue to lag behind the
   developments of nanomaterials
  Communication of both risks and safety critical in an
   environment susceptible to sensationalism
       Substantiated through science and practice
       There is no single or simple answer

       Not limited to scientific community – must include others such
        as economists, sociologists, and ethicists
       Nanotechnology will challenge conventional approaches to
        addressing occupational safety and health risk

Managing Uncertainty
                       Websites for More Information

  National Nanotechnology Initiative

  NIOSH Nanotechnology Home Page

  USEPA White Paper

  United Kingdom Health and Safety Executive

  ASTM Committee E56 on Nanotechnology
Thank You

                     Managing Uncertainty