Addressing the Issue of SH E Management and Nanotechnology

Addressing the Issue of SH&E Management and Nanotechnology Managing Uncertainty Presented by Robert C. Adams, MS, CIH, CSP ENVIRON International Corporation Princeton NJ

Managing Uncertainty Overview § Nanotechnology Background § The Media and Nanotechnology § The Good News § The (Potential) Bad News § Regulatory Status § Considerations for Best Management Practices 2

Managing Uncertainty Nanotechnology Background § Nanotechnology is the understanding and control of matter at dimensions of roughly 1 to 100 nanometers q In perspective; a nanometer is to a meter what a dime is to planet Earth q Nanotechnology involves imaging, measuring, modeling, and manipulating matter in this scale q § Nanomaterial Any material that has some dimension in the nanoscale (< 100 nm) q Examples: q • • • 3 Nanoparticles Nanowire and Nanotubes Nanocoating and Nanolayers Quantum Dots Nanoshells

Managing Uncertainty 4 Nanotechnology Background

Managing Uncertainty Nanotechnology Background § Nanoparticles follow the laws of quantum physics The physics of the incredibly small q The classical laws of physics breakdown at this scale q Quantum physics describes how these materials can assume different physical, optical, electrical or magnetic properties q § Engineered nanoparticles are intentionally produced § Natural nanoparticles exist as a result of combustion processes Welding or diesel fume are two examples q Mechanical processes are not able to produce particles in this range q 5

Managing Uncertainty Nanotechnology Background § Macro particles have physical properties that are well known and understood § At the nanoscale this is generally not the case – the properties are different and that gives rise to the interest in these materials q 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 q Greater reactivity and more adsorption capacity than with macro substances • In environmental remediation, increased adsorption capacity of nanomaterials for some volatile organic compounds such as toluene has been demonstrated 6

Managing Uncertainty The Media and 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 7 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 q Around 100 consumers reported respiratory difficulties q TUV Sued stamp "Production Inspected, Safety Approved” used on product without approval q Product withdrawn from marketplace q Implications q • Galvanizes groups opposed to nanotechnology • Hurts small business and startup sectors of nanotechnology 8 DID NOT CONTAIN NANOMATERIALS

Managing Uncertainty THE GOOD NEWS! § The immense economic impact: NSF estimates a $1 Trillion market by 2015 q Lux Research estimates a $1 Trillion market by 2011 -2012 for nanotechnology-enabled products q Rand estimates that revenues have already surpassed $10 billion q § The potential for the development of advanced products that will have a remarkable impact on everyday life: Improved optics, electronics, and optoelectronics q New medical imaging and treatment technologies q Production of advanced materials for high-efficiency energy storage and generation q 9

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 q 10 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 years § Employment in the nanotechnology sector is expected to grow to 2 million workers within the next decade (US Department of Labor) 11

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 q New material discoveries will spur further growth q § Nanoparticles are here now! Bumpers on cars q Paints and coatings q Stain-free clothing and mattresses q Burn and wound dressings q Ink q Protective and glare-reducing coatings for eyeglasses and windshields q Metal-cutting tools q Sunscreens and cosmetics q Longer-lasting tennis balls and light-weight, stronger tennis racquets q 12

Managing Uncertainty Consumer Benefit q 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 13

Managing Uncertainty Nanotechnology and the Battle Against 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 cells § Overcome the many barriers that the body uses against traditional interventions National Cancer Institute 14

Managing Uncertainty First Two Generations of Nanoproducts § Passive nanomaterials (most current) Constant properties/functions q Products are components (wires, nanotubes, etc. ) q Examples include coatings, dispersions, patterns and bulk materials q § Active nanomaterials (today to 10 -years) Changes states during operation q Products are devices (molecular machines, targeted drugs, transistors, etc. ) q Examples include sensors, energy storage devices, nanoelectromechanical systems q § Nanosystems (multiple interactive structures – future!) 15

Managing Uncertainty The (Potential) Bad News § Do engineered nanomaterials pose unique work-related health risks? § In what ways might employees be exposed to nanomaterials in manufacture and use? § In what ways might nanomaterials enter the body during those exposures? § Once in the body, where would the nanomaterials travel, and how would they interact physiologically and chemically with the body’s systems? § 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 academia Knowledge gaps related to health risks may create liabilities that could stymie the development of beneficial new nanomaterials q Efforts to address the occupational risks are being impeded by shortfalls in fundamental scientific knowledge q Resources allocated to occupational health and environmental risks are not keeping pace with development of new nanomaterials q Cooperation between the public and private sectors is needed q 17

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. 18 Outline of a Policy Advice on Nanotechnologies and Ethics UNESCO 6 -7 December 2005

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 development? and Will we be able to manage the ethical and scientific issues that nanotechnology will present? 19

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. ” NIOSH 20

Managing Uncertainty Potential Exposures to Nanoparticles § The exposure route of primary interest remains inhalation q 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 q Little is known about possible adverse effects from the ingestion of nanoparticles § The potential for direct penetration through the skin has been reported q 21 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 cancer? 100 g Iron: diameter = 50 nm Surface area = 1, 500 m 2 100 g Iron: diameter = 3. 0 cm Surface area = 26 cm 2 22

Managing Uncertainty Other Factors Affecting Toxicity § Coatings q Hydrophilic surface coating on Ti. O 2 induced greater inflammatory response than hydrophobic coating § Chemistry Certain nanomaterials may contain varying types and levels of metals used as catalysts q Differences in toxicity of various nanotubes that have different metal contents q § Structure or shape q 23 C 60 Fullerenes are more reactive than carbon particles or carbon nanotubes

Managing Uncertainty Direct Transport to Brain? Monkey Viruses, UF Gold. Mn Rat Latex Microspheres, UF carbon, Mn, but not Iron Human Mn Fume? Drugs Fish Mn, Fullerenes 24

Managing Uncertainty Dermal Penetration? Lack of dermal penetration for nano Ti. O 2; few studies report dermal penetration q Penetration of 0. 5 -1. 0 µMsized fluorospheres and Be sensitization in human skin – flexing experiments q Oxidative stress, toxicity, and loss of viability of human skin cells - Ha. Ca. T cells - carbon nanotubes q Reactivity with sunlight? q 25

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 NIOSH 26

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 27

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 Director) 28

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 q 29 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 q Working with nanomaterials during pouring or mixing operations, q Working with nanomaterials where there is a high degree of agitation q Generating nanoparticles in the gas phase in non-enclosed systems q Handling nanostructured powders could increase aerosolization q Maintenance of equipment and processes used to produce or fabricate nanomaterials q Cleaning of dust collection systems can pose a potential for both skin and inhalation exposure q § These situations are not unlike the types of situations encountered in industry that historically create significant exposures 30

Managing Uncertainty Lack of Exposure Metrics Remains § Nanoparticles may not be suitable for comparison to ‘traditional’ exposure metrics Mass based metrics may understate exposures q Larger particles will mask nanoparticles q § 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 exposure § Research is still ongoing but there is still no definite answer § Metric to be used will depend on availability of sampling equipment or instruments 31

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 workplace. ” NIOSH 32

Managing Uncertainty Exposure Monitoring § There are limited air sampling methods or instruments Real time particle counters / particle sizers q Size-fractionated aerosol sampling with impactors in the nanoparticle range q High resolution TEM q Surface area estimation q § NIOSH is funding research on air sampling techniques § Many instruments that are available are still limited to research (i. e. ; not portable) 33

Managing Uncertainty Three stage nanoparticle cascade impactor capable of proving three particle size fractions - 32, 18 and 10 nm. Source: MSP Corporation Condensation particle counter capable of measuring particles to 10 nm. Source: TSI 34

Managing Uncertainty Exposure Control § Prudent practice suggests that in the absence of available toxicity data, exposures to nanomaterials must be minimized § Nanoparticle behavior q Behave more like gases • migrate from areas of highest concentration q Tend to agglomerate q Gravitational settling slower than macro particles q Will widely disperse q Can be re-suspended easily 35

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 nanoparticles 36

Managing Uncertainty Exposure Control § Challenges still remain: q Effectiveness of filtration is still not confirmed • NIOSH is conducting research to validate the efficiency of HEPA filter media q Design of hoods and enclosures have not been specified for nanoparticles • Apply current ACGIH design criteria for the control of fine particulate matter q Capture and transport velocities have not been specified • Again, ACGIH criteria are expected to be sufficient for nanoparticle control 37

Managing Uncertainty Exposure Control § Respiratory protection research continues q 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 q Nanoparticles still present the following challenges • • 38 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 q No dermal exposure standards q Small sized particles may penetrate traditional knit clothing q • Penetration efficiencies for nanoparticles have not been studied • Existing ASTM standards incorporate testing with nanometer-sized particles Modern PPE materials of construction will likely provide some protection but the efficacy of that protection is still unclear q Ocular protection still presents some additional challenges and may represent the more significant risk q 39

Managing Uncertainty Exposure Control § Good work practices can help minimize worker exposure to nanomaterials q 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 face washing – Facilities for showering and changing clothes 40

Managing Uncertainty Safety Issues § Fire / Explosion/Catalytic Hazards There has been little research on the potential safety hazards of nanoparticles q From current information, concerns most likely involve catalytic effects or fire and explosion hazards q Nanoscale powders or combustible material could present a higher risk than a similar quantity of coarser material q • Increased surface area = more easily ignited? – Nanoscale Al/Mo. O 3 thermites ignite more than 300 times faster than corresponding micrometer-scale material q 41 Can nanomaterials initiate catalytic reactions that would not otherwise be anticipated from their chemical composition alone?

Managing Uncertainty Will Nanomaterials Behave the Same as 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 q q q 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 42

Managing Uncertainty Regulatory Framework § A realistic regulatory framework will ultimately be needed § 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 wellestablished principles of occupational safety and health to workplace exposures involving nanomaterials. ” q “NIOSH is evaluating the unique benefits that nanotechnology may bring to improving occupational safety and health. ” q 43

Managing Uncertainty NIOSH Activities on Nanotechnology § NIOSH is currently investigating the following areas (FY 2006): Survey of uses and workers involved on nanotechnology industries q Measurement studies of nanoparticles in the workplace q Evaluate control banding options to reduce worker exposures q Analyses of filter efficiency for nanomaterials q § Nanoparticle Information Library q 44 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 q Key question - Is a nanoparticle of a chemical which is intended to impart new chemical and/or physical properties, to be considered: q • • 45 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 substances” q EPA probably will treat each new category of nanoparticles as a “significant new use” q § Recent White Paper (December 2, 2005) q Important recommendations include: • • • 46 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 q Has frequently commented to the EPA that it must consider all nanomaterials as “new” substances § Outcome of Public Meetings on Nanotechnology and TSCA q Being converted into Nanoscale Materials Stewardship Program § Some nanomaterials have already been approved q 47 Carbon nanotubes have been issued a Lo. REx exemption

Managing Uncertainty OSHA Position on Nanotechnology § No change since last year § Reliant on present set of regulations to answer questions: Hazard communication – 1910. 1200 q Occupational exposure to hazardous chemicals in laboratories - 1910. 1450 q Respiratory protection – 1910. 134 q Personal protective equipment – 1910. 132 q § New OSHA Head has commented on need to address nanotechnology 48

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) 49

Managing Uncertainty ASTM E 56 § 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 50

Managing Uncertainty 51 A Concept for Best Management

Managing Uncertainty Best Management Practices § Development of standard operating procedures and best management practices Development of work procedures that emphasize the prevention of inadvertent exposures q Use of job safety analysis and other risk assessment techniques to identify potential exposures routes and identify control approaches q Reduce unnecessary exposures (consider the use of controlled access areas) q 52

Managing Uncertainty Best Management Practices § Development of standard operating procedures and best management practices (cont) Develop standards for construction of nanomaterials work areas q Develop procedures for responding to unexpected releases or spills q Provide up to date hazard information to the workforce including MSDS and other substance specific information q Develop a process to identify the workers that would have potential for exposures to nanomaterials q 53

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 materials q 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) 54

Managing Uncertainty 55 Application of Control Banding

Managing Uncertainty Application of Control Banding § NIOSH has been investigating the potential for the application of control banding methods to nanotechnology § 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 56

Managing Uncertainty 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) q Utilize safe handling practices and minimize potential for contact (think BMP) q Use prudent precautions for protection of the workforce -- Err conservatively q § Multidisciplinary approaches will be needed 57

Managing Uncertainty Conclusions § 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 q There is no single or simple answer q Not limited to scientific community – must include others such as economists, sociologists, and ethicists q Nanotechnology will challenge conventional approaches to addressing occupational safety and health risk q 58

Managing Uncertainty Websites for More Information § National Nanotechnology Initiative q http: //www. nano. gov/ § NIOSH Nanotechnology Home Page q http: //www. cdc. gov/niosh/topics/nanotech/default. html § USEPA White Paper q http: //es. epa. gov/ncer/nano/publications/whitepaper 12022005. pdf § United Kingdom Health and Safety Executive q http: //www. hse. gov. uk/horizons/nanotech/index. htm § ASTM Committee E 56 on Nanotechnology q 59 http: //www. astm. org/cgibin/Soft. Cart. exe/COMMITTEE/E 56. htm? L+mystore+kueb 30 31

Thank You Managing Uncertainty badams@environcorp. com 609. 243. 9848