2006 asse teleweb presentation

Managing Uncertainty

Addressing the Issue of SH&E Management and Nanotechnology

Presented by Robert C. Adams, MS, CIH, CSP

ENVIRON International Corporation

Princeton NJ


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Overview

Nanotechnology Background

The Media and Nanotechnology

The Good News

The (Potential) Bad News

Regulatory Status

Considerations for Best Management Practices


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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

Earth 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


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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 processes Welding or diesel fume are two examples Mechanical processes are not able to produce particles in this

range


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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 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

substances• In environmental remediation, increased adsorption capacity of

nanomaterials for some volatile organic compounds such as toluene has been demonstrated


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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 FuelsJuly 11, 2005


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“Magic Nano” Aerosol spray treatment to make glass/ceramic

water and dirt repellent Around 100 consumers reported respiratory

difficulties TUV Sued stamp "Production Inspected,

Safety Approved” used on product without approval

Product withdrawn from marketplace Implications

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

nanotechnology

DID NOT CONTAIN NANOMATERIALS


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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

billion

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


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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


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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)


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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

windshields Metal-cutting tools Sunscreens and cosmetics Longer-lasting tennis balls and light-weight, stronger tennis racquets


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Consumer Benefit

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


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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


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First Two Generations of Nanoproducts

Passive nanomaterials (most current) Constant properties/functions Products are components (wires, nanotubes, etc.) Examples include coatings, dispersions, patterns and bulk

materials

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!)


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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?

NIOSH Position Statement on Nanotechnology


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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 E orts to address the occupational risks are being impeded by ff

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


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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 EthicsUNESCO 6-7 December 2005


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The Bottom Line RemainsCan 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?


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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


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Potential Exposures to Nanoparticles

The exposure route of primary interest remains inhalation 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


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Effect of Particle Size

Equivalent dose of smaller particles presentsa 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 = 3.0 cm

Surface area = 26 cm2

100 g Iron:

diameter = 50 nm

Surface area = 1,500 m2


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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


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Direct Transport to Brain?

RatRatLatex Microspheres, Latex Microspheres,

UF carbon, Mn,UF carbon, Mn,but not Ironbut not Iron

MonkeyMonkeyViruses, UF Gold. MnViruses, UF Gold. Mn

FishFishMn, FullerenesMn, Fullerenes

HumanHumanMn Fume? Mn Fume?

DrugsDrugs


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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 nanotubes

Reactivity with sunlight?


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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


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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


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"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)


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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


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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 exposures


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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 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


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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


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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)


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Condensation particle counter capable of measuring particles to 10 nm.

Source: TSI

Three stage nanoparticle cascade impactor capable of proving three particle size fractions - 32, 18 and 10 nm.

Source: MSP Corporation


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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


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Exposure Control

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


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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 nanoparticles

• 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

control


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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


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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

particles 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


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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 alone?


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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 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 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 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.”


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NIOSH Activities on Nanotechnology

NIOSH is currently investigating the following areas (FY 2006): Survey of uses and workers involved on nanotechnology

industries 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


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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?


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Most likely, TSCA will apply at some level EPA probably will not treat nanoparticles as “new chemical

substances” 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


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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 TSCA Being converted into Nanoscale Materials Stewardship

Program

Some nanomaterials have already been approved Carbon nanotubes have been issued a LoREx exemption


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OSHA Position on Nanotechnology

No change since last year

Reliant on present set of regulations to answer questions: 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 nanotechnology


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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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Safe handling of nanomaterials

Minimization / prevention of

workforce exposure

Protection of environment

Prevention of fire and

explosion

Response to emergencies

Nanomaterials – Toward Best Management Practices for Safe Handling

How can the material be monitored in the

environment?

What are the material properties (solubility,

reactivity, flammability, toxicity, etc)?

How will the material behave in the environment?

How will people be exposed?

How often can exposure occur?

What are the means, methods and products

of handling / processing?

What is the level of containment?

How much could be released from the

process?

What type of PPE will be needed?

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

areas Develop procedures for responding to unexpected releases or

spills 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


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Application of Control Banding

Control banding is a technique for managing materials where there is uncertainty as to the risks posed by the materials 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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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


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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

conservatively

Multidisciplinary approaches will be needed


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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 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


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Websites for More Information

National Nanotechnology Initiative http://www.nano.gov/

NIOSH Nanotechnology Home Page http://www.cdc.gov/niosh/topics/nanotech/default.html

USEPA White Paper http://es.epa.gov/ncer/nano/publications/whitepaper12022005.pdf

United Kingdom Health and Safety Executive http://www.hse.gov.uk/horizons/nanotech/index.htm

ASTM Committee E56 on Nanotechnology http://www.astm.org/cgi-bin/SoftCart.exe/COMMIT/COMMITTEE/

E56.htm?L+mystore+kueb3031


Thank You

[email protected]

609.243.9848

2006 asse teleweb presentation

Technology

Transcript of 2006 asse teleweb presentation