Emerging Technologies: Nanomaterials-Risk Management with Limited Risk Assessment Information
Larry Gibbs, CIH, FAIHAAssociate Vice ProvostEnvironmental Health & SafetyStanford University
2017 Sacramento Safety and Health SummitOctober 3, 2017
Overview
• Emerging Technology Trends
• Nanotechnology – why the buzz?
• Risk Management with Limited Risk Information
• Ramblings on Oversight and Governance of Nanotechnology
Emerging Technology Hype Cycle Phases
Time
Expectations
Technology Trigger
Peak of Inflated Expectations
Trough of Disillusionment
Slope of Enlightenment
Plateau of Productivity
http://www.gartner.com/technology/research/methodologies/hype-cycle.jsp
Emerging Technology Hype Cycle Phases
Time
Expectations
On the Rise
At the Peak
Sliding into the Trough
Climbing the Slope
Entering the Plateau
Startup companies; first round of venture capital
First-generation products; high price; lots of customization needed
R&D
High-growth adoption phase starts; 20-30% of potential market has adopted the innovation
Early adopters investigate
Mass media hype begins
Supplier proliferation
Activity beyond early adopters
Negative press begins
Supplier consolidation and failures
Methodologies and best practices developing
Second-generation products; some services
Third generation products; out of the box products
Less than 5% of potential market has adopted fully
Second/third rounds of venture capital funding
http://www.gartner.com/technology/research/methodologies/hype-cycle.jsp
Examples of Emerged/Emerging Technologies
rDNA/Genetic Engineering
1970’sNanomaterials
1990sOptogenetics
2010
Synthetic Biology2000s
Top 10 Emerging Technologies of 2016
World Economic Forum 2016 - https://www.weforum.org/agenda/2016/06/top-10-emerging-technologies-2016/
Nano-sensors and the Internet of Nano-things
Next Generation Batteries The Blockchain 2-D Materials Autonomous Vehicles
Organ-on-Chips Perovskite Solar Cells Open AI Ecosystem Optogentics Systems Metabolic Engineering
Top 10 Emerging Technologies of 2017
Sustainable design of
communitiesLiquid fuels
from sunshineThe human
cell atlasDeep learning for visual tasks
Genomic vaccines
Precision farming
Affordable catalysts for
green vehicles
Clean water from air
Liquid biopsies
Quantum computing
World Economic Forum 2017 - https://www.weforum.org/agenda/2017/06/these-are-the-top-10-emerging-technologies-of-2017/
“There’s plenty of room at the bottom.”-Richard Feynman, December 29, 1959
http://www.zyvex.com/nanotech/feynman.html
Nanotechnology Vision
The Nanoscale
Chem
istry
Nanoscale Science is where Physics, Biology and Chemistry fuse.
Nanoscale
Convergence
The new paradigm
• People and organizations are crossing boundaries to create value in innovation
• New models for collaboration
• Central theme: common value of knowledge
This model accelerates ‘lab to market’ and definitely includes academic labs.
Knowledge Creation: Old Model
Knowledge is created within multiple, isolated disciplines
Materials ScienceBiology PhysicsChemistry Engineering
Converging Disciplines
Chemistry
Material Science Biology Engineering
Physics
Innovation occurs at the intersection of multiple disciplines
Nanotechnology: Converged and Emerging
Polymer Science
Biology
Chemistry
Molecular Biology
Physics
Computational Design
Materials Engineering
..and more…
Common Attributes
• Shared knowledge: faster and greater sharing speeds the pace of innovation
• Collaboration leads to physical interaction
• Diverse teams
• Shared infrastructure
• “Speed to market” …… “Get the funding”
Today’s Nanotech Team
Two objectives: new scientific knowledge and the next new nano-based technology
Today’s Nanotech Team in Action
Is there a need for converging safety cultures?
Chemical
Rad
Engineering/Physical
Fire
Bio
Yes!
The ‘Converged’ Safety Model
• An overarching safety culture must be part of the governance of the technology
• Setting the tone for responsible development starts in the workplace, including the lab
• A safety model that accommodates a multi-disciplinary team approach will better support the innovation process.
Nano(Emerging)technology Safety
Polymer Science
Biology
Chemistry
Molecular Biology
Physics
Computational Design
Materials Engineering
The ‘Converged’ Safety Model
• Multi-skilled EHS resources
• Continue with what works (and is required)
• Adopt a risk-based approach for new materials
• “Safety” and “stewardship” for today and tomorrow are already in the language of Nanotechnology (See NNI Strategic Plan)
NNI 2014 Strategic Plan: http://nano.gov/sites/default/files/pub_resource/2014_nni_strategic_plan.pdf
Source: DoE
Things Natural Things Manmade
Mic
row
orld
0.1 nm
1 nanometer (nm)
0.01 µm10 nm
0.1 µm100 nm
1 micrometer (µm)
0.01 mm10 µm
0.1 mm100 µm
1 millimeter (mm)
1 cm10 mm
10-2 m
10-3 m
10-4 m
10-5 m
10-6 m
10-7 m
10-8 m
10-9 m
10-10 m
Nan
owor
ld
Visib
le
1,000 nanometers =
Infra
red
Ultra
violet
Micr
owav
eSo
ft x-
ray
1,000,000 nanometers =
Red blood cells~7-8 µm
Human hair~ 60-120 µm wide
Ant~ 5 mm
Dust mite~200 µm
ATP synthase~10 nm diameter
Atoms of siliconspacing 0.078 nm
DNA~2-1/2 nm diameter
Pariacoto Virus~40 nm diameter
Head of a pin1-2 mm
Quantum corral of 48 iron atoms on copper surfacepositioned one at a time with an STM tipCorral diameter 14 nm
Carbon nanotube~1.3 nm diameter
Zone plate x-ray “lens”Outer ring spacing ~35 nm
Micro Electro Mechanical devices (MEMS)10 -100 µm wide
Carbon buckyball~1 nm diameter
“Nanoscale” ≈ 1-100 nm
The Scale of Things
What’s special about the nanoscale?
• Scale at which surfaces and interfaces play a large role in materials properties and interactions (high surface to volume ratio; wave properties of light are important; allows for miniaturization)
• Scale at which quantum effects dominate properties of materials
• Scale at which much of biology occurs
Nanostructure makes things different at the macroscale
If you keep cutting a cube of gold into smaller and smaller (but bigger than nanoscale) pieces, its color doesn’t change.
But when you make gold nanoparticles, the color that we observe at the macroscale changes with size:
Experiment to detect protein unfolding through gold nanoparticle aggregation (Zare lab)
Nanostructure makes things different at the macroscale
Chad Mirkin, Northwestern University, in NYTimes article by K. Chang - 2005
Ancient Nanotechnologies
Categories of nanoparticles
Naturally occurring Man-made by-product
Engineered Nanomaterials (ENM)
The Nano Researchers Toolkit
Fabrication/synthesis
Characterization(Seeing at the nanoscale)
Applications
Scanning Electron Microscope
Atomic Force Microscope
Electron beam writer EtcherPhotolithography
Cancer detection Photovoltaics Information Storage
Nanomanufacturing
• Chemical vapor deposition
• Molecular beam epitaxy
• Atomic layer epitaxy
• Dip pen lithography
• Nano-imprint lithography
• Roll-to-roll processing
• Self-assembly
A product of nanomanufacturing: A 16 gauge wire (above), approximately 1.3 millimeters in diameter, made from carbon nanotubes that were spun into thread. And the same wire on a 150 ply spool (below.) Courtesy of Nanocomp
Source: nanowerk.com
Waves of Growth Innovation
Project on Emerging Nanotechnologies - Inventories
Consumer products
EH&S research
US nanometro map
Synthetic biology maps
Agriculture and food Medicine Silver
nanotechnologyRemediation
map
http://www.nanotechproject.org/inventories/
Current Medical Applications – Commercialized (FDA approved)
• Appetite Control• Bone Replacement• Cancer• Chemical Substitutes• Cholesterol• Diagnostic Tests• Drug Development• Hormone Therapy• Imaging• Immunosuppressant• Medical Tools
• Over 30+ products already commercialized
• Used by researchers involved in drug discovery
• Better imaging techniques
• Prescriptions to treat particular types of illness
http://www.nanotechproject.org/inventories/medicine/apps/
Nanomaterials/nanoproducts currently in commercial production or use
Eddie Bauer Ruston Fit Nano-Care khakis
Wilson Double Core tennis balls
3M Adper Single Bond Plus dental adhesive
Hummer H2
Mercedes CLS-class
Kodak EasyShare LS633 camera
Laufen Gallery washbasin with Wondergliss
Smith & Nephew Acticoat 7 antimicrobial wound dressing
NanoOpto subwavelengthpolarizing beam splitter/combiner
Samsung Nano SilverSeal Refrigerator
Wyeth Rapamune immuno-suppressant
Vance, M. E., Kuiken, T., Vejerano, E. P., McGinnis, S. P., Hochella, M. F., Jr., Rejeski, D. and Hull, M. S. (2015) Nanotechnology in the real world: Redeveloping the nanomaterial consumer products inventory. Beilstein Journal of Nanotechnology, 6, 1769-1780. http://dx.doi.org/10.3762/bjnano.6.181
Consumer Products Inventory: >1600 listed
• Appliances– Batteries– Heating, Cooling and Air– Large Kitchen Appliances– Laundry & Clothing Care
• Automotive– Exterior– Maintenance & Accessories– Watercraft– Lubricants
• Cross Cutting– Coatings– Bulk
• Electronics and Computers
– Audio– Cameras and Film– Computer Hardware– Display– Mobile Devices and
Communications– Television– Video
• Food and Beverage– Cooking– Food– Storage– Supplements
• Goods for Children– Basics– Toys and Games– Pets
http://www.nanotechproject.org/cpi/
• Health and Fitness– Clothing– Cosmetics– Filtration– Personal Care– Sporting Goods– Sunscreen– Supplements
• Home and Garden– Cleaning– Construction Materials– Home Furnishings– Luggage– Luxury– Paint– Pets
Nanoscale: Benefits and Applications
• Everyday materials and processes
• Electronics and information technology
• Sustainable Energy Applications
• Environmental remediation applications
• Nanobiosystems, medical and health applications
• Future transportation applications
Challenge:• Maintaining focus on benefits of nanotechnology via
EHS and Ethical, Legal and Societal Implications (ELSI)
Source: US NNI EHS Research Strategy
Nanotechnology Development - Opportunity and Risk
• Opportunity goes hand-in-hand with risk
• The global marketplace previously challenged by a variety of risks posed by widely used materials (asbestos, benzene, silica, lead, etc.)
• Risks carry with them the potential for far-reaching effects on market cycles, manufacturing, and the safety, security, and well-being of consumers, and the environment
• Nanotechnology adds an entirely new and largely unexplored realm of possible risks spread across the entire spectrum of modern commerce
Nano (emerging) Technology Risk Management
• Struggle to deal with emergent risks presented by new technologies
• There is no manual for how to address human health risks from increasingly complex technologies
• Stakeholder and citizen engagement is becoming increasingly important
• Uncertainty dominates the decision-making process
• Ill-informed decisions on risks and benefits could be potentially catastrophic
Hazard IdentificationIs there reason to believe this could be harmful?
Exposure AssessmentWill there be exposure in real world conditions?
Risk CharacterizationIs substance hazardous and will there be exposure?
Risk ManagementDevelop procedures tominimize exposures
NanotoxicologyWhat do we know? Are there trends?
ExposureCan it be measured?Where is it Occurring? Metric?
RiskHazard x Exposure
ControlsWhat works? What has been used?What can be reapplied?
Traditional Risk Assessment and Risk Management
RISK PERCEPTION
RISK COMMUNICATION
NIOSH: Overview
Worker Risks• Workers within nanotechnology-related industries have the potential to be
exposed to uniquely engineered materials with novel sizes, shapes, and physical and chemical properties.
• Occupational health risks associated with manufacturing and using nanomaterials are not yet clearly understood.
• Minimal information is currently available on dominant exposure routes, potential exposure levels, and material toxicity of nanomaterials.
Current Research• Studies have indicated that low solubility nanoparticles are more toxic
than larger particles on a mass for mass basis. • There are strong indications that particle surface area and surface
chemistry are responsible for observed responses in cell cultures and animals.
• Studies suggests that some nanoparticles can move from the respiratory system to other organs.
• Research is continuing to understand how these unique properties may lead to specific health effects.
https://www.cdc.gov/niosh/topics/nanotech/
Induction of mesothelioma in p53+/- mouse by intraperitonealapplication of multi-wall carbon nanotube
Takagi et al., J. Toxicol. Sci. 33 (No. 1): 105-116, 2008
Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot studyCRAIG A. POLAND, RODGER DUFFIN, IAN KINLOCH, ANDREW MAYNARD,WILLIAM A. H. WALLACE, ANTHONY SEATON, VICKI STONE, SIMON BROWNWILLIAM MACNEE, AND KEN DONALDSON
Nature Nanotechnology/Vol. 3/July 2008
Induction of mesothelioma by a single intrascrotal administration of multi-wall carbon nanotube in intact male Fischer 344 rats
Sakamoto et al, J.Tox. Sci., 34, 65-76, 2009
Risk Assessment - toxicology
17.5 g TiO2 (P25)
Nano TiO2 repeated intranasal
bolus instillation into mouse:
7.5 mg into mouse = 17.5 grams
into human nose!
Experimental Dosage Human Equivalency
Dose-Rate matters, in vivo and in vitro
Some Considerations for Design and Interpretationof Toxicity Assays with ENMs
• key physico-chemical characteristics (size, agglomeration/ aggregation, solubility, surface properties, contaminants)
• in vivo biokinetic data as guide for in vitro dosing; verifying cellular dose
• use wide range of doses, including realistic/relevant doses• dose rate as potential confounder• impact of modified surface (use of dispersant; stability; does it
affect outcome?• in vivo validation of in vitro system, relevant target cells• analysis of dose-response relationships for in vitro-in vivo
extrapolation• use of reference ENM, positive and negative (benchmarking)• dose – response studies identify and characterize Hazard, not
Risk; (equally important: assessing Exposure during NP life-cycle)
Important to consider: Extrapolation from acute to chronic responsesG. Oberdorster, 2012
Jumping Ahead in the Risk Management Research Framework
Source: US NNI EHS Research Strategy
Nanosciences: Worldwide Research Publication
Velmurugan, Chandran and Radhakrishnan, Natarajan, "Visualizing Global Nanotechnology research on publication deeds,1989-2014" (2016). Library Philosophy and Practice (e-journal). Paper 1372.http://digitalcommons.unl.edu/libphilprac/1372
Grieger, K., Baun, R., Owen, R. 2010. Redefining Risk Research Priorities for Nanomaterials. Journal of Nanoparticle Research,2(2): 383–392
Research is needed in the ‘middle ground’.
NP Risk Management Research
Current State
• ENMs being created and applications developed faster than associated health or hazard data.
• Sufficient health data for concern
• Result: apply risk management practices nowwhile health, exposure and risk assessment studies continue to gather data.
The Motivation
• Workers and consumers worldwide are potentially exposed to nanomaterials during production and use products
• Few occupational exposure limits (OELs) have been developed for specific nanomaterials
• Adequacy of existing OELs for nanomaterial size particles of same substance is often not known
• A prospective risk management approach builds in safeguards in the absence of data and allows the technology to advance
• Decision-making without all of the information necessary for quantitative risk assessment
• Draw from: Established practice Analogous materials and situations Other types of materials (e.g., biologicals) Expert experience and knowledge
• Develop as: Good practices for working with engineered
nanomaterials Use of risk based approaches (e.g., control banding;
ALARA, etc.) Identify new risk management approaches Utilization of existing exposure control techniques
Qualitative Risk Management
Need for Exposure Assessment
• Critical component of risk management
• Identifies populations at risk
• Characterize the exposure, therefore better understanding of risk Nature of exposure: low v. high, short v. long Extent of exposure: few or many; intermittent or chronic Complexity of the exposure Location of the exposure in the life cycle
• Verify controls
The reality of airborne nanomaterials
52
Single-walled CNT MWCNT air samples
Artist’s rendering versus real world
Nanomaterial Processes
It’s not all ‘clean rooms and electron microscopes’
Photos courtesy of NIOSH
Changing Nanotechnology Workforce
• Trend – from laboratory research to scale-up
• Higher potential exposures
“Nanotechnology is unquestionably moving toward manufacturing, involving a still very small but increasing component of the labor force.” [Invernizzi N. J Nanopart Res 2011]
Examples of Potential Exposures
Photos courtesy of NIOSH
Based on what we know so far, is one of these workers at greater risk?
Nano Sized MaterialBulk Material
Evaluating the exposure dose
Which metric to use?Mass, number, size, shape, surface area?
Same Mass
Multiple Metrics Have Been Used to Assess Exposure
• Mass: Links to historical data, lacks sensitivity and specificity
• Elemental Mass More specific, links to toxicology and history
• Size distribution: More information, not always easy, not specific
• Number concentration: Fairly simple with monitors, not specific, question of relevance for health effects
• Surface area: Some relevance based on toxicology, technology is available, not specific
“Each one may help define the dose”
Exposure Evaluation Efforts
• Particle number• Mass concentration• Size distribution (count or
mass by size)• Surface area• Qualitative
– Morphology– Extent of agglomeration– Complexity– Confirmation: e.g. TEM with elemental analysis
Exposure assessment: a combination of• Online Monitoring: Instrumental approach
Number concentration Surface area Size-distribution (number, mass) Mass-concentration size-fractioned Specific monitor (e.g., black carbon monitor)
• Off-line analysis: Integrated sampling approach Electron microscopy X-ray diffraction analysis Elemental analysis
“Nanoparticle” Exposure Assessment Challenges
• Definition of nanoparticle or nanomaterial
• Heterogeneity of nanomaterials
• Agreement on the most appropriate metric
• Lack of evaluation criteria
• Lack of ruggedized exposure evaluation methods
“Convenient” exposure metrics can be used in an initial assessment
Some starting points:• Particle number: is there a potential exposure
• “Gross” Particle number by size: character of the aerosol
• Mass: gross indicator of exposure
• Respirable mass: focus on the biologically relevant fraction
Add some sophistication with:• Detailed size distribution
• Real-time mass and size distribution
• Surface area
Greater Sophistication: an example form NIOSH
NIOSH - Division of Applied Research and Technology
Weighing MWCNTs
Breathing zone sample analyzed by SEM
SEM = scanning electron microscopy
Evidence of Exposure
Photos courtesy of NIOSH
Exposure Data: Summary/Challenges
• New thinking is needed
• Exposures do occur in the workplace
• Exposure limits are being developed
• Mass is still the primary metric reported in hazard studies
• Direct-reading approaches have a place
• Additional metrics need to be explored: e.g., fiber count?
• Confirmatory methods are needed
• Controls can be effective
Hierarchy of Control
1) Engineering Controls– Physical, chemical, or biological changes made to a process
or a product that reduce exposure to hazards– Responsibility for change not placed on exposed person
2) Work Practice and Administrative Controls– Changes in how, when, or by whom tasks are performed in
order to reduce exposure to hazards– Management and exposed person responsible for change
3) Personal Protective Equipment (PPE)– Equipment or clothing used by individual to reduce exposure– Exposed individual primarily responsible for change
Nanoparticle Forms
• Considerations apply principally to engineered nanoparticles!
• Working with nanoparticles in a slurry is less likely to present an inhalation hazard than powders `Caution: Getting nanoparticles into a slurry
or a composite can present hazards!
• Nanoparticles in a composite material are hard to get out of that form
Local Exhaust Ventilation - Exterior Hood Concepts
From: NIOSH, Approaches to Safe Nanotechnology (2009)
Exterior Hood Performance
From: Methner, J. Occup. Environ. Hyg., 5:D63-D69 (2008)
Average of 96% reduction in particle levels
Local Exhaust Ventilation (LEV)
• Exterior hoods can effectively reduce particle concentrations nanoparticles can follow air streamlines into exterior hoods The flow into the hood can be disrupted!
• Enclosure + LEV is even better Lab hoods can be effective But lab hoods aren’t perfect!! Appropriate face velocities should be maintained
Observation: Batch processes during product development and small-scale production sometimes have weak LEV controls
Open Bench
FumeHood
Enclosures/Glove Box
Multipurpose laboratory example with a range of controls
Photo courtesy of NIOSH
Preparing a suspension of metal oxide powder for production of lithium titanate
Photo courtesy of NIOSH
Engineering Controls: filtration
Exposure by inhalation:
-Filtration plays an important role in the control of exposure to airborne particles.
- High Efficiency Particulate Air (HEPA) are mechanical filters used in engineering control systems to clean the air before returning it to the workplace.
Controls: Collection Methods
• Filters can efficiently collect nanoparticles!!
• One caution: not as much is known about changes in filter performance with time as filters collect and load with nanoparticles
• Filters are the best collection method for nanoparticles HEPA filters will work very well They must be seated properly in their housing Electrostatic precipitation less effective for
nanoparticles Particle scrubbers less effective for nanoparticles
Work Practices
• Minimize energy inputs to nanomaterial handling Slower pouring of slurries Scooping of powders rather than dumping them
• Cleanup and disposal follow general best practices (NIOSH Approaches to Safe Nanotechnology) Use damp cleaning Avoid dry sweeping and compressed air Only HEPA vacuums w/o vigorous scrubbing Practice careful personal hygiene
Personal Protective Equipment
• Protective clothing nanoparticles pass through woven cloth with airflow Impermeable clothing likely more protective
• Gloves FUN particles can lodge in protective gloves Not clear they can get through
• Respiratory protection Penetration increases slightly for nanoparticles Change interval should be short Fit important as with any other contaminant
(FUN=fine, ultrafine and nano size particles)
Protocol for ENM Risk Management
Hazard ID ExposurePotential
RiskLevel
Control Elementsto Mitigate Risk
Information and knowledge on specific nanomaterial toxicology and other safety/ health attributes
ENM Particle-Size-Morphology-Chemistry-Solubility-Toxicity
Evaluation of the potential for release and uptake of the nanomaterial. Evaluation of the properties of the nanomaterials or procedure that might result in potential for release/ exposure.
-Amt. of material used-Airborne potential -Duration-Freq. of operation-#persons exposed
Assignment of procedure to a specific determined risk level for subsequent controls.
Variety of schemas ranging from 3-5 levels or bands
Based on specific risk level identified, implement controls that have increasing amount of control characteristics to reduce potential for exposure.
Specific controls used are related to each risk level. Ranges from bench top work to total isolation of the nanomaterial from any individual.
Control Banding Approach
Exposure Duration
Bound Materials
Potential Release
Free / Unbound
Hazard Group A (Known to be inert)
Short 1 1 2
Medium 1 1 2
Long 1 2 2
Hazard Group B (Understand reactivity/function)
Short 1 2 2Medium 1 2 3
Long 1 3 3
Hazard Group C (Unknown Properties)
Short 2 2 3
Medium 2 3 4
Long 2 4 4
Exposure Duration Key:Short: < 4 hours/day, 2 days/weekMedium: 4 to 6 hours/day, 3 to 5 days/weekLong: 6 to >8 hours/day, 3 to 5 days/week
Release KeyBound: Nanoparticles in Solid MatrixPotential: Nanoparticles in friable or sol gel matrixFree/Unbound: Nanoparticles unbound, not aggregated
Control Band (Risk Level) Key1: General ventilation and personal protective equipment ("PPE")2: Engineering controls and/or respirators, additional PPE3: Containment (e.g., glove box)4: Seek specialist advice
goodnanoguide.org
Wisdom Applied to Emerging Technologies
“To know that we know what we know, and that we do not know what we do not know, that is true knowledge"
(Confucius)
Nanomaterials in the WorkplaceWhat we know
• Some potential hazard• Some risk may exist• Some exposure occurs• Nanoparticles can be
measured• Nanoparticles can be
controlled• Filters and respirators should
protect• There are no specific
exposure limits• No specific medical tests, but
hazard surveillance is prudent
What we don’t know
• Nature and extent of hazard?• Nature and extent of risk?• Nature and extent of exposure?• What measures to use?
• Limitations of controls?
• Limitations of protection?
• What limits are appropriate?
• Content of surveillance?
ENM Risk Management Plan for Workplace
Evaluate Determinants of
Exposure
Apply Hierarchy of
Control
Apply Good Management
PracticesVerify Control
Measures
Periodically Re-evaluate Practices
Engineered Nanomaterial and Nanotechnology-Enabled Product Life Cycle Considerations
Human and environmental exposures to ENMs can occur at all life cycle stages of an NEP.
Adapted from the 2011 NNI Environmental, Health, and Safety Research Strategy,www.nano.gov/sites/default/files/pub_resource/nni_2011_ehs_research_strategy.pdf
NNI 2014 Strategic Plan
Nano Risk Management Across the Life-cycle
The risk assessment paradigm (on left) integrated with nanomaterial life cycle stages (across top). (Design credit: N.R. Fuller of Sayo-Art.)
Approaches to Nano Risk Governance
• Government regulation Requires legally defensible issues – legal definition of what is covered Challenges – data gaps; rapid change in technology; unknown risks;
known benefits change perspective from general risks to individual benefits; level playing field across agencies
• Precautionary Approach-prevent harm and prevent risk to public How to operationalize as regulation? Soft laws – non-enforceable standards/guidelines Governance– expanding # parties involved in oversight
• Green Chemistry Approach – eliminate hazard Build/allow only NPs that have no toxicity or hazard One can’t always eliminate the hazard - can’t design away some
properties as those same properties may be the property of interest for beneficial uses
Choice to eliminate exposure rather than eliminate the hazard?
Challenges to Regulatory Development
• Lack of sufficient risk information
• Technology has outpaced risk characterization and government regulation
• Organizations develop own principles, practices and procedures
• National Nanotechnology Initiative (NNI) NNI – 2014 EH&S Strategy
http://www.nano.gov/sites/default/files/pub_resource/2014_nni_ehs_progress_review.pdf
Agencies
• OSHA – General Duty Clause and operational sections of 1910
• Environmental Protection Agency TSCA (Toxic Substances Control Act) FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act)
• CPSC (Consumer Product Safety Commission) FHSA (Federal Hazardous Substances Act) may require labelling
• FDA (Federal Drug Agency)
• REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)
Ethical, Legal and Societal Issues (ELSI)
• How nanotechnology research and applications are introduced into society;
• How transparent is decision making;
• How sensitive and responsive policies are to the needs and perceptions of the full range of stakeholders;
• How ethical, legal and societal issues are addressed will determine public trust and the future of innovation driven by nanotechnology
Summary
• ENMs are being created and applications developed faster than health or risk data is being generated.
• There is sufficient health data for concern; should apply effective risk management practices now while health, exposure and risk assessment studies continue.
• Government regulation is currently in limbo – will be challenging given lack of risk assessment information
• Potential exists for nanotechnology development to be curtailed by inordinate regulations, adverse public perception, and lack of openness by the nano-community to share risk information and knowledge – may create an unrealistic perception of risk
• Future for nanotechnology is very bright and we are on the cusp of a new economic driver for the next 50 years, so long as the technology continues to be responsibly developed with risk information shared.
Public Perception of Emerging Technology
