NANOTECHNOLOGY: UNDERSTANDING

POTENTIAL RISKS AND THE ADOPTION OF PROACTIVE

PARADIGM

Water Research Commission Media Breakfast: Nanotechnology

15th March 2010, Venue: WRC offices - Pula boardroom, Pretoria, South Africa Ndeke Musee, CSIR ,Natural Resources and EnvironmentNatural Resources and

“A man would do nothing if he waited

until he could do it so well that no one would find fault with what he

had done.” Cardinal Newman

Soccer Ball22,64 cm

Nanoparticle, 4 nm

Earth12756 km

1,77 x 10-8 fold

2010 Soccer World Cup:

South Africa VIVA!88 Days To Go

NANOTECHNOLOGY-BASED PRODUCTS

PRESENTATION OUTLINE

SA government policy/strategy on

nanotechnology (Nano)

Why the need for risk assessment of

Nanotechnology?

Risk assessment challenges of Nanotechnology

presently

Development of risk assessment

tools/governance frameworks

South African Government Initiatives on Nano risk

assessment

Concluding remarks

South Africa Government Nanotechnology Underlying Policies

and Strategies

Nanotechnology policies embedded on the National Systems of Innovation (NSI) plan/framework. NSI plan is central to SA’s prospects for continued economic growth and socioeconomic development

NSI is based on a series of strategic government documents since 1996 – see next page

SA Government goal of articulating a national path of innovation based on NSI in support of transforming the national resources based to knowledge-based economy through nanotechnology platform was implemented based on the National Nanotechnology Strategy (2004)

SA GOVERNMENT NANO POLICY/STRATEGY

SA GOVERNMENT NANO-RELATED POLICIES

White Paper on Science & Technology (1996)

National Research and Technology Foresight

(2000)

National Research and Development Strategy

(DST, 2002)

National nanotechnology strategy (DST, 2004)

Innovations towards a knowledge based

economy 2008–2018 plan (DST, 2009)

NATIONAL NANOTECHNOLOGY STRATEGY (2004) Set of strategic/tactical objectives

Support for long-term nanoscience research Support the creation of new and novel devices

for applications in various areas HCD and infrastructure development to allow

Nano growth Stimulate new developments in technology

missions for industrial applications Recommendations on the levels of funding

required Identification of the most critical areas of

concern (social and industrial clusters)

EXAMPLES OF CHALLENGES NANOTECHNOLOGY CAN ADDRESS

Poverty (economy, etc) Climate change Burden of disease (human health –

pathogens driven, occupational, pollution driven, environmental driven, etc)

Environmental protection … Energy

Training of future leaders in nanotechnology must concisely align in addressing part or all of

the challenges

Why Risk Assessment Now for Engineered Nanomaterials

Materials (ENMs)?

NANOMATERIALS OF FOCI

Unintentional sources (natural and anthropogenic)

Intentional sources (anthropogenic)

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UNIQUENESS OF MATERIALS AT NANO-SCALE

Materials reduced to the nano-scale can suddenly show novel properties compared to counterpart bulk materials, for example: Opaque substances become transparent

(copper); Stable materials become combustible

(aluminium); Inert materials become catalysts (platinum); Insulators become conductors (silicon); Solids turn into liquids at room temperature

(gold) Quantum effects become dominant which

potentially causes profound effects to biological receptor organisms

SOME EXAMPLES

20-90% atoms on surface, most dominant effects < 30 nm

Energy band increases with decrease in diameter (< 6 nm effects profound)

HISTORICAL MALEVOLENT TECHNOLOGIES

Dichlorodiphenyltrichloroethane (DDT)

Asbestos (asbestosis disease)

Chlorofluorocarbons (CFS)

Genetically modified organisms (GMOs)

Cell research

Mining (silicosis-related ailments)

Nuclear Industry (nuclear waste management nightmare)

Radiation

MBDT/TBT

Benzene

Space programme

DEFINING HAZARD & EXPOSURE

Hazard – has numerous definitions. Here, the United States Environmental Protection Agency (EPA) definition is adopted:

Hazard is the inherent toxicity of a compound

Exposure is the probability of a hazardous substance to become bioavailable to the receptor organisms

DEFINING RISK

EPA defines risk as a measure of the

probability that damage to life, health,

property, and/or the environment will occur

as a result of a given hazard

If the probability of an exposure to a

hazardous material is high and the

consequences for the health or environment

are significant, then the risk is considered to

be high

BASIC PREMISE OF RISK ASSESSMENT

Hazard X Exposure = Risk

Hazard =0; Risk = 0

Exposure = 0; Risk = 0

Recommended approach: Minimize hazard

and/or exposure

TYPES OF RISKS

Known Risks Cause and effects known Responsibility can be generally attributed &

prevention developed Most macroscale risks known and preventable

Unknown Risks – “Potential Risks” Causality of cause and effects/damage not well

known Thus; danger is unclear Degree of damage/danger not well quantifiable Significance of probability of occurrence unknown Evokes suspicion/perceived risks Applies in case of nanotechnologies both in humans &

the environment

Challenges of Nanotechnology Risk Assessment

EXAMPLES OF RISK ASSESSMENT CHALLENGES (1)

Large diversity of ENMs generated (oxides, metals, carbon-based, QDs, etc) and products/applications (electronics, personal care, drugs, etc)

Dynamic transformation of NMs throughout their entire lifecycle Strong influence on fate and behaviour of NMs

in different macro-environmental systems (pH, salinity, presence or absence of oxidants, zeta potential, effects of macromolecules, presence of macroscale chemicals, indigestion by organisms, methods of production, stability of coating, etc)

Lack of metrology: how easy is it to detect NMs in soils and water systems? (“out of phase effect”) – risk assessment capabilities currently tailing technological advancement

Legislative inertia: Save Berkeley City, USA, Canada, EU (globally) Toxic substances control Act (TSCA) Federal Food, Drug, and Cosmetic Act (FFDCA) European Union Directives (“incremental approach”) Mass per volume toxicity measurement (unit) inadequate

Absence of exposure data Do they partition in the environment? Half-lives unknown Bioaccumulation, biopersistence, biomagnification data

yet to be generated

EXAMPLES OF RISK ASSESSMENT CHALLENGES (2)

No single index for measuring the toxicity of nanomaterials Surface area, particle number, volume, etc

Limited toxicity data Limited acute toxicity data (no clear link between

observed toxicity and physicochemical properties) Almost none chronic data of NMs has been

published Most data available based on laboratory

environments (see reviews of Borm et al., 2006; Handy et al., 2008)

Inconsistence of data (comparison of toxicity for TiO2 Velzeboer et al., 2008 and Lovern and Klopper, 2006 differ significantly)

EXAMPLES OF RISK ASSESSMENT CHALLENGES (3)

Limitations of risk assessment methodologies, for example: Uncertainty in applying standardized tests previously

developed for macroscale chemicals Uncertainty in characterisation of ENMs in test systems Difficulties in detecting and quantifying ENMs in

complex environmental matrices Uncertainty in sample preparations for

nanoecotoxicology studies

EXAMPLES OF RISK ASSESSMENT CHALLENGES (4)

LIMITED DATA TO SUPPORT DECISION MAKING

Grieger et al, 2010:Redefining risk research priorities for nanomaterials, J Nanoparticle Research (2010) 12:383–392

Aspects of serious concerns

RISK ASSESSMENT DATA LIMITATIONS

FIVE GRAND CHALLENGES OF ENMS RISK ASSESSMENT

Maynard et al., 2006. Safe Handling of Nanomaterials. Nature 444 (11):267–269.

Development of risk assessment tools/governance frameworks

RISK ASSESSMENT TOOLS/GOVERNANCE FRAMEWORKS

Not yet in South Africa

European Union

United States of America

Japan

ENMs RISK ASSESSMENT APPROACH IN JAPAN

ENMs RISK ASSESSMENT APPROACH IN USA

ENMs RISK ASSESSMENT APPROACH IN EU

INTEGRATED RISK ASSESSMENT FRAMEWORK

REGULATORY FRAMEWORK

Limitations of the current legislative frameworks for ENMs, viz.: Current regulatory programs, standards and

related exceptions based on mass to mass conc. Yet, other factors e.g. surface area, enhanced surface activity, etc likely to cause advance effects at lower concentrations

Lack of predictive models of NMs toxicity based on previously known toxicity of other ENMs or bulk conventional counterpart chemicals

Highly dispersed production facilities – numerous small and medium sized companies – hinders coherent data collection – wide diversity of applications – lack of expertise on legislative compliance

REGULATORY FRAMEWORK… Cont.

High speed of nanotechnology development outpaces the legislative framework evolution – takes long period of time to conclude. Thus, to date no clear occupational and environmental laws

Breadth of applications will fall under the cracks of legislative frameworks – as some applications of ENMs in products and services are outside legislative frameworks (e.g. household products, etc)

EXAMPLES HIGHER ENMS TOXICITY

ENMs of CuO are up to 50-FOLD more toxic than particles of bulk CuO towards crustaceans (Heinlaan et al., 2008), algae, (Aruoja et al., 2009), protozoa (Mortimer et al., 2009, this issue) and yeast (Kasemets et al., 2009)

TiO2 and Al2O3 ENMs are about TWICE more toxic than their respective bulk formulations towards nematodes (Wang et al., 2009).

Ag ENMS of about 5 nm sizes were more toxic to bacteria than any other fractions of NPs or their bulk species (Choi and Hu, 2008).

SA GOVERNMENT CURRENT INITIATIVES

Setting up of a Environmental, Safety and Health Research Platform, comprise of: Human capital development (HCD) Focussed research Development of infrastructure Database for HSE aspects related to

nanotechnology Establishment of national nanotechnology

ethics committee Initiation of international research

collaborations

Risk Communication

NANOTECHNOLOGY RISK CONCERNS IN SOUTH AFRICA

Web link: http://intraweb.csir.co.za/news/inthenews/2009/TheStar_Nanotech.pdf

Example 1

• •

Star, February 16, 2009• Questions on potential risks

were explicitly raised by the media

• Link of CNTs and asbestos health effects on lungs were inferred

• Robots replacing humans and getting out of control

• Unethical aspects related to nanotechnology were raised

• •

Sunday Times, May 25, 2008• CNTs link to health risks

similar to asbestos suggested

• Current researchers’ findings reported in Journal of Nature supports this view

• Not yet single case of disease has been reported associated with CNTs

• Cautionary approach was proposed

• Risk health effects postulated after the products lifespan

• Greatest risk for workers in research labs and manufacturing sector were raised

Example 2

RISK COMMUNICATION…

Risk communication is critical in enabling public engagement with new technologies (balancing of technology benefits versus risks)

Forms the cornerstone of opinion-forming process on the public acceptance/debate regarding a given technology – has a lasting mark on the development of technologies and their applications

Should reflect current and dynamic social, scientific, and political imperatives

For nanotechnologies – its promises and potential public fears needs to be taken into account, and addressed expeditiously

Requires an on-going debates among different stakeholders to ascertain opportunities and risks (government, industry and the public)

But who remains the most suitable to communicate technology risks?

BENEFITS OF RISK COMMUNICATION…

Increased awareness and understanding of the nanosafety implications for the nanobioscience industry

Ensure future workforce at any level and sector understands the HSE implications for the business sustainability (marketing and customer relationships)

Promote nanobioscience industry’s environmental stewardship and societal responsibility

Training of candidates the emerging protocols in nanotoxicology and nanoecotoxicology

Contribute in the field of risk assessment for nanomaterials with respect to: Standardization Establish occupational threshold limits Meeting and/or setting of regulatory

requirements for nanoscale materials in products and industrial products

RESPONSE TO ADDRESS PRIORITY NEEDS

Ensure sufficient skills are available

Deploy the required technologies

Possess (and use) the necessary equipment

effectively

Obtain sufficient financial support

Be supported by the required legal

instruments (laws) and standards

ACKNOWLEDGEMENTS

CSIR DST WRC

Thank you