product safety in nanotechnology

PRODUCT SAFETY IN PRODUCT SAFETY IN NANOTECHNOLOGYNANOTECHNOLOGY

EIN 5322 Project

Fall 2007

Jonathan Rivera

INTRODUCTIONINTRODUCTION

Overview - A look at the role product safety is playing in the development of nanotechnology, including initiatives by government, private, and international sectors to address safety concerns and challenges.

Why is this topic important? – nanotechnology affects a wide range of people and industries; addressing product safety helps ensure technology reaches its full potential; regulation is forthcoming; protection of public health and safety and the environment is essential in engineering ethics

INTRODUCTIONINTRODUCTION

OUTLINE

I. Development of Nanotechnology

II. Relation of Product Safety to Engineering Ethics

III. Product Safety Concerns in Nanotechnology

IV. Current Governance Initiatives

V. Challenges in Addressing Product Safety

VI. Summary

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

What is nanotechnology? “…the creation and

utilization of materials, devices, and systems through the control of matter on the nanometer-length scale—at the level of atoms, molecules, and supra-molecular structures.” – National Science and Technology Council

“The science and technology of controlling matter at the nanoscale” – Environmental Law Institute & WWISC

“…the processing of, separation, consolidation, and deformation of materials by one atom or by one molecule…” – Norio Taniguchi, Professor, Tokyo Science University, 1974

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

What is nanotechnology?

No official definition; generally accepted definition byNational Nanotechnology Initiative:

1. Research and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1 - 100 nanometers

2. Creating and using structures, devices and systems that have novel properties and functions because of their small and/or intermediate sizes, and

3. Ability to be controlled or manipulated on the atomic scale

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

What is nanotechnology?

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

What is nanotechnology?

A multi-disciplinary field extending existing science into the nanoscale size

Manipulating materials at the nanoscale can change the electronic, magnetic, mechanical, chemical, optical, structural, and functional properties of a substance, producing unique phenomena that can be applied in novel and ground-breaking ways

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

What is nanotechnology?

Identifying what constitutes a nanomaterial is the subject of substantial debate in the scientific, regulatory, and standards communities

Several terms used to describe nanomaterials depending on shape and structure, such as nanoparticles, nanocrystals, nanotubes, nanowires, nanopores, fullerenes, dendrimers, and nanoshels

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

History

1959 – speech by physicist Richard Feynman at Caltech - “There's Plenty of Room at the Bottom” – introduced idea of manipulating individual atoms and molecules

1980s – advances in microscopy enabled developments in nanotechnology

1985 – discovery of fullerene by Robert F. Curl, Jr., Sir Harold W. Kroto, and Richard E. Smalley (Noble Prize in Chemistry 1996)

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

History

1991 - discovery of the nanotube by Sumio Iijima (NEC Corporation) - “jumbotron lamp” in athletic stadiums

2000 - first nano-structured coating for gears of air conditioning units on U.S. Navy ships – DOD estimates $20 million reduction in maintenance costs over 10 years

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

Wide range of impacted industries and products, including:

Electronics

Automobile

Medicine

Building & Household Products

Consumer Products

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

Existing and near term applications

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

Temperature controlling fabrics

Hearing aid implants Cancer tagging

mechanisms Temperature dependent

smart roofs Advanced water filtration

systems

Breakdown of biological warfare agents

Precise surgical tools Groundwater remediation Breakdown of

manufacturing waste

Other applications:

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGYThe market today

Over 700 nano-based products (including consumer products) currently available in U.S.

Over 1600 companies producing and selling nano-based products in U.S.; ½ small businesses

In 2005, U.S. government invested $1.6 billion in research and development; U.S. based corporations invested $1.7 billion

In 2004, state and local governments invested over $400 million in research, facilities, and business incubation programs

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

The market today

In 1990, approx. 200 patent applications filed (worldwide); by 2002 over 1900 patent applications

Number of consumer products (worldwide) using nanotechnology more than doubled since March 2006, from 212 to 475; clothing and cosmetics top the list (77 and 75 products, respectively); others include bedding, jewelry, sporting goods, and nutritional and personal care; over $30 billion in manufactured goods; U.S. leads with 247 products – 58% increase from 2000

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

The market today

One of the top research priorities of the U.S. government today; Japan, China, Korea, as well as several European countries have made leadership in nanotechnology national priorities

Interesting fact: Over 80% of general public knows very little or nothing about nanotechnology

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

The future market

By the year 2015:

Nano-based products could constitute over 15% of the global manufacturing output

Revenues from nano-based products could total over $2.6 trillion

Nanotechnology could surpass the impact of the Industrial Revolution

DEVELOPMENT OF NANOTECHNOLOGYDEVELOPMENT OF NANOTECHNOLOGY

The future market

Nanotechnology is one of three areas of substantial investment [for

General Electric]…potential for helping develop high-heat resistant

blades for gas turbine engines, more efficient MRI contrast agents, and

high-strength lightweight components for a variety of products.- Jeffrey Immelt, General Electric

Nanotechnology will form the foundation for revolutionary discoveries and

advancements in the decades to come. It will profoundly influence the

competitiveness of companies in every relevant industry.

- Herbert Riemenschneider, Degussa Corporation

PRODUCT SAFETY RELATION TO PRODUCT SAFETY RELATION TO ENGINEERING ETHICSENGINEERING ETHICS

Engineering ethics – applying ethical principles to the engineering profession, where engineers are obligated to uphold certain standards of conduct in the interest of the public, clients, employers, and the profession as a whole

All engineers faced with similar ethical issues (e.g., whistle blowing, product liability, quality, legal compliance, conflict of interests, bribery, treatment of confidential or proprietary information, outside employment)

PRODUCT SAFETY RELATION TO PRODUCT SAFETY RELATION TO ENGINEERING ETHICSENGINEERING ETHICS

During the rise of the engineering profession in the 19th century, professional societies were developed, such as ASCE (1851) and AIEE (1884)

With significant structural failures, such as Tay Bridge Disaster (1979) and Quebec bridge collapse (1907), formal codes of ethics where established

PRODUCT SAFETY RELATION TO PRODUCT SAFETY RELATION TO ENGINEERING ETHICSENGINEERING ETHICS

No single, uniform system, or standard, of ethical conduct across entire engineering profession, however codes of ethics established by engineering professional societies (BMES, IEEE, ASCE, ASME, NSPE, International: ICE in UK, several societies in Canada)

PRODUCT SAFETY RELATION TO PRODUCT SAFETY RELATION TO ENGINEERING ETHICSENGINEERING ETHICS

National Society of Professional Engineers (NSPE) extends licensing and code of ethics in the U.S.

Licensed engineers subject to ethics laws; code of ethics written into law in most states

Many similarities between codes of ethics across professional engineering societies

PRODUCT SAFETY RELATION TO PRODUCT SAFETY RELATION TO ENGINEERING ETHICSENGINEERING ETHICS

Core concepts present in engineering code of ethics:

Public Interest – protection and enhancement of the health, safety, welfare, and quality of life of the public

Truth, Honesty, and Fairness – being honest and impartial; communicating consequences of work; maintaining confidential information; acting as a faithful agent or trustee; avoiding conflicts of interest; basing decisions on merit, competence, and knowledge without biases; not giving or accepting bribes; being truthful in discussions, reports, and actions

PRODUCT SAFETY RELATION TO PRODUCT SAFETY RELATION TO ENGINEERING ETHICSENGINEERING ETHICS

Core concepts present in engineering code of ethics:

Professional Performance – possessing competence in work undertaken, and striving to continually improve on competence; extending knowledge to others; accepting responsibility for actions; giving appropriate credit to others

PRODUCT SAFETY RELATION TO PRODUCT SAFETY RELATION TO ENGINEERING ETHICSENGINEERING ETHICS

Core ethic: safety, health, and wellness of the public

"A practitioner shall, regard the practitioner's duty to public welfare as paramount." – Professional Engineers Ontario (PEO)

"Engineers, in the fulfillment of their professional duties, shall: Hold paramount the safety, health, and welfare of the public.“ – National Society of Professional Engineers (NSPE)

"We, the members of the IEEE…do hereby commit ourselves to the highest ethical and professional conduct and agree…to accept responsibility in making decisions consistent with the safety, health and welfare of the public, and to disclose promptly factors that might endanger the public or the environment;" – Institute of Electrical and Electronics Engineers (IEEE)

PRODUCT SAFETY CONCERNS IN PRODUCT SAFETY CONCERNS IN NANOTECHNOLOGYNANOTECHNOLOGY

Overall Concern

Nanomaterials, because of their unique properties, may

behave differently than the same material in bulk form,

having the potential to be toxic to humans and the

environment

PRODUCT SAFETY CONCERNS IN PRODUCT SAFETY CONCERNS IN NANOTECHNOLOGYNANOTECHNOLOGY

Initial studies have indicated that nanomaterials:

can penetrate individual cells

deposit in organ systems

trigger inflammatory responses

affect biological behavior at the cellular, sub-cellular, and protein levels

PRODUCT SAFETY CONCERNS IN PRODUCT SAFETY CONCERNS IN NANOTECHNOLOGYNANOTECHNOLOGY

Studies in 2004

Brain tissue in bass inflamed and damaged as a result of exposure to aqueous fullerenes (Eva Orberdorster, Southern Methodist University, Journal: Environmental Health Perspectives, Vol. 112)

Immune cells gather around clumps of nanotubes in rats’ lungs (David Warheit, researcher, Dupont, Journal: Toxicological Sciences, Vol. 77)

PRODUCT SAFETY CONCERNS IN PRODUCT SAFETY CONCERNS IN NANOTECHNOLOGYNANOTECHNOLOGY

Studies are inconclusive

Research on possible effects on human health and the environment at its early stages; a lot of speculation, but no hard evidence

Little is known about the risk associated with the life cycle of nanoproducts (manufacture, use, and disposal)

Over 81,000 peer-reviewed journal articles on toxicology since 2000 - 0.6% talked about nanomaterials compared to 12% for polymers

PRODUCT SAFETY CONCERNS IN PRODUCT SAFETY CONCERNS IN NANOTECHNOLOGYNANOTECHNOLOGY

Other concerns

No current health and safety governance structure specifically for nanotechnology

Rate of development far exceeding rate of knowledge acquisition on hazardous effects

Disposal of nano-based products has already begun

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVES

“Securing the Promise of Nanotechnology: Is U.S. Environmental Law Up to the Job” (Conference)

May 25 – 26, 2005Washington, DC

Dialogue convened by Woodrow Wilson International Center for Scholars (WWICS) Project on Emerging Nanotechnologies and the Environmental Law Institute (ELI)

Purpose was to examine how U.S. laws and regulations, and other means of governance, can address environmental, health, and safety (EHS) implications on nanotechnologies

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESConference

Forty representatives from private companies, research institutions, law firms, and federal government agencies.

Most frequently cited challenges: rapid rate of nanotechnology development, limited EHS-related data, lack of specific laws and regulations, and the influence of public perception

Helped define framework for governance structure

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESConference

Rate of development:

Pressure for governance structure in a timely manner

Workers and consumers already being exposed, and nanomaterials already being discharged into the environment

As rate of production increases, need for EHS protection will increase

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESConference

Limited data:

The “science is way behind” – may not be available for 10 to 15 years; need for short term action

Cost-efficient methods for monitoring and cleanup not readily available

Little known about nanomaterials in the workplace

Inadequacy of federal funding for EHS research

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESConference

Lack of specific laws and regulations:

Need to evaluate and adapt current laws and regulations; new legislation unlikely in near term

Jurisdiction lies under a diverse spread of federal and state agencies (EPA, state departments of environment, CPSC, FDA, DOD, and others)

Sound EHS data needed for new legislation

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESConference

Possible uses of current regulatory authorities:

Toxic Substances Control Act (TSCA) most apt vehicle, but not optimal; multi-statute approach may be most appropriate

Clean Air ActClean Water ActResource Conservation and Recovery Act (RCRA)Comprehensive Environmental Response,

Compensation, and Liability Act (CERCLA or Superfund Law)

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESConference

Influence of public perception:

Controversies can impede development and deployment of nanotechnologies

Importance of communication of risk and safety information; lack of information could lead to misperceptions and unfound fears

Readiness for “first public scare”

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVES

Restrict dispersive uses

Prioritize substances of concern

Conduct health surveillance

Conduct exposure monitoring

Assume toxicity until shown otherwise

Treat wastes as hazardous materials

Train workers in personal protective equipment and hygiene

Conference

Short-Term Recommendations

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESU.S. Government

The National Nanotechnology Initiative (NNI)

Started FY 2001Consists of 24 federal agenciesNanoscale Science Engineering and Technology

(NSET) Subcommittee appointed by the PresidentCoordinates multi-agency efforts, provide funding for

university laboratories, and support U.S. companiesSupports responsible development of

nanotechnology for protection of health and safety

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESU.S. Government

Environmental Protection Agency (EPA)

Has taken leadership role in planning research directions for the environmental applications and implications of nanotechnology

Twelve recently selected research projects focus on studying the possible harmful effects of manufactured nanomaterials, i.e., toxicity, fate, transport and transformation, and exposure and bioaccumulation

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESU.S. Government

Environmental Protection Agency (EPA)

White Paper (February 2007) – what EPA should do about implications of nanotechnology

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESU.S. Government

National Science Foundation

Solicitation for proposal (due March 17, 2008) to develop Center for the Environmental Implications of Nanotechnology (CEIN) - to conduct fundamental research and education on the implications of nanotechnology for the environment and living systems at all scales

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESU.S. Government

Food and Drug Administration (FDA)

Nanotechnology Task Force

Formed August 2006Identifies and recommends ways to address any

knowledge or policy gaps that exist so as to better enable the agency to evaluate possible adverse health effects from FDA-regulated products that use nanotechnology materials

Task Force Report – July 25, 2007

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESU.S. Government

National Institute for Occupational Safety and Health (NIOSH)

Leading federal agency conducting research and providing guidance on the occupational safety and health implications and applications of nanotechnology

“Approaches to Safe Nanotechnology” – October 2005 document describing what is currently known about toxicity and control, and request to occupational safety and health practitioners, researchers, product innovators and manufacturers, employers, workers, interest group members, and the general public to exchange information

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESPrivate Sector

Nanoparticle Benchmarking Occupational Health Safety and Environment Program – consortium of companies to address analytical needs to measure airborne concentrations and particle sizes, and to assess effectiveness of controls

Design and development of portable workplace monitoring instrumentation; and

Development and testing of protective clothing fabrics as a barrier to an aerosol of nanoparticles

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESNon-profit Organizations

Woodrow Wilson International Center for Scholars (WWICS) – Project on Emerging Nanotechnology – bring together leaders from industry, government, research, and other sectors to take a long-term view of what is known and unknown about potential health and environmental challenges posed by emerging nanotechnologies, and develop recommendations to manage them

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESNon-profit Organizations

Environmental Defense – work with government to develop nanotechnology responsibly – calls for increase in federal funding to research potential risks of nanomaterials

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESOther Organizations

Environmental Law Institute – Nanotechnology Initiative - seeks to respond to the urgent need to develop an effective environmental, health, and safety governance structure for nanotechnologies

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESInternational Standards

ASTM International:

Established Committee E56 in January 2005 to develop standards and guidelines for nanotechnology, which includes a subcommittee on Environmental & Occupational Health & Safety

WK8985 – under development - New Standard Guide For Handling Unbound Engineered Nanoparticles in Occupational Settings

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESInternational Standards

International Organization for Standardization (ISO):

Technical Committee TC 146 (Air Quality) developed ISO/TR 27628:2007 - contains guidelines on characterizing occupational nanoaerosol exposures

CURRENT GOVERNANCE INITIATIVESCURRENT GOVERNANCE INITIATIVESNational Standards

American National Standards Institute (ANSI) – established Nanotechnology Standards Panel in August 2004 to develop and adopt voluntary standards in terminology, materials properties, and procedures for testing, measurement, and characterization

CHALLENGES IN ADDRESSING CHALLENGES IN ADDRESSING PRODUCT SAFETYPRODUCT SAFETY

Pace of development – bringing health and safety knowledge up to speed with a rapidly developing technology

Research funding – allocating the appropriate amount of resources to health and safety research

Regulation – how to effectively regulate by balancing traditional regulation with promotion of good practices

CHALLENGES IN ADDRESSING CHALLENGES IN ADDRESSING PRODUCT SAFETYPRODUCT SAFETY

Information dissemination – how and when to disseminate information to the public

Public perception – maintaining legitimacy in light of the likelihood that mistakes will be made

International framework – coordinating approaches with other nations, using such models as the United Nations Framework Convention on Climate Change

Innovation – flexibility in performance standards so as to not hinder the development of the technology

CHALLENGES IN ADDRESSING CHALLENGES IN ADDRESSING PRODUCT SAFETYPRODUCT SAFETY

Prioritization – assessment of products to establish degree of danger or hazard

Data gathering – producing, screening, managing, and maintaining information on health and safety, and risk

Standardization – establishment of safety standards to harmonize governance structures between companies, governments, and nations

Liability – establishing a balance between a “preventative” and an “after-the-fact” liability system

CHALLENGES IN ADDRESSING CHALLENGES IN ADDRESSING PRODUCT SAFETYPRODUCT SAFETY

Proprietary Information – balancing information dissemination with the need to protect private information

Benefits vs. risk – balancing the benefits the technology provides with the potential health and safety risks

EHS/Regulatory costs – understanding the financial impacts governance of health and safety will have

Risk management – developing approaches to mitigating risk in light of limited EHS data

CHALLENGES IN ADDRESSING CHALLENGES IN ADDRESSING PRODUCT SAFETYPRODUCT SAFETY

Timeliness – management of time in developing governance approaches, even in the event of a catastrophic EHS problem

Stakeholder involvement – fostering involvement to understand stakeholder preconceptions and provide information that could address related concerns

SUMMARYSUMMARY

Nanotechnology is a rapidly developing technology with beneficial applications across several industries

Potential for adverse health and environmental effects

Studies are inconclusive; governance structure lacking

Currently several governance initiatives by government, private, and international sectors; regulation forthcoming

Scientific, regulatory, and financial challenges ahead

WEBSITE REFERENCESWEBSITE REFERENCES

http://www2.eli.org/research/nanotech.htmhttp://www.technologyreview.com http://es.epa.gov/ncer/nano/index.html http://www.fda.gov/nanotechnology http://www.cdc.gov/niosh/topics/nanotech/default.htmlhttp://www.nano.govhttp://nano.foe.org.au/node/78http://www.wilsoncenter.org/nano http://ethics.iit.edu/codes/engineer.html http://en.wikipedia.org/wiki/Engineering_ethicshttp://www.nsf.govhttp://www.ceg.org/industryreports/Nanotechnology%20executive%20summary.pdfhttp://www.nsti.org/NanoInvestor2006/slides/TYadav.pdf