PRODUCT SAFETY IN
NANOTECHNOLOGY
EIN 5322 Project
Fall 2007
Jonathan Rivera
INTRODUCTION

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
INTRODUCTION
OUTLINE
I.
II.
III.
IV.
V.
VI.
Development of Nanotechnology
Relation of Product Safety to Engineering Ethics
Product Safety Concerns in Nanotechnology
Current Governance Initiatives
Challenges in Addressing Product Safety
Summary
DEVELOPMENT OF NANOTECHNOLOGY
What is nanotechnology?
 “…the creation and
utilization of materials,
devices, and systems
through the control of
matter on the nanometerlength 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 NANOTECHNOLOGY
What is nanotechnology?
No official definition; generally accepted definition by
National Nanotechnology Initiative:
1.
2.
3.
Research and technology development at the atomic,
molecular or macromolecular levels, in the length scale
of approximately 1 - 100 nanometers
Creating and using structures, devices and systems
that have novel properties and functions because of
their small and/or intermediate sizes, and
Ability to be controlled or manipulated on the atomic
scale
DEVELOPMENT OF NANOTECHNOLOGY
What is nanotechnology?
DEVELOPMENT 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 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 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 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 NANOTECHNOLOGY
Wide range of impacted industries and products, including:
Automobile
Electronics
Building &
Household
Products
Medicine
Consumer
Products
DEVELOPMENT OF NANOTECHNOLOGY
Existing and near term applications
DEVELOPMENT OF NANOTECHNOLOGY
Other applications:





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
DEVELOPMENT OF NANOTECHNOLOGY
DEVELOPMENT OF NANOTECHNOLOGY
The 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 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 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 NANOTECHNOLOGY
DEVELOPMENT OF NANOTECHNOLOGY
DEVELOPMENT OF NANOTECHNOLOGY
DEVELOPMENT 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 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
ENGINEERING 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
ENGINEERING 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
ENGINEERING 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
ENGINEERING 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
ENGINEERING 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
ENGINEERING 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
ENGINEERING 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
NANOTECHNOLOGY
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
NANOTECHNOLOGY
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
NANOTECHNOLOGY
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
NANOTECHNOLOGY
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
NANOTECHNOLOGY
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 INITIATIVES
“Securing the Promise of Nanotechnology: Is U.S.
Environmental Law Up to the Job” (Conference)
May 25 – 26, 2005
Washington, 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 INITIATIVES
Conference

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 INITIATIVES
Conference

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 INITIATIVES
Conference

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 INITIATIVES
Conference

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 INITIATIVES
Conference

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 Act
 Clean Water Act
 Resource Conservation and Recovery Act (RCRA)
 Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA or
Superfund Law)
CURRENT GOVERNANCE INITIATIVES
Conference

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 INITIATIVES
Conference
Short-Term Recommendations

Restrict dispersive uses

Assume toxicity until
shown otherwise

Prioritize substances of
concern

Treat wastes as
hazardous materials
Conduct health
surveillance

Train workers in personal
protective equipment and
hygiene


Conduct exposure
monitoring
CURRENT GOVERNANCE INITIATIVES
U.S. Government

The National Nanotechnology Initiative (NNI)
 Started
FY 2001
 Consists of 24 federal agencies
 Nanoscale Science Engineering and Technology
(NSET) Subcommittee appointed by the President
 Coordinates multi-agency efforts, provide funding
for university laboratories, and support U.S.
companies
 Supports responsible development of
nanotechnology for protection of health and safety
CURRENT GOVERNANCE INITIATIVES
U.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 INITIATIVES
U.S. Government

Environmental Protection Agency (EPA)

White Paper (February 2007) – what EPA should do
about implications of nanotechnology
CURRENT GOVERNANCE INITIATIVES
U.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 INITIATIVES
U.S. Government

Food and Drug Administration (FDA)

Nanotechnology Task Force
 Formed
August 2006
 Identifies 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 INITIATIVES
U.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 INITIATIVES
Private 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 INITIATIVES
Non-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 INITIATIVES
Non-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 INITIATIVES
Other 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 INITIATIVES
International 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 INITIATIVES
International 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 INITIATIVES
National 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
PRODUCT 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
PRODUCT 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
PRODUCT 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
PRODUCT 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
PRODUCT 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
SUMMARY

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 REFERENCES
http://www2.eli.org/research/nanotech.htm
http://www.technologyreview.com
http://es.epa.gov/ncer/nano/index.html
http://www.fda.gov/nanotechnology
http://www.cdc.gov/niosh/topics/nanotech/default.html
http://www.nano.gov
http://nano.foe.org.au/node/78
http://www.wilsoncenter.org/nano
http://ethics.iit.edu/codes/engineer.html
http://en.wikipedia.org/wiki/Engineering_ethics
http://www.nsf.gov
http://www.ceg.org/industryreports/Nanotechnology%20executive%20s
ummary.pdf
http://www.nsti.org/NanoInvestor2006/slides/TYadav.pdf