1. A regulatory outlook for “NanoSafety”
Kimberly Begley Jeskie
Operations Manager
Physical Sciences Directorate
American Chemical Society
Fall 2007 National Convention

2. Numerous government agencies and organizations
are exploring options for regulating engineered
nanoscale materials
• National Nanotechnology Initiative
• Occupational Safety and Health
Administration
• National Institute of Occupational
Safety and Health (later talk)
• Environmental Protection Agency
• ANSI
• Food and Drug Administration
• Congress and Individual States
• European Union
• Department of Energy
OAK RIDGE NATIONAL LABORATORY
U. S. DEPARTMENT OF ENERGY
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3. The National Nanotechnology Initiative
“federal R&D program established to coordinate the multiagency efforts
in nanoscale science, engineering, and technology”
• Interim document for priorities in
EH&S research needs currently
out for comment through
September 17, 2007
• http://www.nano.gov/
Prioritization_EHS_Research_Nee
ds_Engineered_Nanoscale_Materi
als.pdf
• Lists 25 priorities
- Instrumentation, metrology
analytical methods
- Nanomaterials in human health
- Nanomaterials in the environment
- Health and environmental exposure
assessment
- Risk management methods
• The initiative, as a whole is
guiding Federal investments in
R&D for basic research, applied
research, safety and health and to
some degree the regulatory
framework
OAK RIDGE NATIONAL LABORATORY
U. S. DEPARTMENT OF ENERGY
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4. Occupational Safety and Health
Administration
• NanoSafety highlighted as
early as 2004 in OSHA
planning sessions
• In February 2007 Inside OSHA
reported that OSHA plans no
regulatory action in 2008 and
is working with NIOSH
• Highlighted in the Department
of Labor 2006-2011 Strategic
Plan
- “knowledge workers” with
specialized skills and training
• The administration is taking
public criticism for what is
perceived as not taking
action…more later on this.
OAK RIDGE NATIONAL LABORATORY
U. S. DEPARTMENT OF ENERGY
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5. Environmental Protection Agency “supporting research
while evaluating its regulatory responsibility to protect environment and
human health”
• Nanoscale Materials Stewardship Program
- Developed under TSCA framework
- Intended to establish scientific foundation for
regulatory decisions
- Would include voluntary inventory collection
- New chemical determination on a case-by-case
basis
- http://epa.gov/oppt/nano/nmspfr.htm
- Public comments accepted through September 10,
2007
• Working with Organization for Economic
Cooperation and Development (OECD)
- International
- Safe testing and testing guidelines
- Voluntary and regulatory schemes
• EPA is holding a • General interpretation that no current changes
“Pollution to RCRA or CERCLA.
Prevention through - Research being funded in treatment, disposal
Nanotechnology - Agency points to changing characteristics under
RCRA based on particle size
Conference”
• Regulation of silver nanomaterials used in
• September 25-26, consumer products as “germ-killing agents.
2007 Under FIFRA
OAK RIDGE NATIONAL LABORATORY
U. S. DEPARTMENT OF ENERGY
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6. American National Standards Institute
Nanotechnology Standards Panel
“development of standards in the area of nanotechnology”
• Has been in place since 2004
• Focus areas
- Nomenclature/ terminology
- Materials properties
- Testing, measurement and
characterization
• Appears to have been lots of
activity in the nomenclature
and morphology areas.
Additional progress unclear
• Established TAG to ISO TC
229
• http://www.ansi.org/
standards_activities/
standards_boards_panels/
nsp/overview.aspx?menuid=3
OAK RIDGE NATIONAL LABORATORY
U. S. DEPARTMENT OF ENERGY
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7. Food and Drug Administration
Nanotechnology Task Force
“established to determine adequacy and application of regulatory
authorities” • Established in August of 2006.
• Task force report issued July
2007
- http://www.fda.gov/
nanotechnology/
• Cites need to pay attention to
emerging science to predict
and prepare for types of
products
• Calls for timely development
of a transparent, consistent,
and predictable regulatory
pathway
- No immediate need for
additional labeling
- Products that normally do not
require pre-market
authorization requirements
- Public input on adequacy of
FDA’s policies for certain
products containing
nanoparticles
OAK RIDGE NATIONAL LABORATORY - Communication initiated by
U. S. DEPARTMENT OF ENERGY manufacturers
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8. Miscellaneous examples are arising from
Congress and individual states
The Berkeley NanoReg HR 3235, the Nanotechnology
Advancement and New
Opportunities (NANO) Act
• Asked for letter to be sent to • Introduced July 31, 2007 by
elected officials pushing for Mike Honda (D-San Jose)
percentage of funding set
aside for ES&H research • “To ensure the development
and responsible stewardship
• “require all businesses that of nanotechnology”
manufacture or use
nanoparticles to submit a • Tax credits for investment in
written report of the current nanotechnology firms
toxicology of the
nanomaterials reported, and • $30M to EPA for R&D
methods for safe handling,
monitoring, containing, • $30M to Health and Human
disposing, and tracking the Services for R&D
inventory, thus assisting with
prevention and mitigation of
releases”
OAK RIDGE NATIONAL LABORATORY
U. S. DEPARTMENT OF ENERGY
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9. International Focus on NanoSafety
• International Organization for
Standardization
- ISO/TC 229 commissioned in
2005 with strong delegation
from ANSI
- Development of “science-
based health, safety and
environmental practices” ANSI
has lead on this subcommittee
• United Nations
- Environmental Program has
expressed concern for ES&H
implications of nanoparticals
- Has called for treaties to
establish mutually agreed
upon standards
• European Union
- Performing a regulatory
inventory
OAK RIDGE NATIONAL LABORATORY
U. S. DEPARTMENT OF ENERGY
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10. Public perception and involvement: how much
influence will it have?
“Principles for the Oversight of Nanotechnologies and
Nanomaterial”
• Released July 31, 2007 • Health and safety of the public
and workers – employer proactive
• Available at http://www.foe.org/ action and worker involvement in
pdf/Nanotech_Principles.pdf nanosafety without fear of
retaliation
• Interest groups from numerous
countries. Among the list are • Environmental Sustainability –
Greenpeace, United Steelworkers lifecycle assessment prior to
and Friends of the Earth. commercialization
• Report espouses 8 basic • Transparency (to the consumer) –
principles labeling publicly accessible
inventory for health and safety
• Precautionary foundation – “no information
health and safety data, no market”
• Public participation – technology
• Mandatory nano-specific driven by process involving
regulations, esp. environmental informed public
and retroactive
• Inclusion of broader impacts –
social impact, ethical assessment
equity
• Manufacturer liability – including
distributors of products
OAK RIDGE NATIONAL LABORATORY
U. S. DEPARTMENT OF ENERGY
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11. Department of Energy Nanoscience Centers
“Providing the Nation with resources unmatched anywhere else
in the world”
• Issued Policy Statement 456.1 in 2005
- Adopt emerging consensus standards
- Identify and manage potential health and safety
hazards and potential environmental impacts
- Stay informed
- Support ES&H research in the area
• February 2007, 10 CFR 851 issued with a
placeholder called “NanoSafety”
• Talk of a “Nano Order” currently on hold
supporting use of guidelines document
established by working group
OAK RIDGE NATIONAL LABORATORY
U. S. DEPARTMENT OF ENERGY
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12. Numerous government agencies and organizations
are exploring options for regulating engineered
nanoscale materials
• National Nanotechnology Initiative
• Occupational Safety and Health
Administration
• National Institute of Occupational
Safety and Health (later talk)
• Environmental Protection Agency
• ANSI
• Food and Drug Administration
• Congress and Individual States
• European Union
• Department of Energy
OAK RIDGE NATIONAL LABORATORY
U. S. DEPARTMENT OF ENERGY
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