US Legal/Regulatory Governance Framework Initiatives - George ...

Environmental Governance at the Leading Edge of
Technology Symposium
The Strengths and Limitations of
Existing Governance Structure
Washington, D.C.
March 23, 2011
Lynn. L. Bergeson
Bergeson & Campbell, P.C.
www.lawbc.com

U.S. Legal/Regulatory Governance
Framework Initiatives
■ General Approach -- Integrate nanotechnology into
existing regulations, consider new authorities as
necessary
■ U.S. Environmental Protection Agency (EPA)
� Nanotechnology White Paper
(http://www.epa.gov/osa/pdfs/nanotech/epa-nanotechnologywhitepaper-0207.pdf)
� Toxic Substances Control Act (TSCA) -- TSCA Significant New
Use Rules (Section 5), Data Gathering (Sections 4 and 8);
� Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) --
Regulatory Guidance; one-off pesticide registration HeiQ
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U.S. Legal/Regulatory Governance
Framework Initiatives (cont’d)
■ U.S. Food and Drug Administration (FDA)
� Nanotechnology Task Force Report 2007
(http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/N
anotechnologyTaskForceReport2007/default.htm)
● Public Workshop - Medical Devices and Nanotechnology:
Manufacturing, Characterization, and Biocompatibility Considerations, 2010
(http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/
ucm222591.htm)
● FDA Nanotechnology Public Meetings, September 8, 2008, and October
10, 2006: Gather information that will assist the Agency in implementing
the recommendations in the Nanotechnology Task Force Report as well as
furthering FDA understanding of developments in the use of nanoscale
materials in FDA-regulated products
(http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm1
96699.htm)
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U.S. Legal/Regulatory Governance
Framework Initiatives (cont’d)
� Research Partnerships at FDA
(http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/u
cm208110.htm)
● National Cancer Institute (NCI)-National Institute of Standards and
Technology (NIST). The Nanotechnology Characterization Laboratory
● Johns Hopkins University: Training and Outreach
● Alliance for Nanohealth: Speed development of safe and effective medical
products involving nanotechnology
● NCI Alliance for Nanotechnology in Cancer (http://nano.cancer.gov/)
� International Cooperation on Cosmetic Regulation, including detection
and characterization of nanomaterials in cosmetics
(http://www.fda.gov/InternationalPrograms/HarmonizationInitiatives/uc
m114513.htm)
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U.S. Legal/Regulatory Governance
Framework Initiatives (cont’d)
■ The Consumer Product Safety Commission’s (CPSC) 2010 report to
Congress includes three research activities:
� Nanotechnology Annual Data Update (Consumer Product Database): CPSC is
developing an internal database that lists specific products and the materials
contained in the products
� Nanomaterials in Aerosol Products: The National Institute for Occupational
Safety and Health (NIOSH) expects to complete its evaluation of aerosols
released from a spray product and submit a final report to CPSC in early 2011;
CPSC expects to continue this work to test similar products
� Nanosilver in Consumer (Children’s) Products -- CPSC entered into new
agreements with NIOSH and EPA to evaluate potential exposures to consumers
from use of nanosilver-enabled products
■ CPSC’s FY 2012 budget request seeks funding for these activities and
others, including a study concerning carbon nanotubes in selected products;
enhancement of the National Library of Medicine Household Products
Database to provide information on nanomaterials in consumer products;
and a literature search on consumer exposure to nanomaterials from
treated products
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Private-Sector Stewardship Initiatives Quickly Fill Void
Left By Governmental Initiatives
■ Environmental Defense Fund/DuPont Nano Risk Framework
(http://nanoriskframework.com)
■ International Council on Nanotechnology (ICON) GoodNanoGuide
(http://goodnanoguide.org)
■ Nanoparticle Occupational Safety and Health (NOSH) Consortium
■ NanoRelease Project (ILSI-RF)
■ ABA Section of Environment, Energy, and Resources Nano Project
(http://www.americanbar.org/groups/environment_energy_resources
/projects_awards/nanotech.html)
■ B&C Nanoblog (http://nanotech.lawbc.com/)
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Inter-Governmental Cooperative
Initiatives
■ Organization for Economic Cooperation and
Development (OECD)
� Working Party on Manufactured Nanomaterials (WPMN)
(Chemicals Committee)
� Working Party on Nanotechnology (WPN) (Committee for
Scientific and Technological Policy)
■ UNEP International Conference on Chemicals Management (ICCM)
Strategic Approach to International Chemicals Management
(SAICM)
■ NIOSH Approaches to Safe nanotechnology (www.cdc.gov/niosh/)
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Standard-Setting Initiatives
■ International Organization for Standardization (ISO)
� Technical Committee 229 -- Four Nanotechnology
Subcommittees: Terminology and Nomenclature; Measurement
and Characterization; Health, Safety, and Environmental
Aspects; and Material Specifications
■ ASTM
� Technical Committee E56 on Nanotechnology -- Addresses
issues on standards and prepares guidance materials on
nanotechnology and nanomaterials
■ Close coordination with other standard-setting
organizations and entities -- International
Electrotechnology Committee (IEC/TC113), NIST,
among many others
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Evolving Standards of Care
■ In absence of clear government-backed legal/regulatory
standards (and even with them), evolving private sector
codes of conduct are becoming the de facto legal
standard against which to measure corporate behavior
■ Compliance with the highest standard of care will be
most protective of business/commercial interests. Other
business tools are essential to minimize liability:
� Insurance
� Protective contracts/representations/warranties
� Cultivate commercial credibility
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Evolving Standards of Care (cont’d)
■ No published nano-tort or other lawsuit yet
■ Best defense is a good offensive
� Be proactive
� Stay engaged
� Be conservative regarding appetite for risk (commercial or
otherwise)
� Observe highest standard of business practices
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Lynn L. Bergeson
BERGESON & CAMPBELL, P.C.
1203 Nineteenth Street, N.W.
Suite 300
Washington, D.C. 20036
lbergeson@lawbc.com
www.lawbc.com
B&C CONSORTIA MANAGEMENT, L.L.C.
1203 Nineteenth Street, N.W.
Suite 300
Washington, D.C. 20036
lbergeson@bc-cm.com
www.bc-cm.com
Thank you
THE ACTA GROUP, L.L.C.
1203 Nineteenth Street, N.W.
Suite 300
Washington, D.C. 20036
lbergeson@actagroup.com
www.actagroup.com
THE ACTA GROUP EU, LTD
23 New Mount Street
Manchester
M4 4DE
United Kingdom
www.actagroup.com
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