Emerging Training Needs and Issues in Radiological Protection
Nanotechnology EHS Legal Briefing
1. Nanotechnology EHS Legal Briefing: How
companies are reducing their liability exposure
while achieving regulatory compliance and
market acceptance
_______ Insurance Company
Boston, MA
July 15, 2008
Philip A. Moffat
(202) 789-6027
pmoffat@bdlaw.com
2. Overview of Presentation
• Adequacy of existing legal authorities to
regulate EH&S risks
• Tort liability considerations specific to
nanotechnology
• Current voluntary initiatives and practices
to achieve compliance and reduce
potential liability
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4. Observation
• Majority of governments consider existing legal
authorities adequate, although future
amendments are possible
• Few proposals for laws/regs specific to nano
• Near-term focus on improving implementation
through:
- gaining experience with nano;
- developing science for better risk assessment
and management; and
- developing guidance, methodologies,
classifications, implementing regs, etc.
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5. Available Opinions on Adequacy
▪ European Commission Communication to
Parliament and Council – June 2008
- Recent proposed amendment to REACH annexes to
require registration of carbon and graphite
▪ Environment Canada and Health Canada Proposed
Regulatory Framework under CEPA – Sept. 2007
• Council of Canadian Academies – July 2008
• U.S. Council on Envt’l Quality – Nov. 2007
▪ FDA Nanotechnology Task Force – July 2007
▪ American Bar Association SEER – June 2006
▪ Australian Office of Nanotechnology (DIISR) –
Sept. 2007
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6. Important Minority Trend - Local Laws
Specific to Nanotechnology
• Berkeley, CA ordinance effective June
2007:
• Applies to “manufactured nanoparticles” – one
axis < 100 nm
• File written disclosure plans, regardless of
amount used/produced, identifying:
- nanoparticle production or use;
- current toxicity data; and
- plans for safe handling, monitoring, disposal, and
release prevention & mitigation
• Cambridge, MA considering similar
ordinance: advisory panel assembled and
recommendation expected in 2008.
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7. Important Minority Trend - State Laws
Specific to Nanotechnology
• California Assemblyman Mike Feuer (D) held a public
meeting in April to discuss alternative regulatory
approaches that could be incorporated in future
legislation.
- Proposal expected in 2009
• Wisconsin State Representative Terese Berceau (D)
proposing creation of a registry & reporting system
either through legislation or regulation for submission of
information re:
• type of nanomaterials,
• test methods,
• properties,
• use,
• handling, and
• disposal activities.
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8. Improving Implementation
• Variety of international and domestic govt’l and quasi-
govt’l initiatives to improve implementation of existing
legal authorities.
- OECD
- ISO
- UK Defra VRS
- EPA NMSP
- Others
▪ Intended to advance science and methodologies
supporting risk assessment and management, as well
the knowledge and experience of regulators.
▪ Presentation will not emphasize scientific efforts
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9. International Initiatives - OECD
▪ Organization for Economic Cooperation and
Development (OECD)
- 30 member countries
- Important forum for intergovernmental cooperation
▪ Established Working Party on Manufactured
Nanomaterials (WPMN) in September 2006.
• Eight different projects have potential to help establish
a globally-harmonized risk assessment & management
system for nano.
• Work product likely to influence national regulatory
programs and industry practices.
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10. International Initiatives – ISO TC 229
• Voluntary, consensus-based standards
• Strong liaison with OECD WPMN
• Four Working Groups:
- Terminology & Nomenclature (WG1)
- Metrology & Characterization (WG2)
- EH&S (WG3)
- Material Specifications (WG4)
• Technical report on occupational practices and technical
specification on nanoparticle terminology available soon.
• ISO standards may influence future regs, industry
practices, and eventually standards of care.
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11. Foreign Government Initiatives - UK
Many foreign gov’ts active – UK is a good example
• UK Dept of Environment, Food and Rural Affairs
(Defra) Voluntary Reporting Scheme (VRS)
- existing environmental and human health risk data from
industry and research organizations on free, engineered
nanoscale materials in the UK
- unbound at any phase of life cycle, and deliberately
engineered to have ≥ 2 dimensions within 0 – 200 nm
• Environment Agency May 19, 2008 Interim Advice re
CNT wastes
- classify and handle unbound CNT wastes as “inorganic
wastes containing dangerous substances”
- high-temperature incineration recommended
- concern about physiological properties similar to asbestos
• British Standards Institution terminologies & guidance
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12. Domestic Initiatives
Numerous federal agencies involved:
• NNI
- Funding framework for EH&S and other R&D research of 25
federal agencies
• EPA
- White Paper
- Nanoscale Materials Stewardship Program
- TSCA guidance (new v. existing)
- FIFRA enforcement and petition (nanoscale silver)
• FDA
- Nanotechnology Task Force
• NIOSH
- Information Exchange
- Draft Medical Screening Guidance
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13. EPA Nanoscale Materials Stewardship
• Voluntary program under TSCA for “engineered
nanoscale materials”
- Basic program for:
- submission of “known or reasonably ascertainable” data on
“existing” substances (PMN +), and
- Risk management program that “considers” nano.
- In-depth requires:
- data generation; and
- evaluation of effectiveness of risk management measures.
• Proposal criticized for, inter alia, a lack of:
- deadlines, and
- rules mandating data submission by non-participants.
• 16 Participants in “basic” program to date
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14. EPA TSCA Guidance
• Guidance released in July 2007 Federal Register.
• Confirms that physical form (e.g., particle size) or
properties (e.g., reactivity) will not determine
whether a substance is “new” or “existing.”
• Analysis of “molecular identity” will continue to
focus on structural and compositional features:
- types and numbers of atoms in a molecule,
- the types and number of chemical bonds, and
- the connectivity and spatial arrangement of atoms in a
molecule.
• Current Inventory listings include nano- and bulk-
scale versions of chemical substance.
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15. FDA Initiatives
• Nanotechnology Task Force Report
Released in July 2007
• Three-part report:
- Reviews state of science re nanomaterial
biological interactions
- Identifies science issues of importance to mission
(i.e., biological interactions & current testing
methods) and recommends keeping abreast
through collaboration
- Examines regulatory authority and offers
recommendations
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16. NIOSH Initiatives
National Institute of Occ. Safety & Health:
• Lead gov’t agency focusing on nanoparticle
occupational exposure research
- Non-regulatory; part of the CDC
• Information Exchange - guidance document on
current best practices
- Field Research Team site visits
- Seeks collaboration with industry, et al.
• Interim guidance on medical screening of
workers potentially exposed to nanoparticles
- No specific tests recommended at this time
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17. OSHA Initiatives
• No new rulemaking expected in near
future.
• No OSHA nano-specific PELs or other
stds.
• Current general regulations remain
applicable:
– General Duty Clause
– Hazard Communication
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19. Observations
• Common law and statutory tort liability theories
are available and appear adequate for current
and near-term developments.
- Revolutionary new products in mid- to long-term may
require evolution of the law to include new causes of
action, damages, etc.
• Nanotechnology currently has a unique risk
profile that will present litigation challenges for
claims that arise across various aspects of the
product life cycle.
- Worker exposure claims
- Product claims
- Environmental release claims
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20. Unique Litigation Risk Profile
Nanotechnology has a unique litigation risk profile:
• Evolving scientific knowledge re EH&S risks
- Complex general/specific causation analyses possible
- Latent effects could pose challenges for identifying when
cause of action accrued
- Invitation for “junk science” by hired experts
- Invitation for “creative” causes of action (e.g., med
monitoring)
• Evolving industry practices and standards
- Invitation to second-guess past risk assessment and
management practices (e.g., testing, exposure controls,
warnings, instructions)
• Evolving regulatory standards
- Invitation to second-guess past practices and to allege
failure to disclose risk information to regulators or others
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21. Liability for Worker Exposures
• Workers’ Compensation may not always be a complete
defense:
• California: Johns-Manville Corp. v. Rudkin, 27 Cal. 3d 465
(Cal. 1980) (finding actionable at law the aggravation of
disease caused by concealment of its connection with
asbestos hazards) .
• West Virginia: Roney v. Gencorp, 431 F. Supp. 2d 622
(S.D. W.Va. 2006) (finding actionable at law fraud re
hazards of vinyl chloride monomer).
• Tort theories potentially available given company’s superior
knowledge in comparison to workers:
• Intentional Misrepresentation
• Fraudulent Concealment
• Conspiracy
• Traditional product liability theories for injuries to downstream
workers.
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23. Liability for Environmental Releases
• Potential tort claims for harm to natural
resources, human health, & property:
- Product liability theories
- Trespass, nuisance, diminution in value
• Environmental statutes may impose liability
via citizens’ suit or gov’t action:
- State & federal NRD claims, if designated a haz
substance
- Cleanup orders under various statutes (e.g.,
SDWA, RCRA)
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24. Potential Damages
• Personal injury, including “creative” versions
- “subclinical” injuries
- medical monitoring
• Increased risk of future disease
• Fear-based claims
• Property Damages
- alternative water supplies
- natural resources
• Punitive damages
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26. Observation
• Nanotechnology “sector” is proactive
in addressing EH&S concerns to
achieve present/future compliance
and minimize liability risks:
- Many voluntary initiatives underway
outside of government in addition to
Nano Risk Framework
- Indicators of good practice are readily
available
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27. Nanotechnology Occupational Safety &
Health (NOSH) Consortium
• Established in October 2005
• Industry, academia & gov’t members
• Deliverables:
- develop a nanoparticle generator and
characterize the aerosol as a function of time
- measure filtration & barrier efficiency of
various filter media (e.g., respirator, clothing,
gloves) to specific engineered nanoparticles
- develop a prototype device for daily exposure
monitoring of nanoparticles in air
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28. Int’l Council on Nanotechnology
International multi-stakeholder
organization:
• Develop & communicate information re
human health & environmental risks
– EH&S database
– Host events re EHS & nano
– Provide technical info for decision makers
– Communications development for
stakeholders
• Completed studies re best practices in
occupational settings
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29. Responsible Nano Code
• Royal Society, Insight Investment, NIA, and
Knowledge Transfer Network, assembled multi-
stakeholder working group.
• Voluntary, principles-based code of conduct for large
& small organizations along value chain (incl. retail).
• Goal of establishing international consensus on
“good practice” in as many sectors as possible.
• Seven principles & indicators of compliance.
• Framework of Good Practice and Benchmarking
Process under development.
- Independent assessment of adherents & non-adherents
beginning in 2009
• September/October 2008 release date.
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30. Responsible Nano Code
Principles include:
- Board (or delegate) assumes responsibility for
nano-developments & compliance with Code
- Involve stakeholders proactively
- I.D & minimize occupational risk (including
downstream)
- Perform thorough risk assessment & management
across product life cycle
- I.D. & respond to social - ethical implications
- Engage suppliers & partners to adopt Code
- Transparent re activities & Code implementation
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31. Good Practice #1
• Keep updated on science supporting risk
assessment and management.
“Experts are overwhelmingly of the opinion that
the adverse effects of nanoparticles cannot be
reliably predicted or derived from the known
toxicity of the bulk material.” Source: Allianz & OECD, Small Sizes that Matter
(2005)
“Until more is known about their environmental
impact we are keen that the release of
nanoparticles and nanotubes in the environment
be avoided as far as possible.” Source: Royal Society and the Royal
Academy of Engineering, Nanoscience and nanotechologies: Opportunities and uncertainties (2004) (emphasis added).
• ICON, NIOSH, SAFENANO databases
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32. Good Practice #2
An established process for regular
evaluation, mgmt & communication of
potential risks as data develop is important
for minimizing liability and achieving
compliance.
- Include risks across product life cycle
- Independent testing when appropriate
- Employee training integrated into process
- Designated responsible person(s)
- Auditing when appropriate
- Assists with “good” documentation practices
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33. Good Practice #2 – cont’d.
Why is Practice #2 Important?
• Helps satisfy duties to test, warn and may
facilitate I.D. of avoidable risks in product design
- liability avoidance?
- reduces potential for harm/injury and risk of paying
compensatory damages
- may avoid punitive damages
• Helps achieve current and possibly future
regulatory obligations (e.g., OSHA)
• Current opportunities: Nano Risk Framework,
existing product stewardship practices/policies,
Responsible Nano Code, to name but a few
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34. Good Practice #3
• Keep updated on industry standards and practices.
- Benchmarking: N.A. industry worker protection efforts:
- “North American organizations more frequently reported
administering nano-specific EHS programs including
training, and monitoring the work environment than
organizations in other parts of the world. Similarly, North
American organizations more often reported using high
capital cost engineering controls such as clean rooms,
closed piping systems, and separate HVAC systems,
compared to organizations from Asia that indicated more
widespread use of glove boxes, glove bags and respirators.”
Source: ICON, A Survey of Current Practices (2006).
- Life Cycle Assessment ISO 14040: 2006
- Occup. Inhalation Exposure & Assmt ISO TR 27628: 2007
• Many sources of info - ISO, ASTM, NIOSH, NOSH, ICON
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35. Good Practice #4
• Engage regulatory agencies as appropriate.
- May reduce later allegations of withholding information
from regulators.
- May help I.D. current & future compliance obligations.
- May help educate regulators.
- May reassure public and other stakeholders.
• Many opportunities available:
- EPA NMSP
- NIOSH Info Exchange & Field Team Visits
- UK Defra VRS
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36. Conclusion
• Most governments consider current legal
authorities adequate to regulate
nanotechnology, but they are working to
improve implementation with the assistance of
independent scientists and industry.
• Nanotechnology currently has a unique profile
that may increase risk of tort litigation and pose
challenges for defendants.
• Nanotechnology “sector” is proactively
addressing potential liability, regulatory, and
public perception risks.
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