NanoRelease
and
NanoCharacter
projects
1
Agenda
NanoRelease
• Overview, Work Flow, Project Support and Teams
• The Need for the NanoRelease Project
• May 2011 Workshop and Selection of MWCNTs in
Polymer
• Next Steps
NanoCharacter
• The need
• Plan and who we have signed up
Funding sources and needs
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NanoRelease Project Overview
Design
• Multi-stakeholder leadership
• Open and transparent process
• Prioritize challenges & needs
Review current release literature
• Solicit expert input on priorities
• Select first ENM to examine
– Parallel efforts welcome…
• State of Science paper on what we
know and can do now
Goals
• Identify best practices for measuring
release
• Use inter-laboratory testing to
advance the state of science
• Validate methodologies and
demonstrate transportability
• Work with Standard Development
Organizations to develop standard
methodologies for release
• Transfer technical information to
training modules for workplace
safety professionals
www.ilsi.org/ResearchFoundation/Pages/NanoRelease1.aspx
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4
Phase 2 Structure
5
Supporting Organizations
• US Environmental Protection Agency (EPA), Office of
Research and Development and Office of Pollution
Prevention and Toxics (in kind support)
• Environment Canada, Emerging Priorities Division
• Health Canada, New Substances Assessment and Control
Bureau
• American Chemistry Council (ACC), Nanotechnology Panel
• Society of Chemical Manufacturers & Affiliates
• National Institute of Standards and Technology (NIST)
• The Adhesive and Sealant Council
• American Cleaning Institute
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Coordination and Outreach
• Multi-Stakeholder Steering Committee
EPA, National Institute for Occupational Safety and Health
(NIOSH), the Occupational Safety and Health Administration
(OSHA), Consumer Product Safety Commission (CPSC), NIST,
Health Canada, Environment Canada, Consumers Union, American
Chemistry Council, AFL-CIO
• OECD – WPMN / SG8
• INNO:CNT project in Germany
• NanoImpactNet
• ANSI / ISO TC229
• ASTM E56
7
Landscape of nano-safety Literature
Exposure
21%
Release
1%
Hazard
78%
- based on NCBI citations 2011
Within these, the number of studies of what is actually
released from real-world uses of nanomaterials are far fewer.
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Why do we care?
• Risk is defined by both exposure and hazard/toxicity
• To develop safe products we need to measure what is released
and characterize it’s relationship to hazard data
• The science of measuring nanomaterials is evolving, and
because there are current risk assessment needs, policy is also
evolving
• Products with nanomaterials in them are on the market now and
will shape the policies that are developed for all
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NanoRelease Project Adds Value
• Provide focus to broad policy debates by working through
release scenarios for specific nanomaterials;
• Examine the full life cycle of solid material uses;
• Catalogue and disseminate published and unpublished data and
methods used to evaluate release scenarios;
• Develop “state of the science” reports describing what is known
and what research gaps exist for understanding nanomaterial
releases;
• Enable improvements, standardization, and widespread use of
methods through an inter-laboratory approach to methods
improvement.
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Nanomaterial Selection Process
1. A “multi-voting” approach ranked
nanomaterials during two rounds of voting
• The results of each round were discussed as a
group
• The list was refined
• Steering committee members were given time to
consult with colleagues.
2. Nanomaterials were sorted into 3 tiers
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Priority Engineered Nanomaterials
Tier 1:
•Multi-walled
carbon nanotubes
•n-Silver
•n-Titania
•n-Silica dioxide
Tier 2:
•n-Copper
•Single-walled
carbon nanotubes
•n-Clays
•Nanocrystalline
cellulose
Tier 3:
•n-Zinc oxide
•n-Aluminum oxide
•n-Cerium oxide
•Quantum Dots
•Carbon Black
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May 2011 Workshop to Inform the Steering
Committee on which Nanomaterial to Choose
50 participants at EPA in Washington DC
–
–
–
–
US and Canadian agencies (plus EMPA from Switzerland)
Leading industry – general and n-Ag and MWCNT specific
Academics – some doing research that highly overlaps
Non – Governmental Organizations
17 presentations in 4 panels over 2 days
–
–
–
–
Data sharing needs
n-Ag in textiles
MWCNT in polymer
Methods
Breakout sessions
– Low hanging fruit
– Defining the “release/source term”
Presentations are available on the project web site
www.ilsi.org/ResearchFoundation/Pages/NanoReleaseMay2011Workshop.aspx
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What We Learned: Enthusiastic Steering
• Lots of specific details on materials and potential methods.
• Both MWCNT and n-Ag difficult and need this work done –
making it a tough choice for the Steering Committee.
• “Essential project for safe product development”
No one asked “why is this needed”
• This is a leading effort, take advantage of the momentum
• Pay attention to the context/conceptual model so that we don’t
waste opportunities by framing it wrong
• Can easily get confused by the variety of needs here, so be razor
sharp on scope and don’t get side-tracked
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The selection: MWCNT in polymer
In meetings after the Workshop the Steering Committee
selected MWCNT in polymer applications
We are now selecting the specific polymer to use in
methods development, in consideration of applications
such as:
– Fabrics such as flame-retardant toys & blankets
– Tennis racquets, bicycle frames, baseball bats, sports safety
equipment
– Automobile parts
– Boat hulls
– Coaxial cable
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Current Plan for MWCNT Test Materials for
Phase 3 Methods Development
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Next Steps
• Obtaining the carrier system to test
– Identifying potential MWCNT carrier systems for testing,
implementing procedures, obtaining the system
• Selecting the methods to compare
– Prioritizing best practices to compare with an inter-laboratory
approach
• Selecting the release scenarios of greatest value for
consumer products
– Weathering, abrasion, cutting, drilling ??
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Phase 2 Structure
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NanoCharacter project
There are no reporting standards for
nano-toxicity or exposure studies
Multiple efforts to establish standard approaches:
• International Groups
– International Organization of Standardization TC229
– Organization of Economic Cooperation and Development Working Party
on Manufactured Nanomaterials: Guidance for Sponsors
• “Grass roots” multi-sector: http://characterizationmatters.org/
• Sector-specific
– Food toxicology: Card, J. W. and Magnuson, B. A. (2009), Letter to the
Editor. Journal of Food Science, 74: vi–vii.
– Cancer/medical:
http://ncl.cancer.gov/working_assay-cascade.asp
The European Food Safety Authority
Nano Food Guidance, Regarding
Characterization
• Refers to characterization needs at 4 stages of
the material
–
–
–
–
Pristine
In food
For toxicity testing
As in biological fluids
• Most tests do not have standard methods
http://www.efsa.europa.eu/en/efsajournal/pub/2140.htm
“The most prominent characteristics of the
ENM, as determined by its function,
purpose and intended use, should be
described and relevant parameters must be
determined and provided, according to
Table 1.”
http://www.efsa.europa.eu/en/efsajournal/pub/2140.htm
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Does consistent reporting happen?
Nine were chosen for evaluation of the literature for oral
toxicity studies by Card et al. 2010
•
•
•
•
•
•
•
•
•
Agglomeration and/or aggregation
Chemical composition
Crystal structure/crystallinity
Particle size/size distribution
Purity
Shape
Surface area
Surface charge
Surface chemistry (including composition and reactivity)
Card JW, Magnuson BA. 2010. A method to assess the quality of studies that examine the toxicity of
engineered nanomaterials. Intl. J. Toxicology 2010 29(4):402-410. Accessible at
http://ijt.sagepub.com/content/29/4/402.full.pdf+html.
21 oral studies of nanomaterials were evaluated for
reporting of the 9 characteristics
9. Surface chemistry
8. Surface charge
7. Surface area
6. Shape
5. Purity
4. Size distribution
3. Crystallinity
2. Composition
1. Agglomeration
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Card JW, Jonaitis TS, Tafazoli S, Magnuson BA. 2010. An appraisal of the published literature on the safety and
toxicity of food-related nanomaterials. Critical Reviews in Toxicology:
posted online Nov. 16 (doi:10.3109/10408444.2010.524636), accessible at
http://informahealthcare.com/doi/abs/10.3109/10408444.2010.524636
Study
Folkmann et al. (2009)
Warheit et al. (2007)
Warheit et al. (2007)
Rohner et al. (2007)
Wang et al. (2007)
Bisht et al. (2008)
Yoksan and Chirachanchai (2008)
Alkilany et al. (2009)
Jevprasesphant et al. (2003)
Wang et al. (2008)
Huang et al. (2009)
Koeneman et al. (2009)
El-Sayed et al. (2003)
Meng et al. (2007)
Chen et al. (2006b)
Wang et al. (2006)
Zhang et al. (2001)
Balasubramanyam et al. (2009)
Jia et al. (2005)
Kim et al. (2008)
Yu et al. (2008)
Chan et al. (2009)
Gajdošíková et al. (2006)
Zhang et al. (2005)
Pisal et al. (2008)
Mori et al. (2006)
Kitchens et al. (2007)
Chen et al. (1998)
Xu et al. (2004)
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Inconsistent measurement and
reporting precludes comparisons
• Exposure misclassification – exposure and toxicity data can’t be
reliably linked
• Wasted knowledge – data can’t be combined to build knowledge
• Development risk – new data may not be useful to future
assessments
• Vulnerability to “killer studies” – a hazard study can’t be
compared to other nanomaterials
We should tread carefully in data or methods development until we
know what characteristics data will be needed.
NanoCharacter Project Outcomes:
• A framework and roadmap detailing what needs to be done to
gradually adopt characterization consistency for particular
domains (e.g., particle toxicology, regulation of food
constituents, environmental monitoring, regulation of commodity
nanomaterials).
• Outreach to build consensus on the roadmap internationally,
across stovepipes, and across stakeholders (e.g., academics,
funders, regulators, industry, and editors or peer reviewers at
journals).
• A multistakeholder panel to monitor and report out (as letters
to appropriate agencies and journals) the implementation of the
roadmap and to adapt the roadmap as necessary to facilitate
adoption of consistent characterization and reporting.
The framework lays out the needs of key institutional
players, the starting list, the stovepipes, the resource
and technology timing issues with respect to
characteristics on the list, and the approach to
overcoming barriers.
The roadmap lays out goals and milestones in
consideration of the timing of critical control elements
(e.g., funding of research that includes funding of
specified types of characterization, funding of methods
and instrument development, standardization of
methods and regulatory policy adoption,
acceptance/adoption by the research community).
Framework considerations
• Support of academia – can laboratories afford the necessary
equipment, and are researchers willing to accept the standards?
• Support of journal editors and peer reviewers – can the technical
specifications be applied, will it slow publication?
• Support and agreement across funding agencies – to require
characterization and funding for it
• Support that spans national and regional boundaries
• Infrastructure for measurement – standard analysis methods, and
availability of advanced instrumentation
• Cost consideration – phase-in the requirements over time and/or
promote the use of user facilities
This project will work where others have not:
• We are not proposing a competing list that gets added to the
noise. We will select common elements of the many lists as
the starting point in staged implementation
• We seek only to lay out and follow practical implementation
steps
• We are the first to look across funding, inter-discipline,
international, and technical barriers to find solutions
• Getting leaders of past efforts or thought on the topic allow
us to start with a unified front on what to do next, and after
that, and after that.
Partial funding for Step 1 (framework and
roadmap) by Institute of Food Technologists
Expert team recruitment so far
– Andrew Maynard
– Rob Aitken, IOM, UK
– Ken Dawson, University College Dublin
– Shaun Clancy, Evonik
– Ray David, BASF
– David Warheit, Dupont
– Fred Klaessig, consultant - ISO TC229
– Additional experts to be invited.
Funding sources and needs
NanoRelease – MWCNT/Polymer
Phase 2 through June 2012
– $220k committed from ACC, EPA, Environment Canada,
Health Canada
– Need $70k – largely for travel and workshop facility/support
• Need $200k for Phase 3 through mid 2013
– Asked EPA ORD for $50k
NanoCharacter
• Institute for Food Technologists provided $11k seed
funding
• Seeking $30k to complete Roadmap/Framework
33
Thank you
Richard Canady, PhD DABT
Director, RSIA
rcanady@ilsi.org
www.ilsi.org/RESEARCHFOUNDATION/Pages/RSIA.aspx