nanocharacter a collaborative project to improve comparability in how nanomaterials are...
TRANSCRIPT
NanoCharacterA collaborative project to improve comparability in how
nanomaterials are characterized
Presentation by:Richard Canady, Center for Risk Science Innovation and Application,
Washington DC
With collaboration of: Andrew Maynard, University of Michigan Risk Science CenterDiana Bowman , University of Michigan Risk Science Center
Overall Goal
Create a framework and roadmap to implement reporting of comparable nanomaterial characterization data across studies.
Where needed.
Independent Consortium
• Because so many boundaries are crossed by this undertaking, this should not be a project of any one of entity
Government regulatory agencies funding agencies, standards development organization, instrument makers, materials manufacturers, editorial boards of journals, academic institutions, consultants, etc
• The proposal is to – use a set of documents to organize thoughts (framework publication
to start)– if it is clear that there is something to do, then we develop a standing
steering committee to keep the progress going
• So, the first task is to develop a framework and initial roadmap
Framework and roadmap defined (draft)The framework lays out - Specific needs and objectives for reporting consistency in a specified area- The entities or barriers that affect characterization and reporting,- The stovepipes (barriers between entities), - The resource and technology timing issues of making progress, and - An approach to developing beneficial characterization and reporting
The roadmap specifies goals and milestones for beneficial adoption of characterization and reporting For example, – What characteristics to adopt first, and where, and why,– What steps are needed to get it done
• Standardization of methods and regulatory policy adoption• Grants that fund specified types of characterization, • Funding of methods and instrument development• Monitoring?
– What is needed in order to add to the list, and when
Conceptual Framework Relationship Map
Infrastructure- Expertise- Instruments- Facilities- Methods
Standards- Standard testing- Nomenclature- Measurands- Reference
materials
Relevance Utility to - research and
development- exposure assessment- effects assessment
Funding To develop - Instruments- data- standards- expertise
Cross-discipline communication- Materials design- Toxicity - Physics- Chemistry
Regulatory acceptance- International- Cross agency- Cross product-
class
Roadmap example1) Identify measurand 1 (select from ISO?)2) Identify measurement objectives3) Identify impediments and targets, e.g.,
– Availability of instrumentation– Availability of standard methods– Funding for measurement in studies– Acceptance criteria of agencies– Cultural silos
4) Propose timeline for addressing, e.g., – Equivalence-evaluation of agencies criteria – what tests will meet the needs?– Select most promising current methods set that meet measurement objectives– Identify pathway for data development (will vary based on above)
• Expensive instruments and high expertise at user facilities in identified labs • Funding for user facilities in grant offerings, or for specific testing, or for instrument purchase
– Expertise development/identification for cultural adoption• Cross discipline communication• Peer review • Grant review
5) Monitor/evaluate/refine/reiterate
Project outputs
The next 6 months– Framework document to circulate– Publish framework (high profile publication)– Initiation of a roadmap resource as a reference guide to progress?
Living document
If we identify something feasible to accomplish, then we will seek to form a multi-stakeholder Steering Committee to
– Develop the roadmap– Do outreach
• Recruitment to / endorsement of the roadmap• Awareness raising
– Monitor progress• Yearly workshop on progress and adjustment and initiating new focal areas for
roadmaps• Reports to stakeholders on progress• Publication on current need (do we still need to exist), progress, and planning
January 10-11 NanoCharacter Workshop at NIEHS in RTP NC
• Approximately 35 participants from US, Canada, Europe, Australia
• Spent half a day presenting the problem
• Then the participants set to work to: 1) Identify the main elements that impact developing
beneficial characterization and reporting of nanomaterial characteristics.
2) Identify barriers and dependencies for implementing characterization and reporting
3) Draft steps to address the barriers or dependencies.
Initial findings of the project
• Adoption should have clear benefit to users, rather than be a tax on science.
• Adoption will have some “node specificity” – for example characterization and reporting for basic research in
optical materials may be different than for regulatory risk management.
– So, we need to focus on a specific area where consistency can occur
• Based on discussions among participants the first focus is health risk management of materials currently in commerce– Not basic research or materials development
– No particular material types have (yet) been selected
• Take advantage of existing structures wherever possible
Elements of the problem were considered for 4 topic areas
BOG1Different purposes of characterization and reportingChair: Hermann StammRapporteur: Andrew Atkinson BOG2Infrastructure for characterization and reporting Chair: Angela Hight-WalkerRapporteurs: Jo Anne Shatkin and Maria Doa
BOG3Economics of adopting characterization and reportingChair: Qasim ChaudhryRapporteur: Vicki Stone BOG4Cultural adoption Chair: Maxine McCallRapporteur: Shaun Clancy
BOG1Different purposes of characterization and
reporting
For example, • Regulatory compliance– Labeling– Toxicity testing– Good Manufacturing Practice
• Communicating within a knowledge area– Optical materials, aerospace, food processing– Toxicology – Fate and transport modeling
• Marketing for sale in manufacturing supply chain
BOG2Infrastructure for characterization and
reporting
For example, • Testing methods• Standard reference materials• Instrumentation• Expertise • Shared facilities
BOG3Economics of adopting characterization and reporting
• Funding– To develop standard methods– To develop data in a grant– To develop instruments– To monitor
• Scale of operation– Small enterprises without capital to comply– Research labs
• Regional centers of excellence for particular methods
BOG4Cultural adoption
For example, • Peer review boards
Meeting a measurement objective as pre-requisite to acceptance means that the peer reviewers must know how to evaluate the data for the objective.
• Academic acceptanceFits research interest, fits timelines for publishing, comes with money, not annoying
• Bridging separate topic communitiesMaterial design for aerospace may want to use a measurement that fits their culture and engineering needs, that differs from the toxicology need.
Draft – initial outcomes of the workshop (and project)
• General endorsement of the need for a framework focused on a specific area where better reporting is feasible
• Roadmap elements and natural starting points to link together in a framework– Current inter-laboratory testing efforts and structures (QNano, etc)
– Characterization facilities (user facilities) all over the place (some with funding)
– NanoRegistry (a focus for where and a stimulus for how to report)
– Existing consortia• OECD, NIEHS, EU NanoSafety Cluster
– Regulatory, standards, cultural drivers• EU labeling and definitions
• EPA rulemaking under TSCA
• ISO TC/229
• Nature Nanotech call for opinions
Practical realities in developing roadmaps
• Recognition that different measurands will have different roadmaps and frameworks, for example– Surface chemistry is a developing science for what to measure and what
instruments are needed
– Particle size distribution can be done with dozens of established methods in search of standards and rationale for selection of one method vs another
• However, there are similar needs for most if not all, for example– Funding targeted within grants for characterization
– Local and linked expertise, instrumentation, standards that would be used for a study (not just for one method)
– Cultural (scientific community, regulatory community, materials development community, product value chain, risk assessment community) adoption of particular methods or sets of methods
• Therefore, developing a roadmap targeted to a few measurands will improve the adoption of consistent reporting for many
More practical realities
• Methods selection (to be consistent across studies) will be more like a decision tree than a proscriptive list– What material
• CNTs have different dominant characteristics than TiO2
– What matrix is the material bound in (if any)• Food, plastics, metals, etc
– What medium• Water, air, dust, soil
– What is functional about the particle
• However, creating more standard sets of measures at the ends of the decision branches should still be possible
Elements of the framework paper
• Illustrating the challengeCase studies of what barriers are encountered and when for– Researcher at a small institution– Major manufacturer– Small manufacturer
• Framework elements and their dependencies• First steps of a roadmap, and steps to complete a
roadmap
Cost analysis - $/sample analysed for each PCC technique available
Infrastructure = equipment + building/room + trained personnel + standards
Identify current availability of good quality infrastructure
Infrastructure available to all at a feasible cost
Identify current gaps in infrastructure/ or exploit existing infrastructure
Identify cost benefit for industry to improve PCC of products and associated infrastructure
Identify funds to fulfil gaps in infrastructure
Identify scientific evidence for the need for infrastructure – ie is the PCC related to risk?
Prioritise cost effective PCC tech but with acceptable precision and accuracy
Clear definition of the data required to fulfil PCC requirements
A set of guidelines, standard s and equipment to allow PCC to be conducted to acceptable level
Data generation
Framework dependency diagram draft for INFRASTRUCTURE FUNDING: Funding sources for all steps: National and local government, Small – large scale industry
Trans-national funding
Link existing resources to form shortcut solutions
• The framework illustrates key dependencies and sequences
• It will be very complex and appear impossible to address
• However, existing elements can be linked and knowledge of dependencies used to improve adoption
• For example, infrastructure does exist and in some cases is not used, so funding is only needed to convey availability
• Linkage to other flow diagrams (e.g., cultural adoption, regulatory needs) will identify where cross-silo communication is needed
How will we measure success and provide responsive adaptations to the roadmap?
• A critical unaddressed issue for the project is to identify measures of failure and success
• Any ideas?
