In all the scenarios presented below, input from existing and emerging stakeholder and user communities is needed. Standard development organizations (SDOs) such as the International Organization for Standardization and the American Society for Testing and Materials (ASTM) continue to adopt new experimental protocols, guides, and practices from metrology institutes such as the National Institute of Standards and Technology, laboratories such as the National Cancer Institute’s (NCI) Nanotechnology Characterization Laboratory, and industry. Interlaboratory testing of those protocols has been performed by the Asia-Pacific Economic Cooperation (Wang et al. 2007), the International Alliance for NanoEHS Harmonization (IANH 2011), and ASTM, among others, using nanomaterials recommended or developed by the Organisation for Economic Co-operation and Development, metrology institutes, or purchased commercially. Support for nanomaterial registration is becoming established through the National Institute of Biomedical Imaging and Bioengineering Registry. The stakeholder and user groups for modeling, data-sharing, and informatics infrastructure also are broadly based (Nanoinformatics 2011a). Historically, this larger nanotechnology community has interacted through workshops designed to support and harmonize increased collaboration and has adopted successful informatics implementations from other fields. More recently a series of workshops on nanoinformatics has provided a roadmap for collaborations in informatics (InterNano 2011) and to support the development and review of pilot nanoinformatics applications (Nanoinformatics 2011b), including those relevant to the following scenarios.
Method Development and Validation Scenario
This scenario closely follows international recommendations for standard method development and validation and adds video technologies to accelerate the development of the methods and for training. Key principles underlying this approach are that it should be efficient, be flexible, add value, be amenable to establishing data rights, provide for continual improvement of the protocol, document experience in its use, and be tailored to develop and maintain the entire needed dataset. A benefit of the scenario is that it provides a basis for training in new and revised methods and for accrediting contract research organizations (CROs) to allow more outsourcing of extensive nanomaterial characterization with validated methods. Finally, the scenario guarantees publication of sensitivity data that are not normally published but that are useful for establishing quantitative structure-activity relationships (QSARs), for designing and redesigning products and processes, and for assessing risk.
A possible set of best practices for establishing validated analytic methods on the basis of current practice and adapting them for nanomaterials to address the needs discussed in Chapter 4 includes the following: