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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - GRACIOUS (GRACIOUS: Grouping, Read-Across, CharacterIsation and classificatiOn framework for regUlatory risk assessment of manufactured nanomaterials and Safer design of nano-enabled products)

Teaser

Summary

Background: Manufacturing and functionalising materials at the nanoscale leads to a whole array of nanomaterials (NMs) varying in e.g. size, morphology and surface characteristics. Due to financial, time and ethical consideration, safety testing of every unique NM for their potential adverse effects is virtually impossible. For these reasons, more efficient ways to obtain safety information are needed.

Goal: The GRACIOUS consortium is building a Framework that will guide the grouping and read-across of NMs or nanoforms (NFs). This Framework will be useful both in a regulatory risk assessment context, as well as to inform the safe design of new nano-enabled products (NEPs).

To achieve this goal the GRACIOUS consortium will address the following objectives:

Objective 1: Integrate key stakeholder needs with state-of-the-art thinking on grouping and read-across of NMs/NFs (nanomaterials/nanoforms) in order to design, develop and refine a sustainable Framework.

Objective 2: Develop knowledge and generate data as the basis to derive hypotheses, criteria and guiding principles for grouping, leading to classification and read-across, as building blocks for the GRACIOUS Framework.

Objective 3: Refine and integrate tools to build the GRACIOUS Framework, Guidance Document and software module

Work performed

GRACIOUS has generated an inventory of the information, data and tools that are already available for inclusion in the GRACIOUS Framework. This prevented replication of effort from previous projects and allowed the best elements for inclusion/development to be clearly identified.

The inventory content informed development of the preliminary Framework design. The original Framework design in the project Description of Action remained relevant (despite the time passed between grant submission, and the project kick-off), and therefore the process focused on identification of the details required to make the Framework functional. Confirmation and clarification of the Framework design provided a structure for generating relevant Grouping hypotheses in a logical fashion, as well as to develop the Integrated Approaches to Testing and Assessment (IATAs) required to assess the relevance of the Hypotheses. IATAs have been developed for different environmental compartments and different routes of exposure relevant to humans.

It is essential that the GRACIOUS Framework meets the needs of a variety of Stakeholders. The draft Framework was therefore shared extensively with international stakeholders representing policy makers, regulators, industry and academics. The feedback indicated the Framework design was appropriate, but that improved clarity was important. The Framework description was therefore shortened, edited and simplified. The Framework description and the hypothesis template are now being written up for peer-reviewed publication.

Over the next year, the IATAs will be developed further, tested, integrated and converted into a blueprint for software design, as well as for generation of the Guidance document detailing how to use the Framework. Stakeholders will be engaged at each stage to ensure continued relevance and applicability.

Final results

Progress beyond state of art is extensive, and includes templates for hypothesis generation, templates for exposure and release data collection, automated data input into the open access data repository (eNanoMapper), IATAs for human and environmental data/information generation. In addition to the IATAs and hypotheses, we expect to generate basic evidence to underpin some of the IATA aspects, as well as to deliver the entire GRACIOUS Framework to support grouping and read-across. This Framework will be â€˜tunableâ€™ to allow it to be used to inform safer(r) by design during innovation, as well as to support regulatory decision making. Potential impacts are diverse but include streamlining innovation and regulatory decision making for nanoforms, for both industry and regulators. This has the benefit of saving time and money as well as reducing animal use.