The OECD is committed to using state-of-the-art tools to evaluate chemical safety. As a first step towards using new technologies for assessing the effects of chemicals, the data collected and reported can be standardised for all decision-makers to evaluate effects and share information more easily. 

One such tool is the Adverse Outcome Pathway (AOP) framework which allows the organisation of biological information on how chemicals affect biological pathways and summarises the test methods used to measure these effects. AOPs can support regulatory decision-making in numerous ways, including weight of evidence evaluation, organising information in integrated approaches to testing and assessment (IATA), predictive toxicology and more.

The OECD has developed a reporting framework for transcriptomics and metabolomics. The application of Omics data in a regulatory context and the expansion of the reporting framework is now being explored.

While Omics approaches have been used in toxicology research to address a range of questions, standardisation of data collection and reporting is needed to facilitate the use of omics data in regulatory decision-making. A number of challenges for using Omics data in chemical risk assessment have been identified, including:

• Lack of transparency in how Omics data is generated and processed for molecular (gene, protein, metabolite, etc.) endpoints
• Lack of standardisation in how Omics study parameters and results are reported
• Lack of case studies and guidance describing acceptable (and ultimately best) practices

In response to these needs, the OECD is undertaking a number of activities to enable the translation of Omics science towards regulatory decision-making, introduced below.

Increased transparency in the reporting of Omics data used in regulatory toxicology was identified as a critical priority in an expert workshop hosted by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC). To address this need, the OECD EAGMST launched a project to develop a reporting framework and guidance for generating and analysing Omics data. This framework was intended to aid regulatory uptake while remaining sufficiently flexible to allow technologies to evolve. As first steps, the OECD EAGMST developed a Transcriptomics Reporting Framework (TRF) and a Metabolomics Reporting Framework (MRF), and associated guidance for applying the frameworks. The Ecetoc MEtabolomics standaRds Initiative in Toxicology (MERIT) served as the starting point for the MRF. Given the highly overlapping content of the TRF and MRF, they have since been harmonised and now exist as a single, integrated, modular framework.

 OECD Omics Reporting Framework - Guidance document

The Transcriptomics Reporting Framework (TRF) and Metabolomics Reporting Framework (MRF)  were developed by international teams of experts from government agencies, regulatory bodies, industry and academia. In addition, developing reporting templates and supporting guidance for completing templates, the experts also tested the frameworks in a variety of scenarios.

More information can be found in the publication: Progress towards an OECD reporting framework for transcriptomics and metabolomics in regulatory toxicology.

Figure: Modular structure of the omics reporting framework
The four principal types of modules for reporting transcriptomics and metabolomics studies: (1) the Study Summary Reporting Module (SSRM) to provide a high level overview of the whole study; (2) the Toxicology Experiment Reporting Module (TERM) to describe the in vivo or in vitro toxicology study; (3) Data Acquisition and Processing Reporting Modules (DAPRM) that detail the omics assays, data acquisition and processing; and (4) Data Analysis Reporting Modules (DARM) describing the statistical analysis of the Omics data. Orange modules are harmonised across the transcriptomics and metabolomics, blue modules are specific to transcriptomics, and green modules are specific to metabolomics.
Source: Harrill et al.

The framework consists of four types of reporting modules:

1. The Study Summary Reporting Module (SSRM) provides a high-level overview of the regulatory toxicology and Omics experiment
2. The Toxicology Experiment Reporting Module (TERM) reports the key descriptors of the in vivo or in vitro toxicology study
3. Data Acquisition and Processing Reporting Modules (DAPRM) report descriptions of the Omics assays, data acquisition and associated data
4. Data Analysis Reporting Modules (DARM) describe the statistical analysis that has been undertaken in the Omics study. Guidance documents describe each of the reporting modules in detail.