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ISO/NP TS 27101-1 Next-generation sequencing workflows for plant health application — Part 1: Part 1: Metadata and provenance requirements

Source:
ISO
Committee:
AW/275 - Food analysis - Horizontal methods
Categories:
Information management | Standardization. General rules
Comment period start date:
Comment period end date:

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Scope

This document specifies requirements for the recording, linkage, and maintenance of metadata and provenance information associated with next-generation sequencing (NGS) datasets used in the context of plant disease diagnostics and monitoring. The requirements defined in this document apply to metadata and provenance describing plant material and plant material units, sampling context and handling, declared analytical intent, generation of NGS datasets, laboratory and computational processing history, and traceability and linkage across storage, transfer, and exchange. This document is applicable to NGS datasets generated from plant material for the detection and characterization of biological sequences derived from plant-associated organisms, irrespective of the sequencing platform, library preparation method, or bioinformatic implementation used. This document does not specify requirements for NGS analytical or bioinformatic methods, quality evaluation or performance thresholds, interpretation of NGS analytical outputs, diagnostic confirmation, or regulatory, phytosanitary, or certification decision-making. NGS datasets generated in the context of monitoring, surveillance, or research activities are within the scope of this document only with respect to metadata and provenance documentation, and are outside the scope of this document when used as arbiters for regulatory or phytosanitary decisions.

Purpose

Next-generation sequencing (NGS) technologies are increasingly used in plant disease diagnostics and monitoring, enabling the detection and characterization of biological sequences derived from plantassociated organisms. While NGS offers substantial advantages over traditional diagnostic approaches, its adoption across laboratories and jurisdictions has revealed significant challenges related to data comparability, transparency, and reproducibility.

A major contributor to these challenges is the absence of harmonized requirements for recording metadata and provenance associated with NGS datasets. Differences in how plant material is sampled, handled, pooled, processed, and documented can substantially affect the interpretation and downstream use of NGS data. Inconsistent or incomplete documentation limits the ability of competent authorities, laboratories, and other stakeholders to understand the context in which NGS datasets were generated, to trace data lineage, or to compare datasets across organizational or jurisdictional boundaries. Existing standards and guidance documents address aspects of NGS data generation, quality evaluation, bioinformatic processing, and diagnostic interpretation. However, there is currently no focused international specification that defines requirements for metadata and provenance documentation for NGS datasets used in plant disease diagnostics and monitoring, independently of analytical methods or interpretive outcomes.

This proposed Technical Specification addresses that gap by establishing a common framework for recording and linking metadata and provenance information associated with NGS datasets generated from plant material. By standardizing documentation practices at the input and traceability layers, this work is intended to support transparency, reproducibility, and interoperability of NGS data, while remaining compatible with diverse NGS technologies, laboratory workflows, and regulatory frameworks.

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