Literature review on analytical methods for the detection of precision bred products

The aim of this report is to review analytical methods for the detection of the products of precision breeding, culminating in recommendations towards addressing the gaps for further research and development of methods for testing for these products in the UK. The individual objectives of the report are: Review of standardised terminology: A review of national and international expert working groups, standards, regulatory texts and practices has been conducted in order to further refine and harmonise the terminology involved (Annex I). Review of current and novel methods: A review of the potential of current and emerging methods for the detection, identification and quantification of products of precision breeding techniques was completed. This included PCR, sequencing and untargeted techniques, as well as detection of site directed nuclease mediated activity, off-target effects and cisgenic changes. As a benchmark, the evolution of analytical methods for detection of GMOs was examined. Review of the published and updated ENGL guidance of the original ENGL 2019 report (or equivalent): A review of the updated European Network of GMO Laboratories (ENGL) report of the original ENGL 2019 (3) was not published within the timeframe of this project. As an alternative, current best measurement practice guidance and international approaches in the evolving area of methods for the detection of genome edited products and PBOs were assessed and evaluated for impact and implementation from a UK centric perspective. Review supportive tools: A literature review was conducted regarding other tools to augment analytical detection methods. The availability, viability and (where feasible) associated costs/resources of tools such as reference databases and reference and control materials, as well as genetic varietal markers/tags/barcodes, were explored. Knowledge gaps and challenges: An assessment of knowledge gaps, limitations, and current and future challenges in detecting products of precision breeding, was conducted. Practicalities of delivering methods for enforcement bodies and the cost implications for food businesses in the UK were hard to estimate, based on the current deficit in fully effective methods for the detection of PBO products. Recommendations: Recommendations towards establishing a toolkit for the design, development and implementation of analytical methods for these products, have been provided. Consideration was given to a focus on current knowledge gaps, state of the art and scope/limitations of the science, as well as the need to provide objective experimental based experimental evidence to support any of the findings.