FSA 22-09-14 - Risk Analysis Process Update

1. Summary

1.1 The Business Committee is asked to:

• Note the update on issues undergoing risk analysis
• Consider and comment on the ongoing development of performance measures for the process

2. Introduction

2.1    The risk analysis process sets out the FSA approach to its increased role in food and feed safety.

2.2    This paper is part of our regular updates on risk analysis activity and developments to the process.

2.3    A paper to the Business Committee in June recapped the objectives and core principles of the risk analysis process, and contains links to the risk analysis process steps and previous board papers. This paper provides information on the status of issues undergoing risk analysis in summer 2022 and an update on our considerations of monitoring and reporting.

3. Risk analysis status report: June – August 2022

3.1    As expected, the number of issues logged internally for preliminary risk consideration has gradually increased since the implementation of the process in January 2021. Details of issues undergoing risk analysis are published to an online register following initial consideration when it is confirmed that risk assessment or evidence is required, and the risk assessment stage commences.

3.2    We have updated the online register of issues at the end of June to include two issues which have reached the stage of evidence gathering and risk assessment. These both fall under food contact materials and are assessments of bamboo-plastic composite materials and recycling of plastics collected from environmental sources (such as ocean-bound plastic).

3.3    To further improve transparency and make it easy for stakeholders to access information, we have added fields in the register to ‘tell the story’ of each issue by capturing all relevant documents and decisions. For completed issues, links will be provided to evidence such as risk assessments; consultations; board papers; and a summary given of any advice or recommendations made as a result.

3.4    The headline figures for the risk analysis process as of end August 2022 are set out in the table below. Two risk analysis issues have been completed and there are 32 issues under active consideration, up from 29 at the start of 2022. Of these:

• 26 issues are at the preliminary stage of risk consideration
• 6 issues are undergoing risk assessment

4. Progress of high-profile issues

4.1    The review of controls on imported food from Japan following the nuclear accident at Fukushima is now considered a completed issue as risk management action has been taken. Following advice to ministers, legislation was laid in England, Wales and Scotland that resulted in the removal of the controls by the end of June.

4.2    The development of a new regulatory framework for precision bred food and feed in England is being treated as a high-profile risk analysis issue and is receiving additional Board oversight and scrutiny in line with our agreed process. The Genetic Technology (Precision Breeding) Bill, led by Defra, is going through Parliament, and the status of this was discussed in a board paper in the earlier session.

5. Measuring performance and monitoring on Risk Analysis

5.1    In the previous paper to the Business Committee, we described our early thinking on performance measures. We are continuing to develop and refine performance measures as more issues progress through the system and we build our understanding of the data that will be available for completed issues.

5.2    The current risk analysis systems and processes are designed as a structured, flexible process to support policy development and provide assurance on the underpinning principle that advice should be evidence-based, considered on a four-country basis and developed in line with the FSA’s commitment to openness and transparency.

5.3    Some initial suggested measures are outlined below, and we will continue to develop these ahead of the December board meeting. A separate set of performance measures for the Regulated Products Service is discussed in the accompanying paper.

5.4    To demonstrate that the process has been used in line with our commitments to being evidence-based, open and transparent, we propose to report the number of issues that have been completed in the given financial year. We will also continue to provide quarterly updates to the online published register of issues. The Chief Scientific Adviser (CSA) will continue to provide regular assurance on the extent to which our approach to the use of science and evidence follows best practice and is resilient. In addition to the CSA’s annual reporting to the Board, our reporting to Business Committee will confirm that for completed risk analysis issues, appropriate sign-off has occurred in the provision of evidence packages as part of the process. Links to risk assessments and reports on other legitimate factors are included in the public register. The above reporting to business committee will also provide updates on progress of particularly high-profile, complex or contentious issues.

5.5    To demonstrate the effectiveness of four-country working during risk analysis, we propose to report any completed issues where a dispute resolution mechanism was engaged and confirm that it has not been triggered on any active risk analysis issues.

5.6    To measure the speed and efficiency of the process, we propose to monitor and report the time taken to complete the end-to-end process as appropriate to individual issues, and the proportion of risk assessments provided within target timescales where they are set.

6. Conclusion

6.1    The Business Committee is asked to:

• Note the update on issues undergoing risk analysis
• Consider and comment on the ongoing development of performance measures for the process