Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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FSA Consultation, 7 March 2024
The following is part of the summary of responses to the consultation regarding Precision Bred Organisms (PBO). Given below is the Introduction and Executive Summary of the document taken from the FSA web page - see Summary of stakeholder responses.
In addition, there is also an FSA Board Paper for dicussion at the Board Meeting on 20 March 2024 - see: FSA 24-03-05 - Precision Breeding – Response to Public Consultation and Next Steps.
For the previous news item on the consultation, see:
Introduction
This consultation was issued on 8 November 2023 and closed on 8 January 2024. The consultation sought responses from consumers, stakeholders in relevant sectors, non-government organisations, enforcement bodies and third-party assurance organisations on policy proposals for a new framework for the regulation of Precision Bred Organisms (PBOs) used for food and feed in England under the Genetic Technology (Precision Breeding) Act 2023(footnote 1) (the Act).
The key proposals on which the consultation sought views were:
A full impact assessment was not completed since the total impact of the proposals is estimated to be below the minimum threshold of +/-£10m; however, in line with the obligation to assess the impact of the policy proposals, the Food Standards Agency’s (FSA) assessment of impact was included in the consultation. Respondents were invited to comment on the FSA’s conclusions in this assessment.
More information on the assessment of impact can be found in Section 9 of this Summary of Responses. Each section of this Summary of Responses deals with a theme and provides a summary of the comments received and the stakeholders who made them. The FSA’s considered responses to stakeholders’ comments are provided at the close of each section. A summary of next steps resulting from stakeholder comments is set out in Section 10 (Conclusion and next steps).
The FSA is grateful to those stakeholders who responded and sets out a list of those who gave their consent to be named in Annex A.
1. Executive summary
1.1 The draft proposals set out in the consultation were informed by the FSA Board’s discussions in a number of public meetings in 2022 and 2023 culminating in the FSA Board on 20 September 2023, where the Board agreed on their preferred approach for precision breeding policy for food and feed, subject to public consultation.
1.2 The consultation provided the option to respond to questions using an online consultation response form (please see Annex B for a blank copy of this form). The first section of the form collected demographic information from respondents such as location and whether they were responding as an individual or on behalf of an organisation. The first section also asked respondents to state their level of agreement with the intentions of the Genetic Technology (Precision Breeding) Act and provide their reasons. The second section of the form asked respondents to provide their level of agreement or support for the proposals and to respond to long form open questions as well.
1.3 Respondents were also able to respond to the consultation via email. Not all of the responses received by email aligned with the structure of the online form. As a result, the email responses are not reflected in the percentages outlined in the tables contained in this summary (where this differs this is indicated). However, views submitted have been included in the thematic analysis of responses on the specific proposals. For responses to the questions in the second section of the consultation, we have stated the total number of respondents who responded to each question.
1.4 The consultation ran for two months from 8 November 2023 until 8 January 2024. A total of 412 responses were received, of which 358 were received via the online consultation response form. Of these online responses, 79% were from respondents in England, 9% were from Scotland, 4% were from Wales and 2% were from Northern Ireland and 6% were from outside the UK. 66% of total (online form and email) respondents identified as consumers with 34% coming from a range of stakeholders, including businesses, academics and farmers, as well as organisations representing wider groups of stakeholders.
1.5 In some cases, the responses received, either in relation to specific sections of the consultation or the policy more generally, cover challenges that are either out of scope of the FSA’s policy responsibility for precision breeding or its wider statutory remit in relation to England. Examples include responses relating to non-safety related labelling and non-safety related traceability. Whilst we recognise the relevance of these issues to precision breeding policy, they are issues that the FSA is limited in its capacity to address and therefore we consider these issues to be out of scope of the consultation. For this reason, whilst we have still referenced the views of respondents with respect to these issues, we have not directly proposed actions to address them beyond passing the information to the responsible departments.
1.6 We also received comments from respondents regarding the FSA’s approach to independent scientific advice. The work of the independent committees and working groups that advise us helps to ensure that our advice is based on the best and most recent scientific evidence. We consider the advice provided by the Advisory Committee on Novel Foods and Processes (ACNFP) on precision breeding to be the best scientific advice available to us through existing and longstanding arrangements for the provision of independent scientific advice. Our proposals in the consultation are underpinned by this independent scientific advice, in line with the FSA’s principles of science and evidence-led policy making. Given the independence of the ACNFP, the substance of their advice or its validity in respect of policy making is not within the scope of the consultation. The ACNFP is recruited in accordance with the Cabinet Office guidelines (Opens in a new window) and any enquiries regarding the committee or recruitment process for its members should be addressed to the ACNFP Secretariat.
1.7 A full breakdown of issues that fell outside the scope of the consultation and the FSA’s observations of them is included in Annex D.
1.8 There is a very strong correlation between respondent’s rejection of the fundamental objectives of the Act and rejection of the detail of the proposals on which the consultation sought views. Since the objective of the Act is to regulate plants, animals and food and feed products developed using precision breeding technologies proportionately to risk (and by extension remove such organisms from the scope of legislation regulating the use of Genetically Modified Organisms (GMOs) in food and feed(footnote 2) in relation to England), this suggests that the concerns of stakeholders who do not support the objectives of the Act cannot reasonably be addressed by the regulatory approach which is being proposed. Changes to the FSA’s proposals to adequately address these concerns would potentially result in them not being aligned to the overall objective of the policy as underpinned by the Act and would therefore be incompatible with it. Conversely, respondents who supported the objective of the Act generally support the proposed approach to regulation. This correlation suggests that for these respondents the FSA’s proposals are adequately aligned to the objectives of the Act.
1.9 These correlations are apparent throughout the statistical data gathered from questions asked in the second part of the consultation (to varying degrees). We feel it is important to consider this within the context of quantitative responses and have therefore provided additional breakdowns showing how different views are split between those who support the Act’s objectives and those who do not. However, given these are only inferences it is not possible to draw more nuanced conclusions from the statistical data and therefore our responses are primarily focused on the more detailed narrative responses received.
1.10 Following publication of this summary report, our findings will be discussed by the FSA Board, in public, on 20 March 2024. Our analysis of responses to this consultation has not identified any reason to revisit the fundamental decisions made by the FSA Board in September 2023. However, feedback from respondents has identified some issues with how we deliver the proposals that the FSA can address through non-legislative means without any changes to the fundamental approach. These issues are discussed in more detail later in this response.
1.11 Following the outcomes of discussion with the FSA Board on 20 March 2024, we intend to proceed with plans to implement secondary legislation based on the agreed approach of the FSA Board expressed at its meeting on 20 September 2023, including plans for:
1.12 Whilst we have not identified anything through our analysis of responses to alter our fundamental approach on the structural aspects of the regulatory framework, we recognise that stakeholders have expressed a range of views in response to the detailed questions that have been asked in the consultation on how we implement the approach. We have responded to these views at the end Sections 3-9 of this summary of responses indicating what, if any, action the FSA intends to take in response to the comments raised. In cases where the FSA does not intend to take action, we have indicated our reasons for this. We have also set out our overall conclusions and next steps in Section 10.
