Memorandum of Understanding: Annex G- protocol on risk analysis 

37. General principles

Risk analysis is the process by which the FSA and FSS assess, manage and communicate food and animal feed safety risks. Key high-level principles for the process are that:

• risk analysis comprises risk assessment, risk management and risk communication;
• risk assessment and risk management functions should be separate;
• the risk analysis process is open and transparent. We will publish our risk management advice and the evidence and analysis on which that advice is based;
• advice and recommendations presented to Ministers will be risk, science and evidence-based and independent;
• the risk analysis process has the capacity to provide for four nation working and deliver, where appropriate to do so, unified food and feed safety risk management recommendations for the UK; 
• for changes in areas of retained EU law, which are in scope of the FFSH Framework, Ministers in all four nations will be made aware of any differences in advice and be given the opportunity to challenge this.
• or changes in areas of retained EU law, implementation of risk management recommendations through legislation will not take place until there has been communication at official level on a four nation basis. 

Both bodies agree to close working relationships and strong co-ordination and collaboration between the FSA and FSS staff involved in risk analysis. There will be cross departmental and devolved administration engagement throughout the risk analysis process to ensure all relevant issues and interests of other government departments with responsibilities for food and agriculture, health and trade are taken into account. 

Both bodies agree to follow the Food and Feed Safety Risk Analysis Guidelines. These guidelines are stored on internal SharePoints and should be checked quarterly to confirm whether any amendments are required. Should changes to guidelines occur, Risk Analysis teams in both FSA and FSS are responsible for communicating and agreeing these. 

Applications for the authorisation of a regulated food or feed product or process in GB are made using a regulated products application service which is managed by FSA on behalf of both FSA and FSS. FSA officials will share relevant information with the FSS Regulated Products team in line in with the data sharing protocol at [section 10.16] where reasonably required.  Authorisation procedures will follow detailed statutory requirements and any guidance agreed jointly. Decision making should follow the principles set out for risk analysis and the FFSH Framework.

38. Risk assessment

Risk assessment involves using a scientific approach to identify hazards and estimate the potential risk to human and/or animal health. This includes evaluating the likely exposure to risks from food and other relevant sources.

The FSA and FSS will collaborate on risk assessments in areas of agreed FSA expertise where there is a foreseeable UK-wide impact. In doing this, the FSS will notify the FSA with regard to any issues, evidence or analysis specific to Scotland, with the aim of ensuring that assessments properly reflect the situation in Scotland, as far as the evidence and resource capacity allows.

The FSA will be responsible for any risk assessments within its remit that apply exclusively in England, Wales or Northern Ireland. 

FSS will generally be responsible for any risk assessments within its remit that apply exclusively in Scotland other than in relation to feed trials. Depending on the circumstances and expertise required, FSS will either:

• undertake risk assessment in-house;
• collaborate with FSA risk assessors; or
• request risk assessments from specialist scientists within FSA in areas where this expertise does not exist within FSS.

FSS will ensure the FSA is notified at the earliest opportunity when it requires support from the FSA on risk assessments that apply in Scotland. The FSA will advise on any resource implications associated with the type of support requested and whether it is possible to be provided by FSA scientists or will require FSS to seek alternative sources of expertise. 

Where alternative sources of expertise are required, the FSA will work with FSS to identify appropriate external resources. 

The FSA and FSS will undertake risk assessments according to agreed protocols including procedures outlined in the Food and Feed Safety Risk Analysis Guidelines. FSA and FSS will collaborate on any updates to these protocols to ensure methodologies applied for undertaking risk assessment are consistent and in line with international standards.

The FSA and FSS will also work collaboratively in evidencing other legitimate factors related to consumers’ wider interests in relation to food, as circumstances may require, in accordance with the arrangements set out above.

39. Risk management

Risk management is the consideration of potential measures to either prevent or control the risk. It takes into account the findings of risk assessment and other legitimate factors related to consumers’ wider interests in relation to food to identify an appropriate response.

Co-ordination and collaboration between FSA and FSS staff involved in risk management will be through agreed forums/groups that will facilitate:

• prioritisation and triage of issues in the process; 
• working level discussion on specific and/or routine issues, building on existing good policy practice across the four nations;
• Senior Civil Service level discussion between FSA, FSS and with other government departments from across the UK on developing risk management recommendations for non-routine issues and assurance on routine matters.

40. Risk communication

Risk communication is the exchange of information and opinions throughout the risk analysis process between risk assessors, risk managers, consumers, industry, the academic community and other interested parties. It includes understanding the concerns of consumers and other stakeholders, the publication of risk assessment findings and other supporting evidence, and the distribution of final advice.

Risk communication is integrated throughout the risk analysis process. 

FSA and FSS agree to share the plans and details of any relevant communications associated with risk analysis as soon as possible. This includes communication across science, policy and communications teams as issues progress through the risk analysis process, and early sharing of the associated developing communications plans around the publication of information/outputs for issues progressing through the risk analysis process and risk management advice and recommendations.

FSA and FSS are committed to consulting on and publishing the risk management advice we provide to others, and the analysis and evidence on which that advice is based.