Dear Ms Ballard, Re: Prevent future death report for Owen James Carey (date of death 22/04/1Z) (Case Ref:01206-20172 We are responding to vour letter dated 8th October 2019,regarding the above case. Please find our responses to section 5 of the original letter.

Dear Ms Ballard, Thank you for the Prevention of Future Deaths Report; touching on the death of Owen which was received on the ] Oth October 2019. The British Society for Allergy and Clinical Immunology (BSACI) is the national, professional and academic society which represents the specialty of at all levels. Its aim is to improve the management of allergies and related diseases of the immune system in the United Kingdom; through education; training and research: The BSACIs core aim is to improve allergy care by developing range of allergy resources for its members in order to support this, including clinical audits and specialty guidelines and by organising educational meetings A comprehensive list of UK Allergy clinics and the expertise these provide is also available on the public area of the website. WWW bsaci_Og The directors of the BSACI share all of the concerns raised in the report and acknowledge that there significant areas of need around the current shortcomings in both awareness and appropriate safeguards those who suffer food and other potentially severe allergies_ This is something that the BSACI has a track record of advocacy around and we through the National Allergy Group; Www nasguk og been actively lobbying for improvement We consider point outside of our remit but fully acknowledge that the issue of staff training at catering establishment is significant contributor to unnecessary allergic reactions and fully support rigorous measures to address this Points 2 and 3 relate to the need for better allergen labelling on restaurant menus and again, the BSACI fully supports the necd for review and consultation by the Food Standards Agency to ensure that customers with food allergies are given the information that need to eat safely. The recent consultation on labelling in relation to food that is prepacked fof direct sale has been an excellent example of effective consultation and subsequent positive change. Point 4 relates to the need for national registry for the recording and anal_ of severe allergic reactions to food. This is another area where we share your concers. The BSACI is mindful that Shahida Shahid, 18, died in hospital on January 12 2015, three after collapsing following a visit to Almost Famous Burgers in Manchester centre. She was known to a milk allergy and had eaten burger containing chicken that had been marinated in buttermilk She has informed the waiter of her food allergies The ticket (order) that went through to the kitchen contained Shahida's allergies, but these were missed numerous times during the preparation, construction and delivery of the The potential for learnings from this death; to prevent further similar occurrences is clear: The BSACI believes that there is & need for 2 distinct registries_ The first is & national register all anaphylactic reactions, that can be contributed to by any health care professional and would provide invaluable data on emerging patterns of reactions and their circumstances and effectively operate as an Carey; allergy are for from long have; Strategy they allergen lysis days city have burger. for

early warning signal for new risks and highlight specific situations where risk is higher $0 thaf C811 be actively mitigated . Such registry already exists in Europe and the Food Standards Agency has recently issued tender" for & UK centre f0 operate & UK register for anaphylaxis , which will als0 feed into the wider European platform &lready in operation. The BSACI, in partnership with Imperial College, have responded to this call and have received provisional approval, The other critical need is a fatal anaphylaxis register where all fatal allergic reactions are subject to & detailed root cause analysis to ensure maximal learnings from every such event; which can then be published regularly to ensure all relevant agencies have access to high quality information: Longitudinal analyses of these events will provide further information about the risk factors for severe reactions Such registry, the UK Fatal Anaphylaxis Registry (UKFAR), has been in existence since 1992 in Manchester at the University of Manchester: It was initially set up and run by on voluntary basis with valuable academic outputs. Following his retirement; permissions were renewed to retain the data and continue acquisition of data for this registry but with no sustainable funding; the registry has not been kept up to date and significant backlog of cases As consequence, earlier this ycar; the current team in at Manchester University hospitals (who are the custodians of the data) entered into conversations with the BSACI to explore the possibility of closer working in order to find a solution to sustainability of the UKFAR Following from this, BSACI council made commitment to explore this further including consideration of workable operating model and assistance in raising adequate funding; thought to be around €120,000 annually: Whilst funding streams could include charitable donations Or industry support; these carry significant risk and the involvement of industry may be perceived to taint the integrity of the outputs. The BSACI believe that the appropriate funding solution would be for the Foods Standards Agency to support the UKFAR, as part of their responsibility to safeguarding the public This would ensure sustainability and also aid engagement with the coronary system; which UKFAR relies on to provide details of all cases of suspected fatal anaphylaxis. The BSACI directors will be writing to the chair of the FSA to raise this issue, which had been previously highlighted but not led to any offer of 'funding: Please feel fiee to let us know if you would like any firther information. We very much appreciate your efforts in highlighting the concerns we all share in this area.

Dear Ms Ballard Prevent future death report Owen James Carey Case Ref 01206 2017 Thank you for your letter dated 9 October 2019. am sorry to learn of the tragic death of Mr Carey from severe food induced anaphylaxis: note you have sent the letter under Regulations 28 and 29 of the Coroners (Investigations) Regulations which are designed to prevent future deaths_ National Trading Standards (NTS) is a body which commissions specific Trading Standards related work via various grants from Government: This work relates only to regional or national issues (e.g. complex consumer frauds operating across the country) rather than locally based enforcement: The Food Standards Agency does not commission any work via NTS in relation to food safety enforcement_ As such the activities relating to regulation of food safety in general, and allergens in particular; do not fall within our remit. At a local level this responsibility lies with individual local authorities. NTS is not an overseeing body for local authorities. Each local authority is responsible for the level of food safety enforcement it undertakes in its own area_ ACTSO Ltd, subsidiary company of the Trading Standards Institute Registered in England and Wales_ Register Number 8091348. Way the

It seems however that the concerns you raise relate to the underpinning statutory syster, in particular the lack of statutory requirements in relation t0 the notification of allergens in the circumstances {hat Mr Carey purchased his food and also the lack of & national register of such incidents. I see that your letter was aiso sent t0 the Food Standards Agency. The FSA have the responsibility, on behalf 0f Government; for the legislation and policy relating to allergens and for managing national food incidents s0 am sure will be well placed to address the issues you have raised. am very sOrry that am unable to directly assist you in this instance_

Dear Ms Ballard,

Thank you for sending the Regulation 28: Report to Prevent Future Deaths, concerning the inquest into the death of Owen Carey, who died tragically from a severe anaphylactic reaction. We were deeply saddened to hear of the death of Mr Carey in April 2017 and extend our sympathies to his family and friends. In terms of the split of responsibility in Government, the FSA is responsible for food safety labelling and food allergy policy in England, Wales and Northern Ireland. Food information to consumers legislation, which incorporates allergen labelling, sits with Defra. Defra notes your recommendations and supports the Food Standards Agency’s work to ensure that consumers have the information they need to make safe food choices. The adequacy and effectiveness of allergen training at Byron The overarching responsibility of food business operators is set out in Regulation (EC) No. 178/2002 (‘The EU General Food Law’), Article 17(1): Food and feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods or feeds satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met. The reasoning for this is provided in Recital (30) in that a food business operator is best placed to devise a safe system for supplying food and ensuring that the food it supplies is safe; thus, it should have primary legal responsibility for ensuring food safety. Of course, food law places responsibilities on both operators and food businesses through other general and specific requirements too, and such is the case with the provision of allergy information.

To support businesses, the FSA provides support through materials such as the ‘Safer Food, Better Business’ guidance, which is tailored to the needs of different types of business and includes a specific section on allergen management. The FSA also hosts a free online training platform on food allergen management and awareness which is available for anyone to access. This is available here: https://allergytraining.food.gov.uk/English/. When things go wrong, the FSA works with businesses to understand the causes of an incident and consider appropriate action to prevent this from happening again. A free online training course in Root Cause Analysis is available on the FSA website. Local authorities have responsibility for assessing how businesses, such as Byron, comply with food law and will take corrective action where any issues are identified. In carrying out their duties, local authorities will assess levels of compliance, including in relation to allergen management, through inspections, record and traceability checks, food sampling and staff interviews. Where non-compliance is identified, local authorities will work with the business to improve standards and take appropriate, proportionate enforcement action should that be necessary. The FSA has responsibility for oversight of this work and the Food Law Code of Practice is the primary mechanism through which the FSA gives direction to local authorities to ensure a degree of consistency in approach. The effectiveness of the current placement and appearance of allergen notices on restaurant menus to trigger an allergen discussion between a customer and serving staff Food Labelling is an area of EU competence. The EU Food Information for Consumers (“FIC”) Regulation (Regulation (EU) No. 1169/2011) is directly applicable across the EU and requires food businesses to provide consumers with clear information about the food, including information on allergenic ingredients. The domestic Food Information Regulations 2014 (which relates chiefly to England) and similar legislation in Scotland, Wales and Northern Ireland provide for the execution and enforcement of the EU Regulation in the UK. In terms of the provision of allergy information on foods other than prepacked (such as those you might find supplied to and sold in a supermarket) the UK, like other member states, is free to set its own rules that best meet their national requirements. Legislation in the UK requires that any food business selling food that is not prepacked, such as meals sold in a restaurant, must provide allergen information, this can be by any means that the operator chooses, including orally. When a food business operator in- tends to make allergen information available orally, legislation requires that that option must be made clear to the consumer either on a label attached to the food, or on a notice, menu, ticket or label that is readily discernible at the place where the intending purchaser chooses that food stating that details can be obtained by asking a member of staff. If a written notice is chosen, FSA technical guidance is clear that the mandatory information should be easily accessible, in a conspicuous place, easily visible and clearly legible. Information should be indelible (permanent) where appropriate, for example on food labels where it needs to withstand handling. The information should not be hidden, obscured, detracted from or interrupted by other written or pictorial matter or any other intervening material. Businesses should be able to demonstrate the systems they operate for this mandatory provision of allergy information to the relevant enforcement authorities, in England this rests with the Local Authorities. Regardless of the method chosen, the information must be accurate and up-to-date. We are currently updating our guidance for businesses and will ensure that these

requirements remain clear, including the requirement for notices (on menus and elsewhere) to be readily discernible. We want to be sure that businesses are communicating allergen information to consumers in the most effective ways, and we are currently undertaking further research into how businesses understand and act on their responsibilities and how consumers receive and use this information. This research will inform any further updates to business guidance. The lack of key allergen information on the face of restaurant menus and therefore their potential to be falsely reassuring Current legislation does not specifically state that menus need to provide allergen information, however it is one avenue for businesses to provide mandatory allergy information which is required of them. As explained above, businesses must provide accurate allergen information at point of sale but this can be done in a number of ways including in writing or verbally. Where businesses choose to provide information on menus regarding allergenic ingredients used in their products this information must be kept up-to-date and must not be misleading. The EU Food Information for Consumers (“FIC”) Regulation (Regulation (EU) No. 1169/2011) FIC art. 7 states that ‘Food information shall not be misleading’ and ‘Food information shall be accurate, clear and easy to understand for the consumer’. Allergen declarations on menus may be difficult in practice for some businesses that change menus or ingredients frequently and could introduce a risk of false reassurance for customers if the written information cannot be relied upon due to day-to-day changes in ingredients. Again, the choice of the most effective way to provide information is part of the system that businesses should be providing to assure enforcement authorities that they are complying with information requirements. As the FSA said in their evidence to the House of Commons Public Accounts Committee on 28 October, there are four key factors that food businesses need to get right to safeguard consumers in relation to allergens: good food handling practice and avoidance of cross-contamination; making information about ingredients available to consumers; ensuring staff are knowledgeable about what is in the food and are updated on changes so that they are able to provide accurate information to consumers; and ensuring that consumers are able to have conversations with the business, even if written information is provided. The FSA regularly raises awareness of the information that businesses must provide to consumers, but due to the dynamic nature of the food sector, these messages must, however, continue to be reinforced. The FSA is planning a further business and consumer awareness campaign which will be launched in early 2020 to remind business of their responsibility to provide accurate information and to make sure consumers know what information to expect. The campaign and other planned material will engage with businesses and young people, who we know to be the highest risk age group. The FSA will be hosting an Allergy Symposium in February that will bring together key industry sectors, enforcement bodies, consumer groups and clinicians to explore the complexities of managing allergens, showcase good practice, exchange knowledge, while expanding our awareness of food hypersensitivity and assisting food businesses in achieving compliance. The lack of a national register recording severe food anaphylactic reactions

As articulated in your report, this recommendation refers primarily to a register of deaths so that ‘the circumstances of these deaths … could then be analysed and learnt from by allergy specialists.’ The FSA agrees that there needs to be more systematic information collected on anaphylactic reactions, and that the evidence base is currently inadequate. The FSA is exploring how to collect more data on allergic reactions so that we and others can identify emerging patterns or trends and build a better picture of allergic consumer experience of reactions. We have therefore embarked on work investigating a reporting platform for allergic reactions, including better information on severe reactions that do not result in a death. This is in the early stages as it is likely to involve the development of an online reporting system and/or better data sharing and exchange of information between different organisations. The aim of this project is to create a reporting link to the FSA for a range of stakeholders such as consumers, businesses and potentially medical professionals so that the FSA can collect data on currently unreported allergic food reactions, identify trends in a timely fashion and if necessary alert local authorities so as to allow them to take appropriate investigative and enforcement action. The Department of Health and Social Care (DHSC) notes the recommendation on a fatalities register and concurs that it is essential we learn from these tragedies. In conjunction with the FSA’s ongoing programme to collect more information on anaphylactic reactions, DHSC will work to increase information prevalence on these deaths. The Department will identify means of access to relevant records so that they may be included, as is necessary and appropriate in preventing future incidents, within the FSA’s planned reporting platform for the purposes of analysis. In addition to this the Department wishes to underline its emphatic support of the FSA’s strategy on food hypersensitivity. As a final comment from the Food Standards Agency, the FSA Board is committed to review progress on hypersensitivity at each of its public meetings. The extent to which is evident by the many steps the FSA has committed to in the last six months which will improve levels of protection.