Owen Carey

Briony Ballard 
London Inner South Coroner's court, 
Southwark Coroner's court, 
1 Tennis Street,  
London,  
SE1 1YD 

January 2020 

REGULATION  28:    RESPONSE  BY  THE  FOOD  STANDARDS  AGENCY,  THE 
DEPARTMENT  FOR  ENVIRONMENT,  FOOD  AND  RURAL  AFFAIRS  AND  THE 
DEPARTMENT OF HEALTH AND SOCIAL CARE 

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 
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.  

access. This 

anyone 

for 

to 

is 

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 

information  on  allergenic 

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 
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. 

ingredients.  The  domestic  Food 

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’.  

on 

declarations 

Allergen 
in 
menus 
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. 

difficult 

may 

be 

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.   

Yours sincerely, 

, Chief Executive Officer, The Food Standards Agency,  

The Rt Hon the Lord Goldsmith of Richmond Park, Minister State, Department for 
Environment, Food and Rural Affairs,  

Jo  Churchill  MP,  Parliamentary  Under  Secretary  of  State  for  Prevention,  Public 
Health and Primary Care.

sters Houge, &

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improving allergy care Email: info@bsaci.org

through education, training and research Website: www.bsaci.org

Ms Briony Ballard
Assistant Coroner
Coroner for Inner South District Greater London
Southwark Coroner’s Court

I Tennis Street .

Southwark

SEI 1YD

23" October 2019
Dear Ms Ballard,

Thank you for the Prevention of Future Deaths Report, touching on the death of Owen Carey, which
was received on the 10th October 2019. :

The British Society for Allergy and Clinical Immunology (BSACD) is the national, professional and
academic society which represents the specialty of allergy 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 BSACTI's core aim is to improve allergy care by developing a
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.org
The directors of the BSACI share all of the concerns raised in the report and acknowledge that there are
significant areas of need around the current shortcomings in both awareness and appropriate safeguards
for those who suffer from food and other potentially severe allergies. This is something that the BSACI
has a long track record of advocacy around and we have, through the National Allergy Strategy Group,
www.naseguk.org been actively lobbying for improvement.

We consider point_1 outside of our remit but fully acknowledge that the issue of staff training at i
catering establishment is a 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 need for a review and consultation by the
Food Standards Agency to ensure that customers with food allergies are given the information that they
need to eat safely. The recent consultation on allergen labelling in relation to food that is prepacked for
direct sale has been an excellent example of effective consultation and subsequent positive change.

Point 4 relates to the need for a national registry for the recording and analysis of severe allergic
reactions to food. This is another area where we share your concerns, The BSACI is mindful that
Shahida Shahid, 18, died in hospital on January 12 2015, three days after collapsing following a visit to
Almost Famous Burgers in Manchester city centre. She was known to have a milk allergy and had eaten
a 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 i
these were missed numerous times during the preparation, construction and delivery of the burger. The
potential for learnings from this death, to prevent further similar occurrences is clear.

ome

The BSACTI believes that there is a need for 2 distinct registries. The first is a national register for 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

early warning signal for new risks and highlight specific situations where risk is higher so that they can
be actively mitigated. Such a registry already exists in Europe and the Food Standards Agency has
recently issued a tender for a UK centre to operate a UK register for anaphylaxis, which will also feed
into the wider European platform already in operation. The BSACI, in partnership with Inperial
College, have responded to this call and have received provisional approval.

The other critical need is for a fatal anaphylaxis register where all fatal allergic reactions are subject to a
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 key risk factors for severe reactions.
Such a regisiry, 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 b on
a 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 has a significant backlog of cases. As a consequence, earlier
this year, the current allergy 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 the sustainability of the UKFAR. Following from this, BSACI council made a
commitment to explore this further including consideration of a 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 free to let us know if you would like any further information. We very much appreciate your
efforts in highlighting the concerns we all share in this area.
Yours Sincerely,

Aan Aik ®

President, BSACI

Ms Briony Ballard
Southwark Coroners Court,
1 Tennis Street,
Southwark,

SE11YD

Date 17th October 2019

Dear Ms Ballard,

Re: Prevent future death report for Owen James Carey
(date of death 22/04/17) (Case Ref:01206-2017)

We are responding to your letter dated 8" October 2019, regarding the above case. Please find our
responses to section 5 of the original letter.

Yours sincerely

Simon Wilkinson
Chief Executive Officer

BYRON
82 Dean Street
London, W1D 3SP

Byron.co
byron@byron.co

Registered No 07228130
VAT No 178 2206 04

The Matters of concern — responses

1) The adequacy and effectivenes:

as follows;

s of allergen training at Byron O2;

The training at the time of the incident involved on-line training by the employee and their
acknowledgement that such training had taken place and on the job training as highlighted.
One aspect of the on job training which the legal representation failed to stress was that the

minimum amount of on job training

consisted of 7 days shadowing an existing team member

and only then after 7 days if the employee had reached satisfactory levels would they be

signed off and allowed to serve cus

omers on their own. If their competency levels were

inadequate further training would follow. The sign off process had to be done by the General

Manager. This process is above and
it was noted that no records were t
immediately and each employee wi
a market leading training system ca

beyond the industry norm at that time.

en kept of the on-job training so this has been rectified

| now have records kept. Additionally, we are investing in
led “Flow” which is being launched in the business from

November where every employee will have their own personal training modules and records.

2) The effectiveness of current placement and appearance of allergen notices on restaurant on

restaurant menus to trigger an

allergen discussion between a customer and serving staff:

Both the prominence and size of the allergen notice on the latest Byron Menu launched on
October 2" have increased. There is a reference to allergens on both sides and the message

takes up one third of a page
Since 2018 over and above our legal

allergen requirements which we have always adhered

to, we have also added the extra safeguards into our business to increase allergy awareness;

e Anallergy champion is prese
undergone a special allergen

nt in every restaurant - this is a member of staff who has
management training module

« Each customer is asked if they have an allergy at the table before a food order is

taken

e Before a member of staff can enter an order into the till system an additional
message prompt the size of the till screen asks them if they asked the guest about
allergies and if not to go back to the table to do so

e The allergy is recorded on th

e till receipt that is sent to the kitchen as the order is

taken. This member of staff will also verbally alert the kitchen team about the allergy
e An additional flyer is placed on every table to remind customers to inform the staff of

an allergy
e The Byron allergy guide now

includes more detailed sections for those avoiding

certain allergens (avoiding dairy, avoiding gluten, vegan/plant-based diet}

e New training videos are avail
ALL employees will have wat

able for staff: all new starters must watch the video and,
ched it by Nov 1%. The videos were cascaded out for

managers to share with the teams, and formal allergy training is done periodically.

BYRON
82 Dean Street
London, WiD 3SP

Byron.co
byron@byron.co

Registered No 07228130
VAT No 178 2206 04

e Allergy refreshers are now part of menu training and records kept via training portal
e Byron is now working with Ten Kites to introduce a filtering system for the food menu
on the website. Restaurants will soon be receiving tablets to be able to replicate this
on site.

3) The lack of key allergen information on the face of restaurant menus and therefore their
potential to be falsely reassuring:

The legislation requires that a restaurant has a legal requirement to provide allergen
information to customers for each dish they serve, this can be orally or written down in an
allergy guide listing every dish they serve and whether they contain the 14 allergens. This
guide or matrix is given to the guest when requested so that they can order safely, but the
responsibility lies jointly between the guest and the server. We are very keen to work with
the legislative authorities to make this process as robust as possible to see if there are ways
that we can improve how the industry signposts allergen information to customers without
losing that key interaction and discussion between the guest and staff to ensure their
allergies are shared also with the kitchen. We have reached out to both the family of Owen
Carey and the FSA to initiate a meeting and commence a consultative process between them
and industry colleagues, which | want to lead, but have had no response yet. We have also
ensured that menus moving forward are as descriptive as possible without eliminating the
need for the guest to consult the allergy guide. At the time being a specialist burger / one
product restaurant, it was industry standard that a plain burger meant a burger with no
toppings such as onion, mayo, tomato and lettuce rather than that the meat/contents
themselves were plain. As articulated above to try and reassure guests as much as possible
we now have more detailed descriptions on all our menu items.

4) The lack of a:national register recording severe food anaphylactic reactions:

1 concur with the coroner.

BYRON
82 Dean Street
London, W1D 3SP

Byron.co

byron @byron.ce

Registered No 07228130
VAT No 178 2206 04

Chairman: Lord Harris NATIONAL

National Trading Standards TRADING
Sylvan Court

Sylvan Way . STANDARDS
Southfields Business Park Protecting Consumers
Basildon Safeguarding Businesses
Essex

SS 15 6TH

Email contact via
nationaltradingstandards@actso.org.uk

Ms Briony Ballard

Coroner for Inner London South District
Southwark Coroners Court

1 Tennis Street

Southwark

SE1 1YD

30 October 2019

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 the 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, A subsidiary company of the Trading Standards institute. Registered in England and Wales. _ Register Number 8097 348.

|

It seems however that the concerns you raise relate to the underpinning statutory
system, in particular the lack of statutory requirements in relation to the notification of
allergens in the circurnstances that Mr Carey purchased his food and also the lack of a
national register of such incidents. | see that your letter was also sent to the Food
Standards Agency. The FSA have the responsibility, on behalf of Government, for the
legislation and policy relating to allergens and for managing national food incidents so |
am sure they will be well placed to address the issues you have raised.

lam very sorry that | am unable to directly assist you in this instance.

Yours sincerely

Lord Toby Harris
Chairman, National Trading Standards

RECEIVEN

ACTSO Ltd. A subsidiary company of the Trading Standards Institute. Registered in England and Wales. Register Number 8091348.
Registered office: 1 Sylvan Court, Sylvan Way, Southfields Business Park, Basildon, Essex SS156TH VAT Reg. No GB 795 8626 60