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Food allergy – a forensic perspective

Michael Walker and Hazel Gowland discuss the latest allergen measurement techniques and review allergen non-compliance cases in the UK courts.

Introduction
Regular FS&T readers need little introduction to the topic of food allergy. It is an acknowledged public health issue detrimental to the quality of life of those with food allergy and risk of anaphylaxis; it is also an economic and management burden on the food industry. There are many positive developments in train and research results that may help stem the tide of allergy are eagerly awaited. Oral immunotherapy for allergy received a boost with the highly successful outcomes of a phase 2 trial published in January this year by Addenbrookes Hospital. Management of allergen cross contact (cross contamination) in the food industry would begreatly assisted by population thresholds for allergens. However, a 2014 EFSA draft opinion on the evaluation of allergenic foods for labelling purposes pours cold water on the concept of population thresholds with the current state of knowledge. On the other hand, the EAACI Food Allergy and Anaphylaxis Guidelines, also published in 2014, establish a draft set of suggested reference doses for 12 major allergens.

Sound analysis is vital for allergen risk management and the EFSA draft opinion includes a comprehensive review of analytical strategies for allergenic proteins; it concludes that reliable methods for the detection and quantification of food allergens are necessary in order to ensure compliance with food labelling legislation.
EFSA also recommended that any given analytical method needs a well-defined reference material and a reliable method of recovery. The availability of certified reference materials (CRM) is very important for the quantification of allergens. LGC has produced a prototype quality control set based on a EuroPrevall study matrix (chocolate dessert mix) used to assess clinical thresholds; the set comprises a blank material and a material containing 10 ppm (mg kg-1) peanut protein. With proven homogeneity and stability, underpinned by a validation study of the test method, these QC materials address the lack of allergen related reference materials to improve global allergen protein measurement.

Routine analytical techniques for food allergens are described in Table 1. ELISA, the workhorse analytical technique, exhibits variable and manufacturer-specific sensitivities and cross-reactivity [2]. Structural changes caused by food processing or sample extraction may prevent detection by ELISA or LC-MSn, while PCR is probative of the source species rather than the allergen protein. LCMSn methods offer advantages including the possibility of multiplex high throughput analysis, definitive confirmation of epitope, protein molecular identity and measurement traceability. However metrological traceability to the SI [3], that enables valid comparison between measurements carried out in different laboratories across the globe, has been largely neglected. Metrological traceability of allergen proteins is currently possible only by MS based absolute quantification. [4] To our knowledge SI traceable assignment of the concentration of allergenic proteins in food has had very limited study, [5,6] and would greatly facilitate the standardisation of current analytical techniques for allergens.

Food allergy, as might be expected from its potential seriousness, also has a forensic context. Here we touch on some examples of cases in the UK courts involving fatalities, personal injury, sabotage and criminal noncompliance with food law.

Food sabotage
Deliberate food sabotage occurs from time to time. Objects used in sabotage incidents range from the innocuous (paper) to the highly offensive (condoms) and have included glass, needles, blades, staples and mercury. One unusual case involved sabotage, by peanuts, of the production area of a plant manufacturing nut-free ready meals. The case, which reportedly cost the business £1.2m and resulted in a criminal trial in the Crown Court illustrates the difficulties of allergen management in a food manufacturing plant and the challenges facing the investigation of a sabotage incident.

The food business had taken a highly professional approach to the manufacture of nut-free ready meals. Training, signage, hand-washing stations, audit of suppliers, testing of incoming raw materials and finished product along with prerequisite programmes and HACCP were in place. Early in the morning shift peanuts were found in the production area. Over the next few hours more peanuts were found at different locations and production was halted. The company’s customers and FSA were informed and a full product recall initiated. It quickly became obvious that this was deliberate sabotage. A possible suspect was a fitter who had been asked to remove some inappropriate material from his workshop wall. He had access to all parts of the plant. His locker was searched and his overalls and factory clothing were seized and searched. No peanuts were found in the pockets and the clothing was locked in the Production Manager’s office along with the peanuts that had been found in the food handling area. Police were called in and took statements and bagged up the evidence. The fitter was arrested and the exhibits of his clothing and the seized peanuts were sent for forensic examination to LGC. It was hoped that DNA would be recovered from the peanuts pinpointing who had handled them. However no recoverable DNA was found. The next step was to look for traces of peanut protein in the pockets of the overalls and clothing belonging to the defendant and other workers. This was done by swabbing for subsequent ELISA.

The exhibits consisted of 5 sets of overalls, one allegedly from the defendant and 4 from other workers at the plant. In all, 24 swabs were taken from the defendant’s garments and 21 were positive for peanut protein. The overalls belonging to four other workers were swabbed 25 times all with negative results. The defendant was charged with possessing materials for contaminating goods with intent to cause public alarm, injury and economic loss and with threats to kill. The Crown Court jury trial lasted three weeks. The forensic results detailed above formed a major part of the evidence. Part way through the trial, the defence requested experiments to assess the possibility of contact transfer of traces of peanut protein after handling peanuts with subsequent handling of garments and the effects of hand washing. The defence hypothesised that anyone coming into contact with peanuts and then subsequently handling the exhibits could transfer traces of peanut protein and contaminate them. Instructed by the Crown, experiments were set up to see if handling a peanut transferred sufficient peanut protein to the fingers for it to be picked up from fabric. The results indicated that even after brief contact with a peanut, peanut protein was readily transferred to clothing and easily detected by analysis even after 10 successive finger/ fabric contacts. It was also found that only rigorous hand washing stopped the transfer. The defence argued that because the management team who found the peanuts also seized the clothing, it was reasonable to suggest that the management had themselves contaminated the clothing with peanut protein. After over eight hours of deliberations, the jury could not reach a unanimous verdict and was discharged by the Judge. Consequently the defendant was found not guilty. [7,8]

Fatality, Health & Safety Act prosecution, baby Thomas Egan
In April 2002 baby Egan, five months, died of heart failure following an anaphylactic reaction to cow’s milk (skimmed milk powder). The milk powder was contained in a cereal product fed to baby Egan at a privately owned day nursery. On 28 January 2003 an inquest jury at Milton Keynes Coroner’s Court returned a verdict of accidental death contributed to by neglect [by the nursery]. An investigation by police and environmental health officers ensued and the nursery was prosecuted at Milton Keynes Magistrate’s Court on 8 August 2003. The firm pleaded guilty to one charge of failing to ensure health and safety under Section 3 subsection 1 of the Health and Safety at Work Act 1974 and was remitted to Aylesbury Crown Court for sentencing on 30 October 2003, receiving a fine of £60,000 with £19,000 costs.

Fatality, civil action and appeal, Mr Kuldip Bhamra
Mr Kuldip Bhamra died from egg allergy at a Sikh wedding having consumed a dessert. The bride’s family had engaged a caterer to provide a wedding feast for some 500 people in August 2003. Mr Bhamra’s symptoms started shortly after he ate ras malai, an Indian sweet dish consisting of small, flat cakes of paneer (curd cheese) in sweetened, thickened milk with many recipe variations. He was taken to hospital, but died several days later. No sample of the food was retained, but a post mortem examination was carried out. The wedding invitations indicated that the food would be served under temple rules, which exclude meat, fish, alcohol and egg. Mr Bhamra had an allergy to egg, but as a Sikh, he did not expect to find egg in temple food. Following an inquest in June 2004, his widow sued the caterer for personal injury caused by breach of contract and negligence in serving food that contained egg. At trial Mrs Bhamra’s claim under the Contracts (Rights of Third Parties) Act 1999 was dismissed and that decision remained unchallenged. However, the court found in favour of Mrs. Bhamra on her claim of negligence and entered judgment for her in the agreed sum of £415,000, subsequently confirmed on appeal. Food law prosecutions Food law prosecutions by Trading Standards Officers (TSOs) and Environmental Health Officers of non-compliances relating to the presence of allergens are increasing.

A market trader in Shropshire selling imported prepacked chocolates was prosecuted in 2009 for the alleged offence of placing on the market food that was unsafe, namely Milka Frühlingsblumen, in that the labelling did not declare the presence of the allergenic ingredients almond and hazelnut in a language easily understood contrary to Regulation 4 (a) of the General Food Regulations 2004 and Regulation (EC) 178/2002 Article 14 paragraph 1. The ingredients of the food were labelled only in German and French. The trader was convicted and fined £3500 plus costs.

In 2010 a deli counter food business in Kensington was prosecuted for selling Aubergine Rollatini Spinach, the labelling and presentation of which misled the consumer on the presence of walnuts. A customer who suffers from a severe nut allergy had checked the label and walnuts were not listed in the ingredients. She bit into it and suffered an allergic reaction. The business was fined £2,000 with £2,321 costs and a £15 victim surcharge.

A case in January 2014 appears typical of the gradually escalating approach generally adopted by Trading Standards Officers. A Polish company owning three food shops in Essex entered a guilty plea at Chelmsford Magistrates’ Court to 20 charges of selling food not properly labelled in English. The prosecution was brought following a complaint in 2012 that food was not correctly labelled. Advice was given and multiple TSO visits to the trader took place before legal action finally ensued. The significance of allergen ingredients that could cause health problems ranging from minor irritation to, in extreme cases, death, was referred to in the prosecution. A director of the company was personally fined £870 and the company was also ordered to pay £2,250, on the basis of the first offence, costs of £1,350 and a victim surcharge of £120.

Prosecutions - non-prepacked foods

Non pre-packed foods, especially catered meals, have been known for some time to be problematic for people with allergies. A baseline survey in Northern Ireland found one in five take-away meals purporting to be suitable for a peanut allergic customer contained peanut protein [9]. Some 38% of the food induced anaphylaxis fatalities between 1999 and 2006 were due to catered meals [10].

One of the first take-away allergy cases occurred in Derbyshire in 2010 following an incident when a peanut allergic customer asked a Chinese takeaway for a meal without peanuts owing to his severe allergy. He ate the meal and suffered a severe allergic reaction requiring emergency lifesaving treatment in hospital. The remaining food was analysed and found to contain peanut protein at a level of 31 mg kg-1 (ppm). The food business operator was prosecuted under the Food Safety Act 1990 for supplying unsafe food by failing to declare the presence of peanuts. He was fined a total of £2,660, and ordered to pay £1,000 in costs, a £15 victim surcharge and £200 in compensation to the diner.

Local Authority surveys of compliance in the catering takeaway sector have proliferated since the work of Leitch and Walker focusing on allergens, nutrition, species substitution and excessive colours. One such survey has had far reaching consequences. In 2010/11 30 local authorities participated in a nationally coordinated Food Standards Survey of the composition of certain types of take away food. Several authorities chose specifically to request that meals should be nut free, peanut free and allergen free [11]. When two non-compliant chicken tikka masala samples were followed up, the ingredients were traced back to a large Indian food supplier, Euro Foods. This company had supplied peanuts instead of almond powder, as requested, to another wholesaler who had in turn supplied the two takeaway businesses, which had no knowledge that the product they were introducing into their recipe for chicken tikka masala was not almond powder. [12] Euro Foods was prosecuted by Cumbria County Council Trading Standards Department and initially found guilty on charges of supplying almond products adulterated with peanuts. This situation allegedly arose because of the price differential between the two. The firm was fined £6,000 with £12,000 costs [13] but later successfully appealed the conviction. A full report of the appeal appears not to be publically available, however the grounds of appeal included the error in law of laying information (charges) under both sections 15(2) and 15(3) of the Food Safety Act 1990. Section 15(2) creates the offence of falsely describing or misleading as to the nature or substance or quality of the food, while section 15(3) creates the offence of presentation which is likely to mislead as to the nature or substance or quality of the food.

Conclusions
We suggest there should be central collation of allergen related cases in the UK courts. The potentially severe consequences for people with food allergy of contraventions of labelling law have led to enforcement action up to criminal prosecution for what might otherwise be regarded as ‘trivial’ non-compliance. Even so, non-compliances should be followed up in a more rapid and robust manner. Moreover, evidence of fraud in the catering supply chain, such as almond substituted by peanut, supports recent calls for a culture of zero tolerance for food fraud and food crime with the response to major dishonesties being deliberately punitive. Food businesses must guard against short cuts or gaps in allergen management, about which there are many readily available sources of advice, training and guidance, but also against unwitting or fraudulent substitution in the supply chain, where advice, training and guidance need to be developed.

New allergen labelling legislation and a careful consideration of case law appears to place responsibility on food businesses even for the forensically problematic area of allergen cross contamination. The courts can be an effective last resort for vulnerable consumers, however there is evidence of knowledge and skills gaps both in the investigation and prosecution of potentially serious incidents of food allergen mismanagement and mislabelling. Thorough investigation of food allergy deaths, particularly in the catering sector, is required; the skills and capacity for this should be improved. A tenacious and skilled approach is required with the early realisation that, for example, samples of the food and/ or stomach contents from a post mortem examination should be retained and analysed. The supply chain of the meal ingredients must also be rigorously followed up to find out where adulteration or contamination with the fatal allergen occurred.

Michael Walker is MD of Michael Walker Consulting Ltd and facilitator for the LGC/safefood Knowledge Network for Food Allergy & Food Intolerance. He is a Consultant Referee Analyst in the Laboratory of the Government Chemist and manages research on allergen measurement. Michael is currently chair of FSA Northern Ireland’s Strategic Committee on Food Surveillance and has previously served as Chair of IFST Northern Ireland, on the board of AFBI, and the FSA NI Advisory Committee.
Email: Michael.Walker@lgcgroup.com, Tel: +44 (0) 28 9096 8732

Hazel Gowland has had a severe allergy to nuts and peanuts since early childhood. She has worked with the Anaphylaxis Campaign since 1994 and is now its Food Adviser. Hazel advises those at risk from severe food allergies and develops e-learning resources and allergy training courses for food handlers in the workplace. She also investigates deaths and ‘near misses’ from food allergy, provides expert evidence and undertakes scientific, clinical and consumer research into why and how allergen avoidance may fail and how those at risk may be protected.
Email: hazel@allergyaction.org, Tel: +44 (0) 1727 855294
Acknowledgements: The authors thank Kirstin Gray MIFST for expert assistance in the peanut sabotage case and the National Measurement Office for funding as part of the Government Chemist Programme.

Gowland discuss the latest allergen measurement techniques and review allergen non-compliance cases in the UK courts.

Introduction
Regular FS&T readers need little introduction to the topic of food allergy. It is an acknowledged public health issue detrimental to the quality of life of those with food allergy and risk of anaphylaxis; it is also an economic and management burden on the food industry. There are many positive developments in train and research results that may help stem the tide of allergy are eagerly awaited. Oral immunotherapy for allergy received a boost with the highly successful outcomes of a phase 2 trial published in January this year by Addenbrookes Hospital. Management of allergen cross contact (cross contamination) in the food industry would begreatly assisted by population thresholds for allergens. However, a 2014 EFSA draft opinion on the evaluation of allergenic foods for labelling purposes pours cold water on the concept of population thresholds with the current state of knowledge. On the other hand, the EAACI Food Allergy and Anaphylaxis Guidelines, also published in 2014, establish a draft set of suggested reference doses for 12 major allergens.

 

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