Allergy Risk Management Research Articles

Successful SARS-CoV-2 vaccine allergy risk-management: The experience of a large Italian University Hospital

BackgroundNovel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccines have been approved recently, and public concern regarding the risk of anaphylactic reactions arose after a few cases during the first days of mass vaccination. Polyethylene glycol (PEG) has been suggested as the most probable culprit agent for allergic reactions. ObjectiveWe describe the allergy work-up protocol implemented for the vaccination campaign in our Center, aiming to allow the greatest number of people to be vaccinated safely. MethodsThe protocol included the self-report of a history of suspected drug or vaccine allergies, and subsequent teleconsultation and allergometric tests for PEG and Polysorbate 80 (PS80). A desensitizing protocol of vaccine administration was applied to patients sensitized only to PS80, and to those with a suspect allergic reaction after the first vaccine dose. Results10.2% (414 out of 4042) of the entire vaccine population have been screened: only one patient resulted allergic to PEG and therefore excluded from the vaccination. Another patient was sensitized to PS80 only and safely vaccinated applying the desensitizing protocol. Seven subjects without a previous history of allergic disease experienced suspect hypersensitivity reactions to the first administered dose: one of them resulted allergic to PEG and was excluded from the second dose, while the others safely completed the vaccination with the desensitizing protocol. ConclusionA careful allergological risk-assessment protocol significantly reduces the number of patients who would have avoided SARS-CoV-2 vaccination for their allergies and to effectively identify and manage those rare patients with sensitization to PEGs and/or PS80.

Food allergy knowledge, attitudes and practices (KAP) among restaurant's staff in Jordan: a cross-sectional study

PurposePeople with food allergies rely to a great extent on restaurant staff to have a safe meal. The purpose of this paper is to acquire novel data to evaluate knowledge, attitudes and practices of food allergy among the restaurant's staff and factors that could be associated with these domains.Design/methodology/approachA cross-sectional study involving 306 restaurant staff in Amman City, Jordan was conducted using a validated self-reported questionnaire. Logistic regression analysis was performed to identify factors independently associated with knowledge, attitude and practices (KAP).FindingsThe results showed that most restaurant staff had moderate to excellent knowledge, positive attitudes, low to moderate risk practices regarding food allergy. Knowledge level was significantly associated with the staff's age, position, education level and restaurant class. Further, attitude level was significantly associated with staff age, experience, gender, education level, restaurant class and whether the restaurant held food safety certificates. Similarly, staff behavioral practices were significantly associated with staff position, restaurant class and the presence of valid food safety certificates.Practical implicationsThis study suggests that more training for the staff in restaurants would be associated with a lower risk of providing unsafe meals.Originality/valueThis study demonstrated the need for the pre-employment theoretical and practical tests for restaurants’ staff to determine their knowledge level and provide them mandatory developing training programs to support and facilitate food allergy risk management and to develop food allergy policies.

Identifying and managing patients at risk of severe allergic reactions to food: Report from two iFAAM workshops.

Food allergy affects a small but important number of children and adults. Much of the morbidity associated with food allergy is driven by the fear of a severe reaction and fatalities continue to occur. Foods are the commonest cause of anaphylaxis. One of the aims of the European Union-funded Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM) project was to improve the identification and management of children and adults at risk of experiencing a severe reaction. A number of interconnected studies within the project have focused on quantifying the severity of allergic reactions; the impact of food matrix, immunological factors on severity of reactions; the impact of co-factors such as medications on the severity of reactions; utilizing single-dose challenges to understand threshold and severity of reactions; and community studies to understand the experience of patients suffering real-life allergic reactions to food. Associated studies have examined population thresholds and co-factors such as exercise and stress. This paper summarizes two workshops focused on the severity of allergic reactions to food. It outlines the related studies being undertaken in the project indicating how they are likely to impact on our ability to identify individuals at risk of severe reactions and improve their management.

Can dietary strategies in early life prevent childhood food allergy? A report from two iFAAM workshops.

Food allergy affects a small but significant number of children and adults. Food allergy is responsible for considerable morbidity and is the commonest cause of anaphylaxis in children. One of the aims of the European Union-funded "Integrated Approaches to Food Allergen and Allergy Risk Management" (iFAAM) project was to improve our understanding of the best way to prevent the development of food allergy. Groups within the project worked on integrating the current prevention evidence base as well as generating new data to move our understanding forward. This paper from the iFAAM project is a unique addition to the literature on this topic as it not only outlines the recently published randomized controlled trials (as have previous reviews) but also summarizes two iFAAM-associated project workshops. These workshops focused on how we may be able to use dietary strategies in early life to prevent the development of food allergy and summarized the range of opinions amongst experts in this controversial area.

Understanding how consumers with food allergies make decisions based on precautionary labelling.

Understanding consumer perceptions is crucial if effective food safety policy and risk communication are to be developed and implemented. We sought to understand how those living with food allergy assess risk with precautionary allergen labelling (PAL) and their preference in how risks are communicated within a quantitative risk assessment (QRA) framework. The Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM) labelling online survey was developed for adults and parents of children with food allergy and distributed across Germany, Ireland, Netherlands, Spain and UK via patient support groups. There were 1560 complete responses. 'This product is not suitable for' was selected as first choice for PAL by 46% overall and 'May contain' was selected as the first choice by 44%. Seventy-three percent reported that it would improve their trust in a product if a QRA process had been used to make a decision about whether to include 'may contain'. Overall, 66% reported that a 'statement + symbol' on the label indicating a QRA, would help them to understand the risk assessment process that had been used by the food manufacturer. Consumers want to know what process has actually taken place for the placing of a PAL and/or risk assessment statement on a particular food product. Our findings provide a basis for the development of more informative communication around food allergen risk and safety and support evidence-based policy-making in the context of the legislative requirements of the European Union's Food Information for Consumers Regulation.

Evidence-based approaches to the application of precautionary allergen labelling: Report from two iFAAM workshops.

Food allergy is a major public health concern with avoidance of the trigger food(s) being central to management by the patient. Food information legislation mandates the declaration of allergenic ingredients; however, the labelling of the unintentional presence of allergens is less defined. Precautionary allergen labelling (PAL) was introduced by the food industry to help manage and communicate the risk of reaction from the unintended presence of allergens in foods. In its current form, PAL is counterproductive for consumers with food allergies as there is no standardized approach to applying PAL. Foods with a PAL often do not contain the identified food allergen while some products without a PAL contain quantities of common food allergens that are capable of inducing an allergic reaction. Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM) was an EU-funded project that aimed to improve the management of food allergens by the food industry for the benefit of people with food allergies. Within iFAAM, a clinically validated tiered risk assessment approach for food allergens was developed. Two cross-stakeholder iFAAM workshops were held on 13-14 December 2016 and 19-20 April 2018. One of the objectives of these workshops was to develop a proposal to make PAL effective for consumers. This paper describes the outcomes from these workshops. This provides the basis for the development of more informative and transparent labelling that will ultimately improve management and well-being in consumers with food allergy.

Food allergy knowledge, attitudes, and resources of restaurant employees

PurposeRestaurants are unique and challenging environments for accommodating food allergies. The purpose of this paper is to evaluate food allergy knowledge, attitudes and resources among restaurant employees, and identify differences based on restaurant mode of operation.Design/methodology/approachA total of 209 food-service workers were surveyed in full-service restaurants across Southern Ontario, Canada. A paper-based questionnaire was used to evaluate participants’ food allergy knowledge, attitudes toward handling food allergy requests and emergencies, and the availability of food allergen resources at the restaurant.FindingsMost participants were knowledgeable about food allergies, and valued being able to provide safe meals. However, there was a general lack of access to important food allergy risk management resources and training. Food allergy attitudes were significantly different between restaurant modes of operation. Also, food allergy training and resources were positively correlated with employee attitudes toward food allergies.Practical implicationsThe results of this study show that engaging employees in food allergy training can contribute to greater levels in employee awareness and confidence in protecting health and safety of restaurant patrons with food allergies. Restaurants that demonstrate a strong preparedness toward handling food allergy requests can deliver a better customer experience and increase customer loyalty.Originality/valueThe findings of this study underscore the need for the restaurant industry, policy makers and food safety educators to work together to develop training programs and relevant resources to support and facilitate food allergy risk management in restaurants.

ILSI Europe's Food Allergy Task Force: From Defining the Hazard to Assessing the Risk from Food Allergens.

The International Life Sciences Institute (ILSI) Europe Food Allergy Task Force was founded in response to early public concerns about the growing impact of food allergies almost coincidentally with the publication of the 1995 Food and Agriculture Organization-World Health Organization Technical Consultation on Food Allergies. In line with ILSI principles aimed to foster collaboration between stakeholders to promote consensus on science-based approaches to food safety and nutrition, the task force has played a central role since then in the development of risk assessment for food allergens. This ranged from consideration of the criteria to be applied to identifying allergens of public health concern through methodologies to determine the relationship between dose and the proportion of allergic individuals reacting, as well as the nature of the observed responses. The task force also promoted the application of novel, probabilistic risk assessment methods to better delineate the impact of benchmarks, such as reference doses, and actively participated in major European food allergy projects, such as EUROPREVALL, the European Union (EU)-funded project "The prevalence, cost and basis of food allergy across Europe;" and iFAAM, "Integrated approaches to food allergen and allergy risk management," also an EU-funded project. Over the years, the task force's work has evolved as answers to initial questions raised further issues: Its current work program includes a review of analytical methods and how different ones can best be deployed given their strengths and limitations. Another activity, which has just commenced, aims to develop a framework for stakeholders to achieve consensus on acceptable risk.

Integrating Allergen Analysis Within a Risk Assessment Framework: Approaches to Development of Targeted Mass Spectrometry Methods for Allergen Detection and Quantification in the iFAAM Project.

Allergen analysis is central to implementing and monitoring food allergen risk assessment and management processes by the food industry, but current methods for the determination of allergens in foods give highly variable results. The European Union-funded "Integrated Approaches to Food Allergen and Allergy Risk Management" (iFAAM) project has been working to address gaps in knowledge regarding food allergen management and analysis, including the development of novel MS and immuno-based allergen determination methods. Common allergenic food ingredients (peanut, hazelnut, walnut, cow's milk [Bos domesticus], and hen's egg [Gallus domesticus]) and common food matrixes (chocolate dessert and cookie) have been used for both clinical studies and analytical method development to ensure that the new methods are clinically relevant. Allergen molecules have been used as analytical targets and allergenic ingredients incurred into matrixes at levels close to reference doses that may trigger the use of precautionary allergen labeling. An interlaboratory method comparison has been undertaken for the determination of peanut in chocolate dessert using MS and immuno-based methods. The iFAAM approach has highlighted the need for methods to report test results in allergenic protein. This will allow food business operators to use them in risk assessments that are founded on clinical study data in which protein has been used as a measure of allergenic potency.

The Food Allergy Risk Management in the EU Labelling Legislation

Food allergy represents an increasing public health issue, and a large number of food control authorities have provided regulations aimed to minimize the risk of allergic reaction for sensitized consumers. The Food and Agriculture Organization of the United Nations together with the World Health Organization established the Codex Alimentarius Commission whose main goal is to protect the consumers’ health. To purse this task the Commission listed the foods and ingredients causing the most severe allergic reactions that should be labelled. It has been reported that some cases of specific foods hypersensitivity display a different prevalence among different Countries. Thus, the European Union drew up a list of mandatory allergens (that must be labelled) longer than that provided by Codex Alimentarius. As a consequence of the complexity of the legal phraseology of the European Union (EU) and/or European Community (EC) the Regulations and/or Directives were differently translated in all EC/EU official languages determining possible misinterpretations of the legislation. Moreover, food labelling regulations were also established with the goal to promote the consumers’ conscious choice about what they eat. Starting from the case of the fermented beverages, we analysed the European legislative scenario concerning the allergen labelling of the last fifteen years, highlighting that mistranslations, misinterpretations and lack of information in the EU Regulations might lead to health and ethical issues.

Sesame allergy threshold dose distribution

BackgroundSesame is a relevant food allergen in France. Compared to other allergens there is a lack of food challenge data and more data could help sesame allergy risk management. The aim of this study is to collect more sesame challenge data and investigate the most efficient food challenge method for future studies. MethodRecords of patients at University Hospital in Nancy (France) with objective symptoms to sesame challenges were collected and combined with previously published data. An estimation of the sesame allergy population threshold was calculated based on individual NOAELs and LOAELs. Clinical dosing schemes at Nancy were investigated to see if the optimal protocol for sesame is currently used. ResultsFourteen patients (10 M/4 F, 22 ± 14.85 years old) with objective symptoms were added to previously published data making a total of 35 sesame allergic patients. The most sensitive patient reacted to the first dose at challenge of 1.02 mg sesame protein. The ED05 ranges between 1.2 and 4.0 mg of sesame protein (Log-Normal, Log-Logistic, and Weibull models) and the ED10 between 4.2 and 6.2 mg. The optimal food challenge dosing scheme for sesame follows semi-log dose increases from 0.3 to 3000 mg protein. ConclusionThis article provides a valuable update to the existing clinical literature regarding sesame NOAELs and LOAELs. Establishment of a population threshold for sesame could help in increasing the credibility of precautionary labelling and decrease the costs associated with unexpected allergic reactions. Also, the use of an optimal dosing scheme would decrease time spent on diagnostic and thereafter on the economic burden of sesame allergy diagnosis.

Food Allergy Risk Management: More Customers, Less Liability

Food allergies present risk management problems and business opportunities for restaurants. Personal injury litigation may result in million-dollar liability exposure and conviction in the court of public opinion. Many businesses are unprepared or under-prepared to meet the needs of the growing number of food-allergic consumers. Restaurants that implement comprehensive food allergy risk management plans can help reduce liability and capitalize on the emerging market of allergy-conscious consumers.

Food allergy: Stakeholder perspectives on acceptable risk

We have reached a point where it is difficult to improve food allergy risk management without an agreement on levels of acceptable risk. This paper presents and discusses the perspectives of the different stakeholders (allergic consumers, health professionals, public authorities and the food industry) on acceptable risk in food allergy. Understanding where these perspectives diverge and even conflict may help develop an approach to define what is acceptable.Uncertainty about food allergy, its consequences and how to manage them is the common denominator of the stakeholders’ views. In patients, uncertainty is caused by the unpredictability of reactions and the concern about whether avoidance strategies will be effective enough. Variability of symptoms and the lack of markers do not allow stratification of patients according to their reactivity, and force health professionals to give the same advice to all patients despite the fact that the risk to each is not identical. Regulators and the food industry struggle with the fact that the lack of management thresholds forces them to make case-by-case decisions in an area of uncertainty with penalties for under- or over-prediction. As zero risk is not a realistic possibility, consensus on acceptable risk will be needed.