Food allergy is an important chronic disease that can occur in any age group but mainly affects infants and children, some of our most vulnerable populations. For individuals with food allergy and caregivers, food allergy has effects that extend beyond health to quality of life. Food allergy can be life threatening. It has been estimated to cost an overall $24.8 billion annually, including direct medical costs and other costs borne by the family (Gupta et al., 2013). Despite these concerns and general awareness among some in the public, the nation as a whole has not yet devoted adequate resources and efforts to address this important chronic disease.
As explained in Chapter 1, the committee was not charged with developing clinical guidelines but, where appropriate, it states its support for clinical guidelines and recommends that health care providers follow guidelines as they are updated with scientific evidence. The committee was tasked with the following: developing a framework for future directions in understanding food allergy and its impact on individuals, families, and communities; recommending steps to increase public awareness of food allergy; promoting research on both disease causation and management; and informing preventive approaches to food allergy. In their deliberations and recommendations, the committee greatly benefited from information gathered during public sessions, and it is particularly grateful to the advisory panel that so generously came to public meetings and provided their unique perspectives and expectations. Although obviously a cure for food allergies will not result from a scientific report, this committee hopes that its recommendations will generate the ideas and incentives to promote the research needed for an eventual cure. Until that happens, many policies,
practices, and behaviors could be changed to substantially improve food safety, which would enhance the health and quality of life of individuals with food allergy and their caregivers and save lives. The committee’s review of information in leading journals and through the public sessions has underscored the conclusion that solutions are not the responsibility of individuals with food allergy and their caregivers alone. Solutions to food allergy and a roadmap to greater safety will emerge from the efforts of many stakeholders working collaboratively toward the same unifying goal of managing food allergies, and, ultimately, developing safe, effective therapies.
IMPLICATIONS OF AN ECOLOGICAL-DEVELOPMENTAL MODEL
In its consideration of the evidence and recommendations for a roadmap to greater safety, the committee adopted an ecological-developmental perspective (see Figure 10-1). This approach had multiple implications for the work of the committee in delineating the issues, organizing the evidence, drawing conclusions, and making recommendations, and for multifaceted efforts to communicate their conclusions. This perspective underscores the importance of a multidisciplinary and multisystem approach to evaluating the evidence and forming recommendations, calling on the viewpoints of experts and stakeholders representing a range of ecological contexts.
An ecological-developmental model highlights the importance of developmental timing, both for exposures and also for safety planning. The committee considered distinct issues focused on the different developmental periods—prenatal, infancy, early childhood, primary school-age, adolescence, adulthood, and older years. The nature of the human organism changes during each of these periods of development, affecting vulnerability to food allergy (see Chapter 5). The nature of the food context changes as well, for an individual does not control his or her food intake during the very early stages of life. Choices by parents and caregivers, as well as the quality and type of food available will be crucial. Later on in development, children not only will have more choices in what they eat and be less influenced by the restrictions posed on them earlier in life. They also will be more influenced by contexts outside the family, including peers, schools, social media, and mass media (see Chapter 8). The roles of families and schools also are influenced by the food industry, dietary recommendations by health care providers and informal “experts,” as well as by policies about food allergy from the community, culture, or government. Thus, in prenatal development and early life, key contexts for addressing food allergy include the immediate prenatal environment of the mother, caregiving, home, and early care and education settings, and the larger contextual environments comprising health care provider advice, policies for food
allergy safety in early care and education settings, the food industry, and societal policies. Later in life, individuals need knowledge and skills to make their own choices pertinent to food allergy in the broad contexts of everyday life, including schools, workplaces, playgrounds and recreational settings, restaurants, and transportation systems (Chapters 7 and 8).
THE ROADMAP TO SAFETY
Although it is not yet possible to prevent the onset of food allergy (due to lack of a clear understanding of all the relevant genetic and environmental factors) or completely prevent food allergic reactions, multiple improvements could be achieved in the short term with relatively small feasible actions.
The committee conceptualized the answers to the statement of task as articulating a roadmap to safety with key actions (see Figure 10-2). In mapping the road to greater public safety regarding food allergy, it is essential to recognize the roles of multiple systems (and their actors within) at multiple organizational levels in private and public life and their complex interactions, as depicted in Figure 10-1. The committee selected specific settings (and their interactions with others, such as governments or health providers) for their relevance to safety in food allergy: food establishments, early care and education settings, schools, higher education, and the travel industry. In its review, the committee found deficiencies in existing practices or policies in these various settings. Likewise, lack of information or misinformation among the general public and even individuals with food allergy themselves need to be amended. Presentations from the advisory panel to the committee and published statements from individuals with food allergy or their caregivers (see Chapter 1) corroborate the committee’s findings related to these deficiencies.
The committee’s roadmap to safety consists of a multifaceted undertaking that involves the effort of many stakeholders in the different arenas and includes the following actions: (1) obtain accurate prevalence estimates, (2) use proper diagnostic methods and provide evidence-based health care, (3) identify evidence-based prevention approaches, (4) improve education and training of all stakeholders, including health care providers, individuals with food allergy, caregivers, food industry leaders and employers, and others, (5) implement improved policies and practices that prevent and treat severe reactions, and (6) expand research programs related to better diagnostics, effective management and prevention practices, including food allergy therapies and attempts to devise a cure.
The first major action on the road to greater safety is collecting better information about prevalence. Reliable data on the prevalence of food allergy are crucial to inform further advances in food allergy safety and also
to prioritize food allergies in the context of other public health diseases. Prevalence data also are crucial to define the major allergens and to explore risk factors that might differentially affect specific populations. With this in mind, the committee has recommended collecting food allergy prevalence data in a systematic manner.
The second major action on the road to safety is improving the quality of diagnosis and providing evidence-based health care. As recently articulated by the National Academies of Sciences, Engineering, and Medicine report Improving Diagnosis in Health Care (NASEM, 2015), getting the right diagnosis is a key aspect of health care, informing all subsequent health care decisions. That report recognizes that “diagnostic errors can lead to negative health outcomes, psychological distress, and financial costs” and possibly inappropriate or unnecessary treatment (NASEM, 2015, p. 19). In the context of food allergy, proper diagnosis is a challenging activity. It is, however, particularly important given the many misunderstandings about food allergy and the consequences, including death, of a misdiagnosis. Therefore, the committee recommends proper use of current diagnostic methods and identification of better methods in the future.
The third action is defining evidence-based prevention approaches. Many hypotheses have been proposed to explain food allergy etiology (e.g., microbial hypothesis, dual-exposure hypothesis) but none is confirmed yet. Because of their importance in designing prevention approaches, particularly for individuals who carry a genetic predisposition, the committee concluded that understanding the risk determinants is another important element of the road to safety. In this regard, the committee recommends that guidelines be updated with emerging scientific findings. Also, recognizing the weaknesses in current studies and the inconsistencies in findings, the committee outlined research needs related to specific risk determinants and made recommendations for improving study designs, including expanding study participant populations to include all ages, ethnicities, and socioeconomic strata.
The fourth action to greater safety, the committee concluded, is improved education and training of all stakeholders, including health care providers, industry leaders, and employers as appropriate, in recognizing and managing the disease and/or preventing severe reactions. On the one hand, public health and clinical guidelines already exist on how to diagnose, prevent, and manage food allergy (e.g., Guidelines supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health and published by the American Academy of Allergy, Asthma & Immunology). These Guidelines should continue to be updated as new information emerges. The Guidelines are not only meant for all health care providers but also include valuable information for individuals with food allergy and their caregivers as they attempt to manage food allergy in their
homes and various settings. Updating the Guidelines as soon as relevant information emerges is an essential action to prevent and treat reactions. On the other hand, little information is available on the extent to which these evidence-based clinical and public health guidelines are used by health care providers and others. In this digital age, consumers rely on sources of information other that the health care providers, augmenting the possibilities for misunderstanding about a chronic disease for which fundamental data are still emerging. For this reason, it becomes even more important that advice from the health care providers is clear and consistent and based on the most current scientific findings.
Guidelines also are essential for other stakeholders. For example, existing government-led guidelines for early care and education centers and schools (e.g., CDC, 2013) provide excellent starting points for preventing allergic reactions in those settings. Likewise, industry-led guidelines for the food manufacturing (GMA, 2009) or food retail (FMI, 2016) industry as well as training curricula (NRA, 2016) for food service establishments have been developed. Although the committee did not review these food industry guidelines, such guidelines, when complete and scientifically based, can assist industry personnel in understanding food allergy, controlling food allergen cross-contact contamination, and communicating with consumers about their allergies and potential risks. The guidelines for early care and education programs and schools or for the food industry represent best current practices and were developed based on the sound judgement of experts and current scientific knowledge. They are a key component for minimizing risks in settings of concern.
Training in food allergy and appropriate preventive emergency response actions is another critical action to this component of the roadmap to safety. When severe food allergy reactions occur due to accidents, insufficient or inappropriate responses can lead to unnecessary loss of lives. It is well known among the medical community that epinephrine is a safe, adequate treatment for anaphylaxis. However, epinephrine is not always used due to lack of availability, lack of knowledge about on how to administer, or unfounded safety concerns. More extensive emergency training is needed for many more in the community. It is obvious, that although it will not be possible to prevent all severe food allergy reactions for all individuals, much more could be done to decrease the current burden. Overall, the committee concluded that a fundamental need exists to train many stakeholders (e.g., health care providers, industry, consumers at risk, and ultimately the general public) on how to prevent and treat severe food allergy reactions.
The fifth important action is to develop and implement policies and related practices that help to prevent and to properly treat severe reactions. Among them, improved labeling is highlighted by the committee as a key action not only to improve risk communication and safety for consumers,
but also to assist the food industry with applying a labeling system for food products that is based on risk. The implementation of the mandatory labeling rule Food Allergen Labeling and Consumer Protection Act of 2004 and the 2013 Food and Drug Administration Food Code, which provides advice from the Food and Drug Administration (FDA) for uniform systems and practices that address the safety of food sold in food establishments, serves to protect the consumer from severe reactions. Yet, in other important areas, such as preventing the possibility of cross-contamination during food processing, no regulation has been enacted that aims to protect consumers by providing them with information about potential risks. The current voluntary labeling of packaged foods that warns consumers of potential contamination (e.g., “may contain X”) has resulted only in confusion for consumers and industry alike and bears no relationship to risk. In this regard, the committee recommends that the food industry and federal government work together toward a risk-based labeling system. Adoption of the FDA Food Code by all states is another important policy recommendation. The 2013 FDA Food Code includes provisions on preventing food allergic reactions but it has not been adopted by all states.
Additional policies highlighted by the committee focus on safety at settings of concern such as early care and education centers and school settings, from early childhood preschool through college or university. The committee recognized the need to ensure that appropriate guidance and education is in place to create a safe public environment for individuals with food allergy. To that effect, the committee recommends that relevant federal agencies (e.g., the FDA, the Centers for Disease Control and Prevention, the Federal Aviation Administration) convene a special task force to establish and implement policy guidelines.
Finally and critical to future improvements in food allergy safety, the committee has identified a list of research priorities as the sixth action in the road to safety. Key questions about diagnostics, mechanisms, risk determinants, and management require greater research efforts. The committee recommends priorities for research based on those that showed promise for advancing and refining management approaches, including the development of safe and effective therapies and, ultimately, a cure.
As a whole, this report, including its conclusions and recommendations, is intended to provide a roadmap to greater safety for individuals with food allergy, for stakeholders at multiple levels, in families, communities, industries, and the nation as a whole. Although more research is needed, the committee concluded that sufficient evidence is available now to guide these stakeholders to make changes and take actions toward greater safety that will improve the health and quality of life of many individuals with food allergy, and all those who have a stake in their health and well-being. In general, stakeholders in charge of implementing recommendations
should consider the experiences of other countries where management practices (e.g., training of stakeholders or developing anaphylaxis plans) have been standardized.
CDC (Centers for Disease Control and Prevention). 2013. Voluntary guidelines for managing food allergies in schools and early care and education programs. Washington, DC: U.S. Department of Health and Human Services.
FMI (Food Marketing Institute). 2016. Retail allergen resouce document. Arlington, VA: FMI.
GMA (Grocery Manufacturers Association). 2009. Managing allergens in food processing establishments. Washington, DC: Grocery Manufacturers Association.
Gupta, R., D. Holdford, L. Bilaver, A. Dyer, J. L. Holl, and D. Meltzer. 2013. The economic impact of childhood food allergy in the United States. JAMA Pediatr 167(11):1026-1031.
NASEM (National Academies of Sciences, Engineering, and Medicine). 2015. Improving diagnosis in health care. Washington, DC: The National Academies Press.
NRA (National Restaurant Association). 2016. ServSafe. http://www.servsafe.com/allergens (accessed August 30, 2016).