A food allergy is an adverse immune system reaction that occurs soon after exposure to a certain food. The immune response can be severe and life threatening. Although the immune system normally protects people from germs, in people with food allergies, the immune system mistakenly responds to food as if it were harmful. More information on food allergies is on pages 17-21 of the Voluntary Guidelines for Managing Food Allergies.Even a tiny amount of the allergy-causing food can trigger signs and symptoms such as digestive problems, hives or swollen airways. In some people, a food allergy can cause severe symptoms or even a life-threatening reaction known as anaphylaxis.# What is anaphylaxis?
Anaphylaxis is a severe allergic reaction that is rapid in onset and may cause death. Not all allergic reactions will develop into anaphylaxis. In fact, most are mild and resolve without problems. However, early signs of anaphylaxis can resemble a mild allergic reaction. Unless obvious symptoms-such as throat hoarseness or swelling, persistent wheezing, or fainting or low blood pressure-are present, it is not easy to predict whether these initial, mild symptoms will progress to become an anaphylactic reaction that can result in death. Therefore, all children with known or suspected ingestion of a food allergen and the appearance of symptoms consistent with an allergic reaction must be closely monitored and possibly treated for early signs of anaphylaxis. More information on anaphylaxis is on page 19 of the Voluntary Guidelines for Managing Food Allergies.
Why are the Voluntary Guidelines for Managing Food Allergies being disseminated now?
Food allergies affect an estimated 4%-6% of U.S. children, most of whom attend federal-and state-supported schools or early care and education programs every weekday. Allergic reactions can be life threatening and have farreaching effects on children and their families, as well as on the schools or early care and education (ECE) programs they attend.
In 2010 the Centers for Disease Control and Prevention (CDC) convened an expert panel to provide guidance for schools and early care and education programs. These guidelines are based on guidance from the panel and subsequent review and comment provided by the additional experts listed in the Acknowledgements on pages 5-6.
In 2011, Congress passed the FDA Food Safety Modernization Act to improve food safety in the United States by shifting the focus from response to prevention. Section 112 of the act calls for the Secretary of U.S. Department of Health and Human Services, in consultation with the Secretary of the U.S. Department of Education, to develop voluntary guidelines for schools and early childhood education programs to help them manage the risk of food allergies and severe allergic reactions in children. In response, CDC, in consultation with the U.S. Department of Education, developed the Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs.

# What is the purpose of the Voluntary Guidelines for Managing Food Allergies?
The Voluntary Guidelines for Managing Food Allergies are intended to support implementation of food allergy management and prevention plans and practices in schools and early care and education (ECE) programs. They provide practical information, planning steps, and strategies for reducing allergic reactions and responding to lifethreatening reactions for parents, district administrators, school administrators and staff, and ECE program administrators and staff. They can guide improvements in existing food allergy management plans and practices. They can help schools and ECE programs develop a plan where none currently exists.

# What is the FDA Food Safety Modernization Act?
The FDA Food Safety Modernization Act, enacted in 2011, is designed to improve food safety in the United States by shifting the focus from response to prevention. Section 112(b) calls for the Secretary of U.S. Department of Health and Human Services, in consultation with the Secretary of the U.S. Department of Education, to "develop guidelines to be used on a voluntary basis to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs " and "make such guidelines available to local education agencies, schools early childhood education programs, and other interested entities and individuals to be implemented on a voluntary basis only." Learn more at: www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm What are the priority areas in the Voluntary Guidelines for Managing Food Allergies?
Ensure the daily management of food allergies in individual children.
Prepare for food allergy emergencies.
Provide professional development on food allergies for staff members.
Educate children and family members about food allergies.
Create and maintain a healthy and safe educational environment.
Are these the only food allergy guidelines for schools and early care and education (ECE) programs?
Until now, no national guidelines had been developed to help schools and early care and education (ECE) programs address the needs of the growing numbers of children with food allergies. However, some states and many school districts have formal policies or guidelines to improve the management of food allergies in schools. Many schools and ECE programs have implemented some of the steps needed to manage food allergies effectively. Yet systematic planning for managing the risk of food allergies and responding to food allergy emergencies in schools and ECE programs remains incomplete and inconsistent.
Do the Voluntary Guidelines for Managing Food Allergies preempt state law?
No. The FDA Food Safety Modernization Act specifies that nothing in the guidelines should be construed to preempt state law.
Are schools or early care and education (ECE) programs required to implement the Voluntary Guidelines for Managing Food Allergies?
No, implementation of the guidelines is voluntary. However, staff in schools and early care and education (ECE) programs can take concrete actions to protect children with food allergies when they are not in the direct care of their parents or family members. When schools and early care and education programs develop and implement plans to effectively manage the risk of food allergies, they help keep children safe and remove one more health barrier that keeps some children from reaching their full potential.
What are the financial costs of implementing a plan consistent with the Voluntary Guidelines for Managing Food Allergies?
Schools and early care and education (ECE) programs will not need to change their organization or structure or incorporate burdensome practices to respond effectively. If a school has a basic health services delivery and management system to respond to student health needs, integrating response and management for students with food allergies should be routine and not incur additional financial costs. The voluntary guidelines provide recommendations that are consistent with existing practices for health services delivery established in schools.
How do the Voluntary Guidelines for Managing Food Allergies compare to the 2010 Guidelines for the Diagnosis and Management of Food Allergy in the United States developed by an NIAIDsponsored expert panel?
The 2010 National Institute of Allergy and Infectious Diseases (NIAID) guidelines reflect the most up-to-date, extensive systematic review of the literature and assessment of the body of evidence on the science of food allergies. They met the standards of rigorous systematic search and review methods, and they provide clear recommendations that are based on consensus among researchers, scientists, clinical practitioners, and the public. The 2010 NIAID guidelines do not address the management of patients with food allergies outside of clinical settings such as schools and early care and education (ECE) programs. These 2013 Voluntary Guidelines for Managing Food Allergies fill that gap.
Are the Voluntary Guidelines for Managing Food Allergies different from national school health guidelines for other chronic conditions?
While the details focus on the prevention and management of food allergies, the approach is very similar. These guidelines are closely allied with information from the following three publications: Do the Voluntary Guidelines for Managing Food Allergies provide specific information for each state?
No. These guidelines do not address state and local laws or local school district policies because the requirements of these laws and policies vary from state to state and from school district to school district. References to state guidelines reflect support for and consistency with the recommendations in the Voluntary Food Allergy Guidelines, but do not suggest federal endorsement of these state guidelines. While these guidelines provide information related to certain applicable laws, they should not be construed as giving legal advice. Schools and early care and education (ECE) programs should consult local legal professionals for such advice.
Are the recommendations in the Voluntary Guidelines for Managing Food Allergies applied in the same way for early care and education (ECE) programs as they would be in K-12 schools?
Although schools and early care and education (ECE) programs have some common characteristics, they operate under different laws and regulations and serve children with different developmental and supervisory needs. Different practices are needed in each setting to manage the risk of food allergies. These guidelines include recommendations that apply to both settings, and they identify how the recommendations should be applied differently in each setting when appropriate. These guidelines do not provide specific guidance for unlicensed child care settings, although many recommendations can be used in these settings. What actions can be taken by early care and education (ECE) administrators and staff?
Guidance is on the following pages for:
Where can I find more information on federal laws and regulations that govern food allergies in schools and ECE programs?
More information is on the following pages for: