Module 4. Food Allergies and the Legal Environment
After the module, students will be able to:
- Explain current legislation with regard to food allergies
- Discuss the legal ramifications of food allergy reactions
- Identify the proper procedures to document and work with children with food allergies in school food service operations
- Identify ways to prevent food allergy-related lawsuits (e.g., appropriate disclosures, truth in ingredient listings on menus, preventing employee mishaps (including appropriate training and training documentation), and retaining food samples
- Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
- Food Allergy and Anaphylaxis Management Act (FAAMA)
- Americans with Disabilities Act (ADA)
- Section 504 of the Rehabilitation Act of 1973
- Other legal guidance related to food allergies in educational settings
- State legislation
- Additional information
The FALCPA became effective as of January 1, 2006. It is a public law which states that foods containing an ingredient or protein from a "major food allergen" must declare the presence of any allergens.
The major food allergens of "The Big 8" include milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans (USDA, 2012).
The requirements of the FALCPA include the following:
- The FALCPA applies to foods that have FDA labeling regulations, including all foods except poultry, most meats, some egg products, and most alcoholic beverages (USDA, 2012).
- The FALCPA requires manufacturers to clearly disclose food sources that fall into the category of those that contain major food allergens (USDA, 2012).
- The following provisions were added to Section 403 of the Federal Food, Drug, and Cosmetic Act:
- If it is not a raw agricultural commodity and it is or contains/bears a major food allergen:
The word "contains" followed by the "name of the food from which the allergen is derived" should be printed directly after or adjacent to the ingredient list (e.g., "Contains milk")
The major food allergen in the ingredient list should be followed by the "name of the food from which the allergen is derived" in parentheses (e.g., "albumin" (egg)).
- The species of fish or crustacean shellfish and the type of nut should be provided when the "name of the food from which the allergen is derived" is required (FALCPA, 2004).
- If it is not a raw agricultural commodity and it is or contains/bears a major food allergen:
- Any of the eight major allergens present in any amount must be listed, even for ingredients added for colors, flavors, or spices (FARE, 2013).
- Detailed requirements do not address allergen labeling for products that have been unintentionally exposed to an allergen. The FDA is looking for the best ways to manage labeling that addresses this issue (USDA, 2012).
The FDA discourages using statements such as "May contain [allergens]" or "produced in a facility that also uses [allergens]." These statements should not be used in place of good manufacturing practices (USDA, 2012).
Issues with allergen disclosure
Placing a warning label on the menu is discouraged. Such warning signs may lead health inspectors to believe that a restaurant is trying to make up for poor cleaning practices (Kronenberg, 2012).
Excessive use of "may contain" statements is discouraged (Higgins, 2006). Excessive use of such statements may cause consumers with food allergies to ignore ingredient labeling altogether. Such statements elicit uncertainty about manufacturers' cleanliness, and therefore may discourage potential buyers from purchasing.
The FAAMA was passed on December 21, 2010, as part of the Food Safety Modernization Act, and was signed into law by President Obama on January 4, 2011 (FARE 2014). The FAAMA requires the U.S. Secretary of Health and Human Services to develop voluntary food allergy and anaphylaxis guidelines for schools (FAAMA, 2011).
In 2013, the Center for Disease Control and Prevention (CDC) published "Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs," the first national guideline for managing food allergies in schools (CDC, 2013).
The FAAMA supports the implementation of food allergy management guidelines in public schools by providing school-based food allergy management incentive grants to local educational agencies (FAAMA, 2011).
As of July, 2014, the Supreme Court has not ruled on any cases significantly related to food allergies.
There have been some federal appellate decisions related to food allergies and the ADA (Borella, 2010).
Land v. Baptist Medical Center (1998)
A toddler with a peanut allergy, Megan Land, was refused daycare services by the Baptist Medical Center after having a second allergic reaction at the daycare facility. Megan's mother, Marie Land, filed a lawsuit, contending that Megan's allergy deems her disabled under the ADA.
The child was not considered disabled under the ADA. Even though the child had a record of allergic reactions related to peanut ingestion, the child was not "substantially limited" because she could safely eat foods that did not contain peanuts and could breathe as long as she stayed away from peanuts.
- Even a small exposure could produce a fatal reaction.
- The ruling overlooks the significant efforts made by the child, parents, caregivers, and school personnel to avoid exposure (Borella, 2010).
- Such cases brought under the ADA have had no success (as of 2011) due to food allergy reactions being only potential and temporary when it comes to limiting a major life activity (i.e., breathing). However, the ADA Amendments Act of 2008 (ADAAA) made it "substantially more likely that food allergies will be found to be disabilities, giving plaintiffs a better chance of successful litigation under that Act" (Roses, 2011, p. 232).
- The ADAAA specified that "intermittent or sporadic impairments will be considered substantially limiting if they would substantially limit a major life activity when active." This statement serves to make food allergies more easily classified as a disability (Roses, 2011, p. 237).
Approximately 43 million Americans have one or more disabilities. Thus, the scope of the ADA needs to be limited (Borella, 2010) to make food allergies less likely to be considered as disabilities so that food allergy prevention can be achieved. Two reasons food allergies may not be considered a disability under the ADA are as follows:
A food allergy does not significantly limit major life activities (e.g., the Land v. Baptist Medical Center ruling).
Second, Corrective measures can be taken. The court would take the plaintiff's ability to avoid the allergen(s) (e.g., label reading) and the availability of epinephrine into account. The food allergy community argued against this, stating that epinephrine is not a "corrective measure" but a treatment that still does not guarantee the prevention of death. The ADAAA of 2008 addressed this issue, saying that consideration of whether the disability majorly limits life activity should not take "corrective measures" into account (Borella, 2010).
Public schools must provide a free and appropriate public education for disabled students. Students with severe food allergies may qualify as disabled under this act based on physician's statements.
School Access to Emergency Epinephrine Act (H.R. 2094)
This legislation encourages states to adopt laws that require schools to have "stock" epinephrine auto-injectors on hand, which can be used for any student or staff member in an anaphylactic emergency (FARE, 2013).
Individuals with Disabilities Education Act (2004)
The Act requires schools that receive public funding to develop individualized education programs (IEPs) for children with disabilities (Borella, 2010).
- IEPs include records of the child's disabilities, grade level, goals for the academic year, and a description of the accommodations appropriate for the child.
- IEPs are monitored and reviewed yearly by teams that include at least one guardian, pertinent teachers, and "a representative of the local educational agency" (Borella, 2010).
Individualized Healthcare Plans (IHPs) and 504 Plans
Registered professional school nurses are required to write IHPs for students with healthcare needs that can be "complex and unfamiliar to school staff, and the children's requirement for nursing can be frequent and sometimes emergent. Therefore, accurate and adequate documentation of their [the students'] chronic medical conditions and individual needs is critical" (Lyon, 2012, p. 288).
States may also create their own guidelines to address food allergies in schools more specifically than federal laws due to confusion over the classification of "disability" in terms of food allergies (Borella, 2010).
Common areas of focus among state guidelines include the following (Borella, 2010):
- Emergency procedures in response to anaphylaxis or the necessity for epinephrine treatment
- Food allergy awareness training for staff members
- Training of bus drivers regarding food allergies and procedures in response to anaphylactic reactions
- Food allergy prevention training for food service staff
- Specific cleaning directions for custodians and maintenance staff
- Designated allergen-safe tables in the cafeteria
- Procedures for notifying substitute teachers of food-allergic children in their care
- Safety procedures for after-school activities
- Specification of personnel who are responsible for monitoring children with food allergies and administering epinephrine during field trips
- Identifying the responsibilities of the child, parents, and school in terms of food allergy management
Notable lawsuit related to food allergy: Lesley University, Cambridge, Massachusetts
Students sued the institution for not providing or accommodating safe dining for students with allergies.
- Always offer ready-made hot and cold gluten- and allergen-free food options.
- Customize personal meal options for students with food allergies, and allow students to order allergen-free meals in advance.
- Provide a dedicated area in the dining hall to prepare and stock gluten-free and allergen-free foods to avoid cross-contamination.
- Permit students the ability to request and provide allergen-free food.
- Use vendors that offer allergen-free food items while accepting students' meal cards.
- Train staff about food allergy-related issues.
- Pay compensatory damages to previously identified students who have food allergies or celiac disease.
Massachusetts: Food Allergy Awareness Act, Massachusetts Department of Public Health (FARE 2014). Restaurants are required to do the following:
- Display a FARE food allergy awareness poster in an area visible to staff.
- Include the following notice on menus and menu boards: "Before placing your order, please inform your server if a person in your party has a food allergy."
- Have a manager in the workplace who has undergone training with a certified vendor of the Massachusetts Department of Health (FARE, 2014).
Rhode Island: enacted a law similar to that enacted by Massachusetts (FARE, 2014)
New York City, New York, and St. Paul, Minnesota: City councils have already approved proposals requiring restaurants to include food allergy awareness posters (FARE, 2014).
Hoff, D. L., & Mitchell, S. N. (2010). A peanut dilemma. Phi Delta Kappan, 91(7), 59-63.
This article discusses the controversy over peanut-free schools. Experts and parents share opinions on the legal issues of implementing a peanut-free policy, as well as alternative solutions for peanut-free policies that can protect students and reduce liability.
Roses, J. B. (2011) Food allergen law and the Food Allergen Labeling and Consumer Protection Act of 2004: Falling short of true protection for allergy sufferers. Food and Drug Law Journal, 66, 224-242.
This article details a history of food allergen law, difficulties in food allergen litigation, and precautionary statements and food allergen labeling in restaurants.
Allergen labeling specifics are also discussed in Module 3. For more allergen labeling details, visit http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodlabelingnutrition/foodlabelingguide/ucm064880.htm#label
Abbot, J. M., Byrd-Bredbenner, C., & Grasso, D. (2007). "Know before you serve" Developing a food-allergy fact sheet. Cornell Hotel and Restaurant Administration Quarterly, 48, 274-283.
Asthma and Allergy Foundation of America. (2011). State honor roll 2011: Asthma and allergy policies for schools. Retrieved from: http://www.aafa.org/pdfs/2011%20State%20Honor%20Roll%20Full%20Report%20Final.pdf
Borella, M. (2010). Food allergies in public schools: Toward a model code. Chicago-Kent Law Review, 85, 761. Retrieved from http://scholarship.kentlaw.iit.edu/cklawreview/vol85/iss2/10
Centers for Disease Control and Prevention (2013). Voluntary guidelines for managing food allergies in schools and early care and education programs. Washington, DC: US Department of Health and Human Services.
Dahl, D. (2006, July 04). Restaurant industry may face a spate of food allergy suits. St.Louis Daily Record / St.Louis Countian. Retrieved from http://search.proquest.com.er.lib.k-state.edu/docview/342515863?accountid=11789
Food Allergen Labeling and Consumer Protection Act of 2004, 21 U.S.C. § 343 (2004).
Food Allergy & Anaphylaxis Management Act, U.S.C. § 2205 (2011).
Food Allergy Research and Education [FARE] (2014). Food allergies and restaurants. Retrieved from http://www.foodallergy.org/advocacy/restaurants
Food Allergy Research and Education [FARE] (2014). Food allergy facts and statistics for the U.S. Retrieved from http://www.foodallergy.org/facts-and-stats
Higgins, K. T. (2006, March 06). Allergen & labeling: Got it under control? Food Engineering. Retrieved from http://www.foodengineeringmag.com/articles/allergens-labeling-got-it-under-control
Individuals with Disabilities Education Act, 20 U.S.C. § 1400 (2004).
Kronenberg, S. A. (2012). Food allergy risk management: More customers, less liability. Journal of Foodservice Business Research, 15, 117-121.
Land v. Baptist Medical Center, 164 F.3d 423 (8th Cir. 1998).
Lyon, L. (2012). School assessment form for students with special health care needs. NASN School Nurse, 27(6), 288.
Missouri Department of Health and Senior Services. (2012, April). Guidelines for allergy prevention and response. Retrieved from http://health.mo.gov/living/families/schoolhealth/pdf/mo_allergy_manual.pdf
Porter, D. V. (2003). Food labeling: Allergy information. Journal of Medicine, 348, 986-993.
Roses, J. B. (2011). Food allergen law and the food allergen labeling and consumer protection act of 2004: Falling short of true protection for food allergy sufferers. Food & Drug Law Journal, 66, 225-242.
Sheetz, A. H., Goldman, P. G., Millett, K., Franks, J. C., Mclntyre, C. L., Carroll, C. R., ... Carrick, M. A. (2004). Guidelines for managing life‐threatening food allergies in Massachusetts schools. Journal of School Health, 74, 155-160.
Sicherer, S. H., & Mahr, T. (2010). Management of food allergy in the school setting. Pediatrics, 126, 1232-1239.
U.S. Food and Drug Administration. (2012). Food allergies: What you need to know. Retrieved from http://www.fda.gov/downloads/Food/ResourcesForYou/Consumers/UCM220117.pdf