Food Allergies and the Legal Environment: Case study approach

1. Food Allergies and the Legal Environment:Case study approach Module 4

2. Module Content 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 1073 Other legal guidance related to food allergies in educational settings State legislation

3. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) • Effective as of January 1, 2006 • The FALCPA is a public law stating that foods containing an ingredient or protein from a “major food allergen” must bear a label declaring the presence of any allergens. • Major food allergens: TheBig 8 Allergens are milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans (USDA, 2012).

4. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) • Detailed requirements of 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). • requires manufacturers to clearly disclose food sources that fall into the category of those that contain major food allergens (USDA, 2012). • Added the following to Section 403 of the Federal Food, Drug, and Cosmetic Act

5. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) • 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”). -OR- • 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).

6. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) • 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).

7. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) • 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.

8. Food Allergy & Anaphylaxis Management Act [FAAMA] • 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).

9. Americans with Disabilities Act (ADA) • 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).

10. Americans with Disabilities Act (ADA) • Land v. Baptist Medical Center (1998) • Background: • 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. • Ruling: The child was not considered disabled under the ADA basically because- • 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.

11. Americans with Disabilities Act (ADA) • Criticism: • 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). • 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).

12. Americans with Disabilities Act (ADA) • The issue: Approximately 43 million Americans have one or more disability. 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.

13. Americans with Disabilities Act (ADA) • 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). • 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).

14. Section 504 of the Rehabilitation Act of 1973 • 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.

15. Other legal guidance for food allergies in educational settings • School Access to Emergency Epinephrine Act (H.R. 2094) • 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) • Requires schools that receive public funding to develop individualized education programs (IEPs) for children with disabilities (Borella, 2010).

16. Other legal guidance for food allergies in educational settings • 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).

17. Other legal guidance for food allergies in educational settings Food allergy lawsuit: • Lesley University, Cambridge, Massachusetts • Background: students sued the institution for not providing or accommodating safe dining for students with allergies.

18. Other legal guidance for food allergies in educational settings Lesley University food allergy lawsuit • Ruling (Settlement) • 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.

19. State legislation: Massachusetts • 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).

20. State legislation: Massachusetts • Massachusetts (Food Allergy Awareness Act), Massachusetts Department of Public Health (FARE 2014) • Include food allergy training for certified food protection managers: video from Ming Tsai (celebrity chef and FAAN Ambassador Who Cares), training manual, FAAN’s “Welcoming Guests with Food Allergies” program and allergen awareness training • “Welcoming Guests with Food Allergies” program: free publication including case studies, best practices, current research, food labeling education, and strategies to prevent cross-contact

21. What’s going on at the state-level? • 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).

22. SUMMARY • Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) • Food Allergy & Anaphylaxis Management Act (FAAMA) • Americans with Disabilities Act (ADA) • Section 504 of the Rehabilitation Act of 1973 • IEPs and IHPs • State legislation: Massachusetts – Food Allergy Awareness Act