On Friday, April 23, 2021, President Biden signed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 into law. The law contains two main components. First, sesame is added as a major food allergen, marking the first official change to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) since its passage. Second, the FASTER act requires reports on selected food allergy topics to be delivered to Congress, including those on how to establish and implement criteria for future updates to the list of major food allergens.
Sesame seeds (Sesamum indicum) are an oilseed crop, with yellow, white, red, brown, and black varieties grown for various food ingredients. Sesame seeds are approximately 50% fat, 23% carbohydrate, 18% protein, 4% ash, and 5% water. In 2019, the estimated global production of sesame was 6.5 million metric tons; the top producing countries were Sudan, Myanmar, India, Tanzania, Nigeria, and China. Sesame-derived food ingredients can include whole seeds, oils, flours, and pastes (commonly referred to as tahini).
Sesame is also known to cause food allergies and can be responsible for serious and life-threatening allergic reactions in sensitive individuals. The prevalence of sesame allergy varies around the world, with relatively higher prevalence observed in the Middle East, Israel, and Australia and lower prevalence observed in North America and Europe. Recent estimates in the U.S. indicate a convincing self-reported sesame allergy prevalence of approximately 0.2% in both adults and children. In comparison with the prevalence of other food allergies reported in the same studies, allergy to sesame is less prevalent than reported allergies to current major allergens (peanuts, tree nuts, wheat, soy, milk, crustacean shellfish, egg, fish) and molluscan shellfish. The allergenic potency of sesame is broadly similar to other seeds and nuts. The VITAL 3.0 reference dose (the ED01, or the dose expected to elicit reactions in the 1% most sensitive sesame-allergic individuals) is 0.1 mg total sesame protein. For comparative purposes, the sesame ED01 is the same as hazelnut, but higher than cashew and walnut and lower than peanut. The proteins in sesame seeds that have been identified as allergenic are predominantly seed storage proteins, as is also the case with tree nuts and peanuts.
In several regulatory jurisdictions around the world, including Canada, the EU, and Australia and New Zealand, sesame has been a priority food allergen for many years, with corresponding labeling requirements. In the U.S., sesame was not originally considered a major allergen in the context of FALCPA, but labeling of sesame or sesame ingredients was still required for many products in which such ingredients were used. For example, whole sesame seeds used as an ingredient were required to be labeled as such. However, sesame paste might have been declared as tahini, thus requiring sesame-allergic consumers to know that tahini was made from sesame. Additionally, when other forms of sesame (i.e., not whole seeds) were used, there were selected instances where those ingredients could be labeled as “spice” or “flavor.” The FASTER Act sought to remedy some of the potential confusion and improve labeling clarity by requiring sesame-derived ingredients to be subject to the same labeling regulations as other major food allergens.
The Amendment and Implications for FSMA
The FASTER Act amends Section 201(qq) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 (qq)) to read:
(qq) The term “major food allergen” means any of the following:
(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame.
The amendment to include sesame as a major food allergen is effective as of January 1, 2023. With this change, sesame and sesame-derived ingredients will need to follow all FALCPA labeling requirements. Specifically, all sesame and sesame-derived ingredients must be declared as sesame either in the ingredients list or in a “Contains” statement. If a “Contains” statement is used, all major allergen ingredients must be included. As noted above, one common sesame-derived ingredient used in foods is sesame oil. While FALCPA does exempt highly refined oils derived from allergenic foods from labeling, much of the sesame oil used in food production is not highly refined and is therefore not exempt from labeling. FALCPA does not provide a specific definition of highly refined oils, but industry best practice would indicate that processing should include refining, bleaching, and deodorizing. Sesame-derived ingredients must also be declared by their common or usual name; tahini may still be used on the ingredient list, but sesame must appear either parenthetically or in a “Contains” statement.
In addition to direct changes in FALCPA requirements, the inclusion of sesame in the definition of major food allergens also has implications for the Food Safety Modernization Act (FSMA). The FSMA Final Rule for Preventive Controls for Human Food includes the following definition: “Food allergen means a major food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act.” With the FASTER Act amendment, sesame will also be considered a major food allergen in the context of FSMA. As such, manufacturers will need to include sesame in food safety plan hazard assessments and will need to have preventive controls in place for the ingredient, if undeclared sesame is identified as a potential hazard.
Given that sesame has been considered a priority allergen in other regulatory jurisdictions for many years, there are tools and resources available to aid in sesame allergen management. Commercial detection methods for sesame are available in multiple formats, from several different kit manufacturers. Enzyme-linked immunosorbent assay (ELISA) methods are available for the detection and quantification of sesame in ingredients, processed food products, and environmental samples. The sesame ELISA methods, like other allergen ELISAs, are generally most appropriate for use in centralized or third-party laboratories due to the equipment and expertise required. Rapid methods, including lateral flow devices (LFDs), are also available for sesame. LFDs are easy to use, require minimal equipment, and are good options for detecting allergen-specific residues from equipment swabs and rinse waters when conducting allergen change-over validation studies. For selected situations where confirmatory analysis may be required, commercial PCR methods are also available for sesame detection.
When developing an allergen management plan or analysis strategy for sesame, one of the most important considerations is the form of the sesame ingredient. Sesame seeds, sesame paste, sesame flour, and sesame oil present very different challenges for allergen control and detection. With sesame seeds, it is important to recognize the particulate nature of potential cross-contact. In developing allergen change-over procedures, visual inspection for sesame seeds remaining on equipment is likely more crucial than analysis of equipment swabs. If ingredients or finished products are analyzed for cross-contact with sesame seeds, additional rigorous homogenization techniques (e.g., grinding under liquid nitrogen) are often required to break the seed coat and achieve sufficient sesame protein extraction for analysis. In the case of sesame paste, the oily, sticky nature of resulting food soils can be a challenge for allergen cleaning protocols. Soil removal strategies for similar ingredients (e.g., peanut butter and tree nut butters) have been successfully developed, however, and may be applicable to the cleaning of sesame paste. Sesame oil that has not been highly refined is likely to contain sesame protein; however, the protein may not be at concentrations high enough to be detectable in equipment swabs during allergen change-over validations. A swab of dirty equipment, after production of the product containing sesame oil and prior to cleaning, can serve as a positive control to verify the detection of sesame protein residues.
Impact on Food Safety Plans
While sesame has long been known to cause food allergies, the requirements to manage sesame as a major food allergen as a result of the FASTER Act will likely require multiple layers of changes on the part of some food manufacturers. Both allergen labeling controls and allergen cross-contact controls will be required for operations that handle sesame seeds or other sesame-derived ingredients. Despite the changes that may be required for food safety plans, the principles used for other food allergen controls are also relevant for sesame. Food manufacturers should be able to use existing best practices, tools, and resources to comply with the new application of food allergen regulations to sesame going forward.
Dr. Downs is an assistant professor in the department of food science and technology at the University of Nebraska, Lincoln. Reach her at [email protected]. Dr. Taylor is professor emeritus of food science and technology and co-founder and co-director of the Food Allergy Research and Resource Program (FARRP) at the University of Nebraska-Lincoln. Reach him at [email protected].