The Food Safety Modernization Act (FSMA) of 2011, 21 CFR Part 117, significantly shifted the focus to “allergen cross-contact” from its earlier food-safety iteration of Good Manufacturing Practices (GMPs) found in 21 CFR Part 110. The term “allergen cross-contact” was not even mentioned in Part 110, but it appears 37 times in Part 117, indicating the priority FDA places on prevention. Recently, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law, declaring sesame as the 9th major food allergen recognized by the United States. For manufacturers, food allergen testing and development of an allergen control program are more important than ever.
Sesame Added to the FDA “Big List”
The majority of food allergies are caused by one or more allergenic proteins. FDA includes nine allergens in its “big list”:
- Soy
- Wheat
- Tree nuts
- Peanuts
- Milk
- Fish
- Shellfish
- Eggs
- Enforcement of the ninth and newest allergen, sesame, begins Jan. 23, 2023
By this date, the presence of any of these nine allergens must be declared on a product’s label in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA). Both the U.S. food and dietary-supplement industries are subject to FALCPA, which requires the allergen to be listed using its common name, making food allergen testing a necessary part of your developmental process. A note of exemption: Highly refined oils are exempt if processing removes all traces of the allergen.
Unintentional or Intentional Contamination of Food Allergens?
Undeclared allergens continue to be responsible for the highest percentage of reported food recalls. They enter the food supply through system breakdowns in processing, labeling, improper storage or communication between the suppliers, co-packers and the food manufacturer. Sometimes the undeclared allergen is added inadvertently because of these system errors, which must be addressed through appropriate food-safety systems and a good allergen control program.
In other instances, allergens are knowingly included in the product, but their declaration on the label is intentionally and illegally avoided. If this intentional adulteration is for economic gain, then the practice is known as “food fraud”. However, if the adulteration is with the intent to cause harm, then it falls under the category of “food defense”. In FDA’s eyes, regardless of the reason, the inclusion of an undeclared allergen in foods or dietary supplements is an egregious error and must be avoided and will be punished through one or more FDA enforcement actions.
Supplier-Change Control and Food-Safety Assessments
It is all too common in recent years for changes in suppliers to result in allergen introductions. This issue came to a head during the COVID-19 pandemic and continues to be a larger industry-wide concern as supply chain issues are magnified. Risk assessments and mitigation strategies, such as food allergen testing, that ensure suppliers maintain an appropriate level of allergen controls are critical. Even when the same ingredient, additive or processing aid is used, when swapping one supplier for another, the risk of allergen introduction is a real threat.
Allergen Cross Contact Can Come From Anywhere
Allergens can be introduced anywhere in the supply chain, and manufacturing challenges that introduce allergen cross contact arise with ineffective cleaning of utensils or equipment surfaces. Regardless of the urgency of a supplier change, strict change-control procedures and supplier audits will help avoid any unexpected or unintended consequences.
From the supply-chain risk-management standpoint, manufacturers should do everything possible to evaluate suppliers and ingredients through auditing (both internal and third-party), ingredient testing and careful visual specifications. These steps should be part of your allergen control program.
Yet, the manufacturer must go into emergency-management mode when a supplier change is urgently needed, such as when an ingredient is no longer available (or has been implicated in a recall), or an unexpected test result has been returned. Production of any products using that suspect ingredient must cease, any ingredient which hasn’t already been used should be set aside until further evaluation and a determination must be made as to whether there is any consumer risk in products already on the market that warrants a recall. This tracing of the supply chain backward and forward is a necessary part of food-safety management today and will help avoid time-consuming and costly mistakes.
Food Allergen Testing: How Allergens are Identified
Food allergen testing identifies allergens either in the processing facility itself or through a third-party independent laboratory. Using a matrix and appropriate agents, laboratories can identify and quantify their presence.
Several rapid diagnostic food allergen testing platforms exist, including the following:
- Lateral Flow
- ELISA
- PCR
Lateral flow, which detects the absence or presence of allergens, is commonly used at the manufacturing-facility level. A quantitative assessment can be made using ELISA. ATP swabbing is often used in place of lateral flow and ELISA. This option, however, may not be adequate since the test method detects only general proteins and may not have the desired sensitivity. Because of its technical nature and equipment, a quantitative assessment is most often undertaken in a third-party laboratory. PCR testing, which looks at DNA molecules after exposure to thermal processing, is limited in scope because it cannot distinguish the type of DNA.
Allergen Control Programs are a Must for Processors & Suppliers
FSMA requires that both domestic and foreign food facilities conduct a hazard analysis for foreseeable food-safety risks, including the introduction of allergens, and to implement a system of risk-based preventive controls for those identified hazards. Known as Hazard Analysis and Risk-Based Preventative Controls, an allergen control program is included as part of this hazard assessment and preventive strategy.
Allergen control programs are a must for both domestic food processors and their suppliers, including importers of food products. Integral to the overall preventive control-based food-safety program, monitoring for introduction of allergens, developing and implementing corrective-action procedures as necessary and allergen testing are three major components.
Allergen changeover testing, when more than one product is produced on the same production line, is used to validate efficiency of sanitation. Cleaning is not enough to prevent allergen cross contact; sanitizing and confirmation testing must follow. It is also good practice to test products made in the first run after cleaning and sanitizing is complete to assess changeover effectiveness. If any positive results are found, corrective actions, including recleaning and sanitizing, must be undertaken, and that first-run product should be held or destroyed.
It is important to note that one single test may give an incomplete picture. Therefore, a risk-based approach includes routine and random testing of equipment surfaces and foodstuff in appropriate intervals by zone.
Food Allergen Testing Laboratory Accreditation and Certification
Testing laboratories must have the equipment, methods and expertise to perform at a level that ensures accurate identification of allergens. ISO 17025 accreditation and ISO 9001:005 certifications are two such demonstrations of competency and provide assurance of accurate, traceable and reproducible data based on laboratory equipment, methodologies and staff expertise.
EAS Consulting Group, a Certified Group company, assists clients with the development and assessment of Hazard Analysis and Preventive Controls as well as allergen control programs at the supplier and manufacturer level. Their accredited laboratories also offer food allergen testing services and more with some of the fastest turnaround times in the industry. Contact EAS Consulting Group to learn more about our services.
For more on food allergen testing, check out our free webinar: Food Allergens and the FDA
