ne of the preventive controls mandated in FDA’s “Current Good Manufacturing Practice Hazard Analysis and Risk Based Preventive Controls for Human Food” is allergen management. The U.S. Food & Drug Administration, Washington, D.C.,acknowledges that allergens are a significant food safety concern, hence their designation as a preventive control. It is also an issue that has been on the food industry’s radar for a number of years.
Food processors of all kinds have incorporated allergen management into their food safety management systems (FSMS) whether they are handling allergens or not. Yet, even though the regulators—the industry itself, developers of third-party audit schemes and those involved with the development of international standards—all focus on allergen management, there has been a steady increase in recalls attributed to allergens over the past 15 years.
In fact, according to the Food Allergen Research and Resource Program (FARRP) at the University of Nebraska, Lincoln, Neb., allergen recalls have been trending upwards for products regulated by both the FDA and the USDA. But, why the steady increase?
When I obtained the two figures from FARRP (see above), the question was posed as to whether the organization had additional information on the causes of the allergen-related recalls. That is, were these recalls attributed to packaging (use of the wrong or outdated packages), actual or possible cross-contact in process operations, improper formulation or blending or other? FARRP has not incorporated this data into their reports, so the next step was to review a number of individual recalls on the FDA website. Each of the issues noted above were seen when the individual recalls were examined. Those trends were that most recalls are associated with small companies, most recalls were associated with specialty products and over 90% of the recalls stated “no illnesses have been reported.”
Even though there is and has been an upward trend in recalls, studies indicate that the industry is learning that they have issues and is responding to them accordingly, and more importantly, doing so before consumers fall ill.
But, there is still more work that needs to be done, especially by the small operations and those companies doing small lots of specialty products. These companies need to develop, document, implement and maintain as allergen management program that includes the following:
· Vendor approval, certification and partnership
· Product specifications
· Product development programs that address allergens
· Proper labeling
· Production control and scheduling
· Cleaning and sanitizing
· Verification of cleaning
· Control of re-work
· Packaging management
· Product identification and recalls
· Education of management and staff
The biggest challenge for the food industry as a whole is ensuring that small companies that do not have significant technical expertise on staff can develop and implement an effective allergen management program.
Also, note that one of the elements is product identification and recalls. When processors have an allergen issue, the product is question must be recalled to protect the public health. This means that the processor must not only be able to identify the product in question and where it was shipped, but also have the mechanisms in place to get the product out of the public domain.
According to Dr. David Gombas, senior vice president, food safety and technology at the United Fresh Produce Association, Washington, D.C., and Amy Philpott, vice president of crisis services of Watson Green LLC, also based in Washington, D.C., an allergen management program has three legs—food safety/technical, communications and legal/regulatory. Therefore, a recall program must establish in-house programs to properly manage a crisis that adheres to regulatory requirements. The wrong person saying the wrong thing at the wrong time has the potential to turn a minor incident into a major problem, so when building a program, clearly define the communication issues and include the workforce. You don’t want them talking to the 6:00 news.
So, is allergen management and the increasing number of recalls a significant problem? The answer is yes, but with a caveat that the number of recalls indicates an increasing awareness throughout the industry of the importance of allergen management. The data underscores the importance of developing, documenting, implementing and maintaining an allergen management program by all processors large and small.