Snuck into the Preventive Controls proposed rule is an update to current Good Manufacturing Practices. This update hasn’t received nearly the attention as the “new” Hazard Analysis and Risk-Based Preventive Controls (HARBPC) section, but it contains language that is particularly meaningful to me, personally. In addition to some wording switches, a key substantive change is the proposed emphasis on allergens and, specifically, the avoidance of cross contact.
To further stress the importance that FDA places on allergen issues, HARBPC identifies allergen controls as a type of preventive control. The preamble to the proposed rule provides several examples of ways that allergens can be controlled and FDA has suggested that guidance to industry on how allergen controls can be implemented is forthcoming. In the second quarter of 2013, 65% of USDA recalls and 60% of FDA recalls were related to unlabeled allergens. Given this prevalence, it’s easy to see how it is in industry’s best interest to gain a better handle on allergens. But as the mom of a food-allergic child, I have to wonder how this will trickle down to benefit consumers, and I see the possibility of a double-edged sword.
Before FDA wrote the rules implementing the Food Allergen Label and Consumer Protection Act (FALCPA), the agency had the Institute of Food Technologists (IFT) study the terminology used by food processors. While the “big 8” need to be called out and described by their common names, there is no standardization in describing the manufacturing conditions that could result in the accidental inclusion of an allergen.
The inadvertent inclusion of a walnut fragment in a food can kill my child. Naturally, I read allergen declarations, and their accuracy is of the utmost importance to me. With the passage of the FALCPA regulations, it was made clear that statements advising consumers of the potential for allergens could not be used as a substitute for Good Manufacturing Practices. However, this fine line leaves the allergen-affected community wondering about which foods are safe.
More than once I’ve been asked about the value of including a “may contain” declaration on a food label. Sometimes this is the result of the recognition that a piece of equipment can’t be adequately cleaned, sometimes it is because the manufacturer knows that its supplier doesn’t have good allergen controls in place. Sometimes it’s just because a company feels safer from a liability standpoint by making such a declaration.
Similar to the variety of practices by food manufacturers, families that need to navigate food allergens handle things differently. Personally, the presence of a warning label means that I will not bring that food into my home where my daughter could potentially eat it. Thus, the presence of a food allergy doesn’t just impact the affected individual, it can impact the shopping habits of the entire family. It also impacts every aspect of our lives that involves food, such as where we go out to eat, school lunches, etc.
In fact, CDC just released a publication with voluntary guidelines for the schools and early care and education centers on managing food allergies (available at http://www.cdc.gov/healthyyouth/foodallergies). The publication fulfills a provision of the Food Safety Modernization Act (FSMA) to improve food safety in the U.S. and provide practical information and planning steps for parents, district administrators, school administrators, and staff, and for program administrators and staff to develop or strengthen plans for food allergy management and prevention.
The Voluntary Guidelines for Managing Food Allergies also includes recommendations for five priority areas to be addressed in the facilities’ Food Allergy Management Prevention Plans, which include: ensuring the daily management of food allergies in individual children; preparing for emergencies; providing professional development for staff members; educating children and family members about food allergies; and creating and maintaining a healthy and safe educational environment.
Despite the fact that most of the population is able to freely consume any food without concern of an allergy, those of us with food-allergic children welcome the CDC guidelines and hope that schools implement as much as possible, regardless of the “voluntary” label. Unfortunately, it’s impractical for most companies to dedicate allergen-free facilities, but with the increased focus on allergen issues, it’s becoming clear that facilities will need to start demonstrating how allergens are being controlled.
I also have to wonder how many food manufacturers will identify allergens as a hazard reasonably likely to occur, if they don’t already do so? How many will implement allergen controls above and beyond what they have today? Will these result in fewer precautionary statements, since allergens will be better controlled within the manufacturing environment, or will processors realize that they have risk that they can’t control, other than adding a warning label? The former situation is ideal for food-allergic individuals—a world where they have a reasonable number of food choices and confidence that the food they eat will not contain an allergen. However, I fear that the latter might occur, and that the measures taken to protect food-allergic individuals ultimately restrict the number of foods they can eat—and the potential market for these manufacturers.