Posted: June 3rd, 2012 - 12:18pm
Source: Leavitt Partners

The all too common recall headline these days:
XYZ Foods is recalling [product name] because …
… the product contains soy protein, a known allergen, not declared on the label.
… it may contain undeclared traces of egg.
… the burgers contain a seasoning mix with hydrolyzed soy and wheat proteins that are not declared on the label.
… bags were shipped with the ingredient and allergen information not not applied directly to the immediate container and important allergen information may not have reached the end consumer.
During the first quarter of 2012, undeclared allergens or other allergen concerns were the primary cause of recalls, accounting for 40 percent of food recalls. (source: ExpertRecall) And this statistic is nothing new. As we have previously discussed, undeclared allergens have consistently been the top reason for food recalls since overtaking Salmonella in 2011.
This ongoing issue takes on current significance as the month of May encompassed a number of food allergy awareness events, including Food Allergy Awareness Week (week of May 13), the 20th anniversary of the Food Allergy and Anaphylaxis Network, (FAAN) and FAAN’s announcement of its intent to merge with Food Allergy Initiative (FAI), pending regulatory approvals.
As we detailed in FSMA and Preventive Controls: Implications for Industry, FSMA provisions bring new requirements in hazard analysis, including the specific listing of allergens as a hazard and the need for facilities to have broad prerequisite programs in place similar to Good Manufacturing Practices (GMPs) for all hazards, including food allergen control programs.
This means that, when FSMA Section 103 is implemented with the focus on Food Safety Plans, all registered facilities will be required to conduct a hazard analysis, implement preventive controls and develop a food safety plan to document the monitoring, correction, and verification of preventive controls. As part of its food safety plan, which must be made available to FDA during inspections, a facility may be required to document its food allergen control program along with other listed hazard prevention programs.
Additionally, Section 112 of FSMA, “Food Allergy and Anaphylaxis Management” requires the development of guidelines to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs. While analysis of current programs and gaps applicable to the legislation is currently in process, the eventual implementation of this provision is likely also to impact those who supply food to schools.
Also occurring in May was the Food and Nutrition Webinar, co-sponsored by FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the Joint Institute of Food Safety and Applied Nutrition (JIFSAN). Included was a presentation by CFSAN Food Allergen Coordinator Steven Gendel, who noted that allergic individuals need to practice strict avoidance. “That means they and their families become food label readers, and companies need to make sure that food labels include all the ingredients present in the food and avoid unintended allergens in the food, especially those not declared on the label.
“The chief tool that FDA has to help with that process is the providing of information to consumers through food labeling,” he said, explaining that the Reportable Food Registry now provides FDA with an additional means of tracking food labeling recalls. In its first year, reports related to undeclared allergens were second only to Salmonella indicating that problems still remain, he said. As an aside, it is interesting that whileSalmonella was the most frequent RFR report, it was not the most frequent cause of recalls.
As such, Gendel explained that, not only do Good Manufacturing Practices apply in preventing unintended allergens, but, as I stated above, FSMA identifies allergens as one of the hazards that needs to be considered in a hazard analysis, and should be part of the preventive control plan when appropriate. “The details of what all this means should be issued soon in guidance documents being developed,” he said.
As we have stated many times throughout 2012, we cannot be sure when the proposed preventive control rules will finally publish, but it is important that facilities take steps right now to implement or continually improve hazard analysis and prevention programs for allergens and allergen-labeling practices to reduce undeclared allergen recalls – both for the protection of allergic individuals and your own brand protection. Further, as equipment manufacturers continue to look for ways to add value to their food company customers, the more focused they are on providing effective cleaning options and systems to minimize labeling snafus, the greater the value to their customer base.