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Allergen Thresholds

In December, FDA opened a docket to gather information to help them conduct a risk-assessment to establish regulatory thresholds for major food allergens. Undeclared major food allergens continue to be one of the two principal causes of reportable food incidents, typically leading to Class I recalls.  As acknowledged in the notice, the “establishment of regulatory thresholds or action levels for major food allergens would help [FDA] determine whether, or what type of, enforcement action is appropriate when specific problems are identified.”

FDA’s notice suggests a variety of ways that establishment of thresholds could be helpful (i.e., by helping to “establish a clear standard for evaluating claims in the Food Allergen Labeling and Consumer Protection Act (FALCPA) petitions” for exemption from allergen declaration, and by helping industry “conduct allergen hazard analyses and develop standards for evaluating the effectiveness of allergen preventive controls” – actions that will be required under FSMA).  However, the most immediate and tangible benefits could be realized in the context of enforcement.  This point is more clearly recognized in FDA’s release (“If safe thresholds can be established, the FDA could more effectively determine the appropriate corrective action to unintentional allergen contamination issues…[and] better respond to situations where undeclared allergens are found in foods”).  The release also recognizes that the absence of thresholds might be unnecessarily constraining consumer choice.

FDA’s notice hints at the “significant advances in both scientific tools and data resource related to food allergens” that have taken place in the six years since the agency’s Threshold Working Group issued a report summarizing its evaluation of approaches for establishing thresholds.

NAMA is part of an allergen threshold working-group along with other food industry representatives.

Last update March 8, 2013

 

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Threshold Working Group report:

http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106108.htm

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