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FDA Requests Comments on Allergen Thresholds

Date: Dec 14, 2012

On December 14, 2012, FDA opened a docket to gather comments to help them conduct a risk assessment to establish major food allergen thresholds.[1] Comments are due by February 12, 2013.

FDA is specifically seeking comments (including data) on the following:

1. How should we define "an allergic response that poses a risk to human health?"

2. Which major food allergens are of greatest public health concern and what is the size of the at-risk population?

3. How should clinical dose distribution data be used when establishing regulatory thresholds for the major food allergens?

4. What approaches exist for using biological markers or other factors related to the severity of allergic responses in a threshold risk assessment?

5. What data and information exist on dietary exposure patterns for individuals on allergen avoidance diets?

6. What data or other information exist on current levels of exposure associated with the consumption of undeclared major food allergens in packaged foods?

7. What other information or data should we consider in establishing regulatory thresholds for major food allergens?

FDA notes that establishing allergen thresholds will help them to determine whether, or what type of, enforcement action is appropirate in situations where food is unintentionally contaminated. Thresholds will also give FDA a standard to evaluate petitions and notifications for exemptions from allergen labeling. Finally, thresholds will help industry to conduct allergen hazard analyses and develop standards for evaluating the effectiveness of allergen preventive controls.

When the FDA Threshold Working Group evaluating approaches for establishing allergen thresholds in 2006, they identified the quantitative risk assessment-based approach as the "strongest, most transparent" approach.[2] The Working Group also expressed a need for clinical and epidemiological data to support a quantitative risk assessment and to develop risk assessment tools. FDA's action is being taken now because it believes that since 2006 there have been significant advances in scientific tools and data resources related to food allergens. FDA would like a chance to evaluate these advances to determine if they are sufficient to support a quantitative risk assessment and thresholds for one or more of the major food allergens.

We view this notice for comments as a positive development that will help FDA and the food industry more clearly understand at which levels food allergens do not pose a threat to public health.



[1] 77 Fed. Reg. 74485 (Dec. 14, 2012), available here.

[2] Threshold Working Group, 2006, Approaches to Establish Thresholds for Major Food Allergen and for Gluten in Food, available here.