FDA, Risk Assessment for Establishing Food Allergen Thresholds; Request for Comments, 2013

From the FDA:

SUMMARY: The Food and Drug Administration (FDA or we) is establishing a  docket to obtain comments relevant to conducting a risk assessment to  establish regulatory thresholds for major food allergens as defined in  the Food Allergen Labeling and Consumer Protection Act of 2004. 

Establishment of a Docket and Request for Information

    We are establishing a docket to provide an opportunity for interested individuals to submit comments (including data) that we can use to design and carry out a quantitative risk assessment for
establishing regulatory thresholds for major food allergens. In particular, we invite comments on the following matters:

    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?

DATES: Submit either electronic or written comments by February 12,  2013. 


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