FDA Seeks Comments on Setting Food Allergen Thresholds
The Food and Drug Administration (FDA) is seeking comments and other
information, including data, to help determine whether the agency can
establish regulatory thresholds for major food allergens such as milk, eggs,
fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans.
In a recent notice, FDA states that although “[We have] used several risk
management strategies to reduce the risk from unlabeled major food allergens,
such as targeted inspections or discussions with industry organizations,
we have not established regulatory thresholds or action levels for major
food allergens. The establishment of regulatory thresholds or action levels
for major food allergens would help us determine whether, or what type of,
enforcement action is appropriate when specific problems are identified and
also help us establish a clear standard… Regulatory thresholds also would
help industry to conduct allergen hazard analyses and develop standards for
evaluating the effectiveness of allergen preventive controls.”
In particular, FDA invites comments on the following matters: (i) How should
we define “an allergic response that poses a risk to human health?”; (ii) Which
major food allergens are of greatest public health concern and what is the size
of the at-risk population?; (iii) How should clinical dose distribution data be
used when establishing regulatory thresholds for the major food allergens?;
(iv) What approaches exist for using biological markers or other factors related
to the severity of allergic responses in a threshold risk assessment?; (v) What
data and information exist on dietary exposure patterns for individuals on
allergen avoidance diets?; (vi) What data or other information exist on current
levels of exposure associated with the consumption of undeclared major food
allergens in packaged foods?; (vii) What other information or data should
we consider in establishing regulatory thresholds for major food allergens?
Comments may be submitted by February 12, 2013. See Federal Register,
December 14, 2012.
