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Regulatory Priorities

Food Allergen Thresholds

The Food and Drug Administration (FDA) is seeking to understand whether it is possible to safely establish threshold levels for major food allergens. A threshold is the lowest amount of an allergen that elicits an allergic reaction. This issue could have important implications for the food allergy community.

FARE submitted its official comment to the FDA’s public docket on a risk assessment for establishing threshold levels for major food allergens on May 13, 2013. FARE’s comment, which is available for viewing on this link, combines the feedback received via a food allergy community survey that garnered more than 5,400 responses and the guidance of a working group comprising food allergy parents, researchers and regulatory experts. Responses to FARE’s survey may be viewed here. Members of the working group are listed here.

FARE has recommended that the FDA not establish a threshold for any food allergen unless the FDA is in possession of both:

  1. reliable scientific data that clearly identifies a quantity of the allergen that is so small that it will not cause an allergic reaction in even the most sensitive individuals, and

  2. a reliable analytical method for determining compliance with the threshold that can be easily used by food companies and FDA.

FARE supports further efforts to: (a) obtain and evaluate the scientific data needed to determine whether it would be possible to establish thresholds, (b) answer the questions FDA has asked, and (c) develop reliable methods of analysis to determine compliance with any thresholds that might be established in the future. If the FDA decides to use quantitative risk assessment or any other method to establish thresholds, FARE urges the FDA to first engage in outreach to the food allergy community to explain how thresholds would affect families who live with food allergies, and then engage in notice and comment rulemaking to establish any thresholds.

The FDA received more than 400 comments during this information-gathering phase, which is now closed. You may browse through comments that have been submitted by following this link.

Preventive Controls

The FDA is also accepting public comment on preventive controls, which would improve food safety by reducing the risks from all hazards in manufactured foods, including the unintended presence of food allergens. The FDA’s proposed rule to require “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls” is one of several required by the FDA Food Safety Modernization Act.

Public comment on the proposed rule is due no later than September 16, 2013. You may submit your own comment by following this link. Once submitted, FARE will share a link to its public comment on this page.