WASHINGTON — The Food and Drug Administration on Dec. 14 established a docket to accept comments in connection with its intent to set regulatory thresholds for major food allergens as defined by the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. The docket will remain open until Feb. 13, 2013.

In its request for comments published in the Federal Register, the FDA noted FALCPA was enacted to help consumers more easily identify ingredients in foods that may cause an allergic reaction. The FALCPA defined the term “major food allergens” and stated foods regulated under the Food, Drug and Cosmetics Act are misbranded unless they declare the presence of major food allergens on the product label using the common name of the food allergens. The food allergens were defined to include milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts and soybeans as well as food ingredients that contain protein derived from such foods. The definition excludes any highly refined oil derived from a major food allergen and any ingredient derived from such highly refined oil.

The FDA said FALCPA provides two mechanisms through which ingredients may become exempt from the major food allergen labeling requirement. An individual may petition for an exemption by providing scientific evidence, including the analytical method used, that an ingredient “does not cause an allergic response that poses a risk to human health.”

Alternatively, an individual may submit a notification that contains either scientific evidence showing that an ingredient “does not contain allergenic protein” or that a determination has previously been made through a premarket approval process that the ingredient “does not cause an allergic response that poses a risk to human health.”

The FDA notice also pointed to the problem of cross-contact, the inadvertent introduction of an allergen into a product that would not intentionally contain that allergen as an ingredient. It noted most cross-contact may be avoided by controlling the production environment.

Several risk management strategies to reduce the risk from unlabeled major food allergens have been employed by the agency, including targeted inspections and discussions with industry organizations, the FDA said.

“However, we have not established regulatory thresholds or action levels for major food allergens,” the FDA said. “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 for evaluating claims in FALCPA petitions that an ingredient ‘does not cause an allergic response that poses a risk to human health’ or ‘does not contain allergenic protein.’ Regulatory thresholds also would help industry to conduct allergen hazard analyses and develop standards for evaluating the effectiveness of allergen preventive controls.”

The FDA said it established the docket to provide interested individuals an opportunity to submit comments and data the agency can use to “design and carry out a quantitative risk assessment for establishing regulatory thresholds for major food allergens.” In particular, the FDA invited comments on the following:

• How should the FDA define “an allergic response that poses risk to human health?”
• Which major food allergens are of greatest public health concern and what is the size of the at-risk population?
• How should clinical dose distribution data be used when establishing regulatory thresholds for the major food allergens?
• What approaches exist for using biological markers or other factors related to the severity of allergic responses in a threshold risk assessment?
• What data and information exist on dietary exposure patterns for individuals on allergen-avoidance diets?
• What data or other information exist on current levels of exposure associated with the consumption of undeclared major food allergens in packaged foods?
• What other information or data should the FDA consider in establishing regulatory thresholds for major food allergens?

David Acheson, a partner in the law firm Leavitt Partners and former FDA associate commissioner for foods, said, “FDA is seeking input prior to setting a regulation that would have significant impact on anyone who uses any of the major food allergens in any of their products — or if there is any possibility that an allergen was introduced at any point in your chain of supply.”

Acheson noted some questions not expressly addressed in the FDA notice but still may deserve industry comment included: “Is there, in fact, enough science to back up the establishment of a threshold at all? If set, what exactly would be measured — the allergenic food, or the allergy-causing proteins of the food? An example would be a highly processed soy lecithin that no longer retains allergenic proteins. Will the threshold relate to the ‘soy’ or to the soy protein? How will the FDA balance industry and consumer needs in its final assessment?”

Acheson continued, saying “The Food Safety Modernization Act does recognize allergens as a hazard and requires preventive controls, but defining and setting a hard-and-fast threshold certainly needs to take a great deal more information into consideration. I would highly encourage you to respond during the comment period, which ends Feb. 13, 2013, and provide any comment, and especially any data, that would have an impact on the decision.”

To provide comment or information, go to www.regulations.gov. The docket number is FDA-2012-N-0711.