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C. FALCPA As noted, FALCPA amends the FFDCA to prescribe the manner in which food labels must disclose that a food is, or contains an ingredient that bears or contains, a major food allergen. The law also requires the FDA to issue a regulation to define and permit use of the term “gluten-free.”

FALCPA establishes a petition process through which a food ingredient may be exempt from FALCPA's labeling requirements if the ingredient does not cause an allergic response that poses a risk to human health. FALCPA also establishes a notification process under which a food ingredient described in section 201(qq)(2) of the FFDCA may be exempt from FALCPA's labeling requirements if the ingredient does not contain allergenic protein, or if FDA previously has determined, under section 409 of the FFDCA, that the food ingredient does not cause an allergic response that poses a risk to human health.

From the perspective of the Working Group, implementation of the FALCPA petition and notification provisions could present several key scientific issues. First, what is an “allergic response?” Second, do all allergic responses pose a risk to human health, or do some allergic responses pose more of a risk than others? Third, can allergens occur in a food either in a form or at a level that is too low to cause harm (i.e., either the allergen does not cause a biological response or the response is too mild to be considered hazardous)?

Under FALCPA, a “highly refined oil” derived from one of eight foods or food groups and “any ingredient derived from such highly refined oil” are exempt from the definition of "major food allergen" and from FALCPA's labeling requirements. As discussed further below, there is evidence that consumption of highly refined oils does not appear to be associated with allergic responses despite the potential presence of low levels of protein in these oils.

Section 202 of FALCPA requires FDA to issue a proposed rule to define and permit use of the term “gluten-free” on labeling of foods. Section 203 of FALCPA recognizes that “the current recommended treatment is avoidance of glutens in foods that are associated with celiac disease.” FALCPA does not directly state how the term "gluten-free" should be defined.

Revised Threshold Report Page 14 of 108

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