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Steps in Developing a Dose-Response Model

    • 1.

      Determine the population of concern (e.g., infants, children, pregnant women).

    • 2.

      Determine the endpoint or biomarker of concern (e.g., death, severe illness requiring hospitalization, subjective reactions such as tingling of lip).

    • 3.

      Identify available relevant data including animal studies, human clinical studies, and epidemiological data that relate dose to frequency or severity of response.

    • 4.

      Select the appropriate dose-response model(s) that characterize the shape of the dose-response curve.

    • 5.

      Fit the selected model(s) to the data.

    • 6.

      Characterize the uncertainty (i.e., curve weighting and/or use of alternative plausible models).

  • 4.

    Statutorily-Derived Approach. The statutorily-derived approach establishes a

threshold by extrapolating from an exemption established by Congress for another purpose. For example, the FALCPA defines "major food allergen" to include a food ingredient "that contains protein derived" from one of eight foods or food groups, "except… any highly refined oil" derived from one of those foods. If consumption of highly refined oils is not associated with allergic reactions, and if there is nothing unique about the proteins in highly refined oils, then consumption of another food containing levels of protein that result in an exposure that is equal to or less than the level in a typical serving of highly refined oils should not be associated with allergic reactions. Thus, a threshold could be established for all food allergen proteins based on the level of protein in highly refined oils. There is no comparable statutory standard for gluten.

B. General Criteria for Evaluating and Selecting Approaches to Establish Thresholds The general criteria used to evaluate the four approaches to establish thresholds for allergens and gluten are shown in Table IV-2. Specific criteria related to food allergens are given in Section IV-C and gluten in section IV-D. The specific criteria should be weighted appropriately when implementing a particular approach. The general criteria focus on data availability and data quality. The Threshold Working Group recognizes that scientific knowledge is the product of a process which is inherently imperfect and often incomplete. As such, the degree of uncertainty in the data is a key consideration. It is expected that any decisions on approaches for establishing thresholds for food allergens or for gluten would require consideration of additional factors not covered in the current report. For example, ease of compliance and enforcement, stakeholder concerns (i.e., industry, consumers, and other interested parties), economics (e.g., cost/benefit analysis), trade issues, and legal authorities are all significant factors that are likely to influence the practicality of implementing any approach. One option that is implicit in the following discussion of potential approaches is a decision not to establish thresholds at this time, at least for food allergens.

Revised Threshold Report Page 45 of 108

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