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IV. Discussion and Recommendations

A. General Approaches Four general approaches were identified that could be used to establish thresholds for allergens and glutens: analytical methods-based, safety assessment-based, risk assessment-based, and statutorily-derived. With any of these approaches, planned iterative reevaluation of threshold values should be carried out as new knowledge becomes available. These approaches are summarized in Table IV-1 and described in detail below.

Table IV-1. Approaches to Establishing Thresholds

Type of Approach


Analytical methods-based

Safety assessment-based Risk assessment-based


Labeling of sulfiting agents “Zero” tolerance policy for Listeria monocytogenes in ready-to-eat foods Evaluation of food additive petitions Guidance levels for Vibrio parahaemolyticus in raw oysters Labeling exemption for highly refined oil in the FALCPA

1. Analytical Methods-Based Approach. In an analytical methods-based approach, thresholds are determined by the sensitivity of the analytical method(s) that can be used to verify compliance. This effectively establishes a “regulatory threshold,” although this threshold is not necessarily correlated to biological effects. This approach has been used in food labeling. For example, the requirement to declare sulfiting agents on product labels when foods contain 10 ppm or greater is based on the limit of sensitivity of the analytical method used to measure these agents.

The issues that need to be considered when using an analytical methods-based approach to establish a threshold include:

  • What are the sensitivity and specificity of the method?

  • Has the method been adequately validated?

  • How will the method be used?

  • How will the threshold be modified when improved methods are developed?

The strength of this approach is that it is relatively simple, straightforward, and easy to implement. However, it is appropriate to use an analytical methods-based approach to establish thresholds for allergens or gluten only if analytical techniques are available for the food allergen and celiac-associated glutens.

2. Safety Assessment-Based Approach. Safety assessments are routinely applied to public health issues related to substances in foods, such as chemical contaminants or food additives, particularly when a biological threshold can be justified scientifically. The

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