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Any approach used to establish a threshold to protect consumers with food allergies or those susceptible to celiac disease should be reexamined periodically to consider new knowledge, data, and approaches.

Threshold Working Group Findings For Major Food Allergens

Finding 1. The initial approach selected to establish thresholds for major food allergens, the threshold values, and any uncertainty factors used in establishing the threshold values should be reviewed and reconsidered periodically in light of new scientific knowledge and clinical findings.

Finding 2. The analytical methods-based approach can be used to establish thresholds for those major food allergens for which validated analytical methods are available. However, if this approach is used, the thresholds should be replaced by thresholds established using another approach as quickly as possible.

Finding 3. The safety assessment-based approach, based on currently available clinical data, is a viable way to establish thresholds for the major food allergens. If this approach is employed, the Lowest Observed Adverse Effect Level (LOAEL) or No Observed Adverse Effect Level (NOAEL) determinations used should be based on evidence of the “initial objective sign.” Individual thresholds should be established for each of the major food allergens. If it is not feasible to establish individual thresholds, a single threshold based on the most potent food allergens should be established. In those instances where a LOAEL is used rather than a NOAEL to establish a threshold, an appropriate uncertainty factor should be used. Thresholds established using this approach should be reevaluated periodically as new data and tools become available.

Finding 4. Of the four approaches described, the quantitative risk assessment-based approach provides the strongest, most transparent scientific analyses to establish thresholds for the major food allergens. However, this approach has only recently been applied to food allergens, and the currently available data are not sufficient to meet the

requirements of applicable risk

this approach. A assessment tools

research and to

program should be initiated to develop acquire and evaluate the clinical and

epidemiological data needed to support the quantitative Thresholds established using this approach should be data and tools become available.

risk assessment-based approach. reevaluated periodically as new

Finding 5. The statutorily-derived approach provides a mechanism for establishing thresholds for allergenic proteins in foods based on a statutory exemption. Potentially, this approach could be used to set a single threshold level for proteins derived from any of the major food allergens. This approach might yield thresholds that are unnecessarily protective of public health as compared with thresholds established using the safety assessment-based approach or the risk assessment-based approach. However, confirming this would require additional data. If this approach is employed to establish thresholds, it should be used only on an interim basis and should be reevaluated as new knowledge, data, and risk assessment tools become available.

Revised Threshold Report

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