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Threshold Working Group Findings For Gluten

Finding 6. The initial approach selected to establish a threshold for gluten, the threshold value selected, and any uncertainty factors used to establish the threshold should be reviewed and reconsidered periodically in light of new scientific knowledge and clinical findings.

Finding 7. The analytical methods-based approach can be used to establish a threshold for gluten. However, if this approach is used, the threshold should be replaced by a threshold established using another approach as quickly as possible.

Finding 8. The safety assessment-based approach is a viable approach to establish a threshold for gluten using currently available LOAEL data for celiac disease. An overall uncertainty factor should be estimated from the data and applied to the LOAEL to establish a threshold for gluten. Any threshold derived from this approach should be reevaluated as new research data become available. Available data are insufficient at the current time to use this approach to establish a threshold for oat gluten for those individuals with celiac disease who may also be sensitive to oats. However, it is likely that a threshold level based on wheat gluten would be protective for individuals susceptible to oat gluten.

Finding 9.

Use of the quantitative risk assessment-based approach to establish a

threshold for gluten does not appear to be feasible considering the benefits that could be gained from approach, priority should be given to establishing a knowledge and data needed.

at the present

time. However,

using the risk

assessment-based

research

program

to

acquire

the

Finding 10. There appear to be no suitable legal requirements or exemptions that would serve as the rationale for using the statutorily-derived approach to establish a threshold for gluten. This approach is not viable.

Revised Threshold Report

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