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risk assessment-based approach. Thresholds established using this approach should be reevaluated periodically as new data and tools become available.

d. Statutorily-Derived Approach. As discussed above, an allergen threshold could be extrapolated from a statutory exemption established by Congress for another purpose, such as the FALCPA exemption for “highly refined oils.” Thus, a threshold could be established for all food allergen proteins based on the level of protein in highly refined oils.

There are surprisingly few data available in the published scientific literature reporting on the levels of proteins in highly refined oils. The criteria used to evaluate studies measuring protein levels in food oils are shown in Table IV-7 and applied in Appendix 3.

Table IV-7. Specific Criteria for Evaluating Protein in Oil Studies

1. Has the study been published in a peer-

Published, peer-reviewed studies are

reviewed journal?

preferred, although unpublished studies can be considered.



4. Was the method used to quantify protein levels completely described? 5. Were replicate samples or batches tested, and was there a statistical analysis of these data?

The level of processing must be known both to compare values among studies and because each processing step may change the level of protein in oil. Extraction procedures should be described in sufficient detail to allow the extraction to be reproduced and, ideally, extraction efficiencies should be measured and reported. The lack of these data increases the level of uncertainty. The lack of these data and statistical analysis increase the level of uncertainty.

2. Was the oil completely described, including all refining and treatment steps?

3. Was the method used to extract the protein completely described?

Based on the data presented in those studies that reported levels other than “not detected,” the overall range of protein concentrations for highly refined oils was 0.014 to 16.7 µg protein/ml oil, with a mean of 2.35 µg/ml. The combined mean protein concentration for the two most widely used oils derived from food allergens, soy and peanut, is 0.74 µg/ml with a standard deviation (std) of 1.3 µg/ml. A threshold could be based on the mean protein concentrations or on the mean plus some multiple of the standard deviation. For example, using the mean protein concentrations for peanut and soy oils, protein levels for the mean, mean + 1 std, mean + 2 std, or mean + 3 std would be the 0.74, 2.05, 3.36, and 4.67 ug/ml, respectively.

Revised Threshold Report Page 57 of 108

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