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=== Allergenicity ===
Fish allergies are one of the eight most common allergies.<ref>[http://www.mayoclinic.com/health/food-allergies/AA00057 "Food allergies: Watch food labels for these top 8 allergens"], Mayo Clinic, Accessed September 7, 2010.</ref> AquaBounty performed a test to see if its GE salmon would differ in allergenicity from non-GE salmon.
==== Study Design ====
A total of 18 fish, six from each of three groups (diploid GE, triploid GE, and diploid non-GE), were used in the study. Then, blind-coded salmon fillets were shipped to a testing laboratory, which produced a "frozen salmon-fillet homogenate (FSFH)" for use in testing and shipped it to [[IBT Reference Laboratory]] in Kansas. Then, AquaBounty Technologies "unblinded the identities of all 18 samples." Then, sera from humans with salmon allergies to test the salmon's effects on human allergies. The FDA document describes the test, saying "This assay provides a quantitative determination of inhibition of salmon-specific IgE binding which is then used to calculate the potency of salmon allergen in muscle-skin from GE salmon relative to that in a control extract, comprised of equal volumes of all six sponsor control non-GE FSFH extracts."
==== Study Flaws ====
The FDA noted two flaws in the study. First, the sample size was very small. Second, the control group of fish were not farm-raised salmon. Also, instead of noting the "percent inhibition" (a numeric, quantitative measure of allergenicity), the study determined what it called "relative potency" as its measure of allergenicity, a term that the testing laboratory was unable to define when asked by the FDA. To correct for this, the FDA requested the raw data and used it in its analysis. Additionally, Michael Hansen notes, as an additional flaw, that the study was not a blind study.
==== Data and Interpretation ====
The data from this study was analyzed by examining the mean allergenic potency of each individual fish, because salmon is typically eaten as a fillet of an individual fish and not a mix of many different fish. The data for mean allergenic potency is as follows:
* Non-GE Diploid: 1.69, 2.04, 2.17, 2.29, 2.38, 2.65
* GE Diploid: 2.71, 2.90, 3.36, 3.44, 3.57, 4.23
* GE Triploid: 1.70, 2.31, 2.75, 2.88, 2.99, 3.22
The FDA interprets this data as follows: "Although confidence in the data describing the diploid GE-salmon are low, these data indicated that four diploid GE fish had mean allergenic potency greater than 3.00 U/ml, with one fish having a mean allergenic potency value of 4.23 U/ml. Only one triploid GE salmon had a mean allergenic potency value greater than 3.00 U/ml."
However, Michael Hansen points out that every single one of the GE diploid salmon and all but 2 of the GE triploid salmon showed mean allergenic potencies higher than the highest value for non-GE diploid salmon. Coupling this point along with the small sample size of the study, Hansen feels there is good cause to perform another, more comprehensive study.
==== Conclusion ====
The FDA concluded that "The allergenic potency of triploid ABT salmon is not significantly different from that of sponsor control diploid salmon. There is insufficient data and information to draw a conclusion on the allergenic potency of diploid ABT salmon."
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