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.<ref>Jill Richardson, Phone interview with Michael Hansen, September 7, 2010.</ref> Coupling this point along with the small sample size of the study, Hansen feels there is good cause to perform another, more comprehensive study.In comments submitted to the FDA, Consumers' Union stated:<ref>[http://www.consumersunion.org/pdf/CU-comments-GE-salmon-0910.pdf Consumers Union’s Senior Scientist to Appear at Veterinary Medicine Advisory Committee Meeting on Genetically Engineered Salmon, September 19-20: Data Suggests Increased Allergy Risk; FDA Needs Much More Data Before Approval], Consumers' Union, September 17, 2010.</ref> "The data presented, although woefully incomplete, do raise a potential serious human health issue—that of increased allergenicity. If this product (GE animal) does increase the allergenic risk (e.g. an increase in allergenic potency), it should not be approved. Data from a mere 6 salmon (e.g. GE triploids) is not sufficient nor rigorous enough to conclude that no problem exists. Because FDA’s assessment is inadequate, we are particularly concerned that this salmon may pose an increased risk of sever, even life-threatening allergic reactions to sensitive individuals. Instead of approving this product, FDA should be requiring studies with data from many more engineered fish, not the tiny sample of six fish on which it currently bases its conclusions. Unfortunately, even the data from those six fish raises concerns, especially given the data on six GE diploid fish that were ignored."
==== FDA Conclusion ====