CU comments to FDA regarding genetically engineered salmon


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This assessment of a genetically engineered (GE) salmon is the first evaluation of a GE animal and will set a precedent for future approvals of GE animals.  FDA should be especially cognizant of the scientific quality of the data and the rigor of the analysis needed to do a proper safety assessment of GE animals in this case.  Unfortunately, the evidence of FDA’s evaluation of the AquAdvantage salmon suggests that FDA has set the bar very low.  There is sloppy science, small sample sizes (only 6 fish per group for the allergenicity study), questionable practices (manipulating IGF-1 data), and woefully inadequate analysis (a conclusion of growth hormone levels in the flesh, despite having no data at all on growth hormone levels due to use of insensitive test methodology).  This analysis does not conform to FDA standard for assessment of a New Animal Drug (NAD).

FDA requires New Animal Drugs to be shown to be safe for animals, humans and the environment. This has not been shown for the GE salmon.  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.

Bottom line, this safety assessment is insufficient and needs to be redone with all the needed data.  Commissioner Hamburg last week honored Dr. Frances Kelsey for her stand that prevented thalidomide from harming American children many years ago.  FDA needs to bring Dr. Kelsey’s spirit to this assessment and focus on rigorous science with a view toward protecting public health.

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