Human Food Safety and Environmental Assessment of the Use of 17α-Methyltestosterone to Produce Male Tilapia in the United States

Sex reversal of early life stage tilapia (approximately 7–12 d post‐hatch, total length averaging 9–11 mm, and total weight averaging 10–15 mg) is used commonly to produce populations of fish comprised of > 5% phenotypic females. The synthetic androgen, 17α‐methyl testosterone (MT), is used to effect sex reversal in tilapia. This paper evaluates environmental impact and human food safety aspects of MT use for tilapia sex reversal based on a review of the scientific literature and on dilution models of farm discharge. Effect of MT treatment on human food safety was evaluated by regression analysis of radioactivity depletion data and by dilution through growth analysis. Results show that the proposed use of MT for sex reversal of early life stage tilapia presents no negative effects on human food safety. Regression analysis of available depletion data from tilapia shows that whole‐body concentrations of MT and metabolites in tilapia attain levels of