17α-methyltestosterone (MET) is an aquaculture premix and is only available through Rangen Inc. The primary goal of studies conducted under INAD #11-236 is to generate data evaluating the efficacy of MET administered in feed to larval tilapia to produce populations comprised of >90% male fish. The treatment option that is allowed is a dose of 9 mg active drug/kg of fish biomass. MET will be incorporated into tilapia feed by Rangen, Inc. at a rate of 60 mg MET/kg feed. Therefore, based on standardized procedures for tilapia production, newly hatched tilapia fry should be fed 150 g MET-medicated feed/kg fish biomass/day (i.e., fed at 15% body weight daily). MET-medicated feed should be fed to tilapia fry for 28 consecutive days. No retreatment will be allowed. Investigational Withdrawal requirements (days or individual fish weight) depend on whether fish are reared in a “batch culture” system (120-d Investigational withdrawal period) or a “partial-harvest/restock culture” system (individual fish must weigh at least 350 g before being taken to market).This INAD requires all participants to be approved by the FDA Environmental Team prior to participation – this review will take 90 days. To participate in the INAD Program for MET visit the data collecting site.
Please read the Study Protocol prior to any treatments. It contains the protocol, MSDS, and a copy of the forms to be used as a guide for collecting data that will be entered into the online INAD database. The FDA authorization letter(s) for this INAD is currently only available by emailing Bonnie Johnson .
INAD objective/purpose: Collect supportive and pivotal data needed to establish the effectiveness of 17-α methyltestosterone when fed as a feed additive to larval tilapia to produce populations comprising over 90% male fish.
17-α methyltestosterone (MET)
P.O. Box 706
Buhl, ID 83316
Attention: David Brock
Phone: 1-800-657-6446 x ext. 1332
Target pathogen(s): Not Applicable
Method of administration: Medicated feed treatment
Investigational Withdrawal period:
Required test parameters:
Limitations or restrictions on use of drug:
Required INAD fee: $700/facility/year
AADAP Contact Information:
Ms. Bonnie Johnson, FWS-AADAP