Fish and Aquatic Conservation


17α-methyltestosterone INAD #8557

photo of a juvenile rainbow trout
Juvenile Rainbow trout. Credit: Ryan Hagerty/USFWS

Summary

17α-methyltestosterone (MET) is an aquaculture premix and is only available through Rangen Inc. The primary goal of studies conducted under INAD #8557 is to generate data evaluating the efficacy of MET administered in feed to larval rainbow trout and Atlantic salmon to produce masculinized female fish that produce sperm. The treatment option that is allowed for rainbow trout is a dose of 10.8 mg active drug/kg of fish biomass. MET will be incorporated into feed by Rangen, Inc. at a rate of 3 mg MET/kg feed. MET-medicated feed should be fed to rainbow trout for 60 consecutive days. The treatment option that is allowed for Atlantic salmon is a dose of 6.3 mg active drug/kg of fish biomass. MET will be incorporated into feed by Rangen, Inc. at a rate of 1 mg MET/kg feed. MET-medicated feed should be fed to Atlantic salmon for 105 consecutive days. No retreatment will be allowed. Investigational withdrawal is 120 days. This INAD requires all participants to be approved by the FDA Environmental Team prior to participation – this review will take 100 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 rainbow trout and Atlantic salmon to produce masculinized female fish that produce sperm.

Drug Name
17-α methyltestosterone (MET)

Drug Source
Rangen Inc.
P.O. Box 706
Buhl, ID 83316

Attention: David Brock
Phone: 1-800-657-6446 x ext. 1332
Fax: 208-543-8037
email: dbrock@rangen.com

Target pathogen(s): Not Applicable

Method of administration: Medicated feed treatment

Treatment dosage:

  • Rainbow Trout: 10.8 milligrams (mg) MET per kilogram (kg) fish per day; note: MET will typically be incorporated into standard feed at a rate of 3 mg MET per kg feed; fish should be fed at 6% body weight per day.
  • Atlantic Salmon: 6.3 milligrams (mg) MET per kilogram (kg) fish per day; note: MET will typically be incorporated into standard feed at a rate of 1 mg MET per kg feed; fish should be fed at 6% body weight per day.

Treatment regimen:

  • Rainbow Trout: from first feeding 60 consecutive days
  • Atlantic Salmon: from first feeding 105 consecutive days

Investigational Withdrawal period:

  • 120 days

Required test parameters:

  • Investigator needs to report general fish behavior and any adverse effects relating to treatment.

Limitations or restrictions on use of drug:

  • No re-treatment of fish is allowed.
  • Investigator must follow all instructions in the Study Protocol for INAD 8557 regarding drug acquisition and handling, fish treatment and disposition, and data reporting requirements.
  • Investigator must complete Facility Effluent Information Form for discharge of MET before use under the INAD. Contact AADAP for more information.
  • Drug discharge must be in compliance with local NPDES permitting requirements.

Required INAD fee: $700/facility/year

AADAP Contact Information:
Ms. Bonnie Johnson, FWS-AADAP
Phone: 406-994-9905
Fax: 406-582-0242
email: bonnie_johnson@fws.gov