Development of an environmental assessment of oxytetracycline after use and 
discharge from aquaculture facilities

The lack of therapeutants approved by the Food and Drug Administration (FDA) for 
use in fish culture is probably the biggest problem facing federal, state, and 
private fish hatchery managers. The lack of approved drugs for controlling 
diseases of cultured fish impacts virtually every state in the nation. The need 
has been so critical that the International Association of Fish and Wildlife 
Agencies (IAFWA) acting on behalf of the state fish and wildlife agencies has 
contracted with the Biological Resources Division of the U.S. Geological Survey 
to conduct studies necessary to gain approvals from the FDA. One of the 
compounds, for which data is being generated to gain broad approvals, is 
oxytetracycline. Oxytetracycline is currently approved for use in aquaculture, 
however it is only for a few diseases in catfish and salmonids and has lower 
temperatures limits for its use. 
UMESC scientists recently met with regulatory officials from CVM to review work 
completed by the IAFWA Project and discuss any possible shortcomings in data 
requirements for broad approval of Project compounds. One deficiency that was 
not planned or budgeted for in the IAFWA Project, was the need to update the 
environmental assessment of oxytetracycline. UMESC scientists were informed that 
it was likely that no new approvals would be added to the aquaculture label 
without updating the environmental assessment. In another words, even though all 
other requirements may be met to include additional diseases, lower 
temperatures, or new species of fish, the package would not be considered 
complete without a new environmental assessment. Completion of the environmental 
assessment of oxytetracycline would allow legal use of oxytetracycline on all 
state and Fish and Wildlife Service hatcheries that culture cold, cool or warm 
water fishes.