Regulatory Status of Therapeutants for Penaeid Shrimp Culture in the United States

The lack of approved drugs and chemicals needed to manage disease and pests in culture systems is the major constraint facing the penaeid shrimp culture industry in the United States. The industry needs the timely approval of the therapeutants for disease control for cost effectiveness and public safety. The approval process for the needed chemotherapeutants (drugs, parasiticides, disinfectants, and water quality agents) is administered by the US. Food and Drug Administration (FDA) and the US. Environmental Protection Agency (EPA). Both FDA and EPA have procedures for registration of compounds for minor use whereby needed approvals may be obtained at far less cost than is typical for uses in major agricultural industries. Aquatrine® is the only compound with specific approval for use in shrimp culture. Three others—formalin, oxytetracycline, and trifluralin—have entered the approval process. Because of human safety concerns, replacements are needed for malachite green, chloramphenicol, and the nitrofurans. Candidates for replacing these compounds include trifluralin, oxolinic acid, nalidixic acid, the potentiated sulfonamides, erythromycin, and oxytetracycline. A need exists for an environmentally safe and effective agent to treat fusarium disease. The U.S. Department of Agriculture Interregional Research Project Number 4 (IR‐4), in conjunction with FDA, has begun addressing the problems of the aquaculture industry. Thus, the penaeid shrimp industry has an excellent opportunity to obtain the approvals of chemotherapeutants that are needed for continued growth toward a full potential in this country.