Aquaculture producers using non-approved formaldehyde

CVM Reminds Aquaculture Producers to Use Appropriate Formaldehyde
August 24, 2006

[Source: CVM Veterinary Newsletter]

According to reports reaching officials at the Center for Veterinary Medicine (CVM), some aquaculture producers are using chemical grade formaldehyde as a parasiticide drug for their fish, a use that CVM has not approved.

CVM issued an UPDATE in June to remind aquaculture producers to use the appropriate drugs. Using a formaldehyde compound other than the approved product can be unsafe for fish, and the effectiveness of an unapproved compound is questionable.

Three sponsors have approved new animal drug applications for formaldehyde: Western Chemical, PARASITE-S (NADA 140-989), Argent Chemical Laboratories, Inc., Paracide-F (NADA 140-831), and Natchez Animal Supply Company, Formalin-F (NADA 137-687).

PARASITE-S and Formalin-F are approved for the control of:

•   external protozoa (Chilodonella, Costia, Epistylis, Ichthyophthirius, Scyphidia, and Trichodina spp.) and the monogenetic trematodes (Cleidodiscus, Dactylogyrus, and Gyrodactylus spp.) on all finfish;

•   fungi of the family Saprolegniaceae on all finfish eggs; and

•   protozoan parasites (Bodo, Epistylis, and Zoothamnium spp.) on penaeid shrimp.

Paracide-F is approved for the control of:

•   external protozoa and monogenetic trematodes (as above) on salmon, trout, catfish, largemouth bass, and bluegill; and

•   fungi (as above) on salmon, trout, and esocid eggs.

Paracide-F is not currently approved for use on penaeid shrimp.

The sponsors of the aquaculture drugs have approved applications filed with the Food and Drug Administration and have demonstrated that their products are safe and effective for the approved uses. Approved formaldehyde products are manufactured under strict good manufacturing practice standards to ensure quality, purity, and strength. The standards by which chemical grade formaldehyde is manufactured are different, and the products are not appropriate for aquaculture use.

Questions about the use of formaldehyde in aquaculture can be directed to Fran Pell, Consumer Safety Officer, FDA/Center for Veterinary Medicine, Division of Compliance, 240-276-9211, e-mail