NATIONAL COORDINATOR

FOR AQUACULTURE NEW ANIMAL DRUG APPLICATIONS

Recent Approvals (Formalin)

PARASITE-S® AND FORMALIN-FÒ (FORMALIN) APPROVED FOR ALL FINFISH AND PENAEID SHRIMP

SUMMARY: The Food and Drug Administration (FDA) amended the animal drug regulations on June 18, 1998 to reflect approval of a supplemental new animal drug application (NADA # 140-989) filed by Western Chemical, Inc. (1269 Lattimore Road, Ferndale, Washington 98248; telephone: 360-384-5898; fax: 360-384-0270). FDA also amended the animal drug regulations on February 4, 2003 for NADA # 137-687 filed by Natchez Animal Supply Company (PO Box 1528, 201 John R. Junkin Drive, Natchez, Mississippi 39120; telephone:  800-647-6760 or 601-446-5611; fax:  800-647-6762).  The supplements provide for use of formalin solution (an aqueous solution of 37% formaldehyde) in the water (tanks, raceways, and ponds) of all finfish as a parasiticide, all finfish eggs as a fungicide to control fungi of the family Saprolegniaceae, and external protozoan parasites on penaeid shrimp.

Conditions of use. It is added to environmental water as follows:

(1) Indications for use.

(a) All finfish. For control of external protozoa Ichthyopthirius sp., Chilodonella sp., Costia sp., Scyphidia sp., Epistylis sp., and Trichodina sp., and monogenetic trematodes Cleidodiscus sp., Gyrodactylus sp., and Dactylogyrus sp.

Aquatic species           Administer in tanks and raceways for up to 1 hour (microliter/liter or parts per million (muL/L or ppm):

Salmon and trout:        Above 50 degrees F     Up to 170^{1, 2}

                                   Below 50 degrees F    Up to 250^{1, 2}

All other finfish            Up to 250^{1, 2}

Administer in earthen ponds indefinitely (muL/L or ppm):         All finfish15 to 25^{1, 2}

(b) Penaeid shrimp.  For control of external protozoan parasites Bodo spp., Epistylis spp., and Zoothamnium spp.

Penaeid shrimp             Administer in tanks and raceways for up to 4 hours at 50 to 100 ppm

Administer in earthen ponds indefinitely (muL/L or ppm):  Penaeid shrimp   25^{1, 2} and repeated in 5 to 10 days if needed.

Footnote¹: Use the lower concentration when ponds, tanks, or raceways are heavily loaded with phytoplankton or fish to avoid oxygen depletion due to the biological oxygen demand by decay of dead phytoplankton. Alternatively, a higher concentration may be used if dissolved oxygen is strictly monitored.

Footnote²: Although the indicated concentrations are considered safe for cold and warm water finfish, a small number of each lot or pond to be treated should always be used to check for any unusual sensitivity to formalin before proceeding.

(c) All finfish eggs. For control of fungi of the family Saprolegniaceae on eggs of all finfish except Acipenseriformes, 1,000 to 2,000 muL/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 muL/L (ppm).