Approval Date: July 31, 1992
I. GENERAL INFORMATION:
Western Chemical, Inc.
1269 Lattimore Road
Ferndale, Washington 98248
Over the Counter (OTC)
II. INDICATIONS FOR USE
A. Formalin is indicated for the control of external parasites on cultured food fishes: salmon, trout, catfish, largemouth bass, and bluegill sunfish. Organisms controlled include the protozoa: Ichthyophthirius spp. ("Ich"), Chilodonella spp., Costia spp., Scyphidia spp., Epistylis spp., and Trichodina spp. and monogenetic trematodes: Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp.
B. For control of fungi of the family Saprolegniaceae on salmon, trout, and esocid eggs.
III. PRODUCT INFORMATION
Dosage form, route of administration, and recommended dosage are discussed in the FOI Summary of Public Master File (PMF) 3543.
Animal efficacy is discussed in the FOI Summary for PMF 3543.
V. ANIMAL SAFETY
Animal safety is discussed in the FOI Summary for PMF 3543.
VI. HUMAN SAFETY:
Human food safety is discussed in the FOI Summary for PMF 3543.
VII. AGENCY CONCLUSIONS:
The data submitted in support of this NADA satisfy the requirements of 512 of the Act and demonstrate that formalin, when used under its proposed conditions of use, is safe and effective for the control of external protozoa and monogenetic trematodes on salmon, trout, catfish, largemouth bass, and bluegill sunfish, and for the control of fungi on salmon, trout, and esocid eggs.
A tolerance is not required for fish because total residue data showed that mean concentrations of formalin residues at 12 hours after the last treatment (zero withdrawal) were not different from naturally-occurring formaldehyde, which is a product of autolysis.
The proposed labeling is adequate to ensure the safe use of formalin by lay persons. Therefore, this product is an over-the-counter (OTC) product.
VIII. LABELING (Attached)
Copies of applicable labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855