I. GENERAL INFORMATION:

NADA	140-831
Sponsor:	Argent Chemical Laboratories, Inc. 8702 152nd Ave., N.E. Redmond, WA 08052
Generic Name:	Formalin. Formalin is the aqueous solution of formaldehyde gas, U.S.P. grade.
Description:	Formalin, Formal: A solution of about 37% by weight of formaldehyde gas in water, usually with 10 to 15% methanol added to prevent polymerization. The solution is the same strength as Formalin 40% which signifies that it contains 40 grams in 100 ml of the solution and which is equivalent to 37% by weight.
Marketing Status:	OTC
Note:	Data in this FREEDOM OF INFORMAITON SUMMARY are referenced to Public Master 3543 in support of the new animal drug application. The data were generated by: FISH AND WILDLIFE SERVICE United States Department of the Interior Washington, D.C. 20240

II. INDICATIONF FOR USE

a. Formalin is indicated for the control of external parasites on cultured sport and food fishes: salmon, trout, catfish, largemouth bass, and bluegill. 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. DOSAGE FORMS, ROUTE OF ADMINISTRATION, RECOMMENDED DOSAGE

As stated in the FOI Summary for Public Master File (PMF) 3543.

IV. ANIMAL EFFICACY

As discussed in the FOI Summary for PMF 3543.

V. ANIMAL SAFETY

As discussed in the FOI Summary for PMF 3543.

VI. HUMAN SAFETY

As discussed in the FOI Summary for PMF 3543.

VII. AGENCY CONCLUSIONS

The data submitted in support of this NADA comply with the requirements of 512 of the Act and demonstrate that formaldehyde when used under its proposed conditions of use is safe and effective for the control of external protozoa and monogenetic trematodes on trout, salmon, catfish, largemouth bass, and bluegil, and for control of fungi on salmon, trout, and esocid eggs. The proposed labeling is adequate to assure safe use of formalin by aquaculturists. Therefore, this product can be marketed over the counter (OTC).