[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR529.1030]
[Page 324-325]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
Sec. 529.1030 Formalin solution.
(a) Specifications. Formalin solution is an aqueous solution
containing approximately 37 percent by weight of formaldehyde gas,
U.S.P.
(b) Sponsor. Approval to firms identified in Sec. 510.600(c) of this
chapter for use as indicated:
(1) No. 050378 for use as in paragraphs (d)(1)(iii), (d)(1)(iv),
(d)(1)(v), (d)(2)(iii), (d)(2)(iv), (d)(2)(v), and (d)(3).
(2) Nos. 049968 and 051212 for use as in paragraphs (d)(1)(i),
(d)(1)(ii), (d)(2)(i), (d)(2)(ii), and (d)(3).
(c) [Reserved]
(d) Conditions of use. It is added to environmental water as
follows:
(1) Indications for use. (i) Select finfish. For control of external
protozoa Ichthyophthirius spp., Chilodonella spp., Costia spp.,
Scyphidia spp., Epistylis spp., and Trichodina spp., and
[[Page 325]]
monogenetic trematodes Cleidodiscus spp., Gyrodactylus spp., and
Dactylogyrus spp., on salmon, trout, catfish, largemouth bass, and
bluegill.
(ii) Select finfish eggs. For control of fungi of the family
Saprolegniaceae on salmon, trout, and esocid eggs.
(iii) Penaeid shrimp. For control of external protozoan parasites
Bodo spp., Epistylis spp., and Zoothamnium spp.
(iv) All finfish. For control of external protozoa Ichthyophthirius
spp., Chilodonella spp., Costia spp., Scyphidia spp., Epistylis spp.,
and Trichodina spp., and monogenetic trematodes Cleidodiscus spp.,
Gyrodactylus spp., and Dactylogyrus spp.
(v) All finfish eggs: For control of fungi of the family
Saprolegniaceae.
(2) Amount. The drug concentrations required are as follows:
(i) For control of external parasites on select finfish:
------------------------------------------------------------------------
Concentration of formalin
(microliters per liter)
Fish -------------------------------------
Tanks and raceways Earthen ponds
(for up to 1 hour) (indefinitely)
------------------------------------------------------------------------
Salmon and trout:
Above 50 F................... Up to 170........... 15-25
Below 50 F................... Up to 250........... 15-25
Catfish, largemouth bass, and Up to 250........... \1\ 15-25
bluegill.
------------------------------------------------------------------------
\1\ Use the lower concentrations when pond is heavily loaded with fish
or phytoplankton.
(ii) For control of fungi of the Saprolegniaceae on salmon, trout,
and esocid eggs: Apply in constant flow water supply of incubating
facilities for 15 minutes. Concentration of formalin used is 1,000 to
2,000 microliters per liter.
(iii) For control of external protozoan parasites on shrimp:
------------------------------------------------------------------------
Concentration of formalin
(microliters per liter)
---------------------------------------
Shrimp Tanks and
raceways (up to 4 Earthen ponds
hours daily) (single treatment)
------------------------------------------------------------------------
Penaeid Shrimp.................. 50 to 1001....... 252
------------------------------------------------------------------------
\1\Treat for up to 4 hours daily. Treatment may be repeated daily until
parasite control is achieved. Use the lower concentration when the
tanks and raceways are heavily loaded.
\2\Single treatment. Treatment may be repeated in 5 to 10 days if
needed.
(iv) For control of external parasites on all finfish:
------------------------------------------------------------------------
Administer in tanks and
raceways for up to 1 Administer in earthen
Aquatic species hour (microliter/liter ponds indefinitely
or part per million (L/L or ppm)
(L/L or ppm))
------------------------------------------------------------------------
Salmon and trout:
Above 50 1/2F Up to 170 15 to 251, 2
Below 50 1/2F Up to 250 15 to 251, 2
All other finfish Up to 250 15 to 251, 2
------------------------------------------------------------------------
\1\ 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.
\2\ 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.
(v) For control of fungi of the family Saprolegniaceae on all
finfish eggs: Eggs of all finfish except Acipenseriformes, 1,000 to
2,000 L/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to
1,500 L/L (ppm) for 15 minutes.
(3) Limitations. Fish tanks and raceways may be treated daily until
parasite control is achieved. Pond treatment may be repeated in 5 to 10
days if needed. However, pond treatments for Ichthyophthirius should be
made at 2-day intervals until control is achieved. Egg tanks may be
treated as often as necessary to prevent growth of fungi. Do not use
formalin which has been subjected to temperatures below 40 deg.F, or
allowed to freeze. Do not treat ponds containing striped bass.
Treatments in tanks should never exceed 1 hour even if fish show no
signs of stress. Do not apply formalin to ponds with water warmer than
27 deg.C (80 deg.F), when a heavy bloom of phytoplankton is present,
or when the concentration of dissolved oxygen is less than 5 milligrams
per liter.
[51 FR 11441, Apr. 3, 1986, as amended at 58 FR 59169, Nov. 8, 1993; 59
FR 60076, Nov. 22, 1994; 63 FR 38304, July 16, 1998]