[Federal Register Volume 63, Number 136 (Thursday, July 16, 1998)]
[Rules and Regulations]
[Pages 38304-38305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18955]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 529
Certain Other Dosage Form New Animal Drugs; Formalin Solution
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Western Chemical, Inc. The supplement
provides for use of formalin solution in the water of all finfish as a
parasiticide and all finfish eggs as a fungicide.
EFFECTIVE DATE: July 16, 1998.
FOR FURTHER INFORMATION CONTACT: Thomas A. Bell, Center for Veterinary
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1649.
SUPPLEMENTARY INFORMATION: Western Chemical, Inc., 1269 Lattimore Rd.,
Ferndale, WA 98248, is sponsor of NADA 140-989 that provides for use of
Parasite-S (formalin, an aqueous solution of 37 percent
formaldehyde) in the water (tanks, raceways, and ponds) of select fish
and penaeid shrimp for the control of specific external parasites, and
as a fungicide for select fish eggs. Western Chemical, Inc., filed a
supplemental NADA that provides for use of formalin in the water of all
finfish for the control of specific external parasites and as a
fungicide for all finfish eggs. The supplemental NADA is approved as of
June 18, 1998, and the regulations are amended in 21 CFR 529.1030 to
reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness
data and information submitted to support approval of this supplement
may be seen in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects in 21 CFR Part 529
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 529 is
amended as follows:
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 529.1030 is amended by revising paragraphs (b)(1) and
(b)(2), by redesignating paragraph (c) as paragraph (d) and reserving
paragraph (c), by revising newly redesignated paragraphs (d)
introductory text, (d)(1) and (d)(2)(i), and by adding paragraphs
(d)(2)(iv) and (d)(2)(v) to read as follows:
Sec. 529.1030 Formalin solution.
* * * * *
(b) * * *
(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
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) * * *
(i) For control of external parasites on select finfish:
* * * * *
(iv) For control of external parasites on all finfish:
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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))
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Salmon and trout:
Above 50 F Up to 170 15 to 251, 2
Below 50 F Up to 250 15 to 251, 2
All other finfish Up to 250 15 to 251, 2
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\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
[[Page 38305]]
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.
* * * * *
Dated: July 9, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-18955 Filed 7-15-98; 8:45 am]
BILLING CODE 4160-01-F
