[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<Register> (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     (<greek-m>L/L or ppm)
                          (<greek-m>L/L or ppm))                        
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Salmon and trout:                                                       
 Above 50 F              Up to 170                15 to 25<SUP>1, <SUP>2          
Below 50 F               Up to 250                15 to 25<SUP>1, <SUP>2          
All other finfish        Up to 250                15 to 25<SUP>1, <SUP>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 <greek-m>L/L 
(ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 <greek-m>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