[Federal Register Volume 65, Number 75 (Tuesday, April 18, 2000)]
[Rules and Regulations]
[Page 20733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9578]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 556


Tolerances for Residues of New Animal Drugs in Food; Fenbendazole

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 Hoechst Roussel Vet. The supplemental NADA 
provides for establishing tolerances for residues of fenbendazole in 
edible tissues of swine. Technical corrections are also made.

DATES: This rule is effective April 18, 2000.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, Perryville Corporate 
Park III, P.O. Box 4010, Clinton, NJ 08809-4010, filed a supplement to 
NADA 131-675 that provides for use of Safe-Guard<Register> (20 percent 
fenbendazole) Type A medicated articles to make Type B and C medicated 
swine feeds. The supplement provides for establishing tolerances for 
parent fenbendazole in swine liver and muscle. The supplement is 
approved as of February 10, 2000, and Sec. 556.275 (21 CFR 556.275) is 
amended to reflect the approval. The basis of approval is discussed in 
the freedom of information summary.
    Section 556.275 is further amended by deleting references to safe 
concentrations and by adding the previously established acceptable 
daily intake (ADI) of total residues of fenbendazole. The footnote for 
``tolerance'' in that section is also removed.
    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 application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1061, 5630 Fishers Lane, Rockville, MD 20852, from 
9 a.m. to 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 556

    Animal drugs, Foods.

    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 556 is 
amended as follows:

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    1. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.


    2. Section 556.275 is revised to read as follows:


Sec. 556.275  Fenbendazole.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
fenbendazole is 40 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for parent fenbendazole (the marker residue) is 0.8 part per 
million (ppm).
    (ii) [Reserved]
    (iii) Milk. The tolerance for fenbendazole sulfoxide metabolite 
(the marker residue in cattle milk) is 0.6 ppm.
    (2) Swine--(i) Liver (the target tissue). The tolerance for parent 
fenbendazole (the marker residue) is 6 ppm.
    (ii) Muscle. The tolerance for parent fenbendazole (the marker 
residue) is 2 ppm.
    (3) Goats--(i) Liver (the target tissue). The tolerance for parent 
fenbendazole (the marker residue) is 0.8 ppm.
    (ii) [Reserved]

    Dated: March 17, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-9578 Filed 4-17-00; 8:45 am]
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