[Federal Register Volume 59, Number 193 (Thursday, October 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24825]


[[Page Unknown]]

[Federal Register: October 6, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 556

 

Tolerances for Residues of New Animal Drugs in Food; Ivermectin

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 Merck Research Laboratories, Division of 
Merck & Co., Inc. The NADA provides for use of a 1 percent ivermectin 
injection for cattle for the treatment and control of gastrointestinal 
roundworm, lungworm, grub, lice, and mange mite infections. The 
supplement provides for revised tolerances for residues of ivermectin 
in cattle tissues.

EFFECTIVE DATE: October 6, 1994.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Merck Research Laboratories, Division of 
Merck & Co., Inc., P.O. Box 2000, Rahway, NJ 07065, is sponsor of NADA 
128-409 that provides for the use of Ivomec 1 percent 
Injection (ivermectin) for cattle for the treatment and control of 
gastrointestinal roundworm, lungworm, grub, lice, and mange mite 
infections. The supplement provides for revised tolerances for residues 
of ivermectin in cattle liver of 100 parts per billion (ppb) and 
revised safe concentrations in cattle muscle of 120 ppb, in liver of 
240 ppb, in kidney of 360 ppb, and in fat of 480 ppb. The supplement is 
approved as of September 12, 1994, and the regulations in 21 CFR 
556.344 are amended to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    Currently, Sec. 556.344(a) (21 CFR 556.344(a)) provides identical 
tolerances for ivermectin residues in cattle and reindeer. With the 
approval of this supplement, those tolerances will no longer be 
identical. Therefore, Sec. 556.344(a) will reflect the revised cattle 
tolerances and new Sec. 556.344(d) is established to reflect the 
reindeer tolerances.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplement does not 
qualify for marketing exclusivity because the supplement does not 
contain reports of new clinical or field investigations (other than 
bioequivalence or residue studies) essential to the approval and 
conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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.

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: Secs. 402, 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342, 360b, 371).

    2. Section 556.344 is amended by revising paragraph (a) and by 
adding new paragraph (d) to read as follows:


Sec. 556.344  Ivermectin.

* * * * *
    (a) Cattle. The marker residue used to monitor the total residues 
of ivermectin in cattle is 22,23-dihydro-avermectin B1a. The 
target tissue selected is liver. A tolerance is established for 22,23-
dihydro-avermectin B1a in cattle of 100 parts per billion in 
liver. A marker residue concentration of 100 parts per billion in liver 
corresponds to a concentration for total residues of ivermectin of 240 
parts per billion in liver. The safe concentrations for total residues 
of ivermectin in uncooked, edible tissues of cattle is 120 parts per 
billion in muscle, 240 parts per billion in liver, 360 parts per 
billion in kidney, and 480 parts per billion in fat.
* * * * *
    (d) Reindeer. The marker residue used to monitor the total residues 
of ivermectin in reindeer is 22,23-dihydro-avermectin B1a. The 
target tissue selected is liver. A tolerance is established for 22,23-
dihydro-avermectin B1a in reindeer of 15 parts per billion in 
liver. A marker residue concentration of 15 parts per billion in liver 
corresponds to a concentration for total residues of ivermectin of 50 
parts per billion in liver. The safe concentrations for total residues 
of ivermectin in uncooked, edible tissues of reindeer are 25 parts per 
billion in muscle, 50 parts per billion in liver, 75 parts per billion 
in kidney, and 100 parts per billion in fat.

    Dated: September 29, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-24825 Filed 10-5-94; 8:45 am]
BILLING CODE 4160-01-F