[Federal Register Volume 66, Number 172 (Wednesday, September 5, 2001)]
[Rules and Regulations]
[Pages 46370-46371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22164]


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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; 
Oxytetracycline; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the tolerance for the sum of residues of 
the tetracyclines in milk previously established but inadvertently 
removed in a subsequent amendment and to reflect the correct tolerance 
of 0.3 part per million oxytetracycline in milk. This action is being 
taken to improve the accuracy of the agency's regulations.

DATES: This rule is effective September 5, 2001.

FOR FURTHER INFORMATION CONTACT: Lynn G. Friedlander, Center for 
Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6985.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
in Sec. 556.500 (21 CFR 556.500) to reflect the tolerance for the sum 
of residues of the tetracyclines in milk, which had been established in 
a final rule published in the Federal Register of September 30, 1998 
(63 FR 52157 at 52158), but removed in a subsequent amendment to 
Sec. 556.500 in a final rule published in the Federal Register of 
October 27, 1998 (63 FR 57245 at 57246). At this time, Sec. 556.500 is 
being amended to reflect the correct tolerance of 0.3 part per million 
for the sum of residues of the tetracyclines including 
chlortetracycline, oxytetracycline, and tetracycline in milk.
    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. Publication of this document constitutes final 
action on this changes under the Administrative Procedure Act (5 U.S.C. 
553).

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 556.500 is amended by revising paragraph (b) to read as 
follows:


Sec. 556.500  Oxytetracycline.

* * * * *
    (b) Beef cattle, dairy cattle, calves, swine, sheep, chickens, 
turkeys, catfish, lobster, and salmonids. Tolerances are established 
for the sum of residues of the tetracyclines including 
chlortetracycline, oxytetracycline, and tetracycline, in tissues and 
milk as follows:
    (1) 2 parts per million (ppm) in muscle.
    (2) 6 ppm in liver.
    (3) 12 ppm in fat and kidney.

[[Page 46371]]

    (4) 0.3 ppm in milk.

    Dated: August 20, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-22164 Filed 9-4-01; 8:45 am]
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