[Federal Register Volume 59, Number 157 (Tuesday, August 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19985]


[[Page Unknown]]

[Federal Register: August 16, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 556

 

Tolerances for Residues of New Animal Drugs in Food; 
Dihydrostreptomycin

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 Pfizer, Inc. The supplement provides for 
revised tolerances for residues of dihydrostreptomycin in edible animal 
tissues.

EFFECTIVE DATE: August 16, 1994.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center For Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed supplemental NADA 65-483 that provides for revising 
tolerances for residues of dihydrostreptomycin in uncooked, edible 
tissues of cattle and swine, in milk from dairy animals, and in any 
food in which such milk is used. A zero tolerance level was established 
when the drug was originally approved on February 18, 1954. A zero 
tolerance affirmed that no detectable residues of the new animal drug 
were permissible in edible tissues of treated animals when the tissues 
were assayed using available analytical methods.
    As analytical technology improved, advanced methods were developed 
that were more sensitive and capable of measuring progressively smaller 
amounts of residues in tissues. FDA adopted the concept of maximum 
negligible residues to reflect the lower level of quantitative 
sensitivity of the official regulatory analytical method. This concept 
was later modified to consider the consumption levels of various edible 
tissues.
    In addition, dihydrostreptomycin has been approved for use in 
several injectable and intramammary products used for treating bovine, 
porcine, equine, and canine species. Where tolerances for use in food 
animals would have been appropriate, those tolerances were not 
established because of the existing zero level. At this time, 
tolerances for residues in those species are established.
    FDA has determined that a revision of the tolerance from zero to 
0.125 parts per million (ppm) in milk, and 2.0 ppm in kidney and 0.5 
ppm in all other tissues of cattle and swine is appropriate. The new 
tolerance reflects the levels that would have been established when the 
drug was originally approved if the analytical methods had been more 
sensitive. No new toxicity data were submitted. Levels of 2.0 ppm in 
kidney, 0.5 ppm in all other edible tissues, and 0.125 ppm in milk 
reflect the levels that FDA considers to be safe and the residue levels 
that the U.S. Department of Agriculture has been monitoring for a 
number of years.
    The supplement is approved as of July 20, 1994, and the regulations 
in 21 CFR 556.200 are amended to reflect the new tolerance levels.
    The approval of this supplement did not require the submission of 
new data and information. Therefore, a freedom of information summary 
under 21 CFR part 20 and 21 CFR 514.11(e)(2) was not required. Approval 
of the supplement is based on the information submitted with the 
original NADA.
    The agency has determined under 21 CFR 25.24(a)(9) 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 556.200 is revised to read as follows:


Sec. 556.200  Dihydrostreptomycin.

    Tolerances are established for residues of dihydrostreptomycin in 
uncooked, edible tissues of cattle and swine of 2.0 parts per million 
(ppm) in kidney and 0.5 ppm in other tissues, and 0.125 ppm in milk.

    Dated: August 9, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-19985 Filed 8-15-94; 8:45 am]
BILLING CODE 4160-01-F