[Federal Register Volume 62, Number 147 (Thursday, July 31, 1997)]
[Rules and Regulations]
[Pages 40932-40933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20081]
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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; Apramycin
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 two supplemental new animal
drug applications (NADA's) filed by Elanco Animal Health, A Division of
Eli Lilly & Co. The supplemental NADA's provide for revised tolerances
for total residues of apramycin (i.e., the safe concentration) in
edible swine tissues.
EFFECTIVE DATE: July 31, 1997.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1644.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, is sponsor
of supplemental NADA 106-964 that provides for the use of
Apralan (apramycin sulfate) soluble powder in swine drinking
water and supplemental NADA 126-050 that provides for the use of
Apralan (apramycin sulfate) Type A medicated article in swine
feed, both for control of porcine colibacillosis (weanling pig scours)
caused by strains of Escherichia coli sensitive to apramycin. These
supplemental NADA's provide for a change in the tolerance for total
residues of apramycin (i.e., the safe concentration) in edible swine
tissues as provided in Sec. 556.52 (21 CFR 556.52). Review of these
supplements involved a review of new toxicology studies and information
in the original approvals.
In evaluating these supplements, FDA's Center for Veterinary
Medicine also considered that the proof of human food safety for
antimicrobial animal drug residues includes a determination of their
antimicrobial activity for all antimicrobial new animal drug products.
In the absence of studies to determine the microbiological safety of
antimicrobial drug residues, the acceptable daily intake (ADI) for
apramycin is limited to 25 micrograms per kilogram (g/kg) of
body weight per day (for appropriate studies see ``Guidance: Microbial
Testing of Antimicrobial Drug Residues in Food,'' January, 1996). As
indicated in the freedom of information summaries, the safe
concentration for total apramycin residues is established at 5 parts
per million (ppm) for muscle, 15 ppm for liver, and 30 ppm for fat and
kidney. These revised safe concentrations warrant removal of the
existing tolerances for total residues in Sec. 556.52, because those
tolerances are now incorrect. Because this approval does not result in
a different tolerance than that currently codified for marker residue
in swine kidney, and because the sponsor did not petition FDA to change
the tolerance, the tolerance of 0.1 ppm in swine kidney remains
codified. FDA is also codifying the ADI for apramycin of 25 g/
kg of body weight per day. The supplement is
[[Page 40933]]
approved as of June 24, 1997, and the regulations in Sec. 556.52 are
revised to reflect the approval. The basis of approval is discussed in
the freedom of information summary.
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 these
applications may be seen in the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.
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 556.52 is revised to read as follows:
Sec. 556.52 Apramycin.
A tolerance of 0.1 part per million is established for parent
apramycin (marker residue) in kidney (target tissue) of swine. The
acceptable daily intake (ADI) for total residues of apramycin is 25
micrograms per kilogram of body weight per day.
Dated: July 21, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-20081 Filed 7-30-97; 8:45 am]
BILLING CODE 4160-01-F
