[Federal Register Volume 61, Number 247 (Monday, December 23, 1996)]
[Rules and Regulations]
[Page 67453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32430]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 556
Tolerances for Residues of New Animal Drugs in Food;
Oxytetracycline
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 Animal Health. The supplemental NADA
provides for revised tolerances for residues of oxytetracycline in
edible tissues.
EFFECTIVE DATE: December 23, 1996.
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, is sponsor of NADA 113-232, which provides for the use of
Liquamycin LA-200 (oxytetracycline) sterile
suspension for injection in beef cattle, beef calves, nonlactating
dairy cattle, dairy calves, and swine for the indications for use as in
21 CFR 522.1662a.
The supplement provides for a change in the tolerance levels
specified in Sec. 556.500 (21 CFR 556.500) for oxytetracycline residues
in edible tissues of cattle, beef calves, nonlactating dairy cattle,
dairy calves, and swine. Review of the supplement involved a
reevaluation of the data and information in the original approval using
criteria in the ``Human Food Safety Guideline for Antimicrobial
Drugs.'' The supplement is approved as of May 31, 1996, and the
regulation in Sec. 556.500 is revised to reflect the approval.
In evaluating this supplement, FDA's Center for Veterinary
Medicine (CVM) considered the cumulative effects of all tetracyclines
approved for use as new animal drugs because all tetracycline drugs
have a similar end point of toxicological concern, i.e., an effect on
the intestinal microflora. Based on the cumulative effect, the
acceptable daily intake (ADI) was established for total tetracycline
activity at 1.5 milligrams per person per day. Forty percent of that
ADI is being assigned to edible tissues and 60 percent of the ADI is
reserved for milk. Based on this evaluation, CVM has established the
revised tolerance for residues of all tetracycline new animal drugs
(including chlortetracycline, oxytetracycline, and tetracycline) to 2
parts per million (ppm) in muscle, 6 ppm in liver, and 12 ppm in fat
and kidney. As such, Sec. 556.500 has been amended to provide that for
oxytetracycline, tolerances are established for the sum of residues of
the tetracyclines including chlortetracycline, oxytetracycline, and
tetracycline at 2 ppm in muscle, 6 ppm in liver, and 12 ppm in kidney
and fat.
Although approval of Pfizer's supplement did not require submission
of new safety or effectiveness data, a summary of data and information
used to support approval of this supplement as described in 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii) 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.
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) or human food safety studies (other
than bioequivalence or residue studies) essential to the approval and
conducted or sponsored by the applicant.
FDA 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.
Because the revised tolerance approved in this supplement for
oxytetracycline is based on the total tetracycline activity, it, in
effect, revises the tolerances for chlortetracycline and tetracycline.
Therefore, FDA has also revised 21 CFR 556.150 (chlortetracycline) and
556.720 (tetracycline) to be consistent with the new tolerance for
oxytetracycline based on the total tetracycline activity.
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 556.150 is revised to read as follows:
Sec. 556.150 Chlortetracycline.
Tolerances are established for the sum of residues of the
tetracyclines including chlortetracycline, oxytetracycline, and
tetracycline, in tissues of beef cattle, nonlactating dairy cows,
calves, swine, sheep, chickens, turkeys, and ducks, as follows:
(a) 2 parts per million (ppm) in muscle.
(b) 6 ppm in liver.
(c) 12 ppm in fat and kidney.
3. Section 556.500 is revised to read as follows:
Sec. 556.500 Oxytetracycline.
Tolerances are established for the sum of residues of the
tetracyclines including chlortetracycline, oxytetracycline, and
tetracycline, in tissues of cattle, beef calves, nonlactating dairy
cattle, dairy calves, swine, sheep, chickens, turkeys, catfish,
lobsters, and salmonids, as follows:
(a) 2 parts per million (ppm) in muscle.
(b) 6 ppm in liver.
(c) 12 ppm in fat and kidney.
4. Section 556.720 is revised to read as follows:
Sec. 556.720 Tetracycline.
Tolerances are established for the sum of residues of the
tetracyclines including chlortetracycline, oxytetracycline, and
tetracycline, in tissues of calves, swine, sheep, chickens, and
turkeys, as follows:
(a) 2 parts per million (ppm) in muscle.
(b) 6 ppm in liver.
(c) 12 ppm in fat and kidney.
Dated: December 9, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-32430 Filed 12-20-96; 8:45 am]
BILLING CODE 4160-01-F
