Federal Register, Volume 63 Issue 207 (Tuesday, October 27, 1998)

[Federal Register Volume 63, Number 207 (Tuesday, October 27, 1998)]
[Rules and Regulations]
[Pages 57245-57248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28635]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

New Animal Drugs for Use in Animal Feeds; Chlortetracycline

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 Roche Vitamins, Inc. The supplemental NADA
provides for use of a chlortetracycline (CTC) Type A medicated article
in Type C medicated feeds for chickens producing eggs for human
consumption, a tolerance for residues in eggs, and an acceptable daily
intake (ADI) for total tetracycline residues in humans.

EFFECTIVE DATE: October 27, 1998.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0212.

SUPPLEMENTARY INFORMATION: Roche Vitamins, Inc., 45 Waterview Blvd.,
Parsippany, NJ 07054-1298, filed supplemental NADA 48-761 that provides
for use of Aureomycin (50, 90, and 100 grams per pound CTC)
Type A medicated article in Type C medicated feeds for chickens laying
eggs for human consumption. The supplemental NADA is approved as of
July 31, 1998, and the regulations are amended in 21 CFR 558.128(d)(1)
to reflect the approval. The basis of approval is discussed in the
freedom of information summary.
In approving the use of chlortetracycline Type C medicated feeds
for chickens laying eggs for human consumption, a tolerance is
established for chlortetracycline residues in eggs. At this time, FDA
is also establishing the ADI for total tetracycline residues (the total
drug residues from chlortetracycline, oxytetracycline, and
tetracycline, that can safely be

[[Page 57246]]

consumed each day by humans). The regulations in 21 CFR 556.150,
556.500, and 556.720 are amended to establish a tetracycline ADI, and
in Sec. 556.150 to provide for a tolerance for chlortetracycline
residues in eggs.
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 this application
may be seen in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
Under 21 U.S.C. 360b(c)(2)(F)(iii), this supplemental NADA for
food-producing animals qualifies for 3 years of marketing exclusivity
beginning July 31, 1998, because the supplement contains substantial
evidence of the effectiveness of the drug involved, studies of animal
safety or, in the case of food-producing animals, human food safety
studies (other than bioequivalence or residue studies) required for
approval of the supplement and conducted or sponsored by the applicant.
The 3 years marketing exclusivity is limited to use of this drug in the
feed of chickens producing eggs for human consumption.
The agency has determined under 21 CFR 25.33(a)(3) 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

21 CFR Part 556

Animal drugs, Foods.

21 CFR Part 558

Animal drugs, Animal feeds.
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 parts 556 and
558 are 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 556.150 is amended by revising paragraph (b) to read as
follows:

Sec. 556.150 Chlortetracycline.

(a) * * *
(b) Tolerances. (1) Tolerances are established for the sum of
tetracycline residues in tissues of beef cattle, nonlactating dairy
cows, calves, swine, sheep, chickens, turkeys, and ducks, of 2 parts
per million (ppm) in muscle, 6 ppm in liver, and 12 ppm in fat and
kidney.
(2) A tolerance is established for residues of chlortetracycline in
eggs of 0.4 ppm.
3. Section 556.500 is revised to read as follows:

Sec. 556.500 Oxytetracycline.

(a) Acceptable daily intake (ADI). The ADI for total tetracycline
residues (chlortetracycline, oxytetracycline, and tetracycline) is 25
micrograms per kilogram of body weight per day.
(b) Tolerances. Tolerances are established for the sum of
tetracycline residues in tissues of beef cattle, beef calves,
nonlactating dairy cattle, dairy calves, swine, sheep, chickens,
turkeys, catfish, lobsters, and salmonids, of 2 parts per million (ppm)
in muscle, 6 ppm in liver, and 12 ppm in fat and kidney.
4. Section 556.720 is revised to read as follows:

Sec. 556.720 Tetracycline.

(a) Acceptable daily intake (ADI). The ADI for total tetracycline
residues (chlortetracycline, oxytetracycline, and tetracycline) is 25
micrograms per kilogram of body weight per day.
(b) Tolerances. Tolerances are established for the sum of
tetracycline residues in tissues of calves, swine, sheep, chickens, and
turkeys, of 2 parts per million (ppm) in muscle, 6 ppm in liver, and 12
ppm in fat and kidney.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

5. The authority citation for 21 CFR part 558 continues to read as
follows:

Authority: 21 U.S.C. 360b, 371.

6. Section 558.128 is amended in paragraph (d)(1) in the table by
revising entries (i) through (viii) to read as follows:

Sec. 558.128 Chlortetracycline.

* * * * *
(d)(1) * * *

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Chlortetracycline
amount Combination Indications for use Limitations Sponsor
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(i) 10 to 50 g/t 1. Chickens; .................... 063238.
increased rate of
weight gain and
improved feed
efficiency.
Do not feed to 000069, 017519,
chickens producing 046573, 053389.
eggs for human
consumption.
2. Growing turkeys; Do not feed to 000069, 017519,
increased rate of turkeys producing 046573, 053389,
weight gain and eggs for human 063238.
improved feed consumption.
efficiency.
3. Growing swine; Do.
increased rate of
weight gain and
improved feed
efficiency.
(ii) 20 to 50 g/t Growing sheep; 000069, 046573,
increased rate of 053389, 063238.
weight gain and
improved feed
efficiency.

[[Page 57247]]

(iii) 50 to 100 g/t Swine; reducing the 000069, 017519,
incidence of 046573, 053389,
cervical 063238.
lymphadenitis (jowl
abscesses) caused by
Group E.
Streptococci
susceptible to
chlortetracycline.
(iv) 100 to 200 g/t Chickens; control of 1. Feed continuously 063238.
infectious synovitis for 7 to 14 d.
caused by Mycoplasma
synoviae susceptible
to
chlortetracycline.
2. Feed continuously 000069, 017519,
for 7 to 14 d; do 046573, 053389.
not feed to
chickens producing
eggs for human
consumption.
(v) 200 g/t Turkeys; control of Feed continuously 000069, 017519,
infectious synovitis for 7 to 14 d; do 046573, 053389,
caused by M. not feed to turkeys 063238.
synoviae susceptible producing eggs for
to human consumption.
chlortetracycline.
(vi) 200 to 400 g/t 1. Chickens; control 1. Feed continuously 063238.
of chronic for 7 to 14 d.
respiratory disease
(CRD) and air sac
infection caused by
M. gallisepticum and
E. coli susceptible
to
chlortetracycline.
2. Feed continuously 000069, 017519,
for 7 to 14 d; do 046573, 053389.
not feed to
chickens producing
eggs for human
consumption.
2. Ducks; control and Feed in complete 063238.
treatment of fowl ration to provide
cholera caused by from 8 to 28
Pasteurella milligrams per
multocida pound of body
susceptible to weight per day
chlortetracycline. depending upon age
and severity of
disease, for not
more than 21 d. Do
not feed to ducks
producing eggs for
human consumption.
(vii) 400 g/t 1. Turkeys; control Feed continuously 000069, 017519,
of hexamitiasis for 7 to 14 d; do 046573, 053389,
caused by Hexamita not feed to turkeys 063238.
meleagrides producing eggs for
susceptible to human consumption.
chlortetracycline.
2. Turkey poults not Do.
over 4 weeks of age;
reduction of
mortality due to
paratyphoid caused
by Salmonella
typhimurium
susceptible to
chlortetracycline.
3. Breeding swine; Feed continuously Do.
control of for not more than
leptospirosis 14 d.
(reducing the
incidence of
abortion and
shedding of
leptospirae) caused
by Leptospira pomona
susceptible to
chlortetracycline.
(viii) 500 g/t Chickens; reduction 1. Feed for 5 d; 063238.
of mortality due to withdraw 24 h prior
E. coli infections to slaughter.
susceptible to
chlortetracycline.
2. Feed for 5 d; do 000069, 017519,
not feed to 046573, 053389.
chickens producing
eggs for human
consumption;
withdraw 24 h prior
to slaughter.

[[Page 57248]]

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Dated: October 19, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-28635 Filed 10-26-98; 8:45 am]
BILLING CODE 4160-01-F