[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) * * *

----------------------------------------------------------------------------------------------------------------
   Chlortetracycline
        amount               Combination        Indications for use        Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(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