(a) Specifications. Type A medicated articles containing either chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride or, for products intended for use in milk replacer, chlortetracycline hydrochloride.
(b) Approvals. See sponsors in Sec. 510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) Nos. 054771, 066104, and 069254: 50 to 100 grams per pound (g/lb) of Type A medicated article.
(2) No. 012286: 50, 90, or 100 grams per pound of Type A medicated article.
(c) Related tolerances. See Sec. 556.150 of this chapter.
(d) Special considerations. (1) In milk replacers or starter feed; include on labeling the warning: ``A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.''
(1) In milk replacers or starter feed; include on labeling the warning: ``A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.''
(2) Manufacture for use in free-choice feeds as in paragraph (e)(4)(iii) of this section must conform to Sec. 510.455 of this chapter.
(3) When manufactured for use as in paragraph (e)(5)(iv) of this section, include on labeling the warning: ``Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.''
(e) Conditions of use--(1) Chickens. It is used as follows: ----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton...................... Chickens: For increased rate ............................. 054771
of weight gain and improved ............................. ........
feed efficiency.. Do not feed to chickens 012286,
producing eggs for human 054771,
consumption.. 066104,
069254.(ii) 100 to 200 g/ton................... Chickens: For control of 1. Feed continuously for 7 to 054771.
infectious synovitis caused 14 d.. ........
by Mycoplasma synoviae ............................. 012286,
susceptible to 2. Feed continuously for 7 to 054771,
chlortetracycline.. 14 d; do not feed to 066104,
chickens producing eggs for 069254.
human consumption..(iii) 200 to 400 g/ton.................. Chickens: For the control of 1. Feed continuously for 7 to 054771.
chronic respiratory disease 14 d.. ........
(CRD) and air sac infection ............................. 012286,
caused by M. gallisepticum 2. Feed continuously for 7 to 054771,
and Escherichia coli 14 d; do not feed to 066104,
susceptible to chickens producing eggs for 069254.
chlortetracycline.. human consumption..(iv) 500 g/ton.......................... Chickens: For the reduction 1. Feed for 5 d. To sponsor 054771,
of mortality due to E. coli No. 054771 under NADA 048- 069254.
infections susceptible to 761 and No. 069254 under
chlortetracycline. ANADA 200-510: zero
withdrawal time.
2. Feed for 5 d; withdraw 24 012286,
h prior to slaughter; do not 054771,
feed to chickens producing 066104,
eggs for human consumption. 069254.----------------------------------------------------------------------------------------------------------------
(2) Turkeys. It is used as follows: ----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton...................... Growing turkeys: For increased Do not feed to turkeys 012286,
rate of weight gain and producing eggs for human 054771,
improved feed efficiency.. consumption.. 066104,
069254.(ii) 200 g/ton.......................... Turkeys: For control of Feed continuously for 7 to 012286,
infectious synovitis caused 14 d; do not feed to 054771,
by M. synoviae susceptible to turkeys producing eggs for 066104,
chlortetracycline.. human consumption.. 069254.(iii) 400 g/ton......................... 1. Turkeys: For control of Feed continuously for 7 to 012286,
hexamitiasis caused by 14 d; do not feed to 054771,
Hexamita meleagridis turkeys producing eggs for 066104,
susceptible to human consumption.. 069254.
chlortetracycline..
.............................. ........................... .........
2. Turkey poults not over 4 012286,
weeks of age: For reduction 054771,
of mortality due to 066104,
paratyphoid caused by 069254.
Salmonella typhimurium
susceptible to
chlortetracycline..(iv) 25 mg/lb of body weight............ Turkeys: For control of Feed continuously for 7 to 012286,
complicating bacterial 14 d; do not feed to 054771,
organisms associated with turkeys producing eggs for 066104,
bluecomb (transmissible human consumption.. 069254.
enteritis; coronaviral
enteritis) susceptible to
chlortetracycline..----------------------------------------------------------------------------------------------------------------
(3) Swine. It is used as follows: ----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton...................... Growing swine: For increased ........................... 012286,
rate of weight gain and 054771,
improved feed efficiency.. 066104,
069254.(ii) 50 to 100 g/ton.................... Swine: For reducing the ........................... 012286,
incidence of cervical 054771,
lymphadenitis (jowl 066104,
abscesses) caused by Group E. 069254.
Streptococci susceptible to
chlortetracycline..(iii) 400 g/ton......................... Breeding swine: For the Feed continuously for not 012286,
control of leptospirosis more than 14 d.. 054771,
(reducing the incidence of 066104,
abortion and shedding of 069254.
leptospirae) caused by
Leptospira pomona susceptible
to chlortetracycline..(iv) 10 mg/lb of body weight............ 1. Swine: For the treatment of Feed approximately 400 g/t, 012286,
bacterial enteritis caused by varying with body weight 054771,
E. coli and S. choleraesuis and feed consumption to 066104,
and bacterial pneumonia provide 10 mg/lb per day. 069254.
caused by Pasteurella Feed for not more than 14
multocida susceptible to d; withdraw 5 d prior to
chlortetracycline.. slaughter for sponsor
012286..
.............................. ........................... .........
2. Swine: For the control of Feed for not more than 14 054771.
porcine proliferative d..
enteropathies (ileitis)
caused by Lawsonia
intracellularis susceptible
to chlortetracycline..----------------------------------------------------------------------------------------------------------------
(4) Cattle. It is used as follows: ----------------------------------------------------------------------------------------------------------------
(i) 0.1 mg/lb of body weight daily...... Calves (up to 250 lb): For See paragraph (d)(1) of 012286,
increased rate of weight gain this section.. 054771,
and improved feed efficiency.. 066104,
069254.(ii) 0.5 mg/lb of body weight daily..... Beef cattle (over 700 lb); Withdraw 48 h prior to 012286,
control of active infection slaughter. To sponsor Nos. 054771,
of anaplasmosis caused by 054771 and 069254: zero 066104,
Anaplasma marginale withdrawal time.. 069254.
susceptible to
chlortetracycline..(iii) 0.5 to 2.0 mg/lb of body weight Beef cattle and nonlactating In free-choice cattle feeds 054771.
daily.. dairy cattle: As an aid in such as feed blocks or
the control of active salt-mineral mixes
infection of anaplsmosis manufactured from approved
caused by A. marginale Type A articles. See
susceptible to paragraph (d)(2) of this
chlortetracycline.. section..(iv) 10 mg/lb of body weight daily...... 1. Calves, beef and Feed approximately 400 g/ 012286,
nonlactating dairy cattle; ton, varying with body 066104,
treatment of bacterial weight and feed 069254.
enteritis caused by E. coli consumption to provide 10
and bacterial pneumonia mg/lb per day. Treat for
caused by P. multocida not more than 5 d; in feed
organisms susceptible to including milk replacers;
chlortetracycline.. withdraw 10 d prior to
slaughter. To sponsor No.
069254: zero withdrawal
time. See paragraph (d)(1)
of this section..
2. Calves (up to 250 lb): For See paragraph (d)(1) of 012286,
the treatment of bacterial this section.. 054771,
enteritis caused by E. coli 066104,
susceptible to 069254.
chlortetracycline..(v) 500 to 4,000 g/ton.................. Calves, beef and nonlactating Feed continuously for not 054771
dairy cattle; treatment of more than 5 days to 069254
bacterial enteritis caused by provide 10 mg/lb body
E. coli and bacterial weight per day. To sponsor
pneumonia caused by P. No. 054771 under NADA 046-
multocida susceptible to 699: 24-h withdrawal time.
chlortetracycline. To sponsor No. 054771 under
NADA 048-761 and No.
069254 under ANADA 200-
510: Zero withdrawal time.(vi) 4,000 to 20,000 g/ton.............. Calves, beef and nonlactating As a top dress, varying 054771.
dairy cattle; treatment of with body weight and feed
bacterial enteritis caused by consumption, to provide 10
E. coli and bacterial mg/lb per day. Treat for
pneumonia caused by P. not more than 5 days. See
multocida organisms paragraph (d)(1) of this
susceptible to section..
chlortetracycline..
(vii) 25 to 70 mg/head/day.............. Calves (250 to 400 lb): For See paragraph (d)(1) of 012286,
increased rate of weight gain this section.. 054771,
and improved feed efficiency.. 066104,
069254.(viii) 70 mg/head/day................... Growing cattle (over 400 lb): See paragraph (d)(1) of 012286,
For increased rate of weight this section.. 054771,
gain, improved feed 066104,
efficiency, and reduction of 069254.
liver condemnation due to
liver abscesses..(ix) 350 mg/head/day.................... 1. Beef cattle: For control of Withdraw 48 h prior to 012286,
bacterial pneumonia slaughter. To sponsor No. 054771,
associated with shipping 054771 under NADA 046-699: 066104,
fever complex caused by 48-h withdrawal time. To 069254.
Pasteurella spp. susceptible sponsor No. 054771 under
to chlortetracycline. NADA 048-761 and No.
069254 under ANADA 200-
510: Zero withdrawal time.
2. Beef cattle (under 700 lb): Withdraw 48 h prior to 012286,
For control of active slaughter. To sponsor No. 054771,
infection of anaplasmosis 054771 under NADA 046-699: 066104,
caused by A. marginale 48-h withdrawal time. To 069254.
susceptible to sponsor No. 054771 under
chlortetracycline. NADA 048-761 and No.
069254 under ANADA 200-
510: zero withdrawal time.----------------------------------------------------------------------------------------------------------------
(5) Minor species. It is used as follows: ----------------------------------------------------------------------------------------------------------------
(i) 20 to 50 g/ton...................... Growing sheep; increased rate ........................... 054771,
of weight gain and improved 066104,
feed efficiency.. 069254.(ii) 80 mg/head/day..................... Breeding sheep; reducing the ........................... 054771,
incidence of (vibrionic) 066104,
abortion caused by 069254.
Campylobacter fetus infection
susceptible to
chlortetracycline..(iii) 200 to 400 g/ton.................. Ducks: For the control and Feed in complete ration to 054771.
treatment of fowl cholera provide from 8 to 28 mg/lb
caused by P. multocida of body weight per day
susceptible to depending upon age and
chlortetracycline.. severity of disease, for
not more than 21 d. Do not
feed to ducks producing
eggs for human
consumption..(iv) 10 mg/g of finished feed daily..... Psittacine birds (cockatoos, Feed continuously for 45 d; 054771.
macaws, and parrots) each bird should consume
suspected or known to be daily an amount of
infected with psittacosis medicated feed equal to
caused by Chlamydia psittaci one fifth of its body
sensitive to weight..
chlortetracycline.. ...........................
See paragraph (d)(3) of
this section..----------------------------------------------------------------------------------------------------------------
(6) It is used as a free-choice, loose mineral Type C feed as follows:
(i) Specifications. ------------------------------------------------------------------------
Ingredient Percent International Feed No.------------------------------------------------------------------------Dicalcium Phosphate 46.20 6-26-335Sodium Chloride (Salt) 15.00 6-04-152Magnesium Oxide 10.67 6-02-756Cottonseed Meal 10.00 5-01-625Trace Mineral/Vitamin 3.80
Premix\1\Calcium Carbonate 3.50 6-01-069Dried Cane Molasses 3.00 4-04-695Potassium Chloride 2.00 6-03-755Mineral Oil 2.00 8-03-123Iron Oxide 0.50 6-02-431Chlortetracycline Type A 3.33
medicated article (90 gram/
lb)------------------------------------------------------------------------\1\Content of vitamin and trace mineral premixes may be varied. However,
they should be comparable to those used for other free-choice feeds.
Formulation modifications require FDA approval prior to marketing.
Selenium must comply with 21 CFR 573.920. Ethylenediamine
dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides
Sec. 651.100 (CPG 7125.18).
(ii) Amount. 6,000 grams per ton.
(iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.
(iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per pound of body weight per day.
(v) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(7) Chlortetracycline may also be used in combination with:
(i) Amprolium and ethopabate as in Sec. 558.58.
(ii) Bacitracin methylene disalicylate as in Sec. 558.76.
(iii) Clopidol as in Sec. 558.175.
(iv) Decoquinate as in Sec. 558.195.
(v) Hygromycin B as in Sec. 558.274.
(vi) Laidlomycin as in Sec. 558.305.
(vii) Lasalocid as in Sec. 558.311.
(viii) Monensin as in Sec. 558.355.
(ix) Robenidine as in Sec. 558.515.
(x) Salinomycin as in Sec. 558.550.
(xi) Tiamulin as in Sec. 558.600. [41 FR 10995, Mar. 15, 1976]
Editorial Note: For Federal Register citations affecting Sec. 558.128, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.