Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 558  /  Sec. 558.665 Zilpaterol.

(a) Specifications. Type A medicated articles containing 21.77 grams (g) zilpaterol hydrochloride per pound.

(b) Approvals. See No. 000061 in Sec. 510.600(c) of this chapter.

(c) Tolerances. See Sec. 556.765 of this chapter.

(d) Special considerations--(1) Labeling shall bear the following caution statements: ``Zilpaterol hydrochloride is not for use in animals intended for breeding. Do not allow horses or other equines access to feed containing zilpaterol. Do not use in veal calves.''

(1) Labeling shall bear the following caution statements: ``Zilpaterol hydrochloride is not for use in animals intended for breeding. Do not allow horses or other equines access to feed containing zilpaterol. Do not use in veal calves.''

(2) Labeling of Type A medicated articles and Type B medicated feeds used to manufacture complete Type C medicated feeds shall bear the caution statements in paragraph (d)(3) of this section.

(3) Labeling of complete Type C medicated feeds shall bear the following caution statements: ``Not to be fed to cattle in excess of 90 mg zilpaterol/head/day in complete feed. If pen consumption of complete feed exceeds 26.5 lb/head/day (90 percent dry matter basis), zilpaterol should not be fed in complete feed.''

(4) Type B Liquid Feeds can be manufactured containing 68 to 680 g zilpaterol hydrochloride/ton. The liquid Type B feeds must be maintained at a pH of 3.8 to 7.5. For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. For liquid feeds stored in mechanical, air or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(e) Conditions of use in cattle. It is administered in feed as follows: ----------------------------------------------------------------------------------------------------------------

Combination in grams/

(1) 6.8 ....................... Cattle fed in Feed continuously as 000061

confinement for the sole ration during

slaughter: For the last 20 to 40 days

increased rate of on feed to provide 60

weight gain, improved to 90 mg/head/day.

feed efficiency, and Withdrawal period: 3

increased carcass days

leanness in cattle fed

in confinement for

slaughter during the

last 20 to 40 days on

feed----------------------------------------------------------------------------------------------------------------(2) 6.8 to provide 60 to Melengestrol acetate to Heifers fed in As in paragraph (e)(1) 000061

90 mg/head/day provide 0.25 to 0.5 mg/ confinement for of this section; see 000986

head/day slaughter: As in paragraph Sec. Sec.

paragraph (e)(1) of 558.342(d) of this

this section; and for chapter. Melengestrol

suppression of estrus acetate as provided by

(heat). Nos. 000986 or 054771

in Sec. 510.600(c)

of this chapter----------------------------------------------------------------------------------------------------------------(3) 6.8 to provide 60 to Monensin 10 to 40 Cattle fed in As in paragraph (e)(1) 000061

90 mg/head/day confinement for of this section; see

slaughter: As in paragraph Sec.

paragraph (e)(1) of 558.355(d) of this

this section; and for chapter. Monensin as

prevention and control provided by No. 000986

of coccidiosis due to in Sec. 510.600(c)

Eimeria bovis and E. of this chapter.

zuernii.----------------------------------------------------------------------------------------------------------------(4) 6.8 to provide 60 to Melengestrol acetate to Heifers fed in As in paragraph (e)(1) 000061

90 mg/head/day provide 0.25 to 0.5 mg/ confinement for of this section; see 000986

head/day slaughter: As in Sec. Sec.

paragraph (e)(1) of 558.342(d) and

this section; for 558.355(d) of this

prevention and control chapter. Monensin as

of coccidiosis due to provided by No.

Eimeria bovis and E. 000986; and

zuernii; and for melengestrol acetate

suppression of estrus as provided by Nos.

(heat). 000986 or 054771 in

Sec. 510.600(c) of

this chapter----------------------------------------------------------------------------------------------------------------

(5) 6.8 to provide 60 to Monensin 10 to 40, plus Cattle fed in As in paragraph (e)(1) 000061

90 mg/head/day tylosin 8 to 10 confinement for of this section; see 016592

slaughter: As in Sec. Sec.

paragraph (e)(1) of 558.355(d) and

this section; for 558.625(c) of this

prevention and control chapter. Monensin as

of coccidiosis due to provided by No.

Eimeria bovis and E. 000986; tylosin as

zuernii; and for provided by Nos.

reduction of incidence 000986 or 016592 in

of liver abscesses Sec. 510.600(c) of

caused by this chapter

Fusobacterium

necrophorum and

Arcanobacterum

(Actinomyces) pyogenes----------------------------------------------------------------------------------------------------------------(6) 6.8 to provide 60 to Monensin 10 to 40, plus Heifers fed in As in paragraph (e)(1) 000061

90 mg/head/day. tylosin 8 to 10, plus confinement for of this section; see 000986

melengestrol acetate slaughter: As in Sec. Sec. 016592

to provide 0.25 to 0.5 paragraph (e)(1) of 558.342(d),

mg/ head/day. this section; for 558.355(d), and

prevention and control 558.625(c) of this

of coccidiosis due to chapter. Monensin as

Eimeria bovis and E. provided by No.

zuernii; for reduction 000986; tylosin as

of incidence of liver provided by Nos.

abscesses caused by 000986 or 016592; and

Fusobacterium melengestrol acetate

necrophorum and as provided by Nos.

Arcanobacterium 000986 or 054771 in

(Actinomyces) Sec. 510.600(c) of

pyogenes; and for this chapter

suppression of estrus

(heat).----------------------------------------------------------------------------------------------------------------(7) 6.8 to 24 ....................... Cattle fed in Feed continuously to 000061

confinement for cattle during the last

slaughter: For 20 to 40 days on feed

increased rate of to provide 60 mg

weight gain, improved zilpaterol

feed efficiency, and hydrochloride per head

increased carcass per day. Withdrawal

leanness in cattle fed period: 3 days

in confinement for

slaughter during the

last 20 to 40 days on

feed----------------------------------------------------------------------------------------------------------------(8) 6.8 to 24 Monensin 10 to 40, plus Cattle fed in Feed continuously to 000061

tylosin 8 to 10 confinement for cattle during the last

slaughter: For 20 to 40 days on feed

increased rate of to provide 60 mg

weight gain, improved zilpaterol

feed efficiency, and hydrochloride per head

increased carcass per day. See

leanness in cattle fed paragraphs Sec. Sec.

in confinement for 558.355(d) and

slaughter during the 558.625(c). Monensin

last 20 to 40 days on and tylosin as

feed; for prevention provided by No. 000986

and control of in Sec. 510.600(c)

coccidiosis due to of this chapter.

Eimeria bovis and E. Withdrawal period: 3

zuernii; and for days

reduction of incidence

of liver abscesses

caused by

Fusobacterium

necrophorum and

Arcanobacterium

(Actinomyces) pyogenes---------------------------------------------------------------------------------------------------------------- [71 FR 53006, Sept. 8, 2006, as amended at 72 FR 9245, Mar. 1, 2007; 72 FR 6019, Feb. 1, 2008; 73 FR 14385, Mar. 18, 2008; 73 FR 16755, Mar. 31, 2008; 73 FR 18959, Apr. 8, 2008; 73 FR 19432, Apr. 10, 2008; 74 FR 61517, Nov. 25, 2009; 75 FR 11451, Mar. 11, 2010; 77 FR 31724, May 30, 2012; 78 FR 42008, July 15, 2013; 78 FR 52852, Aug. 27, 2013; 80 FR 13232, Mar. 13, 2015]