§ 558.265 - Halofuginone.

§ 558.265 Halofuginone.

(a) Specifications. Type A medicated articles containing 6 grams of halofuginone hydrobromide per kilogram.

(b) ApprovalsSponsor. See No. 016592 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.308 of this chapter.

(d) Conditions of use.

(1)

It is used in feed

for broiler chickens

as follows:

(A) Indications for use.

(

i) Amount. 2.72 grams per ton. (A) Indications for use.

1) Chickens -

Halofuginone in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor
(i) 2.72		Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima

.(B) Limitations.

Feed continuously as sole ration

; withdraw 4 days before slaughter; do

. Do not feed to layers

; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.

. Withdraw 4 days before slaughter	016592
(ii)

Amount per ton. Halofuginone (A) Indications for use.

2.72

grams (0.0003 percent) plus bambermycins 1 to 2 grams.

Bacitracin methylenedisalicylate, 10 to 50

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for

increased rate of weight gain and

improved feed efficiency

. (B) Limitations.

Feed continuously as sole ration

; withdraw 5 days before slaughter; do

. Do not feed to layers. Withdraw 5 days before slaughter	016592
(iii)

-(v) [Reserved] (vi) Amount per ton. Halofuginone (A) Indications for use.

2.72

grams (0.0003 percent) plus bacitracin methylenedisalicylate 10 to 50 grams.

Bambermycins, 1 to 2

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E

.

, acervulina, E. brunetti, E.

mevati

mivati,and E. maxima; for increased rate of weight gain and

for

improved feed efficiency

. (B) Limitations.

Feed continuously as sole ration

; withdraw 5 days before slaughter; do

. Do not feed to layers

; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.

(vii)-(viii) [Reserved]

(2) It is used in feed for turkeys as follows:

(i) Amount per ton. 1.36 to 2.72 grams.

. Withdraw 5 days before slaughter	016592
(iv) 2.72		Replacement broiler breeder chickens and replacement cage laying chickens: For the prevention of coccidiosis

in growing turkeys

caused by Eimeria

adenoeides

tenella, E.

meleagrimitis

necatrix,

and

E.

gallopavonis.(B) Limitations.

acervulina, E. maxima, E. mivati/E. mitis, and E. brunetti

Feed continuously as sole ration

; withdraw 7 days before slaughter; do not feed to layers or water fowl; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams. (ii) Amount per ton. Halofuginone hydrobromide

to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Do not feed to laying chickens or water fowl. Withdraw 4 days before slaughter

016592

(2) Turkeys -

(A) Indications for use. For

Halofuginone in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor
(i) 1.36 to 2.72

grams plus bacitracin methylenedisalicylate 10 to 50 grams.

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis

.

, and E. gallopavonis

, and for increased rate of weight gain in growing turkeys. (B) Limitations.

Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to

laying chickens

layers or water fowl

. Keep out of lakes, ponds, and streams. Halofuginone is toxic to fish and aquatic life. Halofuginone is an irritant to eyes and skin. Avoid contact with skin, eyes, or clothing. (iii) Amount per ton. (A) Indications for use.

016592

(ii) 1.36 to 2.72

grams of halofuginone hydrobromide plus 2 grams of bambermycins.

Bacitracin methylenedisalicylate, 10 to 50

Growing turkeys: For the prevention of coccidiosis caused by Eimeria

adenoides

adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain

in growing turkeys. (B) Limitations.

Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or

waterfowl. Halofuginone hydrobromide is toxic to fish and other aquatic life. Keep out of lakes, ponds, and streams. Halofuginone hydrobromide is an eye and skin irritant. Avoid contact with skin, eyes, and clothing.

(3) It is used in feed for replacement cage laying chickens and replacement broiler breeder chickens as follows:

(i) Amount per ton. 2.72 grams.

(A) Indications for use.

water fowl	016592
(iii) 1.36 to 2.72	Bambermycins, 2	Growing turkeys: For the prevention of coccidiosis caused by Eimeria

tenella

adenoeides, E.

necatrix

meleagrimitis,and E.

acervulina, E. maxima, E. mivati/E. mitis, and E. brunetti. (B) Limitations. Feed continuously as sole ration to replacement cage laying chickens until 20 weeks of age.

gallopavonis, and for increased rate of weight gain

Feed continuously as sole ration

to replacement broiler breeder chickens until 16 weeks of age

. Withdraw

4

7 days before slaughter. Do not feed to laying chickens or

water fowl. Halofuginone hydrobromide is toxic to fish and aquatic life. Keep out of lakes, ponds, and streams. Halofuginone hydrobromide is an irritant to eyes and skin. Avoid contact with skin, eyes, and clothing.

(ii) [Reserved]

(4)

waterfowl

016592

(3) Halofuginone may also be used in combination with:

(i)

[Reserved] (ii)

Lincomycin as in § 558.325.

(

iii) Virginiamycin as in § 558.635.

[

ii) [Reserved]

[50 FR 33719, Aug. 21, 1985, as amended at 50 FR 42518, Oct. 21, 1985; 51 FR 7397, Mar. 3, 1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, Apr. 22, 1986; 51 FR 23737, July 1, 1986; 53 FR 1018, Jan. 15, 1988; 53 FR 11065, Apr. 5, 1988; 54 FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, 1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, May 9, 1996; 61 FR 24694, May 16, 1996; 64 FR 42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; 66 FR 47962, Sept. 17, 2001; 71 FR 27956, May 15, 2006; 79 FR 10982, Feb. 27, 2014; 81 84 FR 176098975, Mar. 30, 2016; 81 FR 95005, Dec. 27, 201613, 2019]