558.258—Fenbendazole.

(a) Specifications. Type A medicated articles: 4 percent (18.1 grams per pound (g/lb)), 8 percent (36.2 g/lb), and 20 percent (90.7 g/lb) fenbendazole.

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

(d) Special considerations. See § 500.25 of this chapter.

(e) Conditions of use— (1) Turkeys.

Amount fenbendazole in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
14.5 (16 parts per million)		Growing turkeys: For the removal and control of gastrointestinal worms: roundworms, adult and larvae (Ascaridia dissimilis); cecal worms, adult and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Blackhead)	Feed continuously as the sole ration for 6 days. For growing turkeys only	000061

(2) Swine.

Amount fenbendazole in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
(i) 10 to 300 (to provide 9 milligrams per kilogram (mg/kg) of body weight) given over a 3- to 12-day period		For the removal and control of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus)	Feed as sole ration	000061
(ii) 10 to 80 (to provide 9 mg/kg of body weight)	Lincomycin 20	As in paragraph (e)(2)(i) of this section; for increased rate of gain in growing-finishing swine	Feed as sole ration. Do not feed to swine that weigh more than 250 pounds (lbs); lincomycin as provided by 000009 in § 510.600(c) of this chapter	000061
(iii) 10 to 80 (to provide 9 mg/kg of body weight)	Lincomycin 40	As in paragraph (e)(2)(i) of this section; for control of swine dysentery in animals on premises with a history of swine dysentery, but where symptoms have not yet occurred	Feed as sole ration. Do not feed to swine that weigh more than 250 lbs.; lincomycin as provided by 000009 in § 510.600(c) of this chapter	000061
Code of Federal Regulations 430
(iv) 10 to 80 (to provide 9 mg/kg of body weight)	Lincomycin 100	As in paragraph (e)(2)(i) of this section; for the treatment of swine dysentery	Feed as sole ration. Do not use within 6 days of slaughter. Do not feed to swine that weigh more than 250 lbs.; lincomycin as provided by 000009 in § 510.600(c) of this chapter	000061
(v) 10 to 80 (to provide 9 mg/kg of body weight)	Lincomycin 200	As in paragraph (e)(2)(i) of this section; for reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae	Feed as sole ration. Do not use within 6 days of slaughter. Do not feed to swine that weigh more than 250 pound (lb); lincomycin as provided by 000009 in § 510.600(c) of this chapter	000061
(vi) 10 to 300 (to provide 9 mg/kg of body weight)	Bacitracin methylene disalicylate 10 to 30	Growing/finishing swine: As in paragraph (e)(2)(i) of this section; for increased rate of weight gain and improved feed efficiency	Feed as sole ration. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter	046573
(vii) 10 to 300 (to provide 9 mg/kg of body weight)	Bacitracin methylene disalicylate 250	1. Growing/finishing swine: As in paragraph (e)(2)(i) of this section; for control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery, but where signs of disease have not yet occurred; or following an approved treatment of the disease condition	1. Growing/finishing swine: Feed as sole ration. Not for use in growing and finishing swine that weigh more than 250 lbs. Diagnosis of swine dysentery should be confirmed by a veterinarian when results are not satisfactory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter	046573
		2. Pregnant sows: As in paragraph (e)(2)(i) of this section; for control of clostridial enteritis in suckling pigs caused by Clostridium perfringens	2. Pregnant sows: Feed as sole ration. Diagnosis of clostridial enteritis should be confirmed by a veterinarian when results are not satisfactory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter

(3) Cattle.

Amount fenbendazole	Indications for use	Limitations	Sponsor
(i) 5 mg/kg body weight (2.27 mg/lb)	Dairy and beef cattle: For the removal and control of: Lungworms (Dictyocaulus viviparus); Stomach worms: barberpole worms (Haemonchus contortus), brown stomach worms (Ostertagia ostertagi), small stomach worms (Trichostrongylus axei); Intestinal worms: hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia oncophora and C. punctata); Bankrupt worms (Trichostrongylus colubriformis); and Nodular worms (Oesophagostomum radiatum).	Feed as the sole ration or as a top dress for one day. Retreatment may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 13 days following last treatment. For dairy cattle the milk discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.	000061
(ii) [Reserved]

(iii) Free-choice feeds —(A) Amount. 5 mg/kg body weight (2.27 mg/lb), including the following formulations:

Ingredient1	Percent	International Feed No.
(1) Free-choice, dry Type C feed:
Salt (sodium chloride)	59.00	6-04-152
Monosodium phosphate	31.16	6-04-288
Dried cane molasses	3.12	4-04-695
Zinc sulfate	0.76	6-05-556
Copper sulfate	0.45	6-01-720
Fenbendazole 20% Type A article	5.51	n/a
(2) Free-choice, dry Type C feed:
Salt (sodium chloride)	35.93	6-04-152
Dicalcium phosphate (18.5% P)	32.44	6-00-080
Calcium carbonate (38% Ca)	15.93	6-01-069
Magnesium oxide (56% Mg)	10.14	6-02-756
Zinc sulfate	1.47	6-05-556
Mineral oil	1.00	8-03-123
Dried cane molasses (46% sugars)	0.98	4-04-695
Potassium iodide	0.01	6-03-759
Fenbendazole 20% Type A article	2.10	n/a
(3) Free-choice, liquid Type C feed:
Cane molasses2	80.902	4-13-251
Water	9.36	n/a
Urea solution, 55%	7.05	5-05-707
Phosphoric acid 75% (feed grade)	2.00	6-03-707
Xantham gum	0.20	8-15-818
Trace minerals	0.20	n/a
Vitamin premix	0.01	n/a
Fenbendazole 20% Type A article	0.278	n/a
1The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer for other free-choice cattle feeds. Formulation modifications require FDA approval prior to marketing. Selenium is not approved for the free-choice formulations described in paragraph (e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published regulations (see 21 CFR 573.920 ).
2The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the brix value of the molasses to the industry standard of 79.5 brix.

(B) Indications for use. As in paragraph (e)(3)(i) of this section.

(C) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3- to 6-day period. Retreatment may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 13 days following last treatment. For dairy cattle the milk discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

(4) Horses.

Amount fenbendazole in grams per ton	Indications for use	Limitations	Sponsor
(i) 4,540	5 mg/kg body weight (2.27 mg/lb) for the control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.), small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp.), and pinworms (Oxyuris equi); 10 mg/kg body weight (4.54 mg/lb) for the control of ascarids (Parascaris equorum).	Feed at the rate of 0. 1lb of feed per 100 lb of body weight to provide 2.27 mg fenbendazole/lb of body weight in a 1-day treatment or 0.2 lb of feed per 100 lb of body weight to provide 4.54 mg fenbendazole/lb of body weight in a 1-day treatment. All horses must be eating normally to ensure that each animal consumes an adequate amount of the medicated feed. Regular deworming at intervals of 6 to 8 weeks may be required due to the possibility of reinfection. Do not use in horses intended for human consumption.	000061
(ii) [Reserved]

(5) Zoo and wildlife animals.

Species/Class	Amount fenbendazole	Indications for use	Limitations	Sponsor
(i) Feral swine (Sus scrofa)	3 mg/kg/day for 3 days.	For the removal and control of kidney worm (Stephanurus dentatus), roundworm (Ascaris suum), nodular worm (Oesophagostomum dentatum)	Use as complete feed. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season	000061
(ii) Ruminants (subfamily Antilopinae, Hippotraginae, Caprinae)	2.5 mg/kg/day for 3 days.	For the removal and control of small stomach worm (Trichostrongylus spp.), thread necked intestinal worm (Nematodirus spp.), barberpole worm (Haemonchus spp.), whipworm (Trichuris spp.)	Use as complete feed. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season	000061
(iii) Rocky mountain bighorn sheep (Ovis c. canadensis)	10 mg/kg/day for 3 days.	For the removal and control of Protostrongylus spp	Use as complete feed. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season	000061

Code of Federal Regulations

[66 FR 58935, Nov. 26, 2001, as amended at 68 FR 34534, June 10, 2003; 72 FR 66046, Nov. 27, 2007; 73 FR 58873, Oct. 8, 2008; 74 FR 61517, Nov. 25, 2009]

CFR

558.258—Fenbendazole.

Code of Federal Regulations