[Code of Federal Regulations] [Title 21, Volume 6] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR558.258] [Page 402-404] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents Subpart B--Specific New Animal Drugs for Use in Animal Feeds Sec. 558.258 Fenbendazole. (a) Approvals. Type A medicated articles: 4 percent (18.1 grams per pound), 8 percent (36.2 grams per pound), and 20 percent (90.7 grams per pound) fenbendazole and all combinations provided for in this section to 012799 in Sec. 510.600(c) of this chapter. (b) Related tolerances. See Sec. 556.275 of this chapter. (c) [Reserved] (d) Conditions of use. (1) Turkeys--(i) Amount. Fenbendazole, 14.5 grams per ton (16 parts per million). (A) Indications for use. For the removal and control of gastrointestinal worms: Round worms, adult and larvae (Ascaridia dissimilis); cecal worms, adult and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Blackhead). (B) Limitations. Feed continuously as the sole ration for 6 days. For growing turkeys only. (ii) [Reserved] (2) It is used in swine feed as follows: (i) Amount. Fenbendazole, 10 to 300 grams per ton (to provide 9 milligrams per kilogram of body weight) given over a 3- to 12-day period. (A) Indications for use. For the removal 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); 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). (B) Feed as sole ration. (ii) Amount. Fenbendazole 10 to 80 grams per ton (to provide 9 milligrams per kilogram body weight) and lincomycin 20 grams per ton. (A) Indications for use. As an anthelmintic (as provided in paragraph (c)(1)(i)(A) of this section) and for increased rate of gain in growing-finishing swine. (B) Limitations. Feed as sole ration. Do not feed to swine that weigh more than 250 pounds; as lincomycin provided by 000009 in Sec. 510.600(c) of this chapter. (iii) Amount. Fenbendazole 10 to 80 grams per ton (to provide 9 milligrams per kilogram body weight) and lincomycin 40 grams per ton. (A) Indications for use. As an anthelmintic (as provided in paragraph (c)(1)(i)(A) of this section) and for control of swine dysentery in animals on premises with a history of swine dysentery, but where symptoms have not yet occurred. (B) Limitations. Feed as sole ration. Do not feed to swine that weigh more than 250 pounds; as lincomycin provided by 000009 in Sec. 510.600(c) of this chapter. (iv) Amount. Fenbendazole 10 to 80 grams per ton (to provide 9 milligrams per kilogram body weight) and lincomycin 100 grams per ton. (A) Indications for use. As an anthelmintic (as provided in paragraph (c)(1)(i)(A) of this section) and for the treatment of swine dysentery. (B) Limitations. Feed as sole ration. Do not use within 6 days of slaughter. Do not feed to swine that weigh more [[Page 403]] than 250 pounds; as lincomycin provided by 000009 in Sec. 510.600(c) of this chapter. (v) Amount. Fenbendazole 10 to 80 grams per ton (to provide 9 milligrams per kilogram body weight) and lincomycin 200 grams per ton. (A) Indications for use. As an anthelmintic (as provided in paragraph (c)(1)(i)(A) of this section) and for reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae. (B) Limitations. Feed as sole ration. Do not use within 6 days of slaughter. Do not feed to swine that weigh more than 250 pounds; as lincomycin provided by 000009 in Sec. 510.600(c) of this chapter. (vi) Amount. Fenbendazole, 10 to 300 grams per ton (to provide 9 milligrams per kilogram body weight), and bacitracin methylene disalicylate, 10 to 30 grams per ton. (A) Indications for use. As an anthelmintic (as provided in paragraph (d)(1)(i)(A) of this section) and for increased rate of weight gain and improved feed efficiency in growing/finishing swine. (B) Limitations. Feed as sole ration. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Bacitracin methylene disalicylate as provided by 046573 in Sec. 510.600(c) of this chapter. (vii) Amount. Fenbendazole, 10 to 300 grams per ton, and bacitracin methylene disalicylate, 250 grams per ton. (A) Indications for use--(1) Growing/finishing swine. As an anthelmintic (as provided in paragraph (d)(1)(i)(A) of this section) and for control of swine dysentery associated withTreponema 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. (2) Pregnant sows. As an anthelmintic (as provided in paragraph (d)(1)(i)(A) of this section) and for control of clostridial enteritis in suckling pigs caused by Clostridium perfringens. (B) Limitations--(1) Growing/finishing swine. Feed as sole ration. Not for use in growing and finishing swine that weigh more than 250 pounds. 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. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Bacitracin methylene disalicylate as provided by 046573 in Sec. 510.600(c) of this chapter. (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. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Bacitracin methylene disalicylate as provided by 046573 in Sec. 510.600(c) of this chapter. (3) It is used in the feed of beef and dairy cattle as follows: (i) Amount. 5 milligrams fenbendazole per kilogram body weight (2.27 milligrams per pound). (ii) Indications for use. For the removal and control of lungworms (Dictyocaulus viviparus); barberpole worms (Haemonchus contortus); brown stomach worms (Ostertagia ostertagi); small stomach worms (Trichostrongylus axei); hookworms (Bunostomum phlebotomum); thread- necked intestinal worms (Nematodirus helvetianus); small intestinal worms (Cooperia punctata (iii) Limitations. Feed as sole ration for one day. Do not use within 13 days of slaughter. (4) It is used in free-choice beef and dairy cattle feed as follows: (i) Amount. 5 milligrams fenbendazole per kilogram body weight (2.27 milligrams per pound). (ii) Indications for use. For the removal and control of infections of lungworms (Dictyocaulus viviparus), barberpole worms (Haemonchus contortus), brown stomach worms (Ostertagia ostertagi), small stomach worms (Trichostrongylus axei), hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia oncophora and C. punctata), bankrupt worms [[Page 404]] (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum) in cattle. (iii) Limitations. Feed a total of 5 milligrams of fenbendazole per kilogram (2.27 milligrams per pound) of body weight to cattle over a 3 to 6 day period. Retreatment may be needed after 4 to 6 weeks. Do not slaughter within 13 days following last treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (iv) May be fed in a Type C feed as follows: ------------------------------------------------------------------------ International Ingredient Percent feed No. ------------------------------------------------------------------------ (A) Ingredient:................................. Copper sulfate.............................. 0.45 6-01-720 Dried Cane Molasses......................... 3.12 4-04-695 Monosodium phosphate........................ 31.16 6-04-288 Salt (sodium chloride)...................... 59.00 6-04-152 Zinc sulfate................................ 0.76 6-05-556 Fenbendazole Type A article (200 grams per 5.51 kilogram).................................. (B) Ingredient:................................. Dicalcium phosphate......................... 32.31 6-00-080 Limestone................................... 17.13 6-02-632 Magnesium oxide............................. 9.79 6-02-756 Zinc sulfate................................ 1.47 6-05-556 Copper sulfate.............................. 0.29 6-01-720 Potassium iodide............................ 0.0098 6-03-759 Dried Cane Molasses......................... 0.98 4-04-695 Selenium.................................... 0.0002 Salt........................................ 35.93 6-04-152 Fenbendazole Type A article (200 grams per 2.09 kilogram).................................. ------------------------------------------------------------------------ (C) The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. The amount of selenium must comply with published regulations. (5) Zoo and wildlife animals. For removal and control of internal parasites in hoofed zoo and wildlife animals as follows: (i) Feral swine (Suis scrofa): 3 milligrams per kilogram per day for 3 days. Treatment for kidney worm (Stephanurus dentatus), roundworm (Ascaris suum), nodular worm (Oesophagostomum dentatum). (ii) Ruminants (subfamily Antilopinae, Hippotraginae, Caprinae): 2.5 milligrams per kilogram per day for 3 days. Treatment for small stomach worm (Trichostrongylus spp.), thread necked intestinal worm (Nematodirus spp.), barberpole worm (Haemonchus spp.), whipworm (Trichuris spp.). (iii) Rocky mountain bighorn sheep (Ovis c. canadensis): 10 milligrams per kilogram per day for 3 days. Treatment and control of Protostrongylus spp. (iv) Limitations. Use as complete feed. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not use 14 days before or during the hunting season. [49 FR 3846, Jan. 31, 1984, as amended at 51 FR 7397, Mar. 3, 1986; 53 FR 14788, Apr. 26, 1988; 54 FR 36963, Sept. 6, 1989; 55 FR 48231, Nov. 20, 1990; 57 FR 34516, Aug. 5, 1992; 58 FR 47973, Sept. 13, 1993; 59 FR 35252, July 11, 1994; 61 FR 29478, June 11, 1996; 64 FR 26844, May 18, 1999; 65 FR 41589, July 6, 2000; 65 FR 50914, Aug. 22, 2000]