[Code of Federal Regulations] [Title 21, Volume 6] [Revised as of January 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR558.195] [Page 398-402] 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. 558.195 Decoquinate. (a) Specifications. Type A medicated article containing 6 percent decoquinate. (b) Approvals. See No. 046573 in Sec. 510.600(c) of this chapter. (c) Related tolerances. See Sec. 556.170 of this chapter. (d) Special considerations. (1) Bentonite should not be used in decoquinate feeds. (2) Type A medicated articles may be used to manufacture dry or liquid Type B cattle (including veal calf), sheep, and goat feeds as in paragraphs (e)(2) and (e)(3) of this section. (3) Type C cattle feeds may be manufactured from decoquinate liquid Type B feeds having a pH between 5.0 to 6.5 and containing a suspending agent to maintain a viscosity of not less than 500 centipoises. (e) Conditions of use. It is used as follows: (1) Chickens. [[Page 399]] ------------------------------------------------------------------------ Decoquinate Combination Indications in grams/ton in grams/ton for use Limitations Sponsor ------------------------------------------------------------------------ (i) 27.2 ............ Broiler Do not feed 046573 chickens: to laying For chickens. prevention of coccidiosi s caused by Eimeria tenella, E. necatrix, E. mivati,E. acervulina , E. maxima, and E. brunetti. (ii) 27.2 Bacitracin Broiler Feed 046573 methylene chickens: continuous disalicylat As in ly as sole e 4 to 50 paragraph ration; do (e)(1)(i) not feed of this to laying section; chickens. and for Bacitracin increased methylene rate of disalicyla weight te as gain and provided improved by No. feed 046573 in efficiency Sec. . 510.600(c) of this chapter. (iii) 27.2 Bacitracin Broiler Feed 046573 zinc 10 to chickens: continuous 50 As in ly as sole paragraph ration; do (e)(1)(ii) not feed of this to laying section. chickens. Bacitracin zinc as provided by No. 046573 in Sec. 510.600(c) of this chapter. (iv) 27.2 Bacitracin Broiler Do not feed 046573 zinc 12 to chickens: to laying 50 plus As in chickens; roxarsone paragraph withdraw 5 11 to 45 (e)(1)(ii) days of this before section. slaughter; as sole source of organic arsenic. ............ ........... Bacitracin .................. zinc and roxarsone as provided by No. 046573 in Sec. 510.600(c) of this chapter. (v) 27.2 Bacitracin Broiler Feed 046573 methylene chickens: continuous disalicylat As in ly as sole e 50 and paragraph ration; do roxarsone (e)(1)(ii) not feed 22.7 to of this to laying 45.4 section; chickens; as an aid withdraw 5 in the days prevention before of slaughter. necrotic Not for enteritis use in caused or breeder complicate chickens. d by Use as Clostridiu sole m spp. or source of other organic organisms arsenic. susceptibl Poultry e to should bacitracin have ; and for access to improved drinking pigmentati water at on. all times. Drug overdosage or lack of drinking water may result in leg weakness or paralysis. Bacitracin methylene disalicyla te and roxarsone as provided by No. 046573 in Sec. 510.600(c) of this chapter. (vi) 27.2 Chlortetracy Chickens: Feed 046573 cline 100 As in continuous to 200 paragraph ly for 7 (e)(1)(i) to 14 of this days; do section; not feed control of to infectious chickens synovitis producing caused by eggs for Mycoplasma human synoviae consumptio susceptibl n. e to chlortetra cycline. (vii) 27.2 Chlortetracy Chickens: As in 046573 cline 200 As in paragraph to 400 paragraph (e)(1)(vi) (e)(1)(i) of this of this section. section; and for control of chronic respirator y disease (CRD) and air sac infection caused by M. gallisepti cum and Escherichi a coli susceptibl e to chlortetra cycline. (viii) 27.2 Lincomycin 2 Broiler Feed as 000009 chickens: sole 046573 As in ration; do paragraph not feed (e)(1)(ii) to laying of this chickens; section. lincomycin provided by No. 000009 in Sec. 510.600(c) of this chapter. (ix) 27.2 Roxarsone Broiler Do not feed 046573 45.4 chickens: to laying As in chickens; paragraph withdraw 5 (e)(1)(ii) days of this before section; slaughter; and for as sole improving source of pigmentati organic on. arsenic. ------------------------------------------------------------------------ (2) Cattle. [[Page 400]] ------------------------------------------------------------------------ Decoquinate Combination Indications in grams/ton in grams/ton for use Limitations Sponsor ------------------------------------------------------------------------ (i) 12.9 to ............ Cattle Feed Type C 046573 90.8 (including feed or ruminating milk and replacer nonruminat at a rate ing calves to provide and veal 22.7 calves): milligrams For (mg) per prevention 100 pounds of (lb) of coccidiosi body s caused weight by Eimeria (0.5 mg/ bovis and kilogram E. (kg)) per zuernii. day. Feed at least 28 days during periods of exposure to coccidiosi s or when it is likely to be a hazard. Do not feed to cows producing milk for food. May be prepared from dry or liquid Type B feed containing 0.0125 to 0.5 percent decoquinat e. See paragraph (d)(3) of this section. (ii) 90.9 to ............ Cattle Feed as a 046573 535.7 (including top dress ruminating at a rate and to provide nonruminat 22.7 mg ing calves per 100 lb and veal of body calves): weight As in (0.5 mg/ paragraph kg) per (e)(2)(i) day. Feed of this at least section. 28 days during periods of exposure to coccidiosi s or when it is likely to be a hazard. Do not feed to cows producing milk for food. May be prepared from dry or liquid Type B feed containing 0.0125 to 0.5 percent decoquinat e. See paragraph (d)(3) of this section. (iii) 13.6 Chlortetracy Calves, Feed Type C 046573 to 27.2 cline beef and feed to approximate nonlactati provide ly 400 ng dairy 22.7 mg (varying cattle: As decoquinat with body in e and 1 weight and paragraph gram (g) feed (e)(2)(i) chlortetra consumption of this cycline to provide section; per 100 lb 10 mg/lb of for body body weight treatment weight per day) of (0.5 mg/ bacterial kg) per enteritis day for caused by not more E. coli; than 5 and for days. Type treatment C feed may of be bacterial prepared pneumonia from Type caused by B feed Pasteurell containing a 535.8 to multocida 5,440 g/ organisms ton susceptibl decoquinat e to e and chlortetra 6,700 to cycline. 80,000 g/ ton chlortetra cycline. When consumed, feed 22.7 mg decoquinat e per 100 lb body weight/day for a total of 28 days to prevent coccidiosi s. Withdraw 24 hours prior to slaughter when manufactur ed from CTC (chlortetr acycline) Type A medicated articles under NADA 141-147. Zero withdrawal time when manufactur ed from AUREOMYCIN (chlortetr acycline) Type A medicated articles under NADA 141-185. Do not feed to calves to be processed for veal. Do not feed to animals producing milk for food. [[Page 401]] (iv) 13.6 to Monensin 5 Cattle fed Feed only 046573 27.2 to 30 in to cattle confinemen fed in t for confinemen slaughter: t for As in slaughter. paragraph Feed (e)(2)(i) continuous of this ly as the section; sole and for ration to improved provide feed 22.7 mg of efficiency decoquinat . e per 100 lb body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during period of exposure to coccidiosi s or when it is likely to be a hazard. Do not feed to animals producing milk for food. Also see paragraph (d)(1) of this section and Sec. 558.355(d) (8). Monensin as provided by No. 000986 in Sec. 510.600(c) of this chapter. (v) 13.6 to Monensin 5 Cattle fed Feed only 046573 27.2 to 30 plus in to cattle tylosin 8 confinemen fed in to 10 t for confinemen slaughter: t for As in slaughter. paragraph Feed (e)(2)(i) continuous of this ly as the section; sole for ration to improved provide feed 22.7 mg of efficiency decoquinat ; and for e per 100 reduction lb body of weight per incidence day, 50 to of liver 360 mg of abscesses monensin caused by per head Fusobacter per day, ium and 60 to necrophoru 90 mg of m and tylosin Actinomyce per head s per day. (Corynebac Feed at terium) least 28 pyogenes. days during period of exposure to coccidiosi s or when it is likely to be a hazard. Do not feed to animals producing milk for food. Also see paragraph (d)(1) of this section and Sec. 558.355(d) (8). Monensin and tylosin as provided by No. 000986 in Sec. 510.600(c) of this chapter. ------------------------------------------------------------------------ (3) Minor species. ------------------------------------------------------------------------ Decoquinate Combination Indications in grams/ton in grams/ton for use Limitations Sponsor ------------------------------------------------------------------------ (i) 12.9 to ............ 1. Young Feed Type C 046573 90.8 sheep: For feed or the milk prevention replacer of at a rate coccidiosi to provide s caused 22.7 mg by Eimeria per 100 lb ovinoidali of body s, E. weight crandallis (0.5 mg , E. per kg) parva, and per day; E. feed for bakuensis. at least 28 days during periods of exposure to coccidiosi s or when it is likely to be a hazard. Do not feed to sheep producing milk for food. ............ 2. Young Feed Type C .................. goats: For feed or the milk prevention replacer of at a rate coccidiosi to provide s caused 22.7 mg by E. per 100 lb christense of body ni and E. weight ninakohlya (0.5 mg kimovae. per kg) per day; feed for at least 28 days during periods of exposure to coccidiosi s or when it is likely to be a hazard. Do not feed to goats producing milk for food. [[Page 402]] (ii) 90.9 to ............ 1. Young Feed as a 046573 535.7 sheep: As top dress in item 1 at a rate of to provide paragraph 22.7 mg (e)(3)(i) per 100 lb of this of body section. weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosi s or when it is likely to be a hazard. Do not feed to sheep producing milk for food. ............ 2. Young Feed as a .................. goats: As top dress in item 2 at a rate of to provide paragraph 22.7 mg (e)(3)(i) per 100 lb of this of body section. weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosi s or when it is likely to be a hazard. Do not feed to goats producing milk for food. ------------------------------------------------------------------------ [67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, 2003]