(a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is not approved.

(b) The following definitions apply to terms used in this part:

(1) New animal drugs approved for use in animal feed are placed in two categories as follows:

(i) Category I—These drugs require no withdrawal period at the lowest use level in each species for which they are approved.

(ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern regardless of whether a withdrawal period is required, or are a veterinary feed directive drug.

(2) A “Type A medicated article” is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. It consists of a new animal drug(s), with or without carrier (e.g., calcium carbonate, rice hull, corn, gluten) with or without inactive ingredients. The manufacture of a Type A medicated article requires an application approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter.

(3) A “Type B medicated feed” is intended solely for the manufacture of other medicated feeds (Type B or Type C). It contains a substantial quantity of nutrients including vitamins and/or minerals and/or other nutritional ingredients in an amount not less than 25 percent of the weight. It is manufactured by diluting a Type A medicated article or another Type B medicated feed. The maximum concentration of animal drug(s) in a Type B medicated feed is 200 times the highest continuous use level for Category I drugs and 100 times the highest continuous use level for Category II drugs. The term “highest continuous use level” means the highest dosage at which the drug is approved for continuous use (14 days or more), or, if the drug is not approved for continuous use, it means the highest level used for disease prevention or control. If the drug is approved for multiple species at different use levels, the highest approved level of use would govern under this definition. The manufacture of a Type B medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under § 515.20 of this chapter.

(4) A “Type C medicated feed” is intended as the complete feed for the animal or may be fed “top dressed” (added on top of usual ration) on or offered “free-choice” (e.g., supplement) in conjunction with other animal feed. It contains a substantial quantity of nutrients including vitamins, minerals, and/or other nutritional ingredients. It is manufactured by diluting a Type A medicated article or a Type B medicated feed. A Type C medicated feed may be further diluted to produce another Type C medicated feed. The manufacture of a Type C medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under § 515.20 of this chapter.

(5) A Type B or Type C medicated feed manufactured from a drug component (bulk or “drum-run” (dried crude fermentation product)) requires an application approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter.

(6) A “veterinary feed directive (VFD) drug” is a new animal drug approved under section 512(b) of the Federal Food, Drug, and Cosmetic Act (the act) or listed in the index under section 572 of the act for use in or on animal feed. Use of a VFD drug must be under the professional supervision of a licensed veterinarian.

(7) A “veterinary feed directive” is a written statement issued by a licensed veterinarian in the course of the veterinarian's professional practice that orders the use of a VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use the VFD drug in or on an animal feed to treat the client's animals only in accordance with the directions for use approved or indexed by the Food and Drug Administration (FDA). A veterinarian may issue a VFD only if a valid veterinarian-client-patient relationship exists, as defined in § 530.3(i) of this chapter.

(8) A “medicated feed” means a Type B medicated feed as defined in paragraph (b)(3) of this section or a Type C medicated feed as defined in paragraph (b)(4) of this section.

(9) For the purposes of this part, a “distributor” means any person who distributes a medicated feed containing a VFD drug to another distributor or to the client-recipient of the VFD.

(10) An “animal production facility” is a location where animals are raised for any purpose, but does not include the specific location where medicated feed is made.

(11) An “acknowledgment letter” is a written communication provided to a distributor by a consignee who is not the ultimate user of medicated feed containing a VFD drug. An acknowledgment letter affirms that the consignee will not ship such medicated animal feed to an animal production facility that does not have a VFD, and will not ship such feed to another distributor without receiving a similar written acknowledgment letter.

(a) A feed manufacturing facility must possess a medicated feed mill license in order to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.

(b) The manufacture of the following types of feed are exempt from the required license, unless otherwise specified:

(1) Type B or Type C medicated feed using Category I, Type A medicated articles or Category I, Type B or Type C medicated feeds; and

(2) Type B or Type C medicated feed using Category II, Type B or Type C medicated feeds.

(c) The use of Type B and Type C medicated feeds shall also conform to the conditions of use provided for in subpart B of this part and in § 558.15 of this chapter.

(d) This paragraph identifies each drug by category, the maximum level of drug in Type B medicated feeds, and the assay limits for the drug in Type A medicated articles and Type B and Type C medicated feeds, as follows:

(a) What types of liquid medicated feeds are covered by this section? This section covers the following types of liquid medicated feed:

(1) Type B feed that is intended for further manufacture of other medicated feeds (§ 558.3(b)(3)) or:

(2) Type C feed that is intended for the following:

(i) Further manufacture of another Type C feed, or

(ii) Top-dressing (adding on top of the usual ration) (§ 558.3(b)(4)).

(b) How is liquid free-choice medicated feed regulated? Liquid free-choice medicated feed is covered by this section and by § 510.455.

(c) What is required for new animal drugs intended for use in liquid feed? Any new animal drug intended for use in liquid feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) or index listed under section 572 of the act. Such approvals under section 512 of the act must be:

(1) An original NADA,

(2) A supplemental NADA, or

(3) An abbreviated NADA.

(d) What are the approval requirements under section 512 of the act for new animal drugs intended for use in liquid feed? An approval under section 512 of the act for a new animal drug intended for use in liquid feed must contain the following information:

(1) Data, or a reference to data in a master file (MF), that shows the relevant ranges of conditions under which the drug will be chemically stable in liquid feed under field use conditions; and

(2) Data, or a reference to data in an MF, that shows that the drug is physically stable in liquid feed under field conditions; or

(3) Feed labeling with recirculation or agitation directions as follows:

(i) 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.

(ii) 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) How are chemical and physical stability data to be submitted? The data must be submitted as follows:

(1) Directly in the NADA,

(2) By a sponsor, or

(3) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder.

(f) What will be stated in the published approval for a new animal drug intended for use in liquid feed? The approval of a new animal drug intended for use in liquid feed as published in this subchapter will include the following requirements:

(1) The formula and/or specifications of the liquid medicated feed, where the owner of this information requests such publication; and/or

(2) A statement that the approval has been granted for a proprietary formula and/or specifications.

(g) When is a medicated feed mill license required for the manufacture of a liquid medicated feed? An approved medicated feed mill license is required for the manufacture of the following types of feeds:

(1) All liquid medicated feeds that contain a Category II drug, and

(2) Liquid medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications.

(h) What measures are in place to prevent certain drugs, approved for use in animal feed or drinking water but not in liquid medicated feed, from being diverted to use in liquid feeds? Any product containing any form of bacitracin, oxytetracycline, or chlortetracycline, intended for oral administration via animal feed and/or drinking water, and not approved for use in a liquid medicated feed must include in its labeling the following statement: “FOR USE IN ___ ONLY. NOT FOR USE IN LIQUID MEDICATED FEEDS.” The blank may be filled in with the words: “DRY FEEDS”, “DRINKING WATER”, or “DRY FEEDS AND DRINKING WATER”.

(i) Can the labeling provisions of paragraph (h) of this section be waived, and how can I apply for a waiver? (1) The labeling provisions of paragraph (h) of this section may be waived if there is evidence to indicate that it is unlikely a new animal drug would be used in the manufacture of a liquid medicated feed.

(2) To obtain a waiver, you must submit a letter requesting a waiver to the Office of New Animal Drug Evaluation (HFV-100), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.

(3) The letter must include a copy of the product label; a description of the formulation; and information to establish that the physical, chemical, or other properties of the new animal drug are such that diversion to use in liquid medicated feed is unlikely.

(j) What else do I need to know about the labeling provisions of paragraph (h) of this section? The labeling provisions of paragraph (h) of this section may be implemented without prior approval as provided for in § 514.8(c)(3) of this chapter.

(a) What conditions must I meet if I am a veterinarian issuing a veterinary feed directive (VFD)?

(1) You must be appropriately licensed.

(2) You must issue a VFD only within the confines of a valid veterinarian-client-patient relationship (see definition at § 530.3(i) of this chapter).

(3) You must complete the VFD in writing and sign it or it will be invalid.

(4) You must include all of the following information in the VFD or it will be invalid:

(i) You and your client's name, address and telephone and, if the VFD is faxed, facsimile number.

(ii) Identification and number of animals to be treated/fed the medicated feed, including identification of the species of animals, and the location of the animals.

(iii) Date of treatment, and, if different, date of prescribing the VFD drug.

(iv) Approved or index listed indications for use.

(v) Name of the animal drug.

(vi) Level of animal drug in the feed, and the amount of feed required to treat the animals in paragraph (a)(4)(ii) of this section.

(vii) Feeding instructions with the withdrawal time.

(viii) Any special instructions and cautionary statements necessary for use of the drug in conformance with the approval.

(ix) Expiration date of the VFD.

(x) Number of refills (reorders) if necessary and permitted by the approval.

(xi) Your license number and the name of the State issuing the license.

(xii) The statement: “Extra-label use, (i.e., use of this VFD feed in a manner other than as provided for in the VFD drug approval) is strictly prohibited.”

(xiii) Any other information required by the VFD drug approval regulation.

(5) You must produce the VFD in triplicate.

(6) You must issue a VFD only for the approved or indexed conditions and indications for use of the VFD drug.

(b) What must I do with the VFD if I am a veterinarian?

(1) You must give the original VFD to the feed distributor (directly or through the client).

(2) You must keep one copy of the VFD.

(3) You must give the client a copy of the VFD.

(4) You may send a VFD to the client or distributor by facsimile or other electronic means provided you assure that the distributor receives the original signed VFD within 5 working days of receipt of the facsimile or other electronic order.

(5) You may not transmit a VFD by telephone.

(c) What are the VFD recordkeeping requirements?

(1) The VFD feed distributor must keep the VFD original for 2 years from the date of issuance. The veterinarian and the client must keep their copies for the same period of time.

(2) All involved parties must make the VFD available for inspection and copying by FDA.

(3) All involved parties (the VFD feed distributor, the veterinarian, and the client) must keep VFD's transmitted by facsimile or other electronic means for a period of 2 years from date of issuance.

(4) All involved parties must have a copy of the VFD before distribution of a VFD feed to the ultimate user.

(d) What are the notification requirements if I am a distributor of animal feed containing a VFD drug?

(1) You must notify FDA only once, by letter, that you intend to distribute animal feed containing a VFD drug.

(i) The notification letter must include the complete name and address of each business site from which distribution will occur.

(ii) A responsible person from your firm must sign and date the notification letter.

(iii) You must submit the notification letter to the Center for Veterinary Medicine, Division of Animal Feeds (HFV-220), 7500 Standish Pl., Rockville, MD 20855, prior to beginning your first distribution.

(iv) You must notify the Center for Veterinary Medicine at the above address within 30 days of any change in name or business address.

(2) If you are a distributor who ships an animal feed containing a VFD drug to another consignee-distributor in the absence of a valid VFD, you must obtain an “acknowledgment letter,” as defined in § 558.3(b)(11), from the consignee-distributor. The letter must include a statement affirming that the consignee-distributor has complied with “distributor notification” requirements of paragraph (d)(1) of this section.

(e) What are the additional recordkeeping requirements if I am a distributor?

(1) You must keep records of receipt and distribution of all medicated animal feed containing a VFD drug.

(2) You must keep these records for 2 years from date of receipt and distribution.

(3) You must make records available for inspection and copying by FDA.

(f) What cautionary statements are required for VFD drugs and animal feeds containing VFD drugs? All labeling and advertising must prominently and conspicuously display the following cautionary statement: “Caution: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian's professional practice.”

(a) The Commissioner of Food and Drugs will propose to revoke currently approved subtherapeutic (increased rate of gain, disease prevention. etc.) uses in animal feed of antibiotic and sulfonamide drugs whether granted by approval of new animal drug applications, master files and/or antibiotic or food additive regulations, by no later than April 20, 1975, or the nitrofuran drugs by no later than September 5, 1975, unless data are submitted which resolve conclusively the issues concerning their safety to man and animals and their effectiveness under specific criteria established by the Food and Drug Administration based on the guidelines included in the report of the FDA task force on the use of antibiotics in animal feeds. All persons or firms previously marketing identical, related, or similar products except the nitrofuran drugs not the subject of an approved new animal drug application must submit a new animal drug application by July 19, 1973, or by December 4, 1973, in the case of nitrofuran drugs, if marketing is to continue during the interim. New animal drug entities with antibacterial activity not previously marketed, now pending approval or submitted for approval prior to, on, or following the effective date of this publication, shall satisfy such criteria prior to approval.

(b) Any person interested in developing data which will support retaining approval for such uses of such antibiotic, nitrofuran, and sulfonamide drugs pursuant to section 512(l) of the Federal Food, Drug, and Cosmetic Act shall submit to the Commissioner the following:

(1) By July 19, 1973, records and reports of completed, ongoing, or planned studies, including protocols, on the tetracyclines, streptomycin, dihydrostreptomycin, penicillin, and the sulfonamides; for all other antibiotics by October 17, 1973; and for the nitrofuran drugs by March 4, 1974. The Food and Drug Administration encourages sponsors to consult with the Center for Veterinary Medicine on protocol design and plans for future studies.

(2) By April 20, 1974, data from completed studies on the tetracyclines, streptomycin, dihydrostreptomycin, the sulfonamides, and penicillin assessing the effect of the subtherapeutic use of the drug in feed on the salmonella reservoir in the target animal as compared to that in nonmedicated controls. Failure to complete the salmonella studies for any of these drugs by that time will be grounds for proceeding to immediately withdraw approval.

(3) By April 20, 1975, data satisfying all other specified criteria for safety and effectiveness, including the effect on the salmonella reservoir for any antibiotic or sulfonamide drugs and by September 5, 1975, for the nitrofuran drugs, approved for subtherapeutic use in animal feeds. Drug efficacy data shall be submitted for any feed-use combination product containing such drug and any feed-use single ingredient antibiotic, nitrofuran, or sulfonamide not reviewed by the National Academy of Sciences—National Research Council, Drug Efficacy Study covering drugs marketed between 1938 and 1962.

(4) Progress reports on studies underway every January 1 and July 1 until completion.

(c) Failure on the part of any sponsor to comply with any of the provisions of paragraph (b) of this section for any of the antibacterial drugs included in paragraph (b)(1) of this section, or interim results indicating a health hazard, will be considered as grounds for immediately proceeding to withdraw approval of that drug for use in animal feeds under section 512(l) of the act in the case of failure to submit required records and reports and under section 512(e) where new information shows that such drug is not shown to be safe.

(d) Criteria based upon the guidelines laid down by the task force may be obtained from the Food and Drug Administration, Center for Veterinary Medicine, 7500 Standish Pl., Rockville, MD 20855.

(e) Reports as specified in this section shall be submitted to: Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation (HFV-100), 7500 Standish Pl., Rockville, MD 20855.

(f) Following the completion of the requirements of paragraphs (a) and (b) of this section and the studies provided for therein:

(1) Those antibiotic, nitrofuran, and sulfonamide drugs which fail to meet the prescribed criteria for subtherapeutic uses but which are found to be effective for the therapeutic purposes will be permitted in feed only for high-level, short-term therapeutic use and only by or on the order of a licensed veterinarian.

(2) Animal feeds containing antibacterial drugs permitted to remain in use for subtherapeutic purposes shall be labeled to include a statement of the quantity of such drugs.

(g) The submission of applications and data required by paragraphs (a) and (b) of this section is not required for the continued manufacture of any Type A medicated article which is produced solely from a Type A article that is in compliance with the requirements of this section: Provided, That the Type A medicated article contains no drug ingredient whose use in or on animal feed requires an approved application pursuant to section 512(m) of the act and/or where the Type A article is approved by regulation in this part.

(1) The following antibacterial Type A articles manufactured by the designated sponsors are eligible for interim marketing based on their compliance with the requirements of this section:

(2) The following is a list of drug combinations permitted when prepared from antibacterial Type A articles listed in paragraph (g)(1) of this section. Drug combinations listed in subpart B of this part name their sponsors and are incorporated herein by reference since they are safe and effective by contemporary standards, or such sponsors have been notified of any additional safety or efficacy data required on an individual basis:

(a) Approvals. Type A medicated articles: to 053501 in § 510.600(c) of this chapter, as follows:

(1) 50 percent aklomide.

(2) 20 percent sulfanitran and 25 percent aklomide.

(3) 25 percent aklomide, 20 percent sulfanitran, and 5 percent roxarsone.

(4) 50 percent aklomide and 10 percent roxarsone.

(b) Related tolerances. See § 556.30 of this chapter.

(c) Conditions of use. It is used in feed for chickens as follows:

(1) Amount per ton. Aklomide, 227 grams (0.025 percent).

(i) Indications for use. As an aid in the prevention of coccidiosis caused by E. tenella and E. necatrix.

(ii) Limitations. Not to be fed to birds laying eggs for human consumption.

(2) Amount per ton. Aklomide, 227 grams (0.025 percent) combined with sulfanitran, 181.6 grams (0.02 percent).

(i) Indications for use. As an aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, and E. acervulina.

(ii) Limitations. Not to be fed to laying chickens; withdraw 5 days before slaughter.

(3) Amount per ton. Aklomide, 227 grams (0.025 percent) combined with sulfanitran, 181.6 grams (0.02 percent) + roxarsone, 22.7-45.4 grams (0.0025-0.005 percent).

(i) Indications for use. As an aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, and E. acervulina; growth promition and feed efficiency; improving pigmentation.

(ii) Limitations. Not to be fed to laying chickens; withdraw 5 days before slaughter; as sole source of organic arsenic; chickens should have access to drinking water at all times.

(4) Amount per ton. Aklomide, 227 grams (0.025 percent) combined with roxarsone, 22.7-45.4 grams (0.0025-0.005 percent).

(i) Indications for use. As an aid in the prevention of coccidiosis caused by E. tenella, and E. necatrix; growth promotion and feed efficiency; improving pigmentation.

(ii) Limitations. Not to be fed to birds laying eggs for human consumption; withdraw 5 days before slaughter; as sole source of organic arsenic; chickens should have access to drinking water at all times.

(a) Approvals. Type A medicated articles: 25 percent to No. 016592 in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(b) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

(c) Related tolerances. See § 556.50 of this chapter.

(d) Conditions of use—(1) Cattle. It is used as follows:

(i) Amount. 227 milligrams per 100 pounds (5 milligrams per kilogram) body weight per day.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii.

(b) Limitations. Administer from a Type B feed containing from 0.05 to 1.25 percent amprolium with the usual amount of feed consumed in 1 day; feed for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard; withdraw 24 hours before slaughter; as sole source of amprolium. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(ii) Amount. 454 milligrams per 100 pounds (10 milligrams per kilogram) body weight per day.

(a) Indications for use. As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zurnii.

(b) Limitations. Administer from a Type B feed containing from 0.05 to 1.25 percent amprolium with the usual amount of feed consumed in 1 day; feed for 5 days; for a satisfactory diagnosis, a microscopic examination of the feces should be done by a veterinarian or diagnostic laboratory before treatment; when treating outbreaks, the drug should be administered promptly after diagnosis is determined; withdraw 24 hours before slaughter; as sole source of amprolium. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(2) Chickens and turkeys. It is used as follows:

(3) Pheasants. It is used as follows:

(i) Amount. 0.0175 percent (159 grams per ton).

(ii) Indications for use. For the prevention of coccidiosis in growing pheasants caused by Eimeria colchici, E. duodenalis, and E. phasiani.

(iii) Limitations. Feed continuously as sole ration. Use as sole source of amprolium. Fertility, hatchability, and other reproductive data are not available on amprolium in breeding pheasants. Do not use in feeds containing bentonite.

(a) Approvals. Type A articles to sponsors identified in § 510.600(c) of this chapter as follows:

(1) 000986 for 75 grams apramycin (as apramycin sulfate) per pound for use as in paragraph (d)(1) of this section.

(2) [Reserved]

(b) [Reserved]

(c) Related tolerances. See § 556.52 of this chapter.

(d) Conditions of use—(1) Swine—(i) Amount. 150 grams per ton.

(ii) Indications for use. For control of porcine colibacillosis (weanling pig scours) caused by susceptible strains of Escherichia coli.

(iii) Limitations. Use for 14 days. Withdraw 28 days before slaughter.

(2) [Reserved]

(a) Appprovals. Type A medicated articles: 20, 50, or 100 percent to 015565 in § 510.600(c) of this chapter.

(b) Related tolerances. See § 556.60 of this chapter.

(c) Conditions of use. (1) It is used for chickens and turkeys as follows:

(i) Grams per ton. 90 (0.01 percent).

(ii) Indications for use. For growth promotion and feed efficiency; improving pigmentation.

(iii) Limitations. Withdraw 5 days before slaughter; as sole source of organic arsenic.

(2) Arsanilate sodium may be used in accordance with the provisions of this section in the combinations provided as follows:

(i) Amprolium in accordance with § 558.55.

(ii) Zoalene in accordance with § 558.680.

(a) Approvals. Type A medicated articles to sponsors in § 510.600(c) of this chapter as follows:

(1) To 015565: 20, 50, and 100 percent for use as in the table in paragraph (c)(1), entry (ii), item 1; entry (ii), item 2; entry (iv); entry (vi); and entry (vii) of this section.

(2) To 015565: 20 percent for use as in paragraph (c)(1), entry (i); entry (ii), item 3 of this section.

(3) To 061133: 90 grams per pound arsanilic acid and 4.6 grams per pound erythromycin equivalents as erythromycin thiocyanate for use as in paragraph (c)(1), entry (iii); 90 grams per pound arsanilic acid and 9.25 grams per pound erythromycin equivalents as erythromycin thiocyanate for use as in paragraph (c)(1), entry (v).

(b) Related tolerances. See § 556.60 of this chapter.

(c) Conditions of use. (1) It is used as follows:

(2) Arsanilic acid may be used in accordance with the provisions of this section in the combinations provided as follows:

(i) Amprolium in accordance with § 558.55.

(ii) Amprolium and ethopabate in accordance with § 558.58.

(iii) Bacitracin zinc in accordance with § 558.78.

(iv) Bacitracin and zoalene in accordance with § 558.680.

(v) Zoalene in accordance with § 558.680.

(a) Approvals. Type A medicated articles: 10, 25, 30, 40, 50, 60, or 75 grams per pound to 046573 in § 510.600(c) of this chapter.

(b) Special considerations. The quantities of antibiotics are expressed in terms of the equivalent amount of antibiotic standard.

(c) Related tolerances. See § 556.70 of this chapter.

(d) Conditions of use. (1) It is used as follows:

(2) It is used as bacitracin methylene disalicylate in feed for animals as follows:

(i) Amount. 70 milligrams per head per day.

(a) Indications for use. Feedlot beef cattle; reduction in the number of liver condemnations due to abscesses.

(b) Limitations. Administer continuously throughout the feeding period.

(ii) Amount. 250 milligrams per head per day.

(a) Indications for use. Feedlot beef cattle; reduction in the number of liver condemnations due to abscesses.

(b) Limitations. Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period.

(3) Bacitracin methylene disalicylate may also be used with:

(i) Amprolium as in § 558.55.

(ii) Amprolium and ethopabate as in § 558.58.

(iii) Carbarsone (not USP) as in § 558.120.

(iv) Decoquinate alone and with roxarsone as in § 558.195.

(v) Diclazuril alone and with roxarsone as in § 558.198.

(vi) Fenbendazole as in § 558.258.

(vii) Halofuginone hydrobromide alone and with roxarsone as in § 558.265.

(viii) Hygromycin B as in § 588.274.

(ix) Ivermectin as in § 558.300.

(x) Lasalocid sodium alone and with roxarsone as in § 558.311.

(xi) Monensin alone and with roxarsone as in § 588.355.

(xii) Narasin alone and with roxarsone as in § 558.363.

(xiii) Nicarbazin alone or with narasin or roxarsone or with narasin and roxarsone as in § 558.366.

(xiv) Nitarsone as in § 558.369.

(xv) Robenidine alone and with roxarsone as in § 558.515.

(xvi) Salinomycin alone and with roxarsone as in § 558.550.

(xvii) Semduramicin alone and with roxarsone as in § 558.555.

(xviii) Zoalene alone and with arsanilic acid or roxarsone as in § 558.680.

(a) Specifications. Type A medicated articles containing bacitracin zinc equivalent to 10, 25, 40, or 50 grams per pound bacitracin.

(b) Approvals. See No. 046573 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.70 of this chapter.

(d) Conditions of use. (1) It is used as follows:

(2) It is used in feed for growing cattle at 35 to 70 milligrams per head per day as follows:

(i) To aid in stimulating growth and improving feed efficiency.

(ii) For increased rate of weight gain and improved feed efficiency; see sponsor 046573.

(3) It may be used as approved in combination with:

(i) Amprolium alone and with roxarsone as in § 558.55.

(ii) Amprolium and ethopabate alone and with roxarsone as in § 558.58.

(iii) Carbarsone as in § 558.120.

(iv) Clopidol alone and with roxarsone as in § 558.175.

(v) Decoquinate alone and with roxarsone as in § 558.195.

(vi) Hygromycin B alone and with penicillin as in § 558.274.

(vii) Lasalocid sodium alone or with roxarsone as in § 558.311.

(viii) Monensin alone and with roxarsone as in § 558.355.

(ix) Naracin as in § 558.363.

(x) Nitarsone as in § 558.369.

(xi) Robenidine as in § 558.515.

(xii) Salinomycin alone and with roxarsone as in § 558.550.

(xiii) Zoalene alone and with arsanilic acid or roxarsone as in § 558.680.

(a) Approvals. To sponsors identified by drug labeler codes in § 510.600(c) of this chapter for use of bambermycins Type A medicated articles as bambermycins activity per pound in paragraph (d) of this section as follows:

(1) To 016592: 2, 4, and 10 grams for use as in paragraphs (d)(1), (d)(2), (d)(3), and (d)(4) of this section.

(2) To 016592: 0.4 gram for use as in paragraph (d)(2) of this section.

(3) [Reserved]

(4) To Nos. 012286, 016968, and 017790: 0.4 and 2 grams for use as in paragraph (d)(2) and 2 grams for use as in paragraph (d)(3) of this section.

(5) To 016592: 10 grams to make 40 to 800 grams per ton Type B feed for use as in paragraph (d)(4) of this section.

(b) Special considerations. (1) Bambermycins liquid Type B feeds may be manufactured from dry bambermycins Type A articles. The liquid Type B feeds must have a pH of 3.8 to 7.5, moisture content of 30 to 45 percent.

(2) The expiration date for the liquid Type B feed is 8 weeks after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 1 week after date of manufacture.

(c) [Reserved]

(d) Conditions of use—(1) Broiler chickens. It is used as follows:

(i) Amount per ton. 1 to 2 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency.

(b) Limitations. Feed continuously as the sole ration.

(ii) [Reserved]

(2) Growing-finishing swine. It is used as follows:

(i) Amount per ton. 2 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency.

(b) Limitations. Feed continuously as sole ration.

(ii) Amount per ton. 2 to 4 grams.

(a) Indications for use. For increased rate of weight gain.

(b) Limitations. Feed continuously as sole ration.

(3) Growing turkeys. It is used as follows:

(i) Amount per ton. 1 to 2 grams.

(a) Indications for use. For improved feed efficiency.

(b) Limitations. Feed continuously as the sole ration.

(ii) Amount per ton. 2 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency.

(b) Limitations. Feed continuously as sole ration.

(4) Cattle—(i) Amount per ton. 1 to 4 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency.

(b) Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously in a Type C medicated feed at a rate of 10 to 20 milligrams of bambermycins per head per day. Liquid Type B feeds containing bambermycins may be used in the preparation of dry complete ration Type C feeds.

(ii) Amount per ton. 2 to 40 grams.

(a) Indications for use. For increased rate of weight gain.

(b) Limitations. Feed continuously to pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers) at a rate of 10 to 40 milligrams of bambermycins per head per day in at least 1 pound and not more than 10 pounds of Type C medicated feed. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.

(iii) Used as a free-choice Type C medicated loose mineral feed for pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers) as follows:

(a) Specifications.

(b) Amount per ton. 120 grams.

(c)Indications for use. For increased rate of weight gain.

(d) Limitations. For free-choice feeding to pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers). Feed a nonmedicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.

(iv) Use free-choice Type C medicated feeds for pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers) as follows:

(a) Amount. Feed continuously to provide 10 to 40 milligrams of bambermycins per head per day.

(b) Indications for use. For increased rate of weight gain.

(c) Limitations. Each use in a free-choice Type C medicated feed must be the subject of an approved new animal drug application (NADA) or supplemental NADA as required by 21 CFR 510.455. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.

(5) Bambermycins may also be used in combination with:

(i) Amprolium alone or with roxarsone as in § 558.55.

(ii) Amprolium and ethopabate alone or with roxarsone as in § 558.58.

(iii) Diclazuril as in § 558.198.

(iv) Halofuginone as in § 558.265.

(v) Lasalocid alone or with roxarsone as in § 558.311.

(vi) Monensin alone or with roxarsone as in § 558.355.

(vii) Narasin alone or with nicarbazin or roxarsone as in § 558.363.

(viii) Nicarbazin as in § 558.366.

(ix) Salinomycin alone or with roxarsone as in § 558.550.

(x) Zoalene alone or with roxarsone as in § 558.680.

(a) Approvals. Type A medicated articles: 2.2. percent (10 grams per pound) to 066104 in § 510.600(c) of this chapter.

(b) Related tolerances. See § 556.100 of this chapter.

(c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

(d) Conditions of use. It is used for swine as follows:

(1) Amount per ton. 10-25 grams (0.0011-0.00275 percent).

(i) Indications for use. For increase in rate of weight gain and improvement of feed efficiency.

(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.

(2) Amount per ton. 50 grams (0.0055 percent).

(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); increased rate of weight gain and improved feed efficiency.

(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.

(3) Amount per ton. Carbadox 50 grams (0.0055 percent) plus pyrantel tartrate, 96 grams (0.0106 percent).

(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections.

(ii) Limitations. Do not feed to swine over 75 pounds; do not feed within 10 weeks of slaughter; consult a veterinarian before feeding to severely debilitated animals; feed continuously as sole ration. Do not use in complete feeds containing less than 15 percent crude protein.

(4) Amount. Carbadox, 10 to 25 grams per ton of feed; plus oxytetracycline, 10 milligrams per pound of body weight.

(i) Indications for use. For treatment of bacterial enteritis caused by Escherichia coli and S. choleraesuis susceptible to oxytetracycline, for treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; and for increased rate of weight gain and improved feed efficiency.

(ii) Limitations. Feed continuously for 7 to 14 days. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.

(a) Specifications. Type A medicated articles containing either chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride or, for products intended for use in milk replacer, chlortetracycline hydrochloride.

(b) Approvals. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) Nos. 046573, 048164, and 066104: 50 to 100 grams per pound (g/lb) of Type A medicated article.

(2) No. 012286: 50, 90, or 100 grams per pound of Type A medicated article.

(c) Related tolerances. See § 556.150 of this chapter.

(d) Special considerations. (1) In milk replacers or starter feed; include on labeling the warning: “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.”

(2) Manufacture for use in free-choice feeds as in paragraph (e)(4)(iii) of this section must conform to § 510.455 of this chapter.

(3) When manufactured for use as in paragraph (e)(5)(iv) of this section, include on labeling the warning: “Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.”

(e) Conditions of use—(1) Chickens. It is used as follows:

(2) Turkeys. It is used as follows:

(3) Swine. It is used as follows:

(4) Cattle. It is used as follows:

(5) Minor species. It is used as follows:

(6) It is used as a free-choice, loose mineral Type C feed as follows:

(i) Specifications.

(ii) Amount. 6,000 grams per ton.

(iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.

(iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per head per day.

(v) Sponsor. See No. 046573 in § 510.600(c) of this chapter.

(7) Chlortetracycline. It may be used in accordance with this section in combinations as follows:

(i) Amprolium in accordance with § 558.55.

(ii) Amprolium plus ethopabate in accordance with § 558.58.

(iii) Bacitracin methylene disalicylate in accordance with § 558.76.

(iv) Clopidol in accordance with § 558.175.

(v) Decoquinate in accordance with § 558.195.

(vi) Hygromycin B in accordance with § 558.274.

(vii) Laidlomycin in accordance with § 558.305.

(viii) Lasalocid in accordance with § 558.311.

(ix) Monensin in accordance with § 558.355.

(x) Robenidine hydrochloride in accordance with § 558.515.

(xi) Roxarsone in accordance with § 558.530.

(xii) Salinomycin alone or with roxarsone in accordance with § 558.550.

(xiii) Tiamulin in accordance with § 558.600.

(xiv) Zoalene in accordance with § 558.680.

(a) Approvals. Type A medicated articles: 35 grams of chlortetracycline per pound with 7.7 percent (35 grams) of sulfamethazine to Nos. 046573 and 048164 in § 510.600(c) of this chapter.

(b) Related tolerances. See §§ 556.150 and 556.670 of this chapter.

(c) It is used in feed for beef cattle as follows:

(1) Amount per head per day. Chlortetracycline, 350 milligrams plus sulfamethazine, 350 milligrams.

(2) Indications for use. Aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever.

(3) Limitations. Feed for 28 days; withdraw 7 days prior to slaughter.

(a) Approvals. Type A medicated articles: (1) 20 grams of chlortetracycline per pound, 4.4 percent (20 grams) of sulfamethazine, and procaine penicillin equivalent in activity to 10 grams of penicillin per pound to 046573 in § 510.600(c) of this chapter.

(2) 40 grams of chlortetracycline per pound, 8.8 percent of sulfamethazine, and penicillin procaine equivalent in activity to 20 grams of penicillin per pound to 046573 and 048164 in § 510.600(c) of this chapter.

(b) Specifications. (1) The antibiotic substance refers to the antibiotic or feed-grade antibiotic.

(2) The antibiotic activities are expressed in terms of the appropriate antibiotic standards.

(3) Type C medicated feed contains in each ton, 100 grams of chlortetracycline, 50 grams of penicillin as procaine penicillin, and 100 grams of sulfamethazine.

(c) Related tolerances. See §§ 556.150, 556.510, and 556.670 of this chapter.

(d) Conditions of use. (1) It is administered to swine in a Type C feed for reduction of the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); prevention of these diseases during times of stress; maintenance of weight gains in the presence of atrophic rhinitis; growth promotion and increased feed efficiency in swine weighing up to 75 pounds.

(2) Withdraw 15 days prior to slaughter.

(a) Approvals. Type A medicated articles: (1) 20 grams of chlortetracycline hydrochloride, 4.4 percent (20 grams) sulfathiazole, and procaine penicillin equivalent to 10 grams of penicillin per pound to No. 046573 in § 510.600(c) of this chapter.

(2) 40 grams of chlortetracycline hydrochloride, 8.8 percent (40 grams) sulfathiazole and procaine penicillin equivalent in activity to 20 grams of penicillin per pound to No. 046573 in § 510.600(c) of this chapter.

(b) Specifications. (1) The antibiotic substance refers to the antibiotic or feed-grade antibiotic.

(2) The antibiotic activities are expressed in terms of the appropriate antibiotic standards.

(c) Related tolerances. See §§ 556.150, 556.510, and 556.690 of this chapter.

(d) Conditions of use. It is used for swine as follows:

(1) Amount per ton. Chlortetracycline, 100 grams plus penicillin, 50 grams plus sulfathiazole, 100 grams.

(2) Indications for use. For reduction of incidence of cervical abscesses. Treatment of bacterial enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery). Maintenance of weight gains in the presence of atrophic rhinitis. Swine 10 pounds of body weight to 6 weeks post-weaning: Increased rate of weight gain and improved feed efficiency. Swine 6 to 16 weeks post-weaning: Increased rate of weight gain.

(3) Limitations. For swine raised in confinement (dry-lot) or on limited pasture. Feed as sole ration. Withdraw 7 days prior to slaughter.

(a) Specifications. Type A medicated article containing 25 percent clopidol.

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

(c) [Reserved]

(d) Conditions of use. It is used as follows:

(a) Specifications. Type A medicated articles containing 1.12, 2.0, 11.2, or 50 percent coumaphos.

(b) Approvals. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) No. 000859 for use of Type A medicated articles containing 1.12, 2.0, 11.2, or 50 percent coumaphos as in paragraphs (e)(2) and (e)(3) of this section.

(2) No. 017800 for use of Type A medicated articles containing 11.2 percent coumaphos as in paragraph (e)(1) of this section.

(3) No. 051311 for use of Type A medicated articles containing 1.12 percent coumaphos as in paragraph (e)(1) of this section.

(c) Related tolerances. See 40 CFR 180.189.

(d) Special considerations. Labeling shall bear the following caution statement: “The active ingredient coumaphos is a cholinesterase inhibitor. Do not use this product on animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.” Also, see § 500.25 of this chapter.

(e) Conditions of use—(1) Beef and dairy cattle—(i) Amount. 0.0002 lb. (0.091 gram) per 100 lb. body weight per day for 6 consecutive days. Should conditions warrant, repeat treatment at 30-day intervals.

(ii) Indications for use. Control of gastrointestinal roundworms (Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Trichostrongylus spp.).

(iii) Limitations. Feed in the normal grain ration to which the animals are accustomed, but not in rations containing more than 0.1 percent coumaphos. Do not feed to animals less than 3 months old. Do not feed to sick animals or animals under stress, such as those just shipped, dehorned, castrated, or weaned within the last 3 weeks. Do not feed in conjunction with oral drenches or with feeds containing phenothiazine.

(2) Laying chickens—(i) Amount. Coumaphos 27.2 grams per ton (0.003 percent).

(ii) Indications for use. For control of capillary worm (Capillaria obsignata) and as an aid in control of common round worm (Ascaridia galli) and cecal worm (Heterakis gallinae).

(iii) Limitations. In Type C feed; administer continuously as the total feed ration for 14 days; when reinfection occurs, treatment may be repeated but not sooner than 3 weeks after the end of the previous treatment; do not feed to chickens within 10 days of vaccination or other conditions of stress; treatment of colored breeds of commercial layers should be avoided while in production since these breeds appear to be more sensitive to coumaphos than white breeds; as sole medication; medications in general should be avoided while birds are approaching peak production; such interruption of normal feeding practices may upset the flock and lower egg production; diagnosis by competent personnel is essential; flock condition and production records should be carefully evaluated prior to treatment.

(3) Replacement pullets—(i) Amount. Coumaphos 36.3 grams per ton (0.004 percent).

(ii) Indications for use. For control of capillary worm (Capillaria obsignata) and as an aid in control of common roundworm (Ascaridia galli) and cecal worm (Heterakis gallinae).

(iii) Limitations. In Type C feed; administer before the onset of production; diagnosis by competent personnel is essential; administer continuously as total feed ration for from 10 to 14 days; do not feed to chickens under 8 weeks of age nor within 10 days of vaccination or other conditions of stress; if birds are maintained on contaminated litter or exposed to infected birds, a second 10 to 14 day treatment is recommended but not sooner than 3 weeks after the end of the previous treatment; as sole medication; if reinfection occurs after production begins, repeat treatment as recommended for laying flocks.

(a) Specifications. Type A medicated article containing 6 percent decoquinate.

(b) Approvals. See No. 046573 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 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.

(2) Cattle.

(3) Minor species.

(a) Specifications. Type A medicated article containing 0.2 percent diclazuril.

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

(c) Related tolerances. See § 556.185 of this chapter.

(d) Conditions of use. (1) Chickens. For chickens it is used as follows:

(2) Turkeys. For turkeys it is used as follows:

(a) Approvals. Type A medicated articles: 3.1 and 9.6 percent to 000010 in § 510.600(c) of this chapter.

(b) Special considerations. (1) Dichlorvos is to be included in meal or mash or mixed with feed in crumble form only after the crumble feed has been manufactured. Do not mix in feeds to be pelleted nor with pelleted feed. Do not soak the feed or administer as wet mash. Feed must be dry when administered. Do not use in animals other than swine. Do not allow fowl access to feed containing this preparation or to feces from treated animals.

(2) Dichlorvos is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. If human or animal poisoning should occur, immediately consult a physician or a veterinarian. Atropine is antidotal.

(3) Labeling for Type A articles and Type B feeds must include a statement that containers or materials used in packaging such Type A articles and Type B feeds are not to be reused and all such packaging materials must be destroyed after the product has been used.

(c) Related tolerances. See § 556.180 of this chapter.

(d) Conditions of use. It is used in feed for swine as follows:

(1) Amount per ton. Dichlorvos, 348 grams (0.0384 percent).

(i) Indications for use. For the removal and control of mature, immature, and/or fourth-stage larvae of the whipworm (Trichuris suis), nodular worm (Oesophagostomum sp. ), large roundworm (Ascaris suum) and the thick stomach worm (Ascarops strongylina) of the gastrointestinal tract.

(ii) Limitations. For swine up to 70 pounds body weight, feed as sole ration for 2 consecutive days. For swine from 70 pounds to market weight, feed as sole ration at the rate of 8.4 pounds of feed per head until the medicated feed has been consumed. For boars, open or bred gilts, and sows, feed as sole ration at the rate of 4.2 pounds per head per day for 2 consecutive days.

(2) Amount per ton. Dichlorvos, 479 grams (0.0528 percent).

(i) Indications for use. For the removal and control of mature, immature, and/or fourth-stage larvae of the whipworm (Trichuris suis), nodular worm (Oesophagostomum sp. ), large roundworm (Ascaris suum), and the thick stomach worm (Ascarops strongylina) of the gastrointestinal tract.

(ii) Limitations. For boars, open or bred gilts, and sows, feed as sole ration at the rate of 6 pounds per head for one feeding.

(3) Amount per ton. Dichlorvos, 334-500 grams (0.0366-0.0550 percent).

(i) Indications for use. An aid in improving litter production efficiency by increasing pigs born alive, birth weights, survival to market, and rate of weight gain. Treatment also removes and controls mature, immature and/or fourth stage larvae of whipworm (Trichuris suis), nodular worm (Oesophagostomum supp. ) large roundworm (Ascaris suum), and the thick stomach worm (Ascarops strongylina) occurring in the gastrointestinal tract of the sow or gilt.

(ii) Limitations. For pregnant swine; mix into a gestation feed to provide 1,000 milligrams per head daily during last 30 days of gestation.

(a) Approvals. Type A medicated article: 14.5 grams per pound to 050604 in § 510.600(c) of this chapter.

(b) Conditions of use—(1) Swine—(i) Amount. 3.6 grams per ton.

(A) Indications for use. For improved feed efficiency.

(B) Limitations. Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds.

(ii) Amount. 3.6 to 14.5 grams per ton.

(A) Indications for use. For increased rate of weight gain.

(B) Limitations. Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds.

(2) [Reserved]

(a) Approvals. Type A medicated articles: (1) 2.2 percent to 061623 in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(2) 5 and 10 percent to 061623 for use in paragraphs (d)(1)(i) and (ii) of this section.

(b) Special considerations. The levels of antibiotic are expressed in terms of erythromycin master standard. One gram of erythromycin thiocyanate is equivalent to 0.925 gram of erythromycin master standard.

(c) Related tolerances. See § 556.230 of this chapter.

(d) Condition of use. (1) It is used as follows:

(2) In feed for feedlot beef cattle at 37 milligrams per head per day as an aid in stimulating growth and improving feed efficiency.

(3) Erythromycin thiocyanate may be used in accordance with the provisions of this section in the combinations provided as follows:

(i) Amprolium in accordance with § 558.55.

(ii) Amprolium and ethopabate in accordance with § 558.58.

(iii) Arsanilic acid in accordance with § 558.62.

(iv) Zoalene in accordance with § 558.680.

(a) Approvals. Type A medicated articles: 13.2 and 33.3 percent to 000061 in § 510.600(c) of this chapter.

(b) Special considerations. Famphur is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.

(c) Related tolerances. See § 556.273 of this chapter.

(d) Conditions of use. It is used in the feed for cattle as follows:

(1) Amount. 1.1 milligrams per pound body weight per day.

(i) Indications for use. For control of grubs and as an aid in control of sucking lice.

(ii) Limitations. For beef cattle and nonlactating dairy cows; feed for 30 days; withdraw from dry dairy cows and heifers 21 days prior to freshening; withdraw 4 days prior to slaughter.

(2) Amount. 2.3 milligrams per pound body weight per day.

(i) Indications for use. For control of grubs.

(ii) Limitations. For beef cattle and nonlactating dairy cows; feed for 10 days; withdraw from dry dairy cows and heifers 21 days prior to freshening; withdraw 4 days prior to slaughter.

(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.

(c) Related tolerances. See § 556.275 of this chapter.

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

(e) Conditions of use—(1) Turkeys.

(2) Swine.

(3) Cattle.

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

(a) Specifications. Type A medicated articles containing florfenicol in the following concentrations:

(1) 40 grams per kilogram for use as in paragraph (e)(1) of this section.

(2) 500 grams per kilogram for use as in paragraphs (e)(2) and (e)(3) of this section.

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

(c) Special considerations—(1) Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See § 558.6 of this chapter for additional requirements.

(2) The expiration date of veterinary feed directives (VFDs) for florfenicol medicated feeds:

(i) For catfish and freshwater-reared salmonids, must not exceed 15 days from the date of issuance;

(ii) For swine must not exceed 90 days from the date of issuance.

(3) VFDs for florfenicol shall not be refilled.

(d) Related tolerances. See § 556.283 of this chapter.

(e) Conditions of use—(1) Swine—

(2) Fish—

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

(b) Approvals. 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:

(i) Amount. 2.72 grams per ton.

(A) Indications for use. 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 not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.

(ii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus bambermycins 1 to 2 grams.

(A) Indications for use. 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 not feed to layers.

(iii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus virginiamycin 5 grams.

(A) Indications for use. 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 6 days before slaughter; do not feed to layers.

(iv) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus virginiamycin 5 to 15 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mevati, and E. maxima; for increased rate of weight gain.

(B) Limitations. Feed continuously as sole ration; withdraw 6 days before slaughter; do not feed to layers.

(v) Amount per ton. Halofuginone hydrobromide 2.72 grams (0.0003 percent) plus bacitracin methylene disalicylate 10 to 50 grams and roxarsone 22.7 to 45.4 grams.

(A) Indications for use. 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 for improved feed efficiency.

(B) Limitations. Feed continuously as sole ration; withdraw 5 days before slaughter; use as sole source of organic arsenic; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.

(vi) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus bacitracin methylene disalicylate 10 to 50 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mevati, E. maxima and for improved feed efficiency.

(B) Limitations. Feed continuously as sole ration; withdraw 5 days before slaughter; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.

(vii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus lincomycin 2 to 4 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima and for improved feed efficiency.

(B) Limitations. Feed continuously as sole ration; withdraw 4 days before slaughter; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams.

(viii) Amount per ton. Halofuginone hydrobromide, 2.72 grams plus roxarsone, 22.7 to 45.4 grams.

(A) Indications for use. 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, improved feed efficiency, and improved pigmentation.

(B) Limitations. Feed continuously as sole ration 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. Use as the sole source of organic arsenic; drug overdose or lack of water intake may result in leg weakness or paralysis. Do not feed to laying chickens or waterfowl. Withdraw 5 days before slaughter.

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

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

(A) Indications for use. For the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis.

(B) Limitations. 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 1.36 to 2.72 grams plus bacitracin methylene disalicylate 10 to 50 grams.

(A) Indications for use. For 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 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. 1.36 to 2.72 grams of halofuginone hydrobromide plus 2 grams of bambermycins.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria adenoides, 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. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, 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. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Withdraw 4 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) Amount per ton. Halofuginone hydrobromide, 2.72 grams plus roxarsone, 22.7 to 45.4 grams.

(A) Indications for use. 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, improved feed efficiency, and improved pigmentation.

(B) Limitations. Feed continuously as sole ration 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. Use as the sole source of organic arsenic; drug overdose or lack of water intake may result in leg weakness or paralysis. Do not feed to laying chickens or waterfowl. Withdraw 5 days before slaughter.

(a) Approvals. (1) Type A medicated articles: 2.4 and 8 grams per pound to 000986 in § 510.600(c) of this chapter for use as in paragraph (c) of this section.

(2) 2.4 grams per pound to No. 051311 in § 510.600(c) of this chapter for use in swine feed as in paragraph (c)(1)(ii) of this section.

(3) [Reserved]

(4) 0.6 gram per pound to 017790 and 043733 in § 510.600(c) of this chapter for use in chickens as in paragraph (c)(1)(i) of this section and in swine as in paragraph (c)(1)(ii) of this section.

(5)-(6) [Reserved]

(7) 2.4 grams per pound to No. 012286 in § 510.600(c) of this chapter for use in chickens as in paragraph (c)(1)(i) and in swine as in paragraph (c)(1)(ii) of this section.

(8) 0.6 and 1.6 grams per pound granted to 046573 in § 510.600(c) of this chapter for use in chickens as in paragraph (c)(1)(i) and in swine as in paragraph (c)(1)(ii) of this section.

(b) Related tolerances. See § 556.330 of this chapter.

(c) Conditions of use. (1) It may be used as follows:

(2) Hygromycin B may also be used in combination with:

(i) Amprolium in accordance with § 558.55.

(ii) Zoalene in accordance with § 558.680.

(a) Approvals. See 017762 in § 510.600(c) of this chapter.

(b) NAS/NRC status. The use of this drug is NAS/NRC reviewed and found effective. Applications for these uses need not include efficacy data as required by § 514.111 of this chapter but may require bioequivalency or safety data.

(c) Conditions of use—(1) Ducks—(i) Amount per ton. 100 to 200 grams.

(ii) Indications for use. For increased rate of weight gain and improved feathering in growing ducks.

(2) Dairy cows—(i) Amount per pound. 1/2 to 11/2 grams per 100 lb of body weight.

(ii) Indications for use. For increased milk production in dairy cows.

(iii) Limitations. This drug is effective for limited periods of time, and the effectiveness is limited to the declining phase of lactation. Administration must be accompanied with increased feed intake; administration may increase heat sensitivity of the animal.

(a) Specifications. Type A medicated article containing 2.72 grams ivermectin per pound (g/lb).

(b) Sponsor. See No. 050604 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.344 of this chapter.

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

(e) Conditions of use in swine. It is used in feed as follows:

(a) Specifications. Type A medicated articles containing 50 grams laidlomycin propionate potassium per pound.

(b) Approvals. See No. 046573 in § 510.600(c) of this chapter.

(c) Tolerances. See § 556.346 of this chapter.

(d) Special considerations. (1) Laidlomycin liquid Type B feeds may be manufactured from dry laidlomycin Type A articles. The liquid Type B feeds must have a pH of 6.0 to 8.0, dry matter of 62 to 75 percent, and bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no 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.

(ii) 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.

(2) The expiration date for the liquid Type B feed is 21 days after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 7 days after date of manufacture.

(3) Labeling for all Type B feeds (liquid and dry) and Type C feeds containing laidlomycin shall bear the following statements:

(i) Do not allow horses or other equines access to feeds containing laidlomycin propionate potassium.

(ii) The safety of laidlomycin propionate potassium in unapproved species has not been established.

(iii) Not for use in animals intended for breeding.

(e) Conditions of use. It is used in cattle being fed in confinement for slaughter as follows:

(a) Specifications. A minimum of 90 percent of lasalocid activity is derived from lasalocid A.

(b) Approvals. Type A medicated articles approved for sponsors identified in § 510.600(c) of this chapter for use as in paragraph (e) of this section as follows:

(1) 3.0, 3.3, 3.8, 4.0, 4.3, 4.4, 5.0, 5.1, 5.5, 5.7, 6.0, 6.3, 6.7, 7.2, 7.5, 8.0, 8.3, 10.0, 12.5, 15, 20, and 50 percent activity to No. 046573 for use as in paragraphs (e)(1) (i), (ii), (iii), (iv), and (x) of this section.

(2) 15 percent activity to No. 066104 as provided by No. 046573 for use as in paragraph (e)(1)(v) of this section.

(3) 15, 20, 33.1, and 50 percent activity to No. 046573 for use in cattle feeds as in paragraphs (e)(1)(vi), (vii), (ix), (xi), (xii), and (xv) of this section, and for use in sheep as in paragraph (e)(1)(viii) of this section.

(4) 15 percent activity to No. 046573 for use in Type C rabbit feeds as in paragraph (e)(1)(xvi) of this section and for use in ruminant free-choice Type C feeds as in paragraphs (e)(2), (e)(3), and (e)(4) of this section.

(5) 15 and 20 percent activity to Nos. 012286 and 017800 for use in free-choice mineral feeds for cattle as in paragraph (e)(1)(xviii) of this section.

(6) 20 percent activity as a liquid Type A article to No. 046573 for use in cattle feeds as in paragraphs (e)(1)(vi), (e)(1)(vii), (e)(1)(ix), (e)(1)(xi), (e)(1)(xii), and (e)(3) of this section, and for use in sheep feeds as in paragraph (e)(1)(viii) of this section.

(7) 20 percent activity to No. 046573 for use as follows:

(i) Chukar partridges as in paragraph (e)(1)(xiii).

(ii) Turkeys as in paragraph (e)(1)(xiv).

(iii) Rabbits as in paragraph (e)(1)(xvi).

(8) [Reserved]

(9) 15 percent activity to No. 068287 for use in free-choice protein blocks for cattle as in paragraphs (e)(1)(xix) of this section.

(c) Related tolerance. See § 556.347 of this chapter.

(d) Special considerations. (1) Type C cattle and sheep feeds may be manufactured from lasalocid liquid Type B feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no 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.

(ii) 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.

(2) A physically stable lasalocid liquid feed will not be subject to the requirements for mixing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months.

(3) If a manufacturer is unable to meet the requirements of paragraph (d)(1) or (d)(2) of this section, the manufacturer may secure approval of a positionally stable liquid feed by:

(i) Either filing a new animal drug application for the product or establishing a master file containing data to support the stability of its product;

(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental new animal drug application to establish physical stability; and

(iii) Requesting the sponsor of an approved new animal drug application to file a supplement to provide for use of its lasalocid Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the supplemental new animal drug application will be approved. The approval will provide a basis for the individual liquid feed manufacturer to manufacture under a medicated feed license the liquid mediated feed described in the master file. A manufacturer who seeks to market a physically unstable lasalocid liquid feed with mixing directions different from the standard directions established in paragraph (d)(1) of this section may also follow this procedure.

(4) If adequate information is submitted to show that a particular liquid feed containing lasalocid is stable outside the pH of 4.0 to 8.0, the pH restriction described in paragraphs (d)(1) and (d)(2) of this section may be waived.

(5) Required label statements:

(i) For liquid Type B feed (cattle and sheep): Mix thoroughly with grain and/or roughage prior to feeding. Feeding undiluted, mixing errors, or inadequate mixing (recirculation or agitation) may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.

(ii) For Type A articles or Type B feeds (cattle and sheep): Feeding undiluted or mixing errors may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.

(iii) For Type A articles, Type B or Type C feeds (cattle): A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(6) Lasalocid Type A medicated articles containing lasalocid dried fermentation residue are for use in cattle and sheep feed only.

(7) Each use in a free-choice Type C cattle feed as in paragraphs (e)(1)(xii) and (e)(1)(xviii) of this section must be the subject of an approved NADA or supplemental NADA as provided in § 510.455 of this chapter.

(e)(1) Conditions of use. It is used as follows:

(2) It is used as a free-choice mineral Type C feed as follows:

(i) Specifications.

(ii) Amount. 1,440 grams per ton.

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers); feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.

(v) Sponsor. See No. 046573 in § 510.600(c) of this chapter.

(3) It is used as a ruminant free-choice liquid Type C feed as follows:

(i) Specifications.

(ii) Amount. 150 grams per ton.

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). Feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.

(v) Sponsor. See No. 046573 in § 510.600(c) of this chapter.

(4) It is used as a free-choice, loose mineral Type C feed as follows:

(i) Specifications.

(ii) Amount. 1,088 grams per ton.

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. Feed continuously on a free-choice basis at a rate of 60 to 300 mg lasalocid per head per day.

(v) Sponsor. See No. 046573 in § 510.600(c) of this chapter.

(5) Additional combinations. Lasalocid may be used in accordance with the provisions of this section in combination as follows:

(i) Melengestrol acetate alone or in combination with tylosin in accordance with § 558.342.

(ii) [Reserved]

(a) Approvals. Type A medicated articles: 227 grams per pound to No. 053501 in § 510.600(c) of this chapter.

(b) Related tolerances. See § 556.350 of this chapter.

(c) Conditions of use. It is used in Type C medicated feed as follows:

(1) Cattle—(i) Amount per pound. 0.36-3.6 grams (0.08-0.8 percent).

(ii) Indications for use. Treatment of the following gastrointestinal worms and lung worm infections; stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms (Dictyocaulus).

(iii) Limitations. Administer medicated feed mixed thoroughly in one half the usual amount of morning feed; the medicated feed mix should be consumed within 6 hours; when medicated feed is consumed resume normal feeding; medicated feed is to be fed at the rate of 0.36 gram of levamisole hydrochloride (equivalent) per 100 lb. of body weight; conditions of constant helminth exposure may require retreatment within 2 to 4 weeks after the first treatment; do not slaughter for food within 48 hours of treatment; consult veterinarian before using in severely debilitated animals; do not administer to dairy animals of breeding age; for use in pelleted or meal feeds only; the label shall bear the caution, “Muzzle foam may be observed. However, this reaction will disappear within a few hours. If this condition persists, a veterinarian should be consulted. Follow recommended dosage carefully.”

(2) Swine—(i) Amount per pound. 0.36 grams (0.08 percent).

(ii) Indications for use. Treatment of the following nematode infections: large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal threadworms (Strongyloides ransomi), swine kidney worms $(Stephanurus dentatus).

(iii) Limitations. It is recommended that regular feed be withheld overnight and worming feed administered the following morning; dilute supplement with nonmedicated feed as directed; feed the equivalent of 1 lb. of 0.08 percent worming feed per 100 lbs. of body weight of pigs to be treated; may be fed as sole feed or thoroughly mixed with 1 to 2 parts of regular feed prior to feeding; when medicated feed is consumed, resume normal feeding. Pigs maintained under conditions of constant worm exposure may require retreatment within 4 to 5 weeks after the first treatment due to reinfection; do not slaughter for food within 72 hours of treatment; the label shall bear the caution, “Excessive salivation or muzzle foam may be observed. This reaction is occasionally seen and will disappear in a short time after medication. If pigs are infected with mature lungworms, coughing and vomiting may be observed soon after medicated feed is consumed. This reaction is due to the expulsion of worms from the lungs and will be over in several hours.”

(a) Approvals. Type A articles and Type B feeds approved for sponsors in § 510.600(c) of this chapter for specific uses as in paragraph (d) of this section as follows:

(1) No. 000009 for 20 and 50 grams per pound.

(2)-(4) [Reserved]

(5) No. 043733 for 8 and 20 grams per pound.

(6)-(12) [Reserved]

(13) No. 051311 for 2.5 and 8 grams per pound.

(14)-(15) [Reserved]

(b) Related tolerances. See § 556.360 of this chapter.

(c) Special considerations—(1) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following directions: “CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.”

(2) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following directions: “CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.”

(3) Labeling of Type A medicated articles and single-ingredient Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following directions:

(i) No. 000009: “CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined. Not for use in swine intended for breeding when lincomycin is fed at 20 grams per ton of complete feed.”

(ii) Nos. 043733 and 051311: “CAUTION: Not to be fed to swine that weigh more than 250 lb.”

(d) Conditions of use—(1) Chickens. It is used in feed as follows:

(2) Swine. It is used in feed as follows:

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

(i) Amprolium and ethopabate or amprolium and ethopabate with roxarsone in accordance with § 558.58.

(ii) Clopidol in accordance with § 558.175.

(iii) Decoquinate in accordance with § 558.195.

(iv) Fenbendazole as provided in § 558.258.

(v) Halofuginone in accordance with § 558.265.

(vi) Ivermectin as in § 558.300.

(vii) Lasalocid alone or with roxarsone in accordance with § 558.311.

(viii) Monensin alone or with roxarsone in accordance with § 558.355.

(ix) Nicarbazin alone or with narasin or roxarsone as in § 558.366.

(x) Pyrantel as in § 558.485.

(xi) Robenidine in accordance with § 558.515.

(xii) Roxarsone in accordance with § 558.530.

(xiii) Salinomycin with or without roxarsone as in § 558.550.

(xiv) Zoalene in accordance with § 558.680.

(a) Approvals. Type A medicated articles: 4.54 grams per pound to 046573 in § 510.600(c) of this chapter.

(b) Tolerances. See § 556.375 of this chapter.

(c) Conditions of use—(1) Amount. 4.54 to 5.45 grams per ton (5 to 6 parts per million) (1 to 1.2 pounds per ton).

(i) Indications for use. For prevention of coccidiosis caused by Eimeria acervulina, E. tenella, E. brunetti, E. maxima, E. necatrix, and E. mivati.

(ii) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Withdraw 5 days before slaughter.

(2) [Reserved]

(a) Specifications. (1) Dry Type A medicated articles containing 100 or 200 milligrams (mg) melengestrol acetate per pound.

(2) Liquid Type A medicated article containing 500 mg melengestrol acetate per pound.

(b) Approvals. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) No. 000009 for use of products described in paragraph (a) of this section.

(2) No. 021641 for use of product described in paragraph (a)(2) of this section.

(c) Related tolerances. See § 556.380 of this chapter.

(d) Special considerations. (1) Type B or C medicated feeds may be manufactured from melengestrol acetate liquid Type A articles or Type B or C medicated feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no 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.

(ii) 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.

(2) A physically stable melengestrol acetate liquid Type B or C feed will not be subject to the requirements for mixing directions prescribed in paragraphs (c)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months.

(3) Combination Type B or C medicated feeds containing lasalocid must be labeled in accordance with § 558.311(d)(5) of this chapter.

(4) Liquid combination Type B or C medicated feeds containing melengestrol acetate and lasalocid must be manufactured in accordance with § 558.311(d) of this chapter.

(5) Combination Type B or C medicated feeds containing monensin must be labeled in accordance with § 558.355(d) of this chapter.

(6) Liquid combination Type B or C medicated feeds containing melengestrol acetate and monensin must be manufactured in accordance with § 558.355(f)(3)(i) of this chapter.

(7) Liquid combination Type B or C medicated feeds containing melengestrol acetate and tylosin must be manufactured in accordance with § 558.625(c) of this chapter.

(8) Liquid melengestrol acetate may not be mixed with oxytetracycline in a common liquid feed supplement.

(e) Conditions of use—(1) Cattle.

(a) Approvals. To No. 000009 in § 510.600(c) of this chapter for a canned dog food, each 61/2 ounce can containing 30 or 60 micrograms of mibolerone.

(b) Conditions of use—(1) Amount. 30 micrograms for animals weighing up to 25 pounds; 60 micrograms for animals weighing 26 to 50 pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 micrograms for animals weighing over 100 pounds, or German Shepherds or German Shepherd mix weighing 30 to 80 pounds.

(2) Indications for use. For the prevention of estrus (heat) in adult female dogs not intended primarily for breeding purposes.

(3) Limitations. Administer daily at least 30 days before expected initiation of heat and continue as long as desired, but for not more than 12 months. Mibolerone should not be used in bitches before first estrous period or in purebred Bedlington terriers. It is not intended for animals being used primarily for breeding purposes. Use orally in adult female dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(a) Specifications. Type A medicated articles containing monensin, USP.

(b) Approvals. Approvals for Type A medicated articles containing the specified levels of monensin activity granted to firms identified by sponsor numbers in § 510.600(c) of this chapter for the conditions of use indicated in paragraph (f) of this section are as follows:

(1) To No. 000986: 36.3 (for export only), 44, 45, 60, or 90.7 grams per pound for use as in paragraphs (f)(1)(i) and (f)(4) of this section.

(2) To 000986: 110 grams per lb., paragraphs (f)(1) (i), (iii), (iv), (v), (ix), and (x).

(3) To 000986: 44 grams per lb. with 18 grams per lb. of roxarsone, 110 grams per lb. with 45 grams per lb. of roxarsone, paragraph (f)(1)(ii).

(4) To No. 000986: 45, 60, or 90.7 grams per pound for use as in paragraph (f)(2) of this section.

(5) To 066104: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraphs (f)(1)(xiii), (xx), and (xxi) of this section.

(6) To No. 000986: 45, 60, or 90.7 grams per pound for use as in paragraph (f)(5) of this section.

(7) To 000986: 20, 30, 45, 60, 80, and 90.7 grams per pound, as monensin sodium, paragraph (f)(3) of this section.

(8) To 046573: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraph (f)(1)(xiv) of this section.

(9) To 046573: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraphs (f)(1)(xv) and (xvi) of this section.

(10) To 016592: 45 and 60 grams per pound, as monensin sodium, paragraph (f)(1)(xvii) of this section.

(11) To 046573: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraphs (f)(1)(xiv), (xviii), (xix), (xxiii), (xxiv), (xxv), (xxvi), and (xxvii) of this section.

(12) To 066104: 45 and 60 grams per pound, as monensin sodium provided by No. 000986, paragraph (f)(1)(xxii) of this section.

(13) To No. 012286: 60 and 80 grams per pound, paragraph (f)(3)(v) of this section.

(14) To 000986: 60, 80, and 90.7 grams per pound, as monensin sodium, paragraph (f)(6) of this section.

(c) [Reserved]

(d) Special considerations. (1) Type C chicken feed containing monensin as the mycelial cake shall bear an expiration date of 90 days after its date of manufacture.

(2)—(3) [Reserved]

(4) Liquid Type B feeds shall bear an expiration date of 8 weeks after its date of manufacture.

(5) All Type A medicated articles containing monensin shall bear the following warning statement: When mixing and handling monensin Type A medicated articles, use protective clothing, impervious gloves, and a dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water.

(6) All formulations containing monensin shall bear the following caution statement: Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal.

(7) Type A medicated articles containing monensin intended for use in cattle and goats shall bear, in addition to the caution statement in paragraph (d)(6) of this section, the following statements:

(i) Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions.

(ii) Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats.

(iii) Must be thoroughly mixed in feeds before use.

(iv) Do not feed undiluted.

(v) Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result.

(vi) Do not feed to lactating goats.

(vii) If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing.

(viii) A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

(ix) You may notice the following: Reduced voluntary feed intake in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Rule out monensin as the cause of reduced feed intake before attributing to other causes such as illness, feed management, or the environment. Reduced milk fat percentage in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Increased incidence of cystic ovaries and metritis in dairy cows fed monensin. Reduced conception rates, increased services per animal, and extended days open and corresponding calving intervals in dairy cows fed monensin. Have a comprehensive and ongoing nutritional, reproductive, and herd health program in place when feeding monensin to dairy cows.

(x) Inadequate mixing (recirculation or agitation) of monensin liquid Type B or Type C medicated feeds has resulted in increased monensin concentration which has been fatal to cattle and could be fatal to goats.

(8) Type A medicated articles containing monensin intended for use in chickens, turkeys, and quail shall bear the following statements:

(i) Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal.

(ii) Must be thoroughly mixed in feeds before use.

(iii) Do not feed undiluted.

(iv) Do not feed to laying chickens.

(v) Do not feed to chickens over 16 weeks of age.

(vi) For replacement chickens intended for use as cage layers only.

(vii) Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis.

(viii) In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain.

(9) Type B feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in:

(i) Cattle (as described in paragraphs (f)(3)(i) through (f)(3)(xii) of this section): See paragraphs (d)(6), (d)(7)(i) through (d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of this section.

(ii) Dairy cows (as described in paragraphs (f)(3)(xiii) and (f)(3)(xiv) of this section): See paragraphs (d)(6), (d)(7)(i) through (d)(7)(iv), (d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of this section.

(iii) Goats: See paragraphs (d)(6) and (d)(7)(i) through (d)(7)(vi) of this section.

(iv) Chickens: See paragraphs (d)(8)(i) through (d)(8)(vi), and (d)(8)(viii) of this section.

(v) Turkeys: See paragraphs (d)(8)(i), (d)(8)(ii), (d)(8)(iii), and (d)(8)(vii) of this section.

(vi) Quail: See paragraphs (d)(8)(i), (d)(8)(ii), and (d)(8)(iii) of this section.

(10) Type C feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in:

(i) Cattle (as described in paragraphs (f)(3)(i) through (f)(3)(xii) of this section): See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of this section.

(ii) Dairy cows (as described in paragraphs (f)(3)(xiii) and (f)(3)(xiv) of this section): See paragraphs (d)(6), (d)(7)(i), (d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of this section.

(iii) Goats: See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), and (d)(7)(vi) of this section.

(iv) Chickens: See paragraphs (d)(8)(i), (d)(8)(iv), (d)(8)(v), (d)(8)(vi), and (d)(8)(viii) of this section.

(v) Turkeys: See paragraphs (d)(8)(i) and (d)(8)(vii) of this section.

(vi) Quail: See paragraph (d)(8)(i) of this section.

(11) Type B and Type C liquid feeds requiring recirculation or agitation that contain monensin and are intended for use in cattle (including dairy cows) and goats shall bear the caution statement specified in paragraph (d)(7)(x) of this section.

(12) Mixing directions for liquid feeds requiring recirculation or agitation:

(i) 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.

(ii) 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) Related tolerances. See § 556.420 of this chapter.

(f) Conditions of use. It is used as follows:

(1) Broiler chickens—(i) Amount per ton. Monensin, 90-110 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously as sole ration at the rate of 50 to 480 milligrams of monensin and 60 to 90 milligrams of tylosin per head per day. Combination drug liquid Type B medicated feeds may be used to manufacture dry Type C medicated feeds as in § 558.625(c) of this chapter.

(ii) Amount per ton. Monensin, 90-110 grams, plus roxarsone 45.4 grams (0.005 percent).

(a) Indications for use. Growth promotion and feed efficiency, improving pigmentation; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin or monensin sodium.

(iii) Amount per ton. Monensin, 90-110 grams plus bacitracin, 5-25 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as bacitracin methylene disalicylate provided by No. 046573 in § 510.600(c) of this chapter; as monensin sodium.

(iv) Amount per ton. Monensin, 90-110 grams plus bacitracin, 10 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as zinc bacitracin provided by No. 046573 in § 510.600(c) of this chapter; as monensin sodium.

(v) Amount per ton. Monensin, 90-110 grams plus bacitracin, 10-30 grams.

(a) Indications for use. For improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as zinc bacitracin provided by No. 046573 in § 510.600(c) of this chapter; as monensin sodium.

(vi) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins, 1 to 2 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency; and as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella,E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Feed continuously as sole ration; do not feed to laying chickens. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter.

(vii) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins, 1 gram; plus roxarsone, 22.7 to 45.4 grams

(a) Indications for use. For increased rate of weight gain and improved feed efficiency; and as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Feed continuously as sole ration; use as sole source of organic arsenic; withdraw 5 d before slaughter; do not feed to laying chickens. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter; roxarsone provided by No. 046573.

(viii) Amount per ton. Monensin, 90 to 110 grams plus oxytetracycline, 200 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of complicated chronic respiratory disease (CRD or air-sac infection) caused by Mycoplasma gallisepticum and Escherichia coli.

(b) Limitations. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; do not feed to laying chickens; feed continuously as sole ration; as monensin sodium.

(ix) Amount per ton. Monensin, 90-110 grams plus lincomycin, 2 grams.

(a) Indications for use. For increase in rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; to be fed as a sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as monensin sodium.

(x) Amount per ton. Monensin, 90-110 grams plus lincomycin, 2 grams and roxarsone, 15-45 grams.

(a) Indications for use. For increase in rate of weight gain; as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as roxarsone provided by No. 046573, § 510.600(c) of this chapter; as monensin sodium provided by No. 000986, § 510.600(c) of this chapter; as lincomycin provided by No. 000009, § 510.600(c) of this chapter; as a combination provided by No. 000009, § 510.600(c) of this chapter.

(xi) Amount per ton. Monensin, 90 to 110 grams, plus lincomycin, 2 grams and roxarsone, 15 to 30 grams.

(a) Indications for use. For increase in rate of weight gain, improved feed efficiency, improved pigmentation, and as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as roxarsone provided by No. 046573 in § 510.600(c) of this chapter; as monensin sodium provided by No. 000986 in § 510.600(c) of this chapter; as lincomycin provided by No. 000009 in § 510.600(c) of this chapter; as a combination provided by No. 000009 in § 510.600(c) of this chapter.

(xii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin methylene disalicylate, 10 to 25 grams, and roxarsone, 11.3 to 45.4 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati; for increased rate of weight gain and for improved feed efficiency.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin sodium provided by No. 000986 in § 510.600 of this chapter; as bacitracin methylene disalicylate provided by No. 046573 in § 510.600 of this chapter; as roxarsone provided by No. 011526 or 046573 in § 510.600 of this chapter.

(xiii) Amount per ton. Monensin, 90 to 110 grams, plus 5 grams virginiamycin.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati; for increased rate of weight gain and improved feed efficiency.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; as monensin sodium provided by No. 000986 in § 510.600 of this chapter; virginiamycin provided by No. 066104 in § 510.600 of this chapter.

(xiv) Amount per ton. Monensin, 90 to 110 grams, plus 500 grams chlortetracycline.

(a) Indications for use. As an aid in the reduction of mortality due to Escherichia coli infections susceptible to such treatment. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed for 5 days as the sole ration; withdraw 24 hours before slaughter; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; not to be fed continuously for more than 5 days; as monensin sodium; as chlortetracycline hydrochloride provided by Nos. 046573 and 048164 in § 510.600(c) of this chapter.

(xv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin zinc, 10 grams, and roxarsone, 15 grams (0.0017 percent).

(a) Indications for use. For increase in rate of weight gain; for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; feed must be used within 4 weeks of manufacture; as monensin sodium; as bacitracin zinc provided by No. 046573 in § 510.600(c) of this chapter; as roxarsone provided by No. 046573 in § 510.600(c) of this chapter.

(xvi) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin zinc, 4 to 50 grams, and roxarsone, 15 to 45.4 grams (0.0017 percent to 0.005 percent).

(a) Indications for use. For improved feed efficiency; for improved pigmentation by enhancing carotenoid and xanthophyll utilization; for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; feed must be used within 4 weeks of manufacture; as monensin sodium; as bacitracin zinc provided by No. 046573 in § 510.600(c) of this chapter; as roxarsone provided by No. 046573 in § 510.600(c) of this chapter.

(xvii) Amount per ton. Bambermycins, 1 to 2 grams plus monensin, 90 to 110 grams plus roxarsone, 22.7 to 45.4 grams.

(a) Indications for use. For increased rate of weight gain; and as an aid in prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Feed continuously as sole ration; use as sole source of organic arsenic; withdraw 5 d before slaughter; do not feed to laying chickens. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter; roxarsone provided by No. 046573.

(xviii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin methylene disalicylate, 50 grams, and roxarsone, 22.7 to 34.0 grams (0.0025 percent to .00375 percent).

(a) Indications for use. For increase in rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp or other organisms susceptible to bacitracin methylene disalicylate.

(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin sodium provided by No. 000986 in § 510.600(c) of this chapter; as bacitracin methylene disalicylate provided by No. 046573 in § 510.600(c) of this chapter; as roxarsone provided by No. 046573 in § 510.600(c) of this chapter.

(xix) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin methylene disalicylate, 50 grams, and roxarsone, 22.7 to 45.4 grams (0.0025 percent to .005 percent).

(a) Indications for use. For increased rate of weight gain; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp or other organisms susceptible to bacitracin methylene disalicylate; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin sodium provided by No. 000986 in § 510.600(c) of this chapter; as bacitracin methylene disalicylate provided by No. 046573 in § 510.600(c) of this chapter; as roxarsone provided by No. 046573 in § 510.600(c) of this chapter.

(xx) Amount per ton. Monensin, 90 to 110 grams, plus virginiamycin, 5 to 15 grams, and roxarsone, 22.7 grams (0.0025 percent).

(a) Indications for use. For incease in rate of weight gain; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin sodium provided by No. 000986 in § 510.600(c) of this chapter; as virginiamycin provided by No. 066104 in § 510.600(c) of this chapter; roxarsone provided by Nos. 046753 and 011526 in § 510.600(c) of this chapter.

(xxi) Amount per ton. Monensin, 90 to 110 grams, plus virginiamycin, 5 to 15 grams.

(a) Indications for use. For increase in rate of weight gain; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; as monensin sodium provided by No. 000986 in § 510.600 of this chapter; virginiamycin provided by No. 066104 in § 510.600 of this chapter.

(xxii) Amount per ton. Monensin, 90 to 110 grams plus oxytetracycline, 500 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. Mivati, and E. maxima; as an aid in the reduction of mortality due to air-sacculities (air-sac infection) caused by Escherichia coli sensitive to oxytetracycline.

(b) Limitations. Feed for 5 days as sole ration. Do not feed to laying chickens. Withdraw 24 hours before slaughter. As monensin sodium provided by No. 000986 in § 510.600(c) of this chapter. As mono-alkyl (C8-C18) trimethylammonium oxytetracycline provided by No. 066104 in § 510.600(c) of this chapter.

(xxiii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin zinc, 4 to 50 grams, and roxarsone, 22.7 to 45.4 grams (0.0025 percent to 0.005 percent).

(a) Indications for use. For improved feed efficiency; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(b) Limitations. Do not feed to laying chickens; feed continuously as the sole ration; withdraw 5 days before slaughter; as sole source of organic arsenic; as monensin sodium provided by No. 000986 in § 510.600(c) of this chapter; as bacitracin zinc provided by No. 046573 in § 510.600(c) of this chapter; as roxarsone provided by No. 046573 in § 510.600(c) of this chapter.

(xxiv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin methylene disalicylate, 4 to 50 grams.

(xxv) Amount per ton. Monensin, 90 to 110 grams plus bacitracin, 4 to 50 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as bacitracin zinc provided by No. 046573 in § 510.600(c) of this chapter, as monensin sodium.

(xxvi) Amount per ton. Monensin 90 to 110 grams plus bacitracin 100 to 200 grams and roxarsone 22.7 to 34.0 grams.

(a) Indications for use. As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin methylene disalicylate; as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; for increased rate of weight gain and improved feed efficiency.

(b) Limitations. For broiler chickens only. Feed continuously as sole ration. Use as sole source of organic arsenic. Withdraw 5 days before slaughter. Do not feed to laying hens. To control necrotic enteritis, start medication at first clinical signs of disease. The dosage range permitted provides for different levels based on the severity of infection. Use continuously for 5 to 7 days or as long as clinical signs persist, then reduce dosage to prevention level. Animals should have access to drinking water at all times. Drug overdosage or lack of water may result in leg weakness. As roxarsone and bacitracin methylene disalicylate provided by No. 046573 in § 510.600(c) of this chapter.

(xxvii) Amount per ton. Monensin 90 to 110 grams plus bacitracin 100 to 200 grams and roxarsone 22.7 to 45.4 grams.

(a) Indications for use. As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin methylene disalicylate; as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; for increased rate of weight gain.

(b) Limitations. For broiler chickens only. Feed continuously as sole ration. Use as sole source of organic arsenic. Withdraw 5 days before slaughter. Do not feed to laying hens. To control necrotic enteritis, start medication at first clinical signs of disease. The dosage range permitted provides for different levels based on the severity of infection. Use continuously for 5 to 7 days or as long as clinical signs persist, then reduce dosage to prevention level. Animals should have access to drinking water at all times. Drug overdosage or lack of water may result in leg weakness. As roxarsone and bacitracin methylene disalicylate provided by No. 046573 in § 510.600(c) of this chapter.

(xxviii) Amount per ton. Monensin, 90 to 110 grams, plus tylosin phosphate, 4 to 50 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, 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. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. As monensin sodium and tylosin phosphate provided by No. 000986 in § 510.600(c) of this chapter.

(xxix) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 50 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter.

(xxx) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 100 to 200 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter.

(2) Turkeys—(i) Amount per ton. Monensin, 54 to 90 grams.

(a) Indications for use. For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis.

(b) Limitations. For growing turkeys only; as monensin sodium; feed continuously as sole ration. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis.

(ii) Amount per ton. Monensin, 54 to 90 grams, and bacitracin methylene disalicylate, 4 to 50 grams.

(a) Indications for use. For prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, for increased rate of weight gain, and for improved feed efficiency.

(b) Limitations. For growing turkeys only; as monensin sodium; feed continuously as sole ration. Do not allow horses, other equines, mature turkeys or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bacitracin methylene disalicylate as provided by No. 046573 in § 510.600(c) of this chapter.

(iii) Amount per ton. Monensin, 54 to 90 grams, and bacitracin methylene disalicylate, 200 grams.

(a) Indications for use. For the prevention of coccidiosis caused by Eimeria adenoides, E. meleagrimitis, and E. gallopavonis, and as an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylene disalicylate.

(b) Limitations. For growing turkeys only; as monensin sodium; feed continuously as sole ration. Do not allow horses, other equines, mature turkeys or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bacitracin methylene disalicylate as provided by No. 046573 in § 510.600(c) of this chapter.

(iv) Amount per ton. Monensin, 54 to 90 grams, with virginiamycin, 10 to 20 grams.

(a) Indications for use. For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.

(b) Limitations. For growing turkeys only. Feed continuously as sole ration. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses, mature turkeys, and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Virginiamycin as provided by No. 066104 in § 510.600(c) of this chapter.

(v) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 1 to 2 grams.

(a) Indications for use. For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for improved feed efficiency in growing turkeys.

(b) Limitations. For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.

(vi) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 2 grams.

(a) Indications for use. For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.

(b) Limitations. For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.

(3) Cattle—(i) Amount per ton. Monensin, 5-40 grams.

(a) Indications for use. Improved feed efficiency.

(b) Limitations. (1) Feed only to cattle being fed in confinement for slaughter. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). Complete feeds may be manufactured from monensin liquid Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 and their labels must bear appropriate mixing directions as defined in paragraph (d)(12) of this section. The liquid feed must bear caution statement as follows: Inadequate mixing, (recirculation or agitation), of liquid feeds has resulted in increased monensin concentration which has been fatal to cattle.

(2) An approved physically stable monensin liquid feed will not be subject to the requirements for mixing directions defined in paragraph (d)(12) of this section. A manufacturer may secure approval of a physically stable liquid feed by:

(i) Either filing an NADA for the product or by establishing a master file containing data to support the stability of its product;

(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental NADA to establish physical stability; and

(iii) Requesting No. 000986 in § 510.600(c) of this chapter to file a supplemental NADA to provide for the use of its monensin Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the agency will approve the supplemental NADA. The approval will provide a basis for the individual liquid feed manufacturer to manufacture the liquid medicated feed under a medicated feed mill license described in the master file. A manufacturer who seeks to market a physically unstable monensin liquid feed with mixing directions different from the standard established in paragraph (d)(12) of this section may also follow this procedure.

(ii) Amount per ton. Monensin, 5 to 40 grams; plus tylosin, 8 to 10 grams.

(a) Indications for use. Cattle fed in confinement for slaughter: For improved feed efficiency; and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.

(b) Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously as sole ration at the rate of 50 to 480 milligrams of monensin and 60 to 90 milligrams of tylosin per head per day. Combination drug liquid Type B medicated feeds may be used to manufacture dry Type C medicated feeds and shall conform to mixing instructions as in 558.625(c) of this chapter.

(iii) Amount per ton. Monensin, 25 to 400 grams.

(a) Indications for use. Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.

(b) Limitations. For increased rate of weight gain, feed at a rate of 50 to 200 milligrams monensin per head per day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams per head per day every other day in not less than 2 pounds of feed. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending on severity of challenge, up to 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per day in not less than 1 pound of feed.

(iv) [Reserved]

(v) Amount. 150 milligrams per pound (0.033 percent).

(a) Indications for use. For increased rate of weight gain and for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii.

(b) Limitations. As protein-mineral blocks to be fed free choice to cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers) on pasture which may require supplemental feed. Provide 50 to 200 milligrams of monensin (0.34 to 1.33 pounds) per head per day, at least 1 block per 10 to 12 head of cattle. Roughage must be available at all times. Do not allow animals access to other protein blocks, salt or mineral, while being fed this product. Do not allow horses or other equines access to formulations containing monensin (ingestion of monensin by equines has been fatal). Block's effectiveness in cull cows and bulls has not been established. Approval must comply with § 510.455 of this chapter.

(vi) Amount per ton. Monensin, 25 to 400 grams.

(a) Indications for use. For improved feed efficiency; for prevention and control of coccidiosis due to E. bovis and E. zuernii.

(b) Limitations. Feed to mature reproducing beef cows. Feed as supplemental feed, either hand-fed in a minimum of 1 pound of feed or mixed in a total ration. For improved feed efficiency, feed continuously at a rate of 50 to 200 milligrams monensin per head per day. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon severity of challenge, up to a maximum of 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per head per day.

(vii) Amount per ton. Monensin, 10 to 40 grams.

(a) Indications for use. For prevention and control of coccidiosis due to E. bovis and E. zuernii.

(b) Limitations. For cattle fed in confinement for slaughter, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day.

(ix) Amount. To 000986: To make liquid Type B medicated feed containing 400 grams per ton monensin sodium with 150 grams per ton tylosin phosphate used to make a dry Type C medicated feed containing 21.4 to 26.8 grams per ton monensin plus 8 to 10 grams per ton tylosin.

(a) Indications for use. Improved feed efficiency; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.

(b) Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously at the rate of 8.2 to 10.2 kilograms (18 to 22.5 pounds) of Type C medicated feed per head per day to supply 240 milligrams of monensin and 90 milligrams of tylosin per head per day; as monensin sodium; as tylosin phosphate. Do not allow horses or other equines access to feeds containing monensin. Ingestion of monensin by equines has been fatal. Safe use in unapproved species and breeding cattle has not been established. The liquid medicated feed must bear expiration date of 14 days after date of manufacture. The mixing directions for this liquid medicated feed stored in recirculation or agitation tank systems are as defined in paragraph (d)(12) of this section.

(x) Amount per ton. Monensin, 1,620 grams as monensin sodium (810 milligrams per pound).

(a) Indications for use. Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.

(b) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows:

(c) Limitations. Feed at a rate of 50 to 200 milligrams per head per day. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with grain or other feeds. Monensin is toxic to cattle when consumed at higher than approved levels. Stressed and/or feed- and/or water-deprived cattle should be adapted to the pasture and to unmedicated mineral supplement before using the monensin mineral supplement. The product's effectiveness in cull cows and bulls has not been established. Consumption by unapproved species may result in toxic reactions.

(xi) Amount per ton. Monensin, 10 to 200 grams.

(a) Indications for use. For prevention and control of coccidiosis due to E. bovis and E. zuernii.

(b) Limitations. For calves excluding veal calves. Feed at a rate of 0.14 to 1.0 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 200 milligrams per head per day.

(xii) Amount per ton. Monensin, 10 to 40 grams; plus tylosin, 8 to 10 grams.

(a) Indications for use. Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to E. bovis and E. zuernii; and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.

(b) Limitations. Feed only to cattle being fed in confinement for slaughter. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligrams monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day; and 60 to 90 milligrams of tylosin per head per day.

(xiii) Amount per ton. Monensin, 11 to 22 grams.

(A) Indications for use. For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) in dairy cows.

(B) Limitations. Feed continuously to dry and lactating dairy cows in a total mixed ration (“complete feed”). See special labeling considerations in paragraph (d) of this section.

(xiv) Amount per ton. Monensin, 11 to 400 grams.

(A) Indications for use. For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) in dairy cows.

(B) Limitations. Feed continuously to dry and lactating dairy cows in a component feeding system (including top dress). The Type C medicated feed must be fed in a minimum of 1 lb of feed to provide 185 to 660 mg/head/day monensin to lactating cows or 115 to 410 mg/head/day monensin to dry cows. See special labeling considerations in paragraph (d) of this section.

(4) Replacement chickens intended for use as cage layers—(i) Amount per ton. Monensin, 90 to 110 grams.

(i)(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(ii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 4 to 50 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, 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. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter.

(iii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 50 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter.

(iv) Limitations. Do not feed to laying chickens; feed continuously as sole ration; as monensin sodium; do not feed to chickens over 16 weeks of age.

(v) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin methylene disalicylate, 100 to 200 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

(b) Limitations. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). As monensin sodium provided by 000986; bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter.

(vi) Amount per ton. Monensin, 90 to 110 grams; bacitracin methylene disalicylate, 50 grams; plus roxarsone, 22.7 to 45.4 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin; and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

(b) Limitations. Feed continuously as sole ration. Do not feed to laying chickens. Use as sole source of organic arsenic. Do not feed to chickens over 16 weeks of age. Poultry should have access to drinking water at all times. Drug overdosage or lack of water may result in leg weakness or paralysis. Withdraw 5 days before slaughter. As monensin sodium provided by 000986; bacitracin methylene disalicylate and roxarsone as provided by 046573 in § 510.600(c) of this chapter.

(vii) Amount per ton. Monensin, 90 to 110 grams; bacitracin methylene disalicylate, 100 to 200 grams; plus roxarsone, 22.7 to 45.4 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin; and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

(b) Limitations. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams/ton). Do not feed to laying chickens. Use as sole source of organic arsenic. Do not feed to chickens over 16 weeks of age. Poultry should have access to drinking water at all times. Drug overdosage or lack of water may result in leg weakness or paralysis. Withdraw 5 days before slaughter. As monensin sodium provided by 000986; bacitracin methylene disalicylate and roxarsone as provided by 046573 in § 510.600(c) of this chapter.

(iv) Amount per ton. Monensin, 90 to 110 grams, plus roxarsone, 22.7 to 45.4 grams.

(a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

(b) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Withdraw 5 days before slaughter. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Poultry should have access to drinking water at all times. Drug overdosage or lack of water may result in leg weakness or paralysis. As monensin sodium provided by 000986; roxarsone as provided by 046573 in § 510.600(c) of this chapter.

(5) Bobwhite quail—(i) Amount per ton. Monensin, 73 grams.

(ii) Indications for use. For the prevention of coccidiosis in growing bobwhite quail caused by Eimeria dispersa and E. Lettyae.

(iii) Limitations. Feed continuously as the sole ration; do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin.

(6) Goats—(i) Amount per ton. Monensin, 20 grams.

(a) Indications for use. For the prevention of coccidiosis caused by Eimeria crandallis, E. christenseni, and E. ninakohlyakimovae.

(b) Limitations. (1) Feed continuously. Feed only to goats being fed in confinement. Do not feed to lactating goats. Type C feeds may be manufactured from monensin liquid Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 and their labels must bear appropriate mixing directions, as defined in paragraph (d)(12) of this section. See special labeling considerations in paragraph (d) of this section.

(2) An approved physically stable monensin liquid feed will not be subject to the requirements for mixing directions defined in paragraph (d)12) of this section. A manufacturer may secure approval of a physically stable liquid feed by:

(i) Either filing an NADA for the product or by establishing a master file containing data to support the stability of its product;

(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental NADA to establish physical stability; and

(iii) Requesting No. 000986 in § 510.600(c) of this chapter to file a supplemental NADA to provide for the use of its monensin Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the agency will approve the supplemental NADA. The approval will provide a basis for the individual liquid feed manufacturer to manufacture the liquid medicated feed under a medicated feed mill license described in the master file. A manufacturer who seeks to market a physically unstable monensin liquid feed with mixing directions different from the standard established in paragraph (d)(12) of this section may also follow this procedure.

(ii) [Reserved]

(7) Monensin may also be used in combination with:

(i) Decoquinate alone or with tylosin as in § 558.195.

(ii) Melengestrol acetate alone or with tylosin as in § 558.342.

(iii) Ractopamine alone or in combination as in § 558.500.

(iv) Zilpaterol alone or in combination as in § 558.665.

(a) Approvals. Type A medicated articles: 88 grams per pound to 066104 in § 510.600(c) of this chapter.

(b) Related tolerances. See § 556.425 of this chapter.

(c) Special considerations. (1) Do not use in Type B or Type C medicated feeds containing bentonite.

(2) Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(d) Conditions of use—(1) Amount. 0.44 to 4.4 grams of morantel tartrate per pound of feed.

(2) Indications for use—(i) Cattle. For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine (Oesophagostomum radiatum).

(ii) Goats. For removal and control of mature gastrointestinal nematode infections of goats including Haemonchus contortus, Ostertagia (Teladorsagia) circumcincta, and Trichostrongylus axei.

(3) Limitations. Feed as a single therapeutic treatment at 0.44 gram of morantel tartrate per 100 pounds of body weight. Fresh water should be available at all times. When medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat cattle within 14 days of slaughter; do not treat goats within 30 days of slaughter.

(a) Approvals. Type A medicated articles containing specified levels of narasin approved for sponsors identified in § 510.600(c) of this chapter for use as in paragraph (d) of this section are as follows:

(1) To 000986: 36, 45, 54, 72, and 90 grams per pound, paragraph (d)(1)(i) of this section.

(2) To 000986: 36, 45, 54, 72, and 90 grams per pound, with 10, 20, 50, and 80 percent roxarsone, paragraph (d)(1)(ii) of this section.

(3) To 000986: 36 grams per pound, with 36 grams per pound nicarbazin, paragraph (d)(1)(iii) of this section.

(4) To 016592: 36, 45, 54, 72, and 90 grams per pound, with 2 and 10 grams per pound bambermycins, paragraph (d)(1)(iv) of this section.

(5) To 016592: 45 grams per pound, with 4 and 10 grams per pound bambermycins, and 45.4, 90, and 227 grams per pound roxarsone, paragraph (d)(1)(vii) of this section.

(6) To 046573: 45 grams per pound with 10, 25, 30, 40, 50, 60, or 75 grams per pound bacitracin methylene disalicylate and 45.4, 90, or 227 grams per pound roxarsone, paragraphs (d)(1)(viii) and (d)(1)(ix) of this section.

(7) To 046573: 36, 45, 54, 72, or 90 grams per pound, with 10, 25, 40, or 50 grams per pound bacitracin zinc, paragraph (d)(1)(x) of this section.

(b) Tolerances. See § 556.428 of this chapter.

(c) [Reserved]

(d) Conditions of use. It is used as follows:

(1) Broiler chickens—(i) Amount per ton. Narasin, 54 to 72 grams.

(A) Indications for use. For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal.

(ii) Amount per ton. Narasin, 54 to 72 grams, plus roxarsone 45.4 grams (0.005 percent).

(A) Indications for use. For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati including some field strains of E. tenella which are more susceptible to roxarsone combined with narasin than to narasin alone.

(B) Limitations. For broiler chickens only; feed continuously as the sole ration; do not feed to laying chickens; may be fatal if accidentally fed to adult turkeys or to horses; withdraw 5 days before slaughter; as sole source of organic arsenic; not approved for use with pellet binders.

(iii) Amount per ton. Narasin, 27 to 45 grams, plus nicarbazin, 27 to 45 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(B) Limitations. For broiler chickens only. Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these animals has been fatal. Withdraw 5 days before slaughter. The 2 drugs can be combined only at a 1:1 ratio for the 27 to 45 grams per ton range. Only granular nicarbazin as provided by No. 000986 in § 510.600(c) of this chapter may be used in the combination.

(iv) Amount per ton. Narasin, 54 to 72 grams, plus bambermycins, 1 to 2 grams.

(A) Indications for use. For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency.

(B) Limitations. For broiler chickens only. Feed continuously as the sole ration. May be fatal if fed to adult turkeys, horses, or other equines. Narasin as provided by No. 000986; bambermycins by No. 016592 in § 510.600(c) of this chapter.

(v) Amount per ton. Narasin 54 to 72 grams, roxarsone 22.7 to 45.4 grams, and bacitracin methylene disalicylate 10 to 50 grams.

(A) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, for increased rate of weight gain, and for improved feed efficiency.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Withdraw 5 days before slaughter. Do not feed to laying hens. Use as sole source of organic arsenic. Drug overdose or lack of water may result in leg weakness. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Narasin as provided by 000986, roxarsone by 046573, bacitracin methylene disalicylate by 046573 in § 510.600(c) of this chapter.

(vi) Amount per ton. Narasin 54 to 72 grams, and bacitracin methylene disalicylate 10 to 50 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati, E. necatrix, and E. tenella, for increased rate of weight gain, and for improved feed efficiency.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Narasin as provided by 000986, bacitracin methylene disalicylate by 046573 in § 510.600(c) of this chapter.

(vii) Amount per ton. Narasin 54 to 72 grams, bambermycins 1 to 2 grams, and roxarsone 22.7 to 45.4 grams.

(A) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler chickens.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Do not allow adult turkeys or horses or other equines access to formulations containing narasin. Ingestion of narasin by these animals has been fatal. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. Withdraw 5 days before slaughter. Narasin as provided by 000986 in § 510.600(c) of this chapter, bambermycins by 016592, and roxarsone by 046573.

(viii) Amount per ton. Narasin, 54 to 72 grams, and bacitracin methylene disalicylate, 50 grams, with roxarsone, 22.7 to 45.4 grams.

(A) Indications for use. For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Withdraw 5 days before slaughter. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdose or lack of water intake may result in leg weakness or paralysis. Narasin as provided by 000986, bacitracin methylene disalicylate and roxarsone by 046573 in § 510.600(c) of this chapter.

(ix) Amount per ton. Narasin, 54 to 72 grams, and bacitracin methylene disalicylate, 100 to 200 grams, with roxarsone, 22.7 to 45.4 grams.

(A) Indications for use. For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Withdraw 5 days before slaughter. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdose or lack of water intake may result in leg weakness or paralysis. Narasin as provided by 000986, bacitracin methylene disalicylate and roxarsone by 046573 in § 510.600(c) of this chapter.

(x) Amount per ton. Narasin, 54 to 72 grams and bacitracin zinc, 4 to 50 grams.

(A) Indications for use. For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin as provided by 000986, bacitracin zinc by 046573 in § 510.600(c) of this chapter.

(xi) Amount per ton. Narasin, 54 to 72 grams, plus tylosin, 4 to 50 grams.

(A) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, for increased rate of weight gain, and improved feed efficiency.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin sodium and tylosin phosphate as provided by 000986 in § 510.600(c) of this chapter.

(2) Narasin may also be used for broilers in combination with:

(i) Nicarbazin with lincomycin as in § 558.366.

(ii) Nicarbazin and bacitracin methylene disalicylate as in § 558.366.

(iii) Bacitracin methylene disalicylate, nicarbazin, and roxarsone as in § 558.366.

(iv) Nicarbazin and roxarsone as in § 558.366.

(a) Approvals. Type A medicated articles: 4 percent to No. 051311 in § 510.600(c) of this chapter.

(b) Related tolerances. See § 556.440 of this chapter.

(c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

(d) Conditions of use. It is used as follows:

(1) Broiler or fryer chickens—(i) Amount per ton. Nequinate, 18.16 grams.

(ii) Indications for use. An aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(iii) Limitations. Feed continuously as the sole ration.

(2) Roaster chickens or replacement chickens for caged layers—(i) Amount per ton. Nequinate, 18.16 grams (0.002 percent).

(ii) Indications for use. An aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(iii) Limitations. Feed continuously as the sole ration; do not feed to chickens over 16 weeks of age.

(a) Specifications. Type A medicated articles containing 25 percent nicarbazin.

(b) Approvals. See Nos. 000986, 060728, and 066104 in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(c) Related tolerances. See § 556.445 of this chapter.

(d) Conditons of use. It is used in chicken feed as follows:

(a) Approvals. Type A medicated articles: 50 percent to 046573 in § 510.600(c) of this chapter.

(b) Related tolerances. See § 556.60 of this chapter.

(c) [Reserved]

(d) Conditions of use. It is used as follows:

(1) Chickens and turkeys—(i) Amount. Nitarsone, 0.01875 percent.

(ii) Indications for use. As an aid in the prevention of blackhead.

(iii) Limitations. Early medication is essential to prevent spread of disease. Adequate drinking water must be provided near feeder at all times. The drug is not effective in preventing blackhead in birds infected more than 4 or 5 days. Discontinue use 5 days before slaughtering animals for human consumption to allow elimination of the drug from edible tissues. The drug is dangerous for ducks, geese, and dogs. Overdosage or lack of water may result in leg weakness or paralysis. Use as sole source of arsenic.

(2) Turkeys—(i) Amount. Nitarsone 0.01875 percent, plus bacitracin methylene disalicylate or bacitracin zinc 4 to 50 grams per ton.

(ii) Indications for use. As an aid in the prevention of blackhead, and for increased rate of weight gain and improved feed efficiency.

(iii) Limitations. For growing turkeys. Feed continuously as sole ration. Early medication is essential to prevent spread of disease. Adequate drinking water must be provided near feeders at all times. Overdosage or lack of water may result in leg weakness or paralysis. The drug is not effective in preventing blackhead in birds infected more than 4 or 5 days. Discontinue use 5 days before slaughtering animals for human consumption to allow elimination of the drug from edible tissues. The drug is dangerous for ducks, geese, and dogs. Use as sole source of arsenic.

(a) Approvals. Type A medicated articles: 25 percent nitromide, 30 percent sulfanitran, with or without 5 percent roxarsone to 053501 in § 510.600(c) of this chapter.

(b) Related tolerances. See §§ 556.220 and 556.680 of this chapter.

(c) Conditions of use. It is used for chickens as follows:

(1) Amount. 227 grams per ton nitromide (0.025 percent) and 272 grams per ton sulfanitran (0.03 percent).

(i) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, and E. acervulina.

(ii) Limitations. Not to be fed to laying chickens; withdraw 5 days before slaughter; from Type A articles containing not more than 25 percent nitromide and 30 percent sulfanitran.

(2) Amount. 227 grams per ton nitromide (0.025 percent) and 272 grams per ton sulfanitran (0.03 percent), plus 45.4 grams per ton roxarsone (0.005 percent).

(i) Indications for use. Prevention of coccidiosis caused by Eimeria tenella, E. necatrix, and E. acervulina; growth promotion and feed efficiency; improving pigmentation.

(ii) Limitations. Not to be fed to laying chickens; withdraw 5 days before slaughter; from Type A articles containing not more than 25 percent nitromide, 30 per cent sulfanitan, and 5 percent roxarsone; as sole source of organic arsenic.

(a) Approvals. Type A medicated articles: 20 grams of activity per pound to 046573 in § 510.600(c) of this chapter.

(b) Related tolerances. See § 556.470 of this chapter.

(c) Conditions of use. It is used for chickens and turkeys as follows:

(1) Amount. 50 grams per ton.

(i) Indications for use. Chickens and turkeys; aid in control of crop mycosis and mycotic diarrhea (Candida albicans).

(ii) Limitations. Growing and laying chickens; growing turkeys.

(2) Amount. 100 grams per ton.

(i) Indications for use. Chickens and turkeys; treatment of crop mycosis and mycotic diarrhea (Candida albicans).

(ii) Limitations. Growing and laying chickens; growing turkeys; to be fed for 7 to 10 days.

(a) Approvals. Type A medicated articles: 5 grams of activity per pound to 066104 in § 510.600(c) of this chapter.

(b) Related tolerances. See § 556.480 of this chapter.

(c) Special considerations. Do not use bentonite in Type B or Type C medicated feeds containing oleandomycin. Oleandomycin refers to oleandomycin or feed-grade oleandomycin.

(d) Conditions of use. It is used in animal feed as follows:

(1) Chickens and turkeys—(i) Amount per ton. Oleandomycin, 1 to 2 grams.

(ii) Indications for use. For increased rate of weight gain and improved feed efficiency for broiler chickens and growing turkeys.

(2) Swine—(i) Amount per ton. Oleandomycin, 5 to 11.25 grams.

(ii) Indications for use. For increased rate of weight gain and improved feed efficiency in growing-finishing swine.

(a) Approvals. Type A medicated articles:

(1) 10, 20, 30, 50, 100, and 200 grams per pound to No. 066104 in § 510.600(c) of this chapter.

(2) 50, 100, and 200 grams per pound to No. 048164 in § 510.600(c) of this chapter.

(b) Special considerations. (1) In accordance with § 558.5 labeling shall bear the statement: “FOR USE IN DRY ANIMAL FEED ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.”

(2) The articles in paragraph (a)(1) of this section contain an amount of mono-alkyl (C8-C18) trimethylammonium oxytetracycline expressed in terms of an equivalent amount of oxytetracycline hydrochloride or an amount of oxytetracycline dihydrate base expressed in terms of an equivalent amount of oxytetracycline hydrochloride.

(3) 50-, 100-, and 200-gram per pound articles in paragraph (a)(2) of this section contain oxytetracycline dihydrate expressed in terms of an equivalent amount of oxytetracycline hydrochloride. Another 100-gram per pound article in paragraph (a)(2) of this section contains oxytetracycline hydrochloride.

(c) Related tolerances. See § 556.500 of this chapter.

(d) Conditions of use—(1) Chickens—

(2) Turkeys—

(3) Swine—

(a) Specifications. As penicillin procaine G or feed grade penicillin procaine.

(b) Sponsors. Type A medicated articles: To 066104, 100 and 227 grams per pound. To 046573, 100 and 227 grams per pound.

(c) Related tolerances. See § 556.510 of this chapter.

(d) Conditions of use. (1) It is used as follows:

(2) Penicillin may be used in accordance with the provisions of this section in the combinations provided as follows:

(i) Amprolium in accordance with § 558.55.

(ii) Amprolium plus ethopatbate in accordance with § 558.58.

(iii) Hygromycin B in accordance with § 558.274.

(iv) Nicarbazin alone or with roxarsone as in § 558.366.

(v) Roxarsone and zoalene in accordance with § 558.680.

(vi) Zoalene in accordance with § 558.680.

(a) Approvals. (1) Dry Type A medicated articles: 53 percent to 000069 in § 510.600(c) of this chapter.

(2) Liquid Type A medicated articles: 99.5 percent to 000069 in § 510.600(c) of this chapter.

(b) Conditions of use. (1) For prevention of legume (alfalfa, clover) and wheat pasture bloat in cattle.

(2) Poloxalene dry Type A article and liquid Type A article must be thoroughly blended and evenly distributed in feed prior to use. This may be accomplished by adding the Type A article to a small quantity of feed, mixing thoroughly, then adding this mixture to the remaining feed and again mixing thoroughly. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily and continued during exposure to bloat producing conditions. If bloating conditions are severe, the dose is doubled. Treatment should be started 2 to 3 days before exposure to bloat-producing conditions. Repeat dosage if animals are exposed to bloat-producing conditions more than 12 hours after the last treatment. Do not exceed the higher dosage levels in any 24-hour period.

(a) Approvals. Type A medicated articles: 99.5 percent to 066104 in § 510.600(c) of this chapter.

(b) Conditions of use. (1) For control of legume (alfalfa, clover) and wheat pasture bloat in cattle, use 7.5 grams of poloxalene per pound of liquid Type C feed (1.65 percent weight/weight). Each animal must consume 0.2 pound of Type C feed per 100 pounds of body weight daily for adequate protection.

(2) For control of legume (alfalfa, clover) bloat in cattle grazing of prebloom legumes, use 10.00 grams of poloxalene per pound of liquid Type C feed (2.2 percent weight/weight). Each animal must consume 0.15 pound of Type C feed per 100 pounds of body weight daily for adequate protection. If consumption exceeds 0.2 pound of Type C feed per 100 pounds of body weight daily, cattle should be changed to a Type C feed containing 7.5 grams of poloxalene per pound.

(3) Poloxalene liquid Type A article must be thoroughly blended and evenly distributed into a liquid Type C feed and offered to cattle in a covered liquid Type C feed feeder with lick wheels. The formula for the liquid Type C feed, on a weight/weight basis, is as follows: Ammonium polyphosphate 2.66 percent, phosphoric acid (75 percent) 3.37 percent, sulfuric acid 1.00 percent, water 10.00 percent, and molasses sufficient to make 100.00 percent, vitamins A and D and/or trace minerals may be added. One free-turning lick wheel per 25 head of cattle must be provided.

(4) The medicated liquid Type C feed must be introduced at least 2 to 5 days before legume consumption to accustom the cattle to the medicated liquid Type C feed and to lick wheel feedings. If the medicated liquid wheel Type C feed feeding is interrupted, this 2- to 5-day introductory feeding should be repeated.

(a) Specifications. Type A medicated articles containing 9.6, 19.2, 48, or 80 grams per pound pyrantel tartrate.

(b) Approvals. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (e) of this section:

(1) No. 066104: 9.6, 19.2, 48, and 80 grams per pound for use as in paragraph (e)(1) of this section.

(2) [Reserved]

(3) Nos. 010439, 011490, 011749, 012286, 016968, 017790, 043733, and 049685: 9.6 and 19.2 grams per pound for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this section.

(4) [Reserved]

(5) No. 051311: 19.2 and 48 grams per pound for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this section.

(6) Nos. 034936 and 046987: 9.6 and 19.2 grams per pound for use as in paragraphs (e)(1)(i) and (e)(1)(ii) of this section.

(7) Nos. 000069 and 017135: 48 grams per pound for use as in paragraph (e)(2) of this section.

(c) Related tolerances. See § 556.560 of this chapter.

(d) Special considerations. (1) See § 500.25 of this chapter. Consult a veterinarian before using in severely debilitated animals.

(2) Do not mix in Type B or Type C medicated feeds containing bentonite.

(e) Conditions of use. It is used as follows:

(1) Swine—(i) Amount per ton. 96 grams (0.0106 percent).

(A) Indications for use. Aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections.

(B) Limitations. Feed continuously as the sole ration in a Type C feed; withdraw 24 hours prior to slaughter.

(ii) Amount per ton. 96 grams (0.0106 percent).

(A) Indications for use. For the removal and control of large roundworm (Ascaris suum) infections.

(B) Limitations. Feed for 3 days as the sole ration in a Type C feed; withdraw 24 hours prior to slaughter.

(iii) Amount per ton. 800 grams (0.0881 percent).

(A) Indications for use. For the removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum) infections.

(B) Limitations. As sole ration for a single therapeutic treatment in Type C feed; feed at the rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb, and 5 lb of feed per head for animals 200 lb or over; withdraw 24 hours prior to slaughter.

(iv) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and carbadox, 50 grams (0.0055 percent).

(A) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections.

(B) Limitations. Do not feed to swine weighing over 75 pounds; do not feed within 10 weeks of slaughter; consult a veterinarian before feeding to severely debilitated animals; feed continuously as sole ration. Do not use in Type C feeds containing less than 15 percent crude protein.

(v) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and tylosin, 40 to 100 grams, as tylosin phosphate.

(A) Indications for use. For prevention of swine dysentery (vibrionic); aid in the prevention of migration and establishment of large roundworms (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp. ) infections.

(B) Limitations. Use 100 grams tylosin per ton for at least 3 weeks followed by 40 grams tylosin per ton until market weight; withdraw 24 hours before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(vi) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and tylosin 40 to 100 grams, as tylosin phosphate.

(A) Indications for use. Treatment and control of swine dysentery (vibrionic); aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp. ) infections.

(B) Limitations. Administer tylosin in feed as tylosin phosphate after treatment with tylosin in drinking water as tylosin base; 0.25 grams per gallon in drinking water for 3 to 10 days, 40 to 100 grams tylosin per ton in feed for 2 to 6 weeks; withdraw 24 hours before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(vii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 40 grams, as lincomycin hydrochloride monohydrate.

(A) Indications for use. For control of swine dysentery; aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.

(B) Limitations. Feed as sole ration; for use in swine on premises with a history of swine dysentery but where symptoms have not yet occurred; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(viii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 100 grams, then 40 grams, as lincomycin hydrochloride monohydrate.

(A) Indications for use. For treatment and control of swine dysentery; aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.

(B) Limitations. Feed 100 grams per ton for 3 weeks or until signs of disease disappear, followed by 40 grams per ton; feed as sole ration; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(ix) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 100 grams, as lincomycin hydrochloride monohydrate.

(A) Indications for use. For treatment of swine dysentery; aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.

(B) Limitations. Feed 100 grams per ton 3 weeks or until signs of disease disappear, followed by 40 grams per ton; feed as sole ration; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter. Consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(x) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 100 or 40 grams.

(A) Indications for use. For treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections.

(B) Limitations. Administer in accordance with paragraph (c)(2)(i), (c)(2)(ii), or (c)(2)(iii) of § 558.325 and paragraph (e)(1)(ii)(B) of this section.

(xi) Amount per ton. Pyrantel tartrate, 800 grams (0.0881 percent) and lincomycin, 100 or 40 grams.

(A) Indications for use. For treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infections.

(B) Limitations. Administer in accordance with paragraph (c)(2)(i), (c)(2)(ii), or (c)(2)(iii) of § 558.325 and paragraph (e)(1)(iii)(B) of this section.

(xii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and lincomycin, 200 grams as lincomycin hydrochloride monohydrate.

(A) Indications for use. For the reduction in severity of swine mycoplasma pneumonia caused by Mycoplasma hyopneumoniae; aid in the prevention of migration and establishment of large roundworms (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections.

(B) Limitations. Feed as sole ration for 21 days; not to be fed to swine that weigh more than 250 pounds; withdraw 6 days before slaughter; consult your veterinarian before feeding to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(C) Sponsor. See No. 000009 in § 510.600(c) of this chapter.

(2) Horses—(i) Amount. Feed continuously at the rate of 1.2 milligrams per pound (2.64 milligrams per kilogram) of body weight.

(A) Indications for use. Prevention of Strongylus vulgaris larval infections; control of adult large strongyles (S. vulgaris, and S. edentatus), adult and 4th stage larvae small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., and Triodontophorus spp.), adult and 4th stage larvae pinworms (Oxyuris equi), and adult and 4th stage larvae ascarids (Parascaris equorum).

(B) Limitations. Administer either as a top-dress (not to exceed 20,000 grams per ton) or mixed in the horse's daily grain ration (not to exceed 1,200 grams per ton) during the time that the animal is at risk of exposure to internal parasites. Not for use in horses intended for food. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

(ii) [Reserved]

(a) Approvals. Type A medicated articles: 30 grams per pound to 046573 in § 510.600(c) of this chapter.

(b) Special considerations. Type C feed containing robenidine hydrochloride must be fed within 50 days from the date of manufacture. Do not use in Type B or Type C medicated feeds containing bentonite.

(c) Related tolerances. See § 556.580 of this chapter.

(d) Conditions of use. It is used in feed for chickens as follows:

(a) Specifications. Type A medicated articles containing 10, 20, 50, or 80 percent roxarsone.

(b) Approvals. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 046573 for use of 10, 20, and 50 percent Type A medicated articles as in paragraph (d)(1)(i) of this section.

(2) No. 046573 for use of 10, 20, 50, and 80 percent Type A medicated articles as in paragraphs (d)(1) through (d)(3) of this section.

(c) Related tolerances. See § 556.60 of this chapter.

(d) Conditions of use—(1) Chickens. It is used in chicken feed as follows:

(2) Turkeys. It is used in turkey feed as follows:

(3) Swine. It is used in swine feed as follows:

(a) Specifications. Type A medicated articles containing 30 or 60 grams of salinomycin activity per pound (as salinomycin sodium biomass).

(b) Approvals. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section:

(1) No. 046573 for use as in paragraph (d) of this section.

(2) No. 016592 for use as in paragraphs (d)(1)(i), (d)(1)(iii) through (d)(1)(xvi), (d)(1)(xxiii) and (d)(1)(xxiv), (d)(2)(i), (d)(3)(i), and (d)(4) of this section.

(3) No. 048164 for use as in paragraphs (d)(1)(xv) and (d)(1)(xvi) of this section.

(c) [Reserved]

(d) Conditions of use. (1) Broilers: It is used as follows:

(i)(a) Amount per ton. Salinomycin 40 to 60 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(c) Limitations. Feed continuously as sole ration. Do not feed to layers. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses.

(ii)(a) Amount per ton. Salinomycin 40 to 60 grams and roxarsone 45.4 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone.

(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Withdraw 5 days before slaughter. Roxarsone as provided by No. 011526 or 046573 in § 510.600(c) of this chapter.

(iii)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin methylene disalicylate 4 to 30 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati for incresed rate of weight gain and improved feed efficiency.

(c) Limitation. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentially fed to adult turkeys or horses. Bacitracin methylene disalicylate as provided by No. 046573 in § 510.600(c) of this chapter.

(iv)(a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 45.4 grams and bacitracin methylene disalicylate 4 to 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone; for increased rate of weight gain.

(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Withdraw 5 days before slaughter. Roxarsone and bacitracin as provided by No. 046573 in § 510.600(c) of this chapter.

(v)(a) Amount per ton. Salinomycin 40 to 60 grams per ton with roxarsone 22.7 to 45.4 grams per ton.

(b) Indications for use. For the prevention of coccidiosis caused by Eimera tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima and for improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidently fed to adult turkeys or to horses. Withdraw 5 days before slaughter. Roxarsone as provided by No. 046573 in § 510.600(c) of this chapter.

(vi)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin methylene disalicylate 4 to 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin MD as provided by No. 046573 in § 510.600(c) of this chapter.

(vii)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin zinc 10 to 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin zinc as provided by No. 046573 in § 510.600(c) of this chapter.

(viii)(a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 45.4 grams and bacitracin zinc 4 to 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone; for increased rate of weight gain and improved feed efficiency.

(c) Limitations. See paragraph (d)(1)(iv)(c) of this section.

(ix)(a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 34.1 grams and bacitracin zinc 10 to 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Use as sole source of organic arsenic. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Withdraw 5 days before slaughter. Roxarsone as provided by No. 046573 and bacitracin as provided by No. 046573 in § 510.600(c) of this chapter.

(x)(a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 5 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers or to chickens over 16 weeks of age. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104 in § 510.600(c) of this chapter.

(xi)(a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 5 to 15 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain.

(c) Limitations. See paragraph (d)(1)(x)(c) of this section.

(xii) (a) Amount per ton. Salinomycin 40 to 60 grams, virginiamycin 5 grams, and roxarsone 45.4 grams.

(b) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone, and for improved feed efficiency.

(c) Limitations. Feed continuously as sole ration. Withdraw 5 days prior to slaughter. Use as sole source of organic arsenic. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104 in § 510.600(c) of this chapter. Roxarsone as provided by No. 046573 in § 510.600(c) of this chapter.

(xiii)(a) Amount per ton. Salinomycin 40 to 60 grams and lincomycin 2 to 4 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati and for improved feed efficiency.