(a) Specifications. Type A medicated articles containing 45, 60, 90.7, or 110 grams monensin, USP, per pound.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.420 of this chapter.
(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 (see paragraphs (d)(10)(i) and (d)(10)(ii) of this section).
(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. Paragraph (d)(7)(vii) of this section does not apply to free-choice Type C medicated feeds as defined in § 510.455 of this chapter.
(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. Paragraph (d)(7)(vii) of this section does not apply to free-choice Type C medicated feeds as defined in § 510.455 of this chapter.
(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) Chickens -
| Monensin in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| (i) 90 to 110 | Broiler chickens: As an aid in the prevention of coccidiosis caused by | Feed continuously as the 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 | 058198 | |
| (ii) 90 to 110 | Replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by | Feed continuously as the sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens | 058198 | |
| (iii) 90 to 110 | Bacitracin methylenedisalicylate, 4 to 50 | Broiler chickens: As an aid in the prevention of coccidiosis caused by | 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. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter | 054771 |
| (iv) 90 to 110 | Bacitracin methylenedisalicylate, 4 to 50 | Replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by | Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter | 054771 |
| (v) 90 to 110 | Bacitracin methylenedisalicylate, 5 to 25 | Broiler chickens: As an aid in the prevention of coccidiosis caused by | 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. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter | 058198 |
| (vi) 90 to 110 | Bacitracin methylenedisalicylate, 50 | Broiler and replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by | Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter | 054771 |
| (vii) 90 to 110 | Bacitracin zinc, 4 to 50 | Broiler chickens: As an aid in the prevention of coccidiosis caused by | 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. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter | 054771 |
| (viii) 90 to 110 | Bacitracin zinc, 10 | Broiler chickens: As an aid in the prevention of coccidiosis caused by | 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. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter | 058198 |
| (ix) 90 to 110 | Bacitracin zinc, 10 to 30 | Broiler chickens: As an aid in the prevention of coccidiosis caused by | 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. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter | 058198 |
| (x) 90 to 110 | Bambermycins, 1 to 2 | Broiler chickens: As an aid in the prevention of coccidiosis caused by | Feed continuously as sole ration. Do not feed to laying chickens. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter | 016592, 058198 |
(2) Turkeys -
| Monensin in
grams/ton | Combination
in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| (i) 54 to 90 | Growing turkeys: For the prevention of coccidiosis caused by | 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. 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 | 058198 | |
| (ii) 54 to 90 | Bacitracin methylenedisalicylate, 4 to 50 | Growing turkeys: For the prevention of coccidiosis caused by | 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. 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. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter | 058198 |
| (iii) 54 to 90 | Bacitracin methylenedisalicylate, 200 | Growing turkeys: For the prevention of coccidiosis caused by | 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. 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. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter | 058198 |
| (iv) 54 to 90 | Bambermycins, 1 to 2 | Growing turkeys: For the prevention of coccidiosis in turkeys caused by | 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 | 058198 |
| (v) 54 to 90 | Bambermycins, 2 | Growing turkeys: For the prevention of coccidiosis caused by | 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 | 058198 |
(3) Cattle -
| Monensin in
grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|
| (i) 5 to 40 | Cattle fed in confinement for slaughter: For improved feed efficiency | 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) | 058198 |
| (ii) 10 to 40 | Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to | 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 | 058198 |
| (iii) 10 to 200 | Calves excluding veal calves: For prevention and control of coccidiosis due to | 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 | 058198 |
| (iv) 11 to 22 | Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) | 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 | 058198 |
| (v) 11 to 400 | Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) | 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 | 058198 |
| (vi) 15 to 400 | Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain, and for prevention and control of coccidiosis due to | 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 | 058198 |
| (vii) 25 to 400 | For improved feed efficiency, and for prevention and control of coccidiosis due to | 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 | 058198 |
(4) Free-choice cattle feeds -
| Monensin
amount | Indications for use | Limitations | Sponsor |
|---|---|---|---|
| (i) 150 milligrams per pound of protein-mineral block (0.033%) | Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gain, and for prevention and control of coccidiosis caused by | Provide 50 to 200 milligrams of monensin (0.34 to 1.33 pounds of block) 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. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section | 058198 |
| (ii) 175 milligrams per pound of protein-mineral block (0.038%) | Pasture cattle (slaughter, stocker, and feeder): For increased rate of weight gain | Provide 40 to 200 milligrams of monensin (0.25 to 1.13 pounds or 4 to 18 ounces of block) per head per day, at least 1 block per 4 head of cattle. Do not allow cattle access to salt or mineral while being fed this product. Ingestion by cattle of monensin at levels of 600 milligrams per head per day and higher has been fatal. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section | 017800 |
| (iii) 400 milligrams per pound of protein-mineral block (0.088%) | Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gain | Provide 80 to 200 milligrams of monensin (0.2 to 0.5 pounds of block) per head per day, at least 1 block per 5 head of cattle. Feed blocks continuously. Do not feed salt or minerals containing salt. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section | 067949 |
| (iv) 400 milligrams per pound of block (0.088%) | Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gain | Provide 50 to 200 milligrams of monensin (2 to 8 ounces of block) per head per day, at least 1 block per 5 head of cattle. Feed blocks continuously. Do not feed salt or mineral supplements in addition to the blocks. Ingestion by cattle of monensin at levels of 600 milligrams per head per day and higher has been fatal. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section | 051267 |
| (v) In free-choice Type C medicated feeds to provide 50 to 200 mg per head per day | 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 | 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 supplement before using the monensin medicated supplement. The product's effectiveness in cull cows and bulls has not been established. See paragraph (d) of this section for other required label warnings | 058198 |
| (vi) 1,620 grams per ton of mineral granules as specified in paragraph
(f)(4)(vi)(A) of this section | Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain, and for prevention and control of coccidiosis due to | 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 | 058198 |
(A) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows:
| Ingredient | Percent | International feed No. |
|---|---|---|
| Monocalcium phosphate (21% phosphorus, 15% calcium) | 29.49 | 6-01-082 |
| Sodium chloride (salt) | 24.37 | 6-04-152 |
| Dried cane molasses | 20.0 | 4-04-695 |
| Ground limestone (33% calcium) or calcium carbonate (38% calcium) | 13.75 | 6-02-632 |
| Cane molasses | 3.0 | 4-04-696 |
| Processed grain by-products (as approved by AAFCO) | 5.0 | |
| Vitamin/trace mineral premix 1 | 2.5 | |
| Monensin Type A article, 90.7 grams per pound | 0.89 | |
| Antidusting oil | 1.0 |
1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
(B) [Reserved]
(5) Bobwhite quail -
| Monensin in
grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|
| (i) 73 | Growing bobwhite quail: For the prevention of coccidiosis caused by | 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) | 058198 |
| (ii) [Reserved] |
(6) Goats -
| Monensin in
grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|
| (i) 20 | For the prevention of coccidiosis caused by | Feed only to goats being fed in confinement. Do not feed to lactating goats. See paragraph (d)(13) of this section for provisions for monensin liquid Type C goat feeds | 058198 |
| (ii) [Reserved] |
(7) Monensin may also be used in combination with:
(i) Avilamycin as in § 558.68.
(ii) Chlortetracycline as in § 558.128.
(iii) Decoquinate as in § 558.195.
(iv) Lubabegron as in § 558.330.
(v) Lincomycin as in § 558.325.
(vi) Melengestrol acetate as in § 558.342.
(vii) Oxytetracycline as in § 558.450.
(viii) Ractopamine alone or in combination as in § 558.500.
(ix) Tilmicosin as in § 558.618.
(x) Tylosin as in § 558.625.
(xi) Virginiamycin as in § 558.635.
(xii) Zilpaterol alone or in combination as in § 558.665.