Specifications. Type A medicated articles containing 45, 60, 90.7, or 110 grams monensin, USP, per pound.

Sponsor. See No. 058198 in § 510.600(c) of this chapter.

Related tolerances. See § 556.420 of this chapter.

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.

[Reserved]

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

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.

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.

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:

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

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

Must be thoroughly mixed in feeds before use.

Do not feed undiluted.

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

Do not feed to lactating goats.

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).

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

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.

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.

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

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.

Must be thoroughly mixed in feeds before use.

Do not feed undiluted.

Do not feed to laying chickens.

Do not feed to chickens over 16 weeks of age.

For replacement chickens intended for use as cage layers only.

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

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.

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

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.

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.

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

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

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

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

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

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.

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.

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

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

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

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

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.

Mixing directions for liquid feeds requiring recirculation or agitation:

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.

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.

Related tolerances. See § 556.420 of this chapter.

Conditions of use. It is used as follows:

Chickens—

Turkeys—

Cattle—

Free-choice cattle feeds—

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

[Reserved]

Bobwhite quail—

Goats—

Monensin may also be used in combination with:

Avilamycin as in § 558.68.

Chlortetracycline as in § 558.128.

Decoquinate as in § 558.195.

Lincomycin as in § 558.325.

Melengestrol acetate as in § 558.342.

Oxytetracycline as in § 558.450.

Ractopamine alone or in combination as in § 558.500.

Tilmicosin as in § 558.618.

Tylosin as in § 558.625.

Virginiamycin as in § 558.635.

Zilpaterol alone or in combination as in § 558.665.

For Federal Register citations affecting § 558.355, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.