(Sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371. Interprets or applies sec. 409, 72 Stat. 1785; 21 U.S.C. 348) [24 F.R. 9368, Nov. 20, 1959, 24 F.R. 9510, Nov. 26, 1959, as amended at 26 F.R. 938, Jan. 31, 1961, 26 F.R. 1444, Feb. 18, 1961, 26 F.R. 3991, May 9, 1961, 26 FR. 5222, June 10, 1961, 26 F.R. 5421, June 17, 1961, 26 F.R. 11210, Nov. 28, 1961] Subpart C-Food Additives Permitted

in Animal Feed or Animal-Feed Supplements

AUTHORITY: §§ 121.201 to 121.255 issued under sec. 409 (c), 72 Stat. 1786; 21 U.S.C. 348 (c) (1). Interprets or applies secs. 201, 402, 52 Stat. 1042, 1046, as amended 68 Stat. 511. 72 Stat. 1784; 21 U.S.C. 321, 342.

§ 121.201 Ethoxyquin in certain dehydrated forage crops.

Ethoxyquin (1,2-dihydro-6-ethoxy2,2,4-trimethylquinoline) may be safely used in the dehydrated forage crops listed in paragraph (a) of this section, when incorporated therein in accordance with the conditions prescribed in this section:

or any mixture of such forage crops, for use only as an animal feed.

(b) Such additive is used only as a chemical preservative for the purpose of retarding oxidative destruction of naturally occurring carotenes and vitamin E in the forage crops.

(c) It is added to the dehydrated forage crops in an oil mixture containing only suitable animal or suitable vegetable oil, prior to grinding and mixing.

(d) The maximum quantity of the additive permitted to be used and to remain in or on the dehydrated forage crop shall not exceed 150 parts per million (0.015 percent).

(e) To assure the safe use of the additive, the label of the market package shall contain, in addition to other information required by the act:

(1) The name of the additive as specified in this section.

(2) Directions for the incorporation of the additive in the forage crops, as specified in paragraph (c) of this section, with the directive that only suitable animal or suitable vegetable oils are to be used in the oil mix.

(f) The label of any dehydrated forage crops treated with the additive or the label of an animal-feed supplement containing such treated forage crops, shall, in addition to other information required by the act, bear the following statements:

(1) "Ethoxyquin, a preservative," or "Ethoxyquin added to retard the oxidative destruction of carotene and vitamin E."

(2) The statement "For use in animal feed only."

[24 F.R. 1095, Feb. 12, 1959, as amended at 24 F.R. 10062, Dec. 12, 1959, 26 F.R. 5004, June 6, 1961, 26 F.R. 5225, June 10, 1961] § 121.202 Ethoxyquin in animal feeds.

Ethoxyquin (1,2-dihydro-6-ethoxy2,2,4-trimethylquinoline) may be safely used in animal feeds, when incorporated therein in accordance with the following prescribed conditions:

(a) It is intended for use only: (1) As a chemical preservative for retarding oxidation of carotene, xanthophylls, and vitamins A and E in animal feed and fish food and, (2) as an aid in preventing the development of organic peroxides in canned pet food.

(b) The maximum quantity of the additive permitted to be used and to remain in or on the treated article shall not exceed 150 parts per million (0.015 percent).

(c) To assure safe use of the additive, the label and labeling of the food additive container and that of any intermediate premixes prepared therefrom shall contain, in addition to other information required by the act:

(1) The name of the additive, ethoxyquin.

(2) A statement of the concentration or strength contained therein.

(3) Adequate use directions to provide for a finished article with the proper concentration of the additive as provided in paragraph (b) of this section, whether or not intermediate premixes are to be used.

(d) The label of any animal feed containing the additive shall, in addition to the other information required by the act, bear the statement "Ethoxyquin, a preservative" or "Ethoxyquin added to retard the oxidative destruction of carotene, xanthophylls, and vitamins A and E."

[26 F.R. 644, January 24, 1961, as amended at 26 F.R. 5005; June 6, 1961]

§ 121.203 Polyoxyethylene glycol (400) mono- and dioleates.

The food additive polyoxyethylene glycol (400) mono- and dioleates may be safely used as an emulsifier in calf-milk replacer formulations.

[27 F.R. 11799, Nov. 30, 1962]

§ 121.204 Dioxathion.

A tolerance of 18 parts per million (0.0018 percent) is established for residues of dioxathion (2,3-p-dioxanedithiol-S,S-bis (0,0-diethylphosphorodi

thioate)) in dehydrated citrus pulp for cattle feed when present therein as a result of the application of the pesticide to the growing agricultural crop. [28 F.R. 14312, Dec. 27, 1963]

§ 121.205 Reserpine.

The food additive reserpine (3,4,5-trimethoxybenzoyl methyl reserpate) may be safely used in animal feed in accordance with the following prescribed conditions:

(a) When used in this section:

(1) The term "reserpine" refers to reserpine or feed grade reserpine.

(2) The quantities of the additive prescribed refer to the weight of reserpine as the base, assaying not less than 94 percent C33H40N2O9.

(3) The antibiotic activities authorized are expressed in terms of the weight of the appropriate antibiotic standard.

(b) Permitted uses of reserpine alone and with certain other additives in medicated feeds are described in tabular form

in this section, and the tables are to be read as follows:

(1) Where the principal ingredient is the sole medicament, the required limitations and indications for use are found on the same line entry.

(2) Where the principal ingredient is combined with a secondary ingredient, the required limitations and indications for use for the secondary ingredient are found on the same line entry. The required limitations and indications for use of the principal ingredient at the designated concentration are found on the line entry for the principal ingredient alone, and both sets of applicable limitations and indications for use shall apply. If duplicate limitations occur, they may be appropriately combined.

(3) Permitted combinations of principal ingredient and secondary ingredient are individually listed. Unless specifically provided by the regulations, the principal ingredient may not be mixed with two or more secondary ingredients.

(4) Where cross-references specify a particular table and item number of another section, use of only the principal ingredient of the numbered item is authorized thereby.

(c) It is used or intended for use as

follows: ~ IN 1/1963 COM

For turkeys over 4 weeks of age; as procaine penicillin.

Principal ingredient 1

Gm. per ton

Combined with

Limitations

For turkeys over 4 weeks of age.

For turkeys over 4 weeks of age; as bacitracin or zinc bacitracin. For turkeys over 4 weeks of age; as chlortetracycline hydrochloride. For turkeys over 4 weeks of age; 121.208(d), table 1, items 2, 6, 11, as chlortetracycline hydrochloride.

For turkeys over 4 weeks of age; feed not to exceed 5 days. For turkeys over 4 weeks of age; feed not to exceed 5 days; as procaine penicillin. For turkeys over 4 weeks of age; feed not to exceed 5 days; as bacitracin or zinc bacitracin. For turkeys over 4 weeks of age; feed not to exceed 5 days; as chlortetracycline hydrochloride. For turkeys over 4 weeks of age; feed not to exceed 5 days; as prescribed in § 121.208(d), table 1, items 2, 6, 11; chlortetracycline

as

hydrochloride.

Indications for use

Prevention of aortic rupture.

Growth promotion and feed efficiency.

Do.

Do.

121.208(d), table 1, items 2, 6, 11.

Treatment of aortic rupture.

Growth promotion and feed efficiency.

Do.

Do.

$121.208(d), table 1, items 2, 6, 11.

(d) To assure safe use, the label and labeling of the additive, any combination of the additives, and any intermediate premix or final feed shall bear, in addition to the other information required by the act, the following:

(1) The name of the additive or additives.

(2) A statement of the quantity or quantities contained therein, except that the final feed label need not bear the quantities of the antibiotic drugs added solely for growth promotion.

(3) Adequate directions and warnings for use.

[27 F.R. 11309, Nov. 16, 1962, as amended at 28 F.R. 10488, Sept. 28, 1963]

§ 121.207 Zoalene.

The food additive zoalene (3,5-dinitroo-toluamide) may be safely used in animal feed when incorporated therein in accordance with the following prescribed conditions:

(a) The antibiotic activities authorized are expressed in this section in terms of the weight of the appropriate antibiotic standard.

(b) Permitted uses of zoalene alone and with certain other additives in medicated feeds are described in tabular form in this section. These tables are to be read as follows:

(1) Where the principal ingredient is the sole medicament, the required limitations and indications for use are found on the same line entry.

(2) Where the principal ingredient is combined with a secondary ingredient, the required limitations and indications for use for the secondary ingredient are found on the same line entry. The required limitations and indications for use of the principal ingredient at the designated concentration are found on the line entry for the principal ingredient alone, and both sets of applicable limitations and indications for use shall

procaine penicillin. For broiler chickens; not less than 0.6 gm. of penicillin, nor less than 3.0 gm. of bacitracin, nor more than 50 gm. in combination; as procaine penicillin plus bacitracin, bacitracin methylene disalicylate, manganese bacitracin, or zinc bacitracin.

For broiler chickens; as bacitracin, bacitracin methylene disalicylate, manganese bacitracin, or zinc bacitracin. For broiler chickens.... For broiler chickens. As prescribed in § 121.208(d), Table 1, Item 1; $121.208(d), Table 1, Item 4; 121.208(d), Table 1. Item 5; 121.208(d), Table 1, Item 10; as chlortetracycline hydrochloride. For broiler chickens; as prescribed in § 121.232 (d), table 1, Item 2.1 or 6.1; § 121.233(d), table 1, item 2.1 or 6.1; as bacitracin or zinc bacitracin. § 121.251(d),

8

table 1, items 2, 4, 6, 8, 9, 10, 12.

For broiler chickens; withdraw 5 days before slaughter.

do..

of coccidiosis. Growth promotion and feed efficiency. Do.

See footnote at end of table.