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Food and Drug Administration, HHS § 573.180

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Food and Drug Administration, HHS § 573.180 Food and Drug Administration, HHS § 573.180 (a) The food additive is the product so treated shall be labeled as con- obtained by the treatment of ground taining ammonium formate. rice hulls with monocalcium phosphate (d) To assure safe use of the additive, and anhydrous ammonia at a tempera- in addition to the other information re- ture of 350 °F and a pressure of 175 quired by the act and paragraph (c) of pounds per square inch. this section, the label and labeling (b) It is used or intended for use in shall contain: the feed of beef cattle as a source of (1) Appropriate warnings and safety crude fiber and as the sole source of precautions concerning ammonium for- nonprotein nitrogen in an amount not mate (37 percent ammonium salt of for- to exceed 20 percent of the total ration. mic acid and 62 percent formic acid). (c) To assure safe use of the additive, (2) Statements identifying ammo- the label and labeling of the additive nium formate in formic acid (37 per- and of any feed additive supplement, cent ammonium salt of formic acid and feed additive concentrate, or feed addi- 62 percent formic acid) as a corrosive tive premix prepared therefrom, shall and possible severe irritant. contain, in addition to other informa- (3) Information about emergency aid tion required by the act, the following: in case of accidental exposure as fol- (1) The name of the additive. lows: (2) The maximum percentage of (i) Statements reflecting require- equivalent crude protein from the non- ments of applicable sections of the protein nitrogen. Superfund Amendments and Reauthor- (3) Directions for use to provide not ization Act (SARA), and the Occupa- more than 20 percent of the additive in tional Safety and Health Administra- the total ration, and a prominent tion’s (OSHA) human safety guidance statement: ‘‘Warning—This feed should regulations. be used only in accordance with the di- (ii) Contact address and telephone rections furnished on the label.’’ number for reporting adverse reactions or to request a copy of the Material § 573.170 Ammonium formate. Safety Data Sheet (MSDS). The food additive, partially ammo- [75 FR 41725, July 19, 2010] nium formate, may be safely used in the manufacture of complete swine § 573.180 Anhydrous ammonia. feeds in accordance with the following (a) The food additive anhydrous am- prescribed conditions: monia is applied directly to corn plant (a) The additive is manufactured by material and thoroughly blended prior the reaction of 99.5 percent ammonia to ensiling. It is used or intended for gas and 99 percent formic acid in a con- use as a source of nonprotein nitrogen tinuous loop reactor to produce a solu- in cattle feed in accordance with para- tion made up of 37 percent ammonium graphs (a)(1), (2), or (3) as follows: salt of formic acid and 62 percent for- (1)(i) The food additive anhydrous mic acid. ammonia is applied as a component of (b) The additive is used or intended an aqueous premix containing 16 to 17 for use as a feed acidifying agent, to percent ammonia, with molasses, min- lower the pH, in complete swine feeds erals, and not less than 83 percent at levels not to exceed 1.2 percent of crude protein. The premix is a source the complete feed. of nonprotein nitrogen and minerals. (c) To assure safe use of the additive, (ii) In addition to the requirements of in addition to the other information re- paragraph (b) of this section, the label- quired by the Federal Food, Drug, and ing shall bear an expiration date of not Cosmetic Act (the act), the label and more than 10 weeks after date of manu- labeling shall contain: facture; a statement that additional (1) The name of the additive. protein should not be fed to lactating (2) Adequate directions for use in- dairy cows producing less than 32 cluding a statement that ammonium pounds of milk per day nor beef cattle formate must be uniformly applied and consuming less than 1 percent of body thoroughly mixed into complete swine weight daily in shelled corn; and a feeds and that the complete swine feeds warning not to use additional trace 535 VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00545 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150.
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