(a) Mechanically Separated (Species) is any finely comminuted product resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of livestock carcasses and parts of carcasses and meeting the other provisions of this paragraph. Examples of such product are “Mechanically Separated Beef”, “Mechanically Separated Veal”, “Mechanically Separated Pork”, and “Mechanically Separated Lamb”. At least 98 percent of the bone particles present in such product shall have a maximum size no greater than 0.5 millimeter in their greatest dimension and there shall be no bone particles larger than 0.85 millimeter in their greatest dimension. The product resulting from the separating process shall not have a calcium content exceeding 0.75 percent, as a measure of a bone solids content of not more than 3 percent, and shall have a minimum PER of 2.5 (except as modified in paragraph (e)(1) of this section). Such product also shall have a protein content of not less than 14 percent and a fat content of not more than 30 percent, or it shall be deemed to be product for processing. Such product failing to meet the bone particle size, calcium, or PER requirements of this paragraph shall only be used in producing animal fats. Where such product meets the bone particle size, calcium, and PER requirements of this paragraph, it may also be used in the formulation of meat food products in accordance with §319.6.

(b) Mechanically Separated (Beef) is inedible and prohibited for use as human food.

(c)-(d) [Reserved]

(e)

(1) An essential amino acid content of at least 33 percent of the total amino acids presents in “Mechanically Separated (Species)” shall be accepted as evidence of compliance with the protein quality requirement set forth in paragraph (a) of this section. For purposes of this paragraph, essential amino acid content includes isoleucine, leucine, lysine, methionine, phenylalanine, threonine, and valine content, and the total amino acids present include isoleucine, leucine, lysine, methionine, phenylalanine, threonine, valine, tyrosine, arginine, histidine, alanine, aspartic acid, glutamic acid, glycine, proline, serine, and hydroxyproline content.

(2) Analytical methods used by establishments in verifying the fat, protein, and calcium content of product consisting of or containing Mechanically Separated (Species) shall be among those listed in “Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC),” 16th edition, 1995, §§960.39, 976.21, 928.08 (Chapter 39), and 940.33 (Chapter 45), which is incorporated by reference, or, if no AOAC method is available, in the “Chemistry Laboratory Guidebook,” U.S. Department of Agriculture, Washington, D.C., March 1986 edition, sections 6.011-6.013, Revised June 1987 (pages 6-35 through 6-65), or by appropriate methods validated by scientific bodies in collaborative trials. The “Official Methods of Analysis of the Association of Official Analytical Chemists,” Chapter 39 and Chapter 45, subsection 45.2.06 (AOAC Official Method 940.33), 16th edition, 1995, are incorporated by reference with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51.

[47 FR 28256, June 29, 1982, as amended at 54 FR 40631, Oct. 3, 1989; 59 FR 33642, June 30, 1994; 62 FR 45026, Aug. 25, 1997; 65 FR 34389, May 30, 2000; 69 FR 1874, Jan. 12, 2004]