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The food additive consists of the meal obtained after the removal of most of the oil from whole seeds or partially dehulled seeds or both obtained from a Carthamus tinctorius L. safflower Centennial variety genetically engineered to express the delta-6-desaturase gene from Saprolegnia diclina Humphrey. The 453 amino acid, delta-6-desaturase enzyme converts the fatty acid linoleic acid to gamma-linolenic acid during seed development. The resulting additive may be safely used in cattle and poultry feeds in accordance with the following prescribed conditions:
(a) The additive shall contain not less than 20 percent crude protein, not more than 40 percent crude fiber, not more than 10 percent moisture, and not more than 2 percent crude fat.
(b) The crude fat in the additive meets the following specifications:
(1) Gamma-linolenic acid content not to exceed 55 percent.
(2) Total content of stearidonic acid and cis, cis-6, 9-octadecadienoic acid not to exceed a total of 0.5 percent.
(3) Total content of palmitic, stearic, oleic, linoleic, and other associated fatty acids to exceed a total of 40 percent.
(c) The additive is used or intended for use in cattle and poultry feeds as a source of protein in accordance with good manufacturing and feeding practices.
(d) To assure safe use of the additive, in addition to the other information required by the Food, Drug, and Cosmetic Act, the label and labeling of the additive, any feed premix, or complete feed shall bear the following:
(1) The name of the additive or the common name, safflower meal.
(2) Adequate directions for use in cattle and poultry feeds.
(e) The additive may be identified by the common or usual name, safflower meal.
[80 FR 35569, June 22, 2015]
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