1. (a) Condensed, Extracted Glutamic Acid Fermentation Product (21 CFR 573.500) is a concentrated mixture of the liquor remaining from the extraction of glutamic acid, combined with the cells of Corynebacterium lilium or Corynebacterium glutamicum used to produce the glutamic acid. It is used or intended for use as follows: in poultry feed as a source of protein in an amount not to exceed five (5) percent of the total ration; and in cattle feed as a source of protein in an amount not to exceed 10 percent of the feed. In order to assure safe use, the label and labeling of the additive shall bear the following: The name of the additive. A statement of the concentration of the additive contained in any mixture. Adequate directions for use. Non-protein nitrogen content must be guaranteed when present.
2. (b) Condensed [Specify] Fermentation Solubles is the product resulting from the removal of a considerable portion of the liquid by-product resulting from the action of the ferment on the basic medium of grain, molasses, whey, or other media. Non-protein nitrogen content (when present) must be guaranteed. The source must be specified on the label; for example, Condensed Whey Fermentation Solubles, Condensed Grain Fermentation Solubles, Condensed Molasses Fermentation Solubles, etc.

3. (c) Direct-Fed Microorganisms. The following microorganisms were reviewed by the Food and Drug Administration, Center for Veterinary Medicine, and found to present no safety concerns when used in direct-fed microbial products. These microorganisms must be nontoxigenic.

   1. (1) Aspergillus niger, Aspergillus oryzae, Bacillus amyloliquefaciens, Bacillus coagulans, Bacillus lentus, Bacillus licheniformis, Bacillus pumilus, Bacillus subtilis, Bacteroides amylophilus, Bacteroides capillosus, Bacteroides ruminocola, Bacteroides suis, Bifidobacterium adolescentis, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium infantis, Bifidobacterium longum, Bifidobacterium thermophilum, Lactococcus cremoris, Lactococcus lactis, Enterococcus faecium, Lactococcus lactis, Lactobacillus acidophilus, Lactobacillus animalis, Lactobacillus brevis, Lactobacillus buchneri (cattle only), Lactobacillus casei, Lactobacillus curvatus, Lactobacillus delbrueckii, Lactobacillus farciminis (swine only), Lactobacillus fermentum, Lactobacillus helveticus, Lactobacillus plantarum, Lactobacillus reuteri, Lactococcus cremoris, Lactococcus lactis, Leuconostoc mesenteroides, Megasphaera elsdenii (cattle only), Pediococcus acidilactici, Pediococcus damnosus, Pediococcus pentosaceus, Propionibacterium acidipropionici (cattle only), Propionibacterium freudenreichii, Rhodopseudomonas palustris (broiler chickens only), Saccharomyces cerevisiae, Streptococcus intermedius, Streptococcus thermophilus, Weissella confusa, Yeast (as defined elsewhere).
4. (d) Dried Extracted [Specify] Fermentation Solubles is the dried extracted broth obtained from a specified source of fermentation. The source must be specified on the label; for example, Dried Extracted Penicillium Fermentation Solubles, Dried Extracted Streptomyces Fermentation Solubles, Dried Extracted Citric Acid Fermentation Solubles, or as permitted by FDA.
5. (e) Dried Fermentation Biomass is a nonviable biomass product resulting from the production of the amino acids by the fermentation of nonpathogenic, nontoxigenic, risk group 1 Escherichia coli. The product must contain a minimum of 75 percent crude protein on a dry matter basis. The product is intended as a source of protein. Non-protein nitrogen content must be guaranteed when present.
6. (f) Dried [Specify] Fermentation Extract is the dried product resulting from extracting and precipitating by means of non-aqueous solvents or other suitable means, the water soluble materials from a fermentation conducted for maximum production of enzymes using a nonpathogenic strain of the microorganism specified in accordance with good manufacturing practices. The source must be specified on the label; for example, Dried Bacillus subtilis Fermentation Extract, Dried Aspergillus oryzae Fermentation Extract, Dried Aspergillus niger Fermentation Extract, or as permitted by FDA.
7. (g) Dried [Specify] Fermentation Product is the product derived by culturing on appropriate nutrient media for the production of one or more of the following: enzymes, fermentation substances, or other microbial metabolites, and dried in accordance with approved methods and good manufacturing practices. Protein, amino acids, fat, fiber, cell count, enzyme activity or nutrient metabolite level shall be guaranteed where applicable. Use of Lactobacillus buchneri, Lactobacillus diolivorans, and Lentilactobacillus hilgardii is limited to silage and high moisture corn grain in plant inoculant products. The source must be specified on the label; for example, Dried Bacillus subtilis Fermentation Product, Dried Aspergillus oryzae Fermentation Product, Dried Aspergillus niger Fermentation Product, Dried Lactobacillus acidophilus Fermentation Product, Dried Lactobacillus buchneri Fermentation Product, Dried Lactobacillus diolivorans Fermentation Product, Dried Lentilactobacillus hilgardii Fermentation Product, Dried Lactobacillus delbrueckii Fermentation Product, Dried Enterococcus faecium Fermentation Product, or as permitted by FDA.
8. (h) Dried [Specify] Fermentation Solubles is the dried material resulting from drying the water soluble materials after separation of suspended solids from a fermentation conducted for maximum production of enzymes using a nonpathogenic strain of the microorganism specified in accordance with good manufacturing practices. The source must be specified on the label; for example, Dried Bacillus subtilis Fermentation Solubles, Dried Aspergillus oryzae Fermentation Solubles, Dried Aspergillus niger Fermentation Solubles, or as permitted by FDA.
9. (i) Dried L-Lysine Fermentation Product is the dry biomass product from the fermentation of Corynebacterium glutamicum on an appropriate nutrient media and stabilized in accordance with good manufacturing practices. The product is intended as a source of lysine in livestock, poultry and aquaculture feeds. The L-lysine content must not be less than 50 percent on a dry matter basis. The label shall include guarantees for minimum L-lysine and maximum sulfur.
10. (j) Extracted [Specify] [Specify] is the filtered and dried mycelium obtained from a specified source of fermentation. The source must be specified as Penicillium, Streptomyces, or citric acid in the second word of the name on the label and the form of the ingredient must be specified in the third word of the name on the label; for example, Extracted Penicillium Presscake, Extracted Streptomyces Meal, Extracted Citric Acid Pellets, etc.
11. (k) Extracted [Specify] Presscake is the filtered and dried mycelium obtained from a specified source of fermentation. The source must be specified on the label; for example, Extracted Penicillium Presscake, Extracted Streptomyces Presscake, Extracted Citric Acid Presscake, etc.
12. (l) Extracted [Specify] Meal is the ground specified fermentation source presscake. The source must be specified on the label; for example, Extracted Penicillium Meal, Extracted Streptomyces Meal, Extracted Citric Acid Meal, etc.
13. (m) Liquid [Specify] Fermentation Product is the liquid product derived by culturing or fermenting a specified fermentation source on appropriate liquid nutrient media for the production of one or more of the following: enzymes, fermentation substances, or other microbial metabolites, and stabilized by approved methods in accordance with good manufacturing practices. Percent solids, cell count, enzyme activity or nutrient metabolite level shall be guaranteed where applicable. The source must be specified on the label; for example, Liquid Bacillus subtilis Fermentation Product, Liquid Aspergillus oryzae Fermentation Product, Liquid Aspergillus niger Fermentation Product, Liquid Lactobacillus acidophilus Fermentation Product, Liquid Lactobacillus delbrueckii Fermentation Product, Liquid Enterococcus faecium Fermentation Product, or as permitted by FDA. For Dried Cultured Skimmed Milk, refer to Milk Products Section. For Condensed Cultured Skimmed Milk, refer to Milk Products Section.
14. (n) Liquid L-Lysine Fermentation Product is the liquid biomass product from the fermentation of Corynebacterium glutamicum on appropriate nutrient media and stabilized in accordance with good manufacturing practices. The product is intended as a source of lysine in livestock and poultry feeds. The L-lysine content must not be less than 50 percent on a dry matter basis. The label shall include guarantees for minimum L-lysine and maximum sulfur.
15. (o) Undried Extracted [Specify] Solids and Fermentation Solubles is undried mycelium and extracted broth or the extracted and undried mycelium and broth obtained from a specified source of fermentation. The source must be specified on the label; for example, Undried Extracted Penicillium Solids and Fermentation Solubles, Undried Extracted Streptomyces Solids and Fermentation Solubles, Undried Extracted Citric Acid Solids and Fermentation Solubles, or as permitted by FDA.

Note: Authority cited: Sections 407 and 14902, Food and Agricultural Code. Reference: Sections 14992 and 15011, Food and Agricultural Code.

History

1. New section filed 11-12-2024 as an emergency; operative 11-12-2024 (Register 2024, No. 46). A Certificate of Compliance must be transmitted to OAL by 5-12-2025 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 5-12-2025 as an emergency; operative 5-12-2025 (Register 2025, No. 20). A Certificate of Compliance must be transmitted to OAL by 8-6-2025 or emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-12-2025 order, including amendment of section, transmitted to OAL 6-10-2025 and filed 7-1-2025; amendments effective 7-1-2025 pursuant to Government Code section 11343.4(b)(3) (Register 2025, No. 27).