Section 2805 - Technical Additives(a) General Provisions.(1) Technical Additives are substances added to feed during manufacturing that assist in the production of feed. Examples include, but are not limited to: acidifying agent, additives for biofuel processes that generate co-products used for feed, anticaking agents, anti-gel, antioxidant, binding agent, bioengineered yeast (biofuel), carrier, clear grease, diluent, dispersant, dust control, emulsifiers, flocculating agents, lubricant, pelleting aids, pH modulation, precipitating agent, preservative, processing aid, recover proteinaceous material, sequestrants, solubilizer, stabilizers, surfactant, suspension aid, and thickener.(b) Aluminum sulfate (21 CFR 582.1125). Classification Under Food Additives Amendment: Anti-gelling agent for molasses, dewater of beetpulp. Limitations or Restrictions: In accordance with good manufacturing practices.(c) Attapulgite clay. Classification Under Food Additives Amendment: Anti-caking agent and pelleting aid. Suspension aid in liquid feed supplement. Limitations or Restrictions: Not to exceed 2.0 percent. Not to exceed 2.5 percent in supplement. GRAS in non-medicated feeds as binder or pelleting aid when used in accordance with good manufacturing practices and do not exceed the limitations listed. Not prohibited in medicated feeds for the same purpose and at the same level when it can be demonstrated that it does not interfere with the analysis of the drug by acceptable methods.(d) Calcium aluminates. Classification Under Food Additives Amendment: Pellet binder. Limitations or Restrictions: Maximum of two (2) percent in poultry, swine, and rodent feeds, and a maximum of one (1) percent in feed for all other species.(e) Calcium silicate (21 CFR 573.260). Classification Under Food Additives Amendment: Anti-caking agent. Limitations or Restrictions: Not to exceed two (2) percent.(f) Calcium stearate (21 CFR 573.280 (feed grade)). Classification Under Food Additives Amendment: Anti-caking agent. Limitations or Restrictions: In accordance with good manufacturing practices.(g) Chondrus extract (21 CFR 582.7255). Classification Under Food Additives Amendment: Stabilizer. Limitations or Restrictions: In accordance with good manufacturing practices.(h) Diacetyl tartaric acid esters of mono and diglycerides of edible fats or oils, or edible fat-forming fatty acids (21 CFR 582.4101). Classification Under Food Additives Amendment: Emulsifying agent. Limitations or Restrictions: In accordance with good manufacturing practices.(i) Diatomaceous earth (21 CFR 573.340). Classification Under Food Additives Amendment: Inert carrier and anti-caking agent. Limitations or Restrictions: Not to exceed two (2) percent of total ration.(j) Disodium EDTA (21 CFR 573.360). Classification Under Food Additives Amendment: To solubilize trace minerals in aqueous solutions. Limitations or Restrictions: Not to exceed 0.024 percent (240 parts per million) in finished feed.(k) Ethoxylated mono and diglycerides (21 CFR 172.834). Classification Under Food Additives Amendment: Emulsifier. Limitations or Restrictions: Not to exceed 0.5 percent in dry milk replacers.(l) Ethyl cellulose (21 CFR 573.420). Classification Under Food Additives Amendment: Binder or filler in dry vitamin preparations.(m) Fumaric acid. Classification Under Food Additives Amendment: pH adjuster, preservative, or flavoring agent. Limitations or Restrictions: Not to exceed 0.5 percent of the diet.(n) Guar gum (mucilage) (21 CFR 582.7339). Classification Under Food Additives Amendment: Stabilizer. Limitations or Restrictions: In accordance with good manufacturing practices.(o) Hydrophobic silica (21 CFR 584.700). Classification Under Food Additives Amendment: Anti-caking free flow agent. Limitations or Restrictions: Not to exceed five (5) percent in vitamin preparations.(p) Iron ammonium citrate (21 CFR 573.560). Classification Under Food Additives Amendment: Anti-caking agent in salt. Limitations or Restrictions: Not to exceed 0.0025 percent (25 parts per million) in the finished salt.(q) Kaolin. Classification Under Food Additives Amendment: Anti-caking agent (in non-medicated feeds). Limitations or Restrictions: Not to exceed 2.5 percent in finished feed. GRAS in non-medicated feeds as binder or pelleting aid when used in accordance with good manufacturing practices and do not exceed the limitations listed. Not prohibited in medicated feeds for the same purpose and at the same level when it can be demonstrated that it does not interfere with the analysis of the drug by acceptable methods.(r) Lecithin (21 CFR 582.1400). Classification Under Food Additives Amendment: Stabilizer. Limitations or Restrictions: In accordance with good manufacturing practices.(s) Locust bean gum (Carob bean gum) (21 CFR 582.7343). Classification Under Food Additives Amendment: Stabilizer. Limitations or Restrictions: In accordance with good manufacturing practices.(t) Magnesium stearate. Classification Under Food Additives Amendment: Die lubricating and release agent in the tableting process. Limitations or Restrictions: In accordance with good manufacturing practices.(u) Methyl glucoside Coconut oil ester (21 CFR 573.660). Classification Under Food Additives Amendment: Surfactant in molasses. Limitations or Restrictions: Not to exceed 0.032 percent (320 parts per million) in the molasses.(v) Mineral oil (21 CFR 573.680). Classification Under Food Additives Amendment: To reduce dustiness of feed or mineral supplements, to serve as a lubricant in the preparation of pellets, cubes, and blocks, to improve resistance to moisture of such pellets, cubes, and blocks, and to prevent segregation of trace minerals in mineralized salt. Limitations or Restrictions: Not to exceed three (3) percent in mineral supplements. Not to exceed 0.06 percent of the total ration. To serve as a diluent carrier in the manufacture of feed grade biuret.(w) Mono and diglycerides of edible fats or oils, or edible fat-forming acids. (21 CFR 582.4505). Classification Under Food Additives Amendment: Emulsifying agent. Limitations or Restrictions: In accordance with good manufacturing practices.(x) Monosodium phosphate derivatives of mono and diglycerides of edible fats or oils, or edible fat-forming fatty acids (21 CFR 582.4521). Classification Under Food Additives Amendment: Emulsifying agent. Limitations or Restrictions: In accordance with good manufacturing practices.(y) Montmorillonite clays. Classification Under Food Additives Amendment: Anti-caking aid, pelleting aid, and non-nutritive carrier. Limitations or Restrictions: Not to exceed two (2) percent of the finished material. GRAS in non-medicated feeds as binder or pelleting aid when used in accordance with good manufacturing practices and do not exceed the limitations listed. Not prohibited in medicated feeds for the same purpose and at the same level when it can be demonstrated that it does not interfere with the analysis of the drug by acceptable methods.(z) Paraffin. Classification Under Food Additives Amendment: Dust control agent. Limitations or Restrictions: Not to exceed three (3) percent in mineral supplements. Not to exceed 0.06 percent of the total ration.(aa) Petrolatum or a combination of mineral oil and petrolatum (21 CFR 573.720). Classification Under Food Additives Amendment: To reduce dustiness of feed or mineral supplements; to serve as a lubricant in the preparation of pellets, cubes, and blocks; to improve resistance to moisture of such pellets, cubes, and blocks. Limitations or Restrictions: Not to exceed three (3) percent in mineral supplements. Not to exceed 0.06 percent of the total ration.(bb) Petroleum jelly (21 CFR 573.720). Classification Under Food Additives Amendment: Dust control agent in mineral mixes. Limitations or Restrictions: Not to exceed three (3) percent in mineral supplements. Not to exceed 0.06 percent of the total ration.(cc) Polyethylene glycol (400) mono and dioleate (21 CFR 573.800). Classification Under Food Additives Amendment: Processing aid when present as a result of its additions to molasses. Limitations or Restrictions: Not to exceed 0.025 percent (250 parts per million) in the molasses.(dd) Polyoxyethylene glycol (400) mono and dioleates (21 CFR 573.820). Classification Under Food Additives Amendment: Emulsifier. Limitations or Restrictions: Calf milk replacers.(ee) Polysorbate 80 (21 CFR 573.860). Classification Under Food Additives Amendment: Emulsifier. Limitations or Restrictions: Calf milk replacers. Vitamin and mineral premixes.(ff) Polysorbate 60 (Polyoxy ethylene (20) sorbitan monostearate) (21 CFR 573.840). Classification Under Food Additives Amendment: Emulsifier. Limitations or Restrictions: Calf milk replacers and mineral premixes.(gg) Polyvinyl alcohol. Classification Under Food Additives Amendment: Processing aid for dry granular feed enzymes. Limitations or Restrictions: Not to exceed 200 milligrams per kilogram in finished feed.(hh) Propylene glycol (21 CFR 582.1666). Classification Under Food Additives Amendment: Emulsifying agent. Limitations or Restrictions: GRAS.(ii) Sodium carboxymethyl-cellulose (21 CFR 582.1745). Classification Under Food Additives Amendment: Stabilizer. Limitations or Restrictions: Not to exceed two (2) percent in finished feed.(jj) Sorbitan mono-stearate with or without polysorbate 60 (21 CFR 573.960). Classification Under Food Additives Amendment: Emulsifier in mineral premixes and dietary supplement for animal feed. Limitations or Restrictions: In accordance with good manufacturing practices.(kk) Stearic acid (21 CFR 172.860). Classification Under Food Additives Amendment: Lubricant/binder in tablets and pellets. Limitations or Restrictions: Not to exceed three (3) percent (weight/weight) in finished feed.(ll) Talc. Classification Under Food Additives Amendment: Die lubricant, finishing agent, and anti-caking agent. Limitations or Restrictions: Not to exceed two (2) percent in the finished feed. Not to exceed 10 percent as a carrier in animal feed premixes.(mm) Tara gum. Classification Under Food Additives Amendment: Thickener, stabilizer in dry powdered and reconstituted liquid calf milk replacers. Limitations or Restrictions: Up to 0.25 percent in dry powdered calf milk replacer, or 0.04 percent in reconstituted liquid calf milk replacer.(nn) Tetra sodium pyrophosphate. (21 CFR 582.6789). Classification Under Food Additives Amendment: Dispersant. Limitations or Restrictions: In accordance with good manufacturing practices.(oo) Yellow prussiate of soda (21 CFR 573.1020). Classification Under Food Additives Amendment: Anti-caking agent in salt. Limitations or Restrictions: Not to exceed 0.0013 percent (13 parts per million).(pp) Acidifiers. (1) Ammonium Formate (21 CFR 573.170). The food additive ammonium formate may be safely used in the manufacture of complete swine feeds in accordance with the following prescribed conditions: (A) The additive is manufactured by the reaction of 99.5 percent ammonia gas and 99 percent formic acid in a continuous loop reactor to produce a solution made up of 37 percent ammonium salt of formic acid and 62 percent formic acid.(B) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine feeds at levels not to exceed 1.2 percent of the complete feed.(C) To ensure safe use of the additive, formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.(D) To assure safe use of the additive, in addition to the other information required by the FD&C, the label and labeling shall contain: The name of the additive. Adequate directions for use including a statement that ammonium formate must be uniformly applied and thoroughly mixed into complete swine feeds and that the complete swine feeds so treated shall be labeled as containing ammonium formate. Cautions for use including this statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.(E) To assure safe use of the additive, in addition to the other information required by the FD&C and this section, the label and labeling shall contain: Appropriate warnings and safety precautions concerning ammonium formate (37 percent ammonium salt of formic acid and 62 percent formic acid). Statements identifying ammonium formate in formic acid (37 percent ammonium salt of formic acid and 62 percent formic acid) as a corrosive and possible severe irritant. Information about emergency aid in case of accidental exposure as follows: Statements reflecting requirements of applicable sections of the Superfund Amendments and Reauthorization Act (SARA), and the Occupational Safety and Health Administration's (OSHA) human safety guidance regulations. Contact address and telephone number for reporting adverse reactions or to request a copy of the Safety Data Sheet (SDS).(2) Benzoic Acid (21 CFR 573.210). The food additive benzoic acid may be safely used in the manufacture of complete swine feeds in accordance with the following prescribed conditions: (A) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine feeds at levels not to exceed 0.5 percent of the complete feed.(B) The additive consists of not less than 99.5 percent benzoic acid (CAS 65-85-0) by weight with the sum of 2-methylbiphenyl, 3-methylbiphenyl, 4-methylbiphenyl, benzyl benzoate, and isomers of dimethylbiphenyl not to exceed 0.01 percent by weight.(C) To assure safe use of the additive, in addition to the other information required by the FD&C and this section, the label and labeling shall contain: The name of the additive; Adequate directions for use, including a statement that benzoic acid must be uniformly applied and thoroughly mixed into complete swine feeds and that the complete swine feeds so treated shall be labeled as containing benzoic acid; Appropriate warnings and safety precautions concerning benzoic acid; A warning statement identifying benzoic acid as a possible irritant; Information about emergency aid in case of accidental exposure; and Contact address and telephone number for reporting adverse reactions or to request a copy of the Material Safety Data Sheet (MSDS).(3) Formic Acid (21 CFR 573.480) is manufactured by heating carbon dioxide and NaOH under pressure and decomposing the resulting sodium formate with H2SO4; the resulting formic acid, CH2O2, has a molecular weight of 46.02. The food additive formic acid may be safely used in accordance with the following conditions:(A) The additive is used as a preservative in hay crop silage in an amount not to exceed 2.25 percent of the silage on a dry weight basis or 0.45 percent when direct cut, as follows: The top foot of silage stored should not contain formic acid and Silage should not be fed to livestock within four (4) weeks of treatment.(B) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine and poultry feeds at levels not to exceed 1.2 percent of the complete feed. The additive consists of not less than 85 percent formic acid (CAS 64-18-6). (i) The additive meets the following specifications:(a) Free methyl alcohol not to exceed 1,000 parts per million;(b) Methyl formate not to exceed 1,000 parts per million; and(c) Moisture not to exceed 15 percent.(ii) To assure safe use of the additive, formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.(C) To assure safe use of the additive, in addition to the other information required by the FD&C, the label and labeling shall contain: The name of the additive. Adequate directions for use including a statement that formic acid must be uniformly applied and thoroughly mixed into complete feeds and that the complete feeds so treated shall be labeled as containing formic acid. Cautions for use including this statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.(D) To ensure safe use of the additive, in addition to the other information required by the FD&C and this section, the label and labeling shall contain: Appropriate warnings and safety precautions concerning formic acid (85 percent formic acid). Statements identifying formic acid (85 percent formic acid) as a corrosive and possible severe irritant. Information about emergency aid in case of accidental exposure. Statements reflecting requirements of applicable sections of the Superfund Amendments and Reauthorization Act (SARA), and the Occupational Safety and Health Administration's (OSHA) human safety guidance regulations. Contact address and telephone number for reporting adverse reactions or to request a copy of the Safety Data Sheet (SDS).(4) Feed Grade Sodium Formate (21 CFR 573.696). The food additive feed grade sodium formate may be safely used in the manufacture of complete swine and poultry feeds in accordance with the following prescribed conditions:(A) The additive is manufactured by the reaction of 99 percent formic acid and 50 percent sodium hydroxide in water to produce a solution made up of at least 20.5 percent sodium salt of formic acid and not more than 61 percent formic acid.(B) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine and poultry feeds at levels not to exceed 1.2 percent of the complete feed.(C) To assure safe use of the additive, formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.(D) To assure safe use of the additive, in addition to the other information required by the FD&C, the label and labeling shall contain: The name of the additive. Adequate directions for use, including a statement that feed grade sodium formate must be uniformly applied and thoroughly mixed into complete feeds and that the complete feeds so treated shall be labeled as containing feed grade sodium formate. Cautions for use including this statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.(E) To assure safe use of the additive, in addition to the other information required by the FD&C and this section, the label and labeling shall contain: Appropriate warnings and safety precautions concerning feed grade sodium formate. Statements identifying feed grade sodium formate as a corrosive and possible severe irritant. Information about emergency aid in case of accidental exposure as follows: Statements reflecting requirements of applicable sections of the Superfund Amendments and Reauthorization Act (SARA), and the Occupational Safety and Health Administration (OSHA) human safety guidance regulations. Contact address and telephone number for reporting adverse reactions or to request a copy of the Material Safety Data Sheet (MSDS).(qq) Antimicrobial Agents. (1) Formaldehyde (21 CFR 573.460). The food additive formaldehyde may be safely used in the manufacture of animal feeds in accordance with the following conditions:(A) The additive is used, or intended for use, to improve the handling characteristics of animal fat in combination with certain oilseed meals by producing them from a dry, free-flowing product as follows: (i) For animal fat in combination with certain oilseed meals, as a component of dry, nonpelleted feeds for beef and non-lactating dairy cattle.(a) For aqueous blend of soybean and sunflower meals in a ratio of 3:1, respectively, is mixed with animal fat such that the oilseed meals and animal fat are in a ratio of 3:2.(b) Formaldehyde (37 percent solution) is added to the mixture at a level of four (4) percent of the dry matter weight of the oilseed meals and animal fat. This mixture, upon drying, contains not more than one (1) percent formaldehyde and not more than 12 percent moisture.(c) To assure the safe use of the additive, in addition to the other information required by the FD&C, the label and labeling of the dried mixture shall bear: The name of the additive. Adequate directions for use providing that the feed as consumed does not contain more than 25 percent of the mixture.(ii) For soybean and canola seeds and/or meals to which there may be added vegetable oil as a component of dry, nonpelleted feeds for beef and dairy cattle, including lactating dairy cattle. (a) An aqueous blend of oilseed and/or meals, with or without added vegetable oil, in a ratio such that, on a dry matter basis, the final protein level will be 25 to 35 percent and the fat content will be 20 to 45 percent.(b) Formaldehyde (37 percent solution) is added to the mixture at a level of 2.7 percent of the dry matter weight basis of the oilseeds and/or meals and the vegetable oil. This mixture, upon drying, contains not more than 0.5 percent formaldehyde and not more than 12 percent moisture.(c) To assure the safe use of the additive, in addition to the other information required by the FD&C, the label and labeling of the dried mixture shall bear: The name of the additive. The statement, "This supplement is not to exceed 12.5 percent of the total ration. Dietary calcium and magnesium levels should be considered when supplementing the diet with fat." The minimum and maximum levels of crude fat must be guaranteed and must be between -5 percent and +5 percent of the analyzed fat content for each batch.(B) The food additive is formaldehyde (CAS No. 50-00-0; 37 percent aqueous solution). It is used at a rate of 5.4 pounds (2.5 kilograms) per ton of animal feed or feed ingredient. It is an antimicrobial agent used to maintain complete animal feeds or feed ingredients Salmonella negative for up to 21 days. (i) To assure safe use of the additive, in addition to the other information required by the FD&C, the label and labeling shall contain: The name of the additive. A statement that formaldehyde solution which has been stored below 40 degrees Fahrenheit or allowed to freeze should not be applied to complete animal feeds or feed ingredients. Adequate directions for use including a statement that formaldehyde should be uniformly sprayed on and thoroughly mixed into the complete animal feeds or feed ingredients and that the complete animal feeds or feed ingredients so treated shall be labeled as containing formaldehyde. The label must prominently display the statement: "Treated with formaldehyde to maintain feed Salmonella negative. Use within 21 days." The labeling for feed or feed ingredients to which formaldehyde has been added under the provisions of this section is required to carry the following statement: "Treated with formaldehyde to maintain feed Salmonella negative. Use within 21 days."(ii) To assure safe use of the additive, in addition to the other information required by the FD&C, the label and labeling shall contain: Appropriate warnings and safety precautions concerning formaldehyde. Statements identifying formaldehyde as a poison with potentials for adverse respiratory effects. Information about emergency aid in case of accidental inhalation. Statements reflecting requirements of applicable sections of the Superfund Amendments and Reauthorization Act (SARA), and the Occupational Safety and Health Administration's (OSHA) human safety guidance regulations. Contact address and phone number for reporting adverse reactions or to request a copy of the Materials Safety Data Sheet (MSDS).(rr) Anticaking Agents. (1) Bentonite (21 CFR 582.1155) is a naturally occurring mineral consisting primarily of the tri-layered aluminum silicate, montmorillonite. It may contain calcium or sodium as the predominant available or exchange ion. It is used or intended for use in non-medicated animal feed as an anti-caking agent and pelleting aid in an amount not to exceed two (2) percent in total ration. It is not prohibited in medicated animal feed for the same purposes and at the same levels when it can be demonstrated that it does not interfere with the bioavailability of the medicament to animals and the analysis of the feed for the medicament by acceptable methods. It is the manufacturer's responsibility to determine and submit adequate data to support the conclusion that interference does not occur before using it in a feed containing medicaments. Medicaments with which it may currently be used are listed in General Provisions.(2) Castor oil is a triglyceride obtained by the extraction of oil from seeds of the castor bean plant, Ricinus communis. It consists predominately of triglyceride ester of fatty acids. It must meet the specifications in the Food Chemical Codex, 5th Edition, 2004, and be guaranteed for not less than 87 percent ricinoleic acid. Castor oil may be safely used as an anticaking agent, a releasing agent, and as diluent in animal feeds at levels not to exceed 250 parts per million in complete feed.(3) Perlite is the expanded, powdered form of a glassy volcanic rock, consisting essentially of fused sodium potassium aluminum silicate. It meets the specifications of current edition and supplements of the Food Chemicals Codex. It is used as a filter aid or pressing aid in the processing of foods and feed ingredients and also may be used as an anti-caking agent. It may not exceed four (4) percent by weight of the product in which it is present as a processing aid.(4) Pyrophyllite (aluminum silicate monohydrate) (21 CFR 573.900) may be safely used as the sole anticaking aid, blending agent, pelleting aid, or carrier in animal feed when incorporated therein in an amount not to exceed two (2) percent in complete animal feed.(5) Silicon Dioxide. The food additive silicon dioxide may be safely used in animal feed in accordance with the following conditions: The food additive is manufactured by vapor phase hydrolysis or by other means whereby the particle size is such as to accomplish the intended effect. It is used or intended for use as an anticaking agent, antifoaming agent, carrier, and/or grinding aid in animal feed, including ingredients, intermediate premixes, premixes, supplements, concentrates, and complete feed. To ensure safe use of the additive, silicon dioxide is to be used in an amount not to exceed that reasonably required to accomplish its intended effect, and silicon dioxide from all sources cannot exceed two (2) percent by weight of the complete feed. To ensure safe use of the additive, the label and labeling of the additive and ingredients, intermediate premixes, premixes, supplements, concentrates, and complete feed containing the additive shall meet the requirements of the FD&C, including 21 CFR 501 . To ensure safe use of the additive, in addition to the other information required by the FD&C, the label and labeling of the additive and ingredients, intermediate premixes, premixes, supplements, and concentrates containing the additive shall have: A statement of the concentration of the additive. A statement that silicon dioxide from all sources cannot exceed two (2) percent by weight of the complete feed.(6) Sodium Bentonite (21 CFR 582.1155) is a naturally occurring mineral consisting primarily of the tri-layered hydrous aluminum silicate, montmorillonite characterized by a sodium exchange or available ion content of not less than one (1) percent and not more than two (2) percent of the air dried material. It is used or intended for use in non-medicated animal feed as an anti-caking agent and pelleting aid in an amount not to exceed two (2) percent in total ration. To reduce seepage in silage, the amount added would not exceed one (1) percent sodium bentonite. It is not prohibited in medicated animal feed for the same purposes and the same levels when it can be demonstrated that it does not interfere with the bioavailability of the medicament to animals and the analysis of the feed for the medicament by acceptable methods. It is the manufacturer's responsibility to determine and submit adequate data to support the conclusion that interference does not occur before using it in a feed containing medicaments. Medicaments with which it may currently be used are listed in General Provisions.(7) Verxite (exfoliated hydrobiotite) (21 CFR 573.1000), an additive, is a magnesium-aluminum-iron silicate conforming to one of the following: (A) Verxite Granules contain a minimum of 98 percent Hydrobiotite, is thermally expanded and has a bulk density of five (5) to nine (9) pounds per cubic foot. It is used or intended for use in poultry feed at a level not to exceed five (5) percent of the weight of the finished feed as a non-nutritive bulking agent for restricting calorie intake in pullet replacement feeds, or as anticaking or blending agent, pelleting aid, or non-nutritive carrier for the incorporation of nutrients in poultry, swine, or ruminant feeds, in an amount not to exceed that necessary to accomplish its intended effect and in no case to exceed five (5) percent of the final feed.(B) Verxite Flakes contain a minimum of 98 percent Hydrobiotite and has a bulk density of 20 to 30 pounds per cubic foot. It is used or intended for use as an anticaking or blending agent in ruminant feeds in an amount not to exceed that necessary to accomplish its intended effect and in no case to exceed one (1) percent by weight of the final feed for ruminants.(C) Verxite Grits contains a minimum of 80 percent Hydrobiotite. It has a bulk density of from 40 to 50 pounds per cubic foot. It is used or intended for use as a partial roughage replacement in ruminant feeds in an amount not to exceed that necessary to accomplish its intended effect and is in no case to exceed one (1) percent by weight of the final feed. To ensure safe use of the additive, the label of any feed additive supplement, feed additive concentrate, feed additive premix, or complete feed prepared therefrom shall bear, in addition to the other information required by the FD&C, the name of the additive (verxite granules or verxite flakes or verxite grits) and when the additive is present in excess of one (1) percent, a statement of the quantity of the additive contained therein and the term "non-nutritive" in juxtaposition therewith.(8) Iron Tartrates is the reaction product of sodium tartrates [D-, L-, and meso-tartrates] and iron(III) chloride for use as an anticaking agent in salt. The molar ratio of iron(III) to meso-tartrate must be 1:1. It must contain no less than eight (8) percent iron(III) on a dry weight basis. It must contain no more than 1.5 percent oxalic acid, three (3) parts per million arsenic, two (2) parts per million lead, and one (1) parts per million mercury on a dry weight basis. The maximum iron tartrates inclusion rate (calculated as iron) is not more than 12 parts per million.(9) Sodium Aluminosilicate is hydrated sodium aluminum silicate having Na2O:Al2O3:SiO2 in molar ratios of approximately 1:1:13, respectively. It can be naturally occurring or synthetic. It consists of 66.0 to 76.0 percent silicon dioxide; nine (9.0) to 13.0 percent aluminum oxide; and four (4.0) to seven (7.0) percent sodium oxide, on a dry basis. It is used as an anticaking agent not to exceed two (2) percent in finished feed.(ss) Binders. (1) Lignin Sulfonate (21 CFR 573.600) is either one, or a combination of, the ammonium, calcium, magnesium, or sodium salts of the extract of spent sulfite liquor derived from the sulfite digestion of wood or of abaca (Musa textilis) or of Sisal (Agave sisalana) in either a liquid form (moisture not to exceed 50 percent by weight) or dry form (moisture not to exceed six (6) percent by weight). It may be used in animal feed in amounts calculated on a dry weight basis, as: (A) A pelleting aid, in the liquid or dry form, in an amount not to exceed four (4) percent of the finished pellets.(B) A binding aid, in the liquid form, in the flaking of feed grains in an amount not to exceed four (4) percent of the flaked grain.(C) A surfactant in molasses used in feeds, as liquid lignin sulfonate, in an amount not to exceed 11 percent of the molasses.(D) A source of metabolizable energy, in the liquid or dry form, in an amount not to exceed four (4) percent of the finished feed.(2) Sodium Salts of Fatty Acids are obtained by the neutralization of feed grade vegetable origin free fatty acids, or saponification of vegetable oil, or a combination thereof. The specifications of the starting materials must meet the requirements stated in the definitions for Hydrolyzed Vegetable Fats, or Oils, Feed Grade and Vegetable Fat, or Oil, respectively. Sodium hydroxide is used in the neutralization or saponification reactions. The resulting sodium salts are used as a binder and/or lubricant in the pelleted and flaked feed. The source of the fatty acids or vegetable oil shall be indicated on the label. Sodium salts are in dry form with the maximum moisture not to exceed eight (8) percent by weight. It may be used in animal feed in amounts calculated on an "as-is" basis not to exceed 5.5 pounds per ton. Sodium Salts of Fatty Acids shall be labeled with guarantees on an "as-is" basis for no more than 0.5 percent free fatty acids, no more than 12 percent glycerin, not less than 67 percent total sodium salts of fatty acids, and no more than one (1) percent unsaponifiable matter.(3) Potassium Salts of Fatty Acids are obtained by the neutralization of feed grade vegetable origin free fatty acids, or saponification of vegetable oil or a combination thereof. The specifications of the starting materials must meet the requirements stated in the definitions for Hydrolyzed Vegetable Fats, or Oils, Feed Grade and Vegetable Fat, or Oil, respectively. Potassium hydroxide is used in the neutralization or saponification reactions. The resulting potassium salts are used as a binder and/or lubricant in the pelleted and flaked feed. The source of the fatty acids or vegetable oil shall be indicated on the label. Potassium salts are in liquid form with the maximum moisture not to exceed 68 percent by weight. It may be used in animal feed in amounts calculated on an "as-is" basis not to exceed 15.5 pounds per ton. Potassium Salts of Fatty Acids shall be labeled with guarantees on an "as-is" basis for no more than 0.5 percent free fatty acids, no more than 10 percent glycerin, not less than 24 percent total potassium salts of fatty acids, and no more than one (1) percent unsaponifiable matter.(tt) Biofuel Production.(1) Yeast for Production of Distillers Products. The ingredients list of the yeast marketed to the ethanol manufacturer should declare the genus species of the yeast and the enzyme(s) expressed.(A) Saccharomyces cerevisiae expressing glucoamylase from Saccharomycopsis fibuligera for use in dry grind corn fuel ethanol production of distillers coproducts for animal feed. Distillers products for use in animal feed contain no live bioengineered yeast.(B) Saccharomyces cerevisiae expressing pyruvate formate lyase activating enzyme, pyruvate formate lyase, and bifunctional acetaldehyde-CoA/alcohol dehydrogenase from Bifidobacterium adolescentis and a glucoamylase from Saccharomycopsis fibuligera for use in dry grind corn fuel ethanol production of distillers products for animal feed. Distillers products for use in animal feed contain no live bioengineered yeast.(uu) Emulsifiers.(1) Xanthan Gum as per 21 CFR 573.1010 is classified as a food additive as a stabilizer, emulsifier, thickener, suspending agent, or bodying agent in calf milk replacer and liquid feed supplements. Also per informal review processes, it can be used as a suspending agent in plant inoculant products. Maximum inclusion levels are 0.1 percent in calf milk replacers (as fed), and 0.25 percent in liquid feed supplements, and two (2) percent in plant inoculant products.(vv) Floculants. (1) Chitosan is a cationic carbohydrate polymer intended for use as a precipitating agent of proteinaceous material from food processing plants. It is chemically derived by deacetylation of the naturally occurring chitin in crab and shrimp shells. It may be used in an amount not to exceed that necessary to accomplish its intended effect. Chitosan when fed as a component of feed to livestock shall be present at no more than 0.1 percent of the feed. Proteinaceous material coagulated with chitosan must have safety and efficacy data approved before it can be registered or offered for sale.(2) Kraft Lignin and its salts (ammonium, calcium, magnesium or sodium) is obtained from the acid precipitation of lignin from spent black liquor produced in the sulfate digestion process of wood and is dehydrated to less than eight (8) percent moisture by weight. It is used; as an aid in recovering proteinaceous material during the rendering process, limited to 0.1 percent of the crax, in the clarification of spent grease, and as a coating agent for fat soluble vitamins limited to 50 percent of the vitamin premix matrix and three (3) percent of the finished feed.(ww) Nutritional Diluents.(1) Reed-Sedge Peat is a natural, partially decomposed plant material, formed from a mixture of reeds, sedges, grasses and some hypnum mosses occurring in wetlands and containing one third to two thirds peat fibers. It should be dehydrated to a moisture content of not more than 15 percent and be in a state free from all harmful micro-organisms. It is intended for use in animal feed as a carrier for liquid products and premixes or as a nutritional diluent for lowered energy diets at a level not to exceed five (5) percent of the total daily ration.(xx) Pelleting Aids. (1) Hide Glue (Technical Gelatin) is a collagen-based product manufactured only from cattle hide pieces. Maximum moisture is 13.5 percent, maximum ash is four (4) percent and minimum protein is 90 percent. The product is used as a processing aid, pelleting aid, or feed binder, not to exceed two (2) percent of the feed by weight. (Either term, "hide glue" or "technical gelatin," may be used in the ingredient statement.)(2) Rice By-Products Fractions is obtained by screening and aspirating Ground Rice Hulls. It is used primarily as a pelleting aid and is composed of such fine particles of Ground Rice Hulls, Spongy Parenchyma, and minute amounts of Rice Flour, Rice Germ, Pericarp, and Rice Starch as will pass an 80 mesh screen and contain not less than five (5) percent crude protein, 1.5 percent crude fat, and not more than 25 percent crude fiber.(3) Urea Formaldehyde Condensation Polymer is an amino resin that may be used in animal feeds: (a) as a pelleting aid, excluding feed for aquatic species. The free formaldehyde must not exceed 0.1 parts per million in the finished pelleted feed, and(b) as an agent to reduce the solubility and fermentation of soybean meal intended for ruminant feed. It must not exceed one (1) percent of the treated soybean meal.(4) Sodium Hydroxide Lignin Dehydrated is obtained from the acid precipitation of lignin from spent black liquor produced in the sodium hydroxide and steam digestion of wheat straw without a bleaching process. The final product is dried to a powder with less than four (4) percent moisture by weight. It must contain, and be guaranteed for, not less than 83 percent total lignin (including acid insoluble and acid soluble lignins) and not more than 3.5 percent of ash. It is used as a pelleting aid in livestock and poultry feeds in an amount calculated on a dry weight basis not to exceed four (4) percent of the finished pellets.(5) Hydrogenated Glycerides are obtained by hydrogenation of animal fats or vegetable oils and are used as a coating agent for ingredients or a binder and lubricant in pelleting of feed (pelleting aid) of all animal species. The maximum use rate of hydrogenated glycerides is four (4) pounds per ton of complete feed. Specifications of animal fats or vegetable oils used to produce the hydrogenated glycerides must meet the requirements stated in the definitions for Animal Fat and Vegetable Fat, or Oil, respectively. The specification for tallow must specify insoluble impurities not more than 0.15 percent to be consistent with BSE feed regulation 21 CFR 589.2000 and 589.2001, and a guaranteed titer above 40 degrees Celsius. The source of the hydrogenated glycerides must be indicated on the label. The hydrogenated glycerides must contain, and be guaranteed for, not less than 90 percent total ester content, not more than 0.8 percent unsaponifiable matter, not more than 0.001 percent heavy metals, and not more than five (5) of iodine value. The maximum moisture, maximum insoluble matter, maximum free fatty acids, saponification value, and melting range must also be guaranteed on the label. If an antioxidant is used, the common name or names must be indicated on the label, followed by the words "used as a preservative."(yy) Surfactants. (1) Poloxalene (21 CFR 573.760) consists of polyoxypropylene-polyoxyethylene glycol non-ionic block polymer. It may be used as a surfactant for the flaking of feed grain, when added to liquid grain conditioner in an amount not to exceed one (1) percent of the conditioner, and the conditioner is added to the feed grain at a rate of one (1) quart per ton of feed grain.(zz) Tracers.(1) Iron Nickel Tracer the particles resulting from water atomization of high purity iron and nickel. The nickel content of the particles is between 35 percent and 51 percent with the remainder being iron. The particle size of the iron nickel alloy must range between 150 and 300 microns. This ingredient may be used in animal foods as a tracer for other ingredients or premixes present in a finished animal food. The inclusion level of the ingredient must not exceed 10 parts per million in the finished food. The label shall include a maximum nickel guarantee and a caution statement indicating the maximum permitted inclusion level.(2) Colored Graphite Tracer are the particles resulting from the milling of naturally occurring graphite coated with a color additive(s) approved for use in animal food. The graphite must be of feed grade material and may be used in animal food as a colored tracer for other ingredients or premixes present in a finished animal food. The inclusion level of the tracer must not exceed 50 parts per million in the finished food. The label shall include a caution statement indicating the maximum permitted inclusion level.(aaa) Antioxidants.(1) Cashew Nut Shell Liquid is the heat extracted liquid from cashew nut shells to be used as an antioxidant in fats and oils (excluding highly unsaturated oils with iodine value higher than 150) that are suitable for use in animal food. Cashew nut shell liquid can be used at levels up to 6000 milligrams per kilogram in fats and oils. The level of cashew nut shell liquid in complete feed must not exceed 600 milligrams per kilogram. The liquid ingredient must contain, and be guaranteed for, not less than 10 percent cardol, not less than 55 percent cardanol, and not more than one (1) percent moisture.Cal. Code Regs. Tit. 3, § 2805
Note: Authority cited: Sections 407 and 14902, Food and Agricultural Code. Reference: Sections 14992 and 15011, Food and Agricultural Code.
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.