ࡱ> jli_ dSbjbj GbbKD  xxxxx8d(|$H!#R9x9xxN---^xx---}-|d0L$oBL$L$xH-99|L$ >: 01-001 DEPARTMENT OF AGRICULTURE, CONSERVATION AND FORESTRY DIVISION OF INSPECTIONS Chapter 311: COMMERCIAL FEED SUMMARY: Provides manufacturer and/or distributor of commercial feeds information as to how feed ingredients and/or mixtures shall be labeled as to guarantees, listing of ingredients, drugs and feed additives, use and cautionary statements and any other information as to limitations and/or prohibitions that may be necessary to protect man and animal. 1. Definitions and Terms A. The names and definitions for commercial feeds shall be the Official Definition of Feed Ingredients adopted by the Association of American Feed Control Officials, except as the Commissioner designates otherwise in specific cases. B. The terms used in reference to commercial feeds shall be the Official Feed Terms adopted by the Association of American Feed Control Officials, except as the Commissioner designates otherwise in specific cases. C. The following commodities are hereby declared exempt from the definition of commercial feed, under the provisions of Section 712 (2) of the Act: hay, straw, stover, silages, cobs, husks, and hulls when unground and when not mixed or intermixed with other materials: Provided that these commodities are not adulterated within the meaning of Section 717 (1), of the Act. 2. Label Format Commercial feeds shall be labeled with the information prescribed in this regulation on the principal display panel of the product and in the following general format: A. Net weight B. Product name and brand name if any C. If drugs are used: 1. The word "medicated" shall appear directly following and below the product name in type size no smaller than one half the type size of the product name. 2. The purpose of medication (claim statement). 3. The required direction for use and precautionary statements or reference to their location if the detailed feeding directions and precautionary statements required by Regulations 6 and 7 appear elsewhere on the label. 4. An active drug ingredient statement listing the active drug ingredients by their established name and the amounts in accordance with Regulation 4 D. D. The guaranteed analysis of the feed as required under the provisions of Section 715 (1) (C) of the Act include the following items, unless exempted in 8 of this subsection, and in the order listed: 1. Minimum percentage of crude protein. 2. Maximum percentage of equivalent protein from non-protein nitrogen as required in Regulation 4 E. 3. Minimum percentage of crude fat. 4. Maximum percentage of crude fiber. 5. Minerals, to include, in the following order: a, minimum and maximum percentages of calcium (Ca), b, minimum percentages of phosphorus (P), c, minimum and maximum percentages of salt (NaCl), and d, other minerals. 6. Vitamins in such terms as specified in Regulation 4 C. 7. Total Sugars as Invert on dried molasses products or products being sold primarily for their molasses content. 8. Exemptions a. Guarantees for minerals are not required when there are no specific label claims and when the commercial feed contains less than 6(% of mineral elements. b. Guarantees for vitamins are not required when the commercial feed is neither formulated for nor represented in any manner as a vitamin supplement. c. Guarantees for crude protein, crude fat, and crude fiber are not required when the commercial feed is intended for purposes other than to furnish these substances or they are of minor significance relating to the primary purpose of the product, such as drug premixes, mineral or vitamin supplements, and molasses. E. Feed ingredients, collective terms for the grouping of feed ingredients, or appropriate statements as provided under the provisions of Section 715 (1) (D) of the Act. 1. The name of each ingredient as defined in the Official Definitions of Feed Ingredients published in the Official Publication of the Association of American Feed Control Officials, common or usual name, or one approved by the Commissioner. 2. Collective terms for the grouping of feed ingredients as defined in the Official Definitions of Feed Ingredients published in the Official Publication of the Association of American Feed Control Officials in lieu of the individual ingredients; Provided that: a. When a collective term for a group of ingredients is used on the label, individual ingredients within that group shall not be listed on the label. b. The manufacturer shall provide the feed control official, upon request, with a listing of individual ingredients, within a defined group, that are or have been used at manufacturing facilities distributing in or into the state. F. Name and principal mailing address of the manufacturer or person responsible for distributing the feed. The principal mailing address shall include the street address, city, state and zip code; however, the street address may be omitted if it is shown in the current city directory or telephone directory. G. The information required in Section 715 (1) (A)-(E) of the Act must appear in its entirety on one side of the label or on one side of the container. The information required by Section 715 (1) (F)-(G) of the Act shall be displayed in a prominent place on the label or container but not necessarily on the same side as the above information. When the information required by Section 715 (1) (F)-(G) is placed on a different side of the label or container, it must be referenced on the front side with a statement such as "see back of label for directions for use". None of the information required by Section 715 of the Act shall be subordinated or obscured by other statements or designs. 3. Brand and Product Names A. The brand or product name must be appropriate for the intended use of the feed and must not be misleading. If the name indicates the feed is made for a specific use, the character of the feed must conform therewith. A mixture labeled "Dairy Feed", for example, must be suitable for that purpose. B. Commercial, registered brand or trade names are not permitted in guarantees or ingredient listings. C. The name of a commercial feed shall not be derived from one or more ingredients of a mixture to the exclusion of other ingredients and shall not be one representing any components of a mixture unless all components are included in the name: Provided, that if any ingredient or combination of ingredients is intended to impart a distinctive characteristic to the product which is of significance to the purchaser, the name of that ingredient or combination of ingredients may be used as a part of the brand name or product name if the ingredient or combination of ingredients is quantitatively guaranteed in the guaranteed analysis, and the brand or product name is not otherwise false or misleading. D. The word "protein" shall not be permitted in the product name of a feed that contains added non-protein nitrogen. E. When the name carries a percentage value, it shall be understood to signify protein and/or equivalent protein content only, even though it may not explicitly modify the percentage with the word "protein": Provided, That other percentage values may be permitted if they are followed by the proper description and conform to good labeling practice. When a figure is used in the brand name (except in mineral, vitamin, or other products where the protein guarantee is nil or unimportant), it shall be preceded by the word "number" or some other suitable designation. F. Single ingredient feeds shall have a product name in accordance with the designated definition of feed ingredients as recognized by the Association of American Feed Control Officials unless the Commissioner designates otherwise. G. The word "vitamin", or a contraction thereof, or any word suggesting vitamin can be used only in the name of a feed which is represented to be a vitamin supplement, and which is labeled with the minimum content of each vitamin declared, as specified in Regulation 4 C. H. The term "mineralized" shall not be used in the name of a feed, except for "TRACE MINERALIZED SALT". When so used, the product must contain significant amounts of trace minerals which are recognized as essential for animal nutrition. I. The term "meat" and "meat by-products" shall be qualified to designate the animal from which the meat and meat by-products is derived unless the meat and meat by-products are from cattle, swine, sheep and goats. 4. Expression of Guarantees A. The guarantees for crude protein, equivalent protein from non-protein nitrogen, crude fat, crude fiber and mineral guarantees (when required) will be in terms of percentage by weight. B. Commercial feeds containing 6(% or more mineral elements shall include in the guaranteed analysis the minimum and maximum percentages of Calcium (Ca), the minimum percentage of phosphorus (P), and if salt is added, the minimum and maximum percentage of salt (NaCl). Minerals, except salt (NaCl), shall be guaranteed in terms of percentage of the element. When calcium and/or salt guarantees are given in the guaranteed analysis such shall be stated and conform to the following: 1. When the minimum is 5.0% or less, the maximum shall not exceed the minimum by more than one percentage point. 2. When the minimum is above 5.0%, the maximum shall not exceed the minimum by more than 20% and in no case shall the maximum exceed the minimum by more than 5 percentage points. C. Guarantees for minimum vitamin content of commercial feeds and feed supplements, when made, shall be stated on the label in milligrams per pound of feed except that: 1. Vitamin A, other than precursors of vitamin A, shall be stated in USP units per pound. 2. Vitamin D, in products offered for poultry feeding, shall be stated in International Chick Units per pound. 3. Vitamin D for other uses shall be stated in USP units per pound. 4. Vitamin E shall be stated in International or USP units per pound. 5. Guarantees for vitamin content on the label of a commercial feed shall state the guarantees as true vitamins, not compounds, with the exception of the compounds, Pyridoxine Hydrochloride, Choline Chloride, Thiamine, and d-Pantothenic Acid. 6. Oils and premixes containing vitamin A or Vitamin D or both may be labeled to show vitamin content in terms of units per gram. D. Guarantees for drugs shall be stated in terms of percent by weight, except: 1. Antibiotics present at less than 2,000 grams per ton (total) of commercial feed shall be stated in grams per ton of commercial feed. 2. Antibiotics present at more than 2,000 grams per ton (total) of commercial feed shall be stated in grams per pound of commercial feed. 3. Labels for commercial feeds containing growth promotion and/or feed efficiency levels of antibiotics, which are to be fed continuously as the sole ration, are not required to make quantitative guarantees except as specifically noted in the Federal Food Additive Regulations for certain antibiotics, wherein, quantitative guarantees are required regardless of the level or purpose of the antibiotic. 4. The term "milligrams per pound" may be used for drugs or antibiotics in those cases where a dosage is given in "milligrams" in the feeding directions. E. Commercial feeds containing any added non-protein nitrogen shall be labeled as follows: 1. Complete feeds, supplements, and concentrates containing added nonprotein nitrogen and containing more than 5% protein from natural sources shall be guaranteed as follows: Crude Protein, minimum, % (This includes not more than % equivalent protein from non-protein nitrogen). 2. Mixed feed concentrates and supplements containing less than 5% protein from natural sources may be guaranteed as follows: Equivalent Crude Protein from Non-Protein Nitrogen, minimum, %. 3. Ingredient sources of non-protein nitrogen such as Urea, Diammonium Phosphate, Ammonium Polyphosphate Solution, Ammoniated Rice Hulls, or other basic non-protein nitrogen ingredients defined by the Association of American Feed Control Officials shall be guaranteed as follows: Nitrogen, minimum, % Equivalent Crude Protein from Non-Protein Nitrogen, minimum, %. F. Mineral phosphatic materials for feeding purposes shall be labeled with the guarantee for minimum and maximum percentage of calcium (when present), the minimum percentage of phosphorus, and the maximum percentage of fluorine. 5. Ingredients A. The name of each ingredient or collective term for the grouping of ingredients, when required to be listed, shall be the name as defined in the Official Definitions of Feed Ingredients as published in the Official Publication of American Feed Control Officials, the common or usual name, or one approved by the Commissioner. B. The name of each ingredient must be shown in letters or type of the same size. C. No reference to quality or grade of an ingredient shall appear in the ingredient statement of a feed. D. The term "dehydrated" may precede the name of any product that has been artificially dried. E. A single ingredient product defined by the Association of American Feed Control Officials is not required to have an ingredient statement. F. Tentative definitions for ingredients shall not be used until adopted as official, unless no official definition exists or the ingredient has a common accepted name that requires no definition, (i.e. sugar). G. When the word "iodized" is used in connection with a feed ingredient, the feed ingredient shall contain not less than 0.007% iodine, uniformly distributed. 6. Directions for Use and Precautionary Statements A. Directions for use and precautionary statements on the labeling of all commercial feeds and customer-formula feeds containing additives (including drugs, special purpose additives, or non-nutritive additives) shall be adequate: 1. To enable safe and effective use for the intended purposes by users with no special knowledge of the purpose and use of such articles; and, 2. Shall include, but not be limited to, all information prescribed by all applicable regulations under the Federal Food, Drug and Cosmetic Act. B. Adequate directions for use and precautionary statements are required for feeds containing non-protein nitrogen as specified in Regulation 7. C. Adequate directions for use and precautionary statements necessary for safe and effective use are required on commercial feeds distributed to supply particular dietary needs or for supplementing or fortifying the usual diet or ration with any vitamin, mineral, or other dietary nutrient or compound. 7. Non-Protein Nitrogen A. Urea and other non-protein nitrogen products defined in the Official Publication of the Association of American Feed Control Officials are acceptable ingredients only in commercial feeds for ruminant animals as a source of equivalent crude protein and are not to be used in commercial feeds for other animals and birds. B .If the commercial feed contains more than 8.75% of equivalent crude protein from all forms of non-protein nitrogen, added as such, or the equivalent crude protein from all forms of non-protein nitrogen added as such, exceeds one third of the total crude protein, the label shall bear adequate directions for the safe use of feeds and a precautionary statement: "CAUTION: USE AS DIRECTED" The directions for use and the caution statement shall be in type of such size so placed on the label that they will be read and understood by ordinary persons under customary conditions of purchase and use. C. On labels such as those for medicated feeds which bear adequate feeding directions and/or warning statements, the presence of added non-protein nitrogen shall not require a duplication of the feeding directions or the precautionary statements as long as those statements include sufficient information to ensure the safe and effective use of this product due to the presence of non-protein nitrogen. 8. Drug and Feed Additives A. Prior to approval of a registration application and/or approval of a label for commercial feed which contain additives (including drugs, other special purpose additives, or non-nutritive additives) the distributor may be required to submit evidence to prove the safety and efficacy of the commercial feed when used according to the directions furnished on the label. B. Satisfactory evidence of safety and efficacy of a commercial feed may be: 1. When the commercial feed contains such additives, the use of which conforms to the requirements of the applicable regulation in the Code of Federal Regulations, Title 21, or which are "prior sanctioned" or "generally recognized as safe" for such use, or 2. When the commercial feed is itself a drug as defined in Section 712 (7) of the Act and is generally recognized as safe and effective for the labeled use or is marketed subject to an application approved by the Food and Drug Administration under Title 21 U.S.C. 360(b). 9. Adulterants A. For the purpose of Section 717 (1) (A) of the Act, the terms "poisonous or deleterious substances" include but are not limited to the following: 1. Fluorine and any mineral or mineral mixture which is to be used directly for the feeding of domestic animals and in which the fluorine exceeds 0.30% for cattle; 0.35% for sheep; 0.45% for swine; and 0.60% for poultry. 2. Fluorine bearing ingredients when used in such amounts that they raise the fluorine content of the total ration-above the following amounts: 0.009% for cattle; 0.01% for sheep; 0.014% for swine; and 0.035% for poultry. 3. Soybean meal, flakes or pellets or other vegetable meals, flakes or pellets which have been extracted with trichlorethylene or other chlorinated solvents. 4. Sulfur dioxide, Sulfurous acid, and salts of Sulfurous acid when used in or on feeds or feed ingredients which are considered or reported to be a significant source of vitamin B1 (Thiamine). B. All screenings or by-products of grains and seeds containing weed seeds, when used in commercial feed or sold as such to the ultimate consumer, shall be ground fine enough or otherwise treated to destroy the viability of such weed seeds so that the finished product meets the restrictions for primary and secondary noxious weed seeds as stated in the fb88 Seed Law. 10. Good Manufacturing Practices A. For the purposes of enforcement of Section 717 (4) of the Act the Commissioner adopts the following as current good manufacturing practices: 1. The regulations prescribing good manufacturing practices for medicated feeds as published in the Code of Federal Regulations, Title 21, Part 133, Sections 133.100-133.110. 2. The regulations prescribing good manufacturing practices for medicated premixes as published in the Code of Federal Regulations, Title 21, Part 133, Sections 133.200-133.210. 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