8 CCR 1202-6
Section 1. Legal Authority Section 35-60-109(1), C.R.S.
Section 2. Definitions and Terms (a) These rules incorporate the Official Definitions of Feed Ingredients as published in the 2001 Official Publication of the Association of American Feed Control Officials, Inc. (“AAFCO”), incorporated herein by reference (later amendments not included), except as the Commissioner of Agriculture (“Commissioner”) designates otherwise in specific cases.
(b) These rules incorporate the Official Feed Terms as published in the 2001 Official Publication of AAFCO, incorporated herein by reference (later amendments not included), 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 35-60-102(2) of the Colorado Commercial Feed Law: Raw meat, individual chemical compounds, hay, loose salt, straw, stover, silage, 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 35-60-107, of the Colorado Commercial Feed Law.
(d) The exemption from the definition of commercial feed is removed for an exempted commodity that bears a label listing nutritional claims or guarantees.
(e) “Contract feeder” means a person, who as an independent contractor, feeds commercial feed to animals pursuant to a contract whereby such commercial feed is supplied, furnished or otherwise provided to such person and whereby such person's remuneration is determined all or in part by feed consumption, mortality, profits or amount or quality of product. Section 3. Label Format (a) Commercial feed, other than customer-formula feed, shall be labeled with the information prescribed in this section on the principal display panel of the product and in the following format:
(1) Product name and brand name, if any, as stipulated in section 4(a)(l).
(2) If a drug is used, label as stipulated in section 4(a)(2).
(3) Purpose Statement as stipulated in section 4(a)(3).
(4) Guaranteed analysis as stipulated in section 4(a)(4).
(5) Feed ingredients as stipulated in section 4(a)(5).
(6) Directions for use and precautionary statements as stipulated in section 4(a)(6).
(7) Name and principal mailing address of the manufacturer or person responsible for distributing the feed as stipulated in section 4(a)(7).
(8) Quantity Statement.
(b) The information required in section 3(a)(l)-(5) and (7)-(8) must appear in its entirety on one side of the label or on one side of the container.
(c) The information required by section 3(a)(6) 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 3(a)(6) 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 3 shall be subordinated or obscured by other statements or designs.
(d) Customer-formula feed shall be accompanied with the information prescribed in this section using labels, invoice, delivery ticket, or other shipping document bearing the following information.
(1) The name and address of the manufacturer.
(2) The name and address of the purchaser.
(3) The date of sale or delivery.
(4) The customer-formula feed name and brand name if any.
(5) The product name and net quantity of each registered commercial feed and each other ingredient used in the mixture.
(6) The direction for use and precautionary statements as required by sections 8 and 9.
(7) If a drug containing product is used:
I. The purpose of the medication (claim statement), II. The established name of each active drug ingredient and the level of each drug used in the final mixture expressed in accordance with section 5 (d). Section 4. Label Information.
(a) Commercial feed, other than customer-formula feed, shall be labeled with the information prescribed in this section.
(1) Product name and brand name if any.
I. 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 herewith. A commercial feed for a particular animal class, must be suitable for that purpose.
II. Commercial, registered brand or trade names are not permitted in guarantees or ingredient listings and only in the product name of feeds produced by or for the firm holding the rights to such a name.
III. 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 ingredients or combination of ingredients is quantitatively guaranteed in the guaranteed analysis, and the brand or product name is not otherwise false or misleading.
IV. The word “protein” shall not be permitted in the product name of a feed that contains added non-protein nitrogen.
V. 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. Digital numbers shall not be used in such a manner as to be misleading or confusing to the customer.
VI. Single ingredient feeds shall have a product name in accordance with the designated definition of feed ingredients as recognized by AAFCO unless the Commissioner designates otherwise. VII. 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 section 5(c). VIII. 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.
IX. 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 made from cattle, swine, sheep and goats.
(2) If a drug is used:
I. 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.
II. Purpose statement as required in section 4(a)(3).
III. The purpose of medication (claim statement).
IV. An active ingredient statement listing the active drug ingredients by their established name and the amounts in accordance with section 5 (d).
(3) Purpose Statement I. The statement of purpose shall contain the specific species and animal class(es) for which the feed is intended as defined in section 4 (a) (4).
II. The manufacturer shall have flexibility in describing in more specific and common language the defined animal class, species and purpose while being consistent with the category of animal class defined in section 4(a)(4) which may include, but is not limited to weight range(s), sex, or ages of the animal(s) for which the feed is manufactured.
III. The purpose statement may be excluded from the label if the product name includes a description of the species and animal class(es) for which the product is intended.
IV. The purpose statement of a premix for the manufacture of feed may exclude the animal class and species and state “For Further Manufacture of Feed” if the nutrients contained in the premix are guaranteed and sufficient for formulation into various animal species feeds and premix specifications are provided by the end user of the premix. [This section applicable to commercial feeds regulated under section 4 (a)(4)(X)(b)(10).] V. The purpose statement of a single purpose ingredient blend, such as a blend of animal protein produce, milk products, fat products, roughage products or molasses products may exclude the animal class and species and state “For Further Manufacture of Feed” if the label guarantees of the nutrients contained in the single purpose nutrient blend are sufficient to provide for formulation into various animal species feeds. [This section applicable to commercial feeds regulated under section 4 (a)(4)(X)(b)(10).] VI. The purpose statement of a product shall include a statement of enzyme functionality if enzymatic activity is represented in any manner.
(4) Guarantees - Crude Protein, Equivalent Crude Protein from Non Protein Nitrogen, Amino Acids, Crude Fat, Crude Fiber, Acid Detergent Fiber, Calcium, Phosphorus, Salt and Sodium shall be the sequence of nutritional guarantees when such guarantee is stated. Other required and voluntary guarantees should follow in a general format such that the units of measure used to express guarantees (percentage, parts per million, International Units, etc.) are listed in a sequence that provides a consistent grouping of the units of measure. All guarantees shall be stated on an “as fed” basis.
I. Required guarantees for swine formula feeds (1) Pre-Starter - 2 to 11 pounds (2) Starter -11 to 44 pounds (3) Grower - 44 to 110 pounds (4) Finisher -110 to 242 pounds (market)
(5) Gilts, Sows and Adult Boars (6) Lactating Gilts and Sows b. Guaranteed Analysis for Swine Complete Feeds and Supplements (all animal classes)
(2) Minimum percentage of Lysine (3) Minimum percentage of Crude Fat (4) Maximum percentage of Crude Fiber (5) Minimum and maximum percentage of Calcium (6) Minimum percentage of Phosphorus (7) Minimum and maximum percentage of Salt (if added)
(8) Minimum and maximum percentage of total Sodium shall be (9) Minimum Selenium in parts per million (ppm)
(10) Minimum Zinc in parts per million (ppm)
II. Required guarantees for Formula Poultry Feeds (Broilers, Layers and Turkeys) (1) Layer - Chickens that are grown to produce eggs for food, e.g., table eggs
(2) Broilers - Chickens that are grown for human food.
(3) Broilers, Breeders - Chickens whose offspring are grown for human food (broilers).
(4) Turkeys
b. Guaranteed Analysis for Poultry Complete Feeds and Supplements (all animal classes)
(2) Minimum percentage of Lysine (3) Minimum percentage of Methionine (4) Minimum percentage of Crude Fat (5) Maximum percentage of Crude Fiber (6) Minimum and maximum percentage of Calcium (7) Minimum percentage of Phosphorus (8) Minimum and maximum percentage of Salt (if added)
(9) Minimum and maximum percentage of total Sodium shall be III. Required Guarantees for Beef Cattle Formula Feeds (1) Calves (birth to weaning)
(2) Cattle on Pasture (may be specific as to production stage; e.g. stocker, feeder, replacement heifers, brood cows, bulls, etc.) (3) Feedlot Cattle b. Guaranteed analysis for Beef Complete Feeds and Supplements (all animal classes)
(2) Maximum percentage of equivale/ill/rude protein from Non-Protein Nitrogen (NPN) when added (3) Minimum percentage of Crude Fat (4) Maximum percentage of Crude Fiber (5) Minimum and maximum percentage of Calcium (6) Minimum percentage of Phosphorus (7) Minimum and maximum percentage of Salt (if added)
(8) Minimum and maximum percentage of total Sodium shall be (9) Minimum percentage of Potassium (10) Minimum Vitamin A, other than precursors of Vitamin A, in c. Guaranteed analysis for Beef Mineral Feeds (if added) (1) Minimum and maximum percentage Calcium (2) Minimum percentage of Phosphorus (3) Minimum and maximum percentage of Salt (4) Minimum and maximum percentage of total Sodium shall be (5) Minimum percentage of Magnesium (6) Minimum percentage of Potassium (7) Minimum Copper in parts per million (ppm)
(8) Minimum Selenium in parts per million (ppm)
(9) Minimum Zinc in parts per million (ppm)
(10) Minimum Vitamin A, other than precursors of Vitamin A, in International Units per pound IV. Required Guarantees for Dairy Formula Feeds (1) Veal Milk Replacer - Milk Replacer to be fed for veal production.
(2) Herd Milk Replacer - Milk Replacer to be fed for herd replacement calves.
(3) Starter - Approximately 3 days to 3 months.
(4) Growing Heifers, Bulls and Dairy Beef
(5) Lactating Dairy Cattle (6) Non-Lactating Dairy Cattle b. Guaranteed Analysis for Veal and Herd Replacement Milk Replacer (1) Minimum percentage Crude Protein (2) Minimum percentage Crude Fat (3) Maximum percentage of Crude Fiber (4) Minimum and maximum percentage Calcium (5) Minimum percentage of Phosphorus (6) Minimum Vitamin A, other than precursors of Vitamin A, in c. Guaranteed Analysis for Dairy Cattle Complete Feeds and Supplements (2) Maximum percentage of Equivalent Crude Protein from Non-Protein Nitrogen (NPN) when added (3) Minimum percentage of Crude Fat (4) Maximum percentage of Crude Fiber (5) Maximum percentage of Acid Detergent Fiber (ADF)
(6) Minimum and maximum percentage of Calcium (7) Minimum percentage of Phosphorus (8) Minimum Selenium in parts per million (ppm)
(9) Minimum Vitamin A, other than precursors of Vitamin A, in d. Required Guaranteed Analysis for Dairy Mixing and Pasture Mineral (1) Minimum and maximum percentage of Calcium (2) Minimum percentage of Phosphorus (3) Minimum and maximum percentage of Salt (4) Minimum and maximum percentage of total Sodium shall be (5) Minimum percentage of Magnesium (6) Minimum percentage of Potassium (7) Minimum Selenium in parts per million (ppm)
(8) Minimum Vitamin A, other man the precursors of Vitamin A, in international Units per pound V. Required Guarantees for Equine Formula Feeds (1) Foal (2) Mare (3) Breeding (4) Maintenance b. Guaranteed Analysis for Equine Complete Feeds and Supplements (all animal classes)
(2) Minimum percentage of Crude Fat (3) Maximum percentage of Crude Fiber (4) Minimum and maximum percentage of Calcium (5) Minimum percentage of Phosphorus (6) Minimum Copper in parts per million (ppm)
(7) Minimum Selenium in parts per million (ppm)
(8) Minimum Zinc in parts per million (ppm)
(9) Minimum Vitamin A, other than the precursors of Vitamin A, in c. Guaranteed Analysis for Equine Mineral Feeds (all animal classes) (1) Minimum and maximum percentage of calcium (2) Minimum percentage of phosphorus (3) Minimum and maximum percentage of salt (if added)
(4) Minimum and maximum percentage of sodium shall be guaranteed only when the total sodium exceeds that furnished by the maximum salt guarantee (5) Minimum copper in parts per million (ppm)
(6) Minimum selenium in parts per million (ppm)
(7) Minimum zinc in parts per million (ppm)
(8) Minimum vitamin A, other than precursors of vitamin A, in VI. Required Guarantees for Goat and Sheep Formula Feeds (1) Starter (2) Grower (3) Finisher (4) Breeder (5) Lactating b. Guaranteed Analysis for Goat and Sheep Complete Feeds and Supplements (all animal classes)
(2) Maximum percentage of equivalent crude protein from Non-Protein Nitrogen (NPN) when added (3) Minimum percentage of Crude Fat (4) Maximum percentage of Crude Fiber (5) Minimum and maximum percentage of Calcium (6) Minimum percentage of Phosphorus (7) Minimum and maximum percentage of Salt (if added)
(8) Minimum and maximum percentage of total Sodium shall be (9) Minimum and maximum Copper in parts per million (ppm) (if added, or if total copper exceeds 20 ppm)
(10) Minimum Selenium in parts per million (ppm)
(11) Minimum Vitamin A, other than precursors of Vitamin A, in VII. Required Guarantees for Duck and Geese Formula Feeds (1) Ducks
(2) Geese
b. Guaranteed Analysis for Duck and Geese Complete Feeds and Supplements (for all animal classes)
(2) Minimum percentage of Crude Fat (3) Maximum percentage of Crude Fiber (4) Minimum and maximum percentage of Calcium (5) Minimum percentage of Phosphorus (6) Minimum and maximum percentage of Salt (if added)
(7) Minimum and maximum percentage of total Sodium shall be VII. Required Guarantees for Fish Complete Feeds and Supplements a. Animal Species shall be declared in lieu of animal class (1) Trout (2) Catfish (3) Species other than trout or catfish b. Guaranteed analysis for all Fish Complete Feeds and Supplements (2) Minimum percentage of Crude Fat (3) Maximum percentage of Crude Fiber (4) Minimum percentage of Phosphorus IX. Required Guarantees for Rabbit Complete Feeds and Supplements (1) Grower - 4 to 12 weeks of age (2) Breeder -12 weeks of age and over b. Guaranteed analysis for Rabbit Complete Feeds and Supplements (all animal classes)
(2) Minimum percentage of Crude Fat (3) Minimum and maximum percentage of Crude Fiber (the maximum crude fiber shall not exceed the minimum by more than 5.0 units) (4) Minimum and maximum percentage of Calcium (5) Minimum percentage of Phosphorus (6) Minimum and maximum percentage of Salt (if added)
(7) Minimum and maximum percentage of total Sodium shall be (8) Minimum Vitamin A, other than precursors of Vitamin A, in X. The required guarantees of grain mixtures with or without molasses and feeds other than those described in section 4(a)(4) (I through DQ shall include the following items, unless exempted in section XI, in the order listed:
a. Animal class(es) and species for which the product is intended, b. Guaranteed analysis (1) Minimum percentage Crude Protein (2) Maximum or minimum percentage of equivalent Crude Protein from Non-Protein Nitrogen as required in section 5(e)
(3) Minimum percentage of Crude Fat (4) Maximum percentage of Crude Fiber (5) Minerals in formula feeds, to include in the following order:
(6) Minerals in feed ingredients - as specified by the Official Definitions of Feed Ingredients published in the 2001 Official Publication of AAFCO.
(7) Vitamins in such terms as specified in section 5(c) (8) Total sugars as invert on dried molasses products or products being sold primarily for their sugar content (9) Viable lactic acid producing microorganisms for use in silage in terms specified in section 5(g)
(10) A commercial feed (e.g. vitamin/mineral premix, base mix, etc.) intended to provide a specialized nutritional source for use in the manufacture of other feeds, must state its intended purpose and guarantee those nutrients relevant to such stated purpose.
XI. Exemptions a. A mineral guarantee for feed, excluding those feeds manufactured as complete feeds and for feed supplements intended to be mixed with grain to produce a complete feed for swine, poultry, fish, and veal and herd milk replacers, is not required when:
(1) The feed or feed ingredient is not intended or represented or does not serve as a principal source of that mineral to the animal; or (2) The feed or feed ingredient is intended for non-food producing animals and contains less than 6.5% total mineral, 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.
d. Guarantees for microorganisms are not required when the commercial feed is intended for a purpose other than to furnish these substances or they are of minor significance relating to the primary purpose of the product, and no specific label claims are made, e. The indication for animal class(es) and species is not required on single ingredient products if the ingredient is not intended, represented, or defined for a specific animal class(es) or species.
(5) Feed ingredients, collective terms for the grouping of feed ingredients, or appropriate statements as provided under the provisions of section 35-60-106(l)(e) of the Colorado Commercial Feed Law.
I. The name of each ingredient listed in descending order of predominance by weight and as defined in the Official Definitions of Feed Ingredients published in the Official Publication of AAFCO, common or usual name, or one approved by the Commissioner.
II. Collective terms for the grouping of feed ingredients as defined in the Official Definitions of Feed Ingredients published in the Official Publication of AAFCO, 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 list of individual ingredients, within a defined group, that are or have been used at manufacturing facilities distributing in or into the state.
III. The registrant may affix the statement, “Ingredients as registered with the State” in lieu of ingredient list on the label. The list of ingredients must be on file with the Commissioner. This list shall be made available to the feed purchaser upon request.
(6) Directions for use and precautionary statements or reference to their location if the detailed feeding directions and precautionary statements required by sections 8 and 9 appear elsewhere on the label.
(7) 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, zip code; However, the street address may be omitted if it is shown in the current city directory or telephone directory.
(8) Quantity Statement.
Section 5. Expression of Guarantees (a) The guarantees for crude protein, equivalent crude protein from non-protein nitrogen, lysine, methionine, other amino acids, crude fat, crude fiber and acid detergent fiber shall be in terms of percentage.
(b) Mineral Guarantees (1) When the calcium, salt, and sodium guarantees are given in the guaranteed analysis such shall be stated and conform to the following:
I. When the minimum is below 2.5%, the maximum shall not exceed the minimum by more than 0.5 percentage point.
II. When the minimum is 2.5% but less than 5.0%, the maximum shall not exceed the minimum by more than one percentage point.
III. When the minimum is above 5.0% or greater the maximum shall not exceed the minimum by more than 20% of the minimum and in no case shall the maximum exceed the minimum by more than five percentage points.
(2) When stated, guarantees for minimum and maximum total sodium and salt: minimum potassium, magnesium, sulfur, phosphorus and maximum fluoride shall be in terms of percentage. Other minimum mineral guarantees shall be stated in parts per million (ppm) when the concentration is less than 10,000 ppm and in percentage when the concentration is 10,000 ppm (1%) or greater.
(3) Products labeled with a quantity statement (e.g., tablets, capsules, granules, or liquid) may state mineral guarantees in milligrams (mg) per unit (e.g., tablets, capsules, granules, or liquids) consistent with the quantity statement and directions for use.
(c) Guarantees for minimum vitamin content of commercial feeds shall be listed in the order specified and are stated in mg/lb or in units consistent with those employed for the quantity statement unless otherwise specified:
(1) Vitamin A, other than precursors of vitamin A, in International Units per pound.
(2) Vitamin D-3 in products offered for poultry feeding, in International Chick Units per pound.
(3) Vitamin D for other uses, International Units per pound.
(4) Vitamin E, in International Units per pound.
(5) Concentrated oils and feed additive premixes containing vitamins A, D and/or E may, at the option of the distributor be stated in units per gram instead of units per pound.
(6) Vitamin B-12, in milligrams or micrograms per pound.
(7) All other vitamin guarantees shall express the vitamin activity in milligrams per pound in terms of the following: menadione; riboflavin; d-pantothenic acid; thiamine; niacin; vitamin B-6; folic acid; choline; biotin; inositol; p-amino benzoic acid; ascorbic acid; and carotene.
(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 2,000 or more 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 Part 558 of the Code of Federal Regulations, Title 21, 2000, incorporated herein by reference (later amendments not included), 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) For ruminants a. Complete feeds, supplements, and concentrates containing added non-protein nitrogen and containing more than 5% protein from natural sources shall be guaranteed as follows:Crude Protein, minimum, _____ %(This includes not more than ____ % equivalent crude protein from non-protein nitrogen).
b. 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, _____ % c. 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 and published in the Official Publication of AAFCO Inc. (later amendments not included) shall be guaranteed as follows:Nitrogen, minimum, ____ %Equivalent Crude Protein from Non-Protein Nitrogen, minimum, ___ % (2) For non-ruminants a. Complete feeds, supplements and concentrates containing crude protein from all forms of non-protein nitrogen, added as such, shall be labeled as follows: Crude protein, minimum ____ % (This includes not more than ____ % equivalent crude protein, which is not nutritionally available to (species of animal for which feed is intended).
b. Premixes, concentrates or supplements intended for non-ruminants containing more than 1.25% equivalent crude protein from all forms of non-protein nitrogen, added as such, must contain adequate directions for use and a prominent statement: WARNING: This feed must be used only in accordance with directions furnished on the label.
(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.
(g) Guarantees for microorganisms shall be stated in colony forming units per gram (CFU/g) when directions are for using the product in grams, or in colony forming units per pound (CFU/lb) when directions are for using the product in pounds. A parenthetical statement following the guarantee shall list each species in order of predominance.
(h) Guarantees for enzymes shall be stated in units of enzymatic activity per unit weight or volume, consistent with label directions. The source organism for each type of enzymatic activity shall be specified, such as: Protease (Bacillus subtilis) 5.5 mg ammo acids liberated/min./milligram. If two or more sources have the same type of activity, they shall be listed in order of predominance based on the amount of enzymatic activity provided.
(i) Guarantees for minimum percentage of total sugars, as invert shall be included for products being sold for their molasses content or products containing more than 16% sugars.
(j) Guarantees for maximum percentage of moisture shall be included for liquid feed supplements and liquid ingredients containing more than 20% moisture.
Section 6. Suitability (a) A commercial feed, other than a customer-formula feed, shall be nutritionally suitable for its intended purpose as represented by its labeling.
(b) If the Commissioner has reasonable cause to believe a feed is not nutritionally suitable, then the Commissioner may request the feed manufacturer to either submit an “Affidavit of Suitability” or an alternate procedure acceptable to the Commissioner, certifying the nutritional adequacy of the feed. The Affidavit of Suitability or alternate procedure of suitability shall serve as substantiation of the suitability of the feed.
(c) If an Affidavit of Suitability, or alternative procedure acceptable to the Commissioner is not submitted by the feed manufacturer within 30 days of written notification, the Commissioner may deem the feed adulterated under section 35-60-107(2)(m), C.R.S., and order the feed removed from the marketplace.
(d) The Affidavit of Suitability shall contain the following information:
(1) The feed company's name;
(2) The feed's product name;
(3) The name and title of the affiant submitting the document;
(4) A statement that the affiant has knowledge of the nutritional content of the feed and based on valid scientific evidence the feed is nutritionally adequate for its intended purpose;
(5) The date of submission; and (6) The signature of the affiant notarized by a certified Notary Public. Section 7. 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 published in the 2001 Official Publication of AAFCO, 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 as defined in the Official Definitions of Feed Ingredients published in the 2001 Official Publication of AAFCO is not required to have an ingredient statement.
(f) Tentative definitions as published in the Official Definitions of Feed Ingredients published in the 2001 Official Publication of AAFCO 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.
Section 8. Directions for Use and Precautionary Statements (a) Directions for use and precautionary statements on the labeling of all commercial feeds and customer-formula feeds including those containing additives shall:
(1) Be adequate 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) Include, but not be limited to, all information described 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 section 9.
(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.
Section 9. Non-Protein Nitrogen (a) Urea and other non-protein nitrogen products defined in the Official Definitions of Feed Ingredients published in the 2001 Official Publication of AAFCO are acceptable ingredients only in commercial feeds for ruminant animals as a source of equivalent crude protein. 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.
(b) Non-protein nitrogen defined in the Official Definitions of Feed Ingredients published in the 2001 Official Publication of AAFCO when so indicated, are acceptable ingredients in commercial feeds distributed to non-ruminant animals as a source of nutrients other than equivalent crude protein. The maximum equivalent crude protein from non-protein nitrogen sources when used in non- ruminant rations shall not exceed 1.25% of the total daily ration, (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 statement 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.
Section 10. Drug and Feed Additives (a) Prior to approval of a registration application and/or approval of a label for commercial feed which contains 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 efficac 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 “informal review sanctioned” or “generally recognized as safe” for such use, or (2) When the commercial feed is itself a drug as defined in section 35-60-102(8) of the Colorado Commercial Feed Law 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,or (3) When one of the purposes for feeding a commercial feed is to impart immunity (that is to act through some immunological process) the constituents imparting immunity have been approved for the purpose through the Federal Virus, Serum and Toxins Act of 1913, as amended, or (4) When the commercial feed is a direct fed microbial product and:
I. The product meets the particular fermentation product definition; and II. The microbial content statement, as expressed in the labeling, is limited to the following: “Contains a source of live (viable) on the label; and III. The source is stated with a corresponding guarantee expressed in accordance with section 5(g).
(5) When the commercial feed is an enzyme product and:
I. The product meets the particular enzyme definition as defined in the Official Definitions of Feed Ingredients published in the 2001 Official Publication of AAFCO, and II. The enzyme is stated with a corresponding guarantee expressed in accordance with section 5(h).
Section 11. Adulterants (a) For the purpose of section 35-60-107(2)(a) of the Colorado Commercial Feed Law, 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 0.20% for breeding and dairy cattle; 0.30% for slaughter cattle; 0.30% for sheep; 0.35% for lambs; 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 (exclusive of roughage) above the following amounts: 0.004% for breeding and dairy cattle; 0.009% for slaughter cattle; 0.006% for sheep; 0.01% for lambs; 0.015% for swine and 0.03% for poultry.
(3) Fluorine bearing ingredients incorporated in any feed that is fed directly to cattle, sheep or goats consuming roughage (with or without) limited amounts of grain, that results in a daily fluorine intake in excess of 50 milligrams of Fluorine per 100 pounds of body weight.
(4) Soybean meal, flakes or pellets or other vegetable meals, flakes or pellets which have been extracted with trichlorethylene or other chlorinated solvents.
(5) 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 Bl (Thiamine).
(6) Aflatoxin B1, B2, G1, G2 above 20 parts per billion (ppb) individually or total when in feed destined for dairy animals, pet food or an unknown use, over 20 ppb for feed and ingredients (excluding cottonseed meal) for immature animals, over 100 ppb for corn and peanut products for breeding cattle breeding swine, and mature poultry, over 200 ppb for com and peanut products for finishing swine over 100 pounds, over 300 ppb for com and peanut products finishing beef cattle, and over 300 ppb for cottonseed meal for beef cattle, swine or poultry.
(7) Fumonisin above 5 parts per million (ppm) except that with proper labeling as approved by the Commissioner less than 15 ppm may be distributed when destined for finishing swine (more than 100 lbs. body weight); less than 50 ppm may be distributed for feedlot cattle, (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 contains no viable prohibited weed seeds and not more than 1 viable restricted weed seeds per pound. For the purposes of this provision, prohibited weed seed and restricted weed seeds shall be those as established by the Commissioner under the Colorado Seed Act (section 35-27-103 (16), C.R.S.) and in the rules adopted thereunder.
Section 12. Good Manufacturing Practices (a) For the purposes of enforcement of section 35-60-107(2)(n) of the Colorado Commercial Feed Law the Commissioner adopts and incorporates by reference the following as current good manufacturing practices:
(1) The Regulations prescribing good manufacturing practices for Type B and Type C medicated feeds as published in the Code of Federal Regulations, Title 21, Part 225, sections 225.1- 225.202, (2000) (later amendments not included).
(2) The Regulations prescribing good manufacturing practices for Type A Medicated Articles as published in the Code of Federal Regulations Title 21, Part 226, sections 226.1-226.115, (2000) (later amendments not included).
Section 13. Material Incorporated by Reference All materials incorporated by reference into these rules may be examined at any state publications depository library. For further information on how the incorporated materials may be obtained or examined, please contact the Technical Services Section Chief at the Division of Inspection and Consumer Services, Department of Agriculture, 2331 West 31st Avenue, Denver, Colorado 80211.