SUBCHAPTER 09E ‑ FEED

02 NCAC 09E .0101 THE DEFINITIONS FOR COMMERCIAL FEEDS

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 Board of Agriculture designates otherwise in specific cases.

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

02 NCAC 09E .0102 TERMS USED IN REFERENCE TO COMMERCIAL FEEDS

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 Board of Agriculture designates otherwise in specific cases. A list of the Official Feed Terms can be found in the AFFCO Official Publication. The publication can be purchased for a fee of seventy dollars ($70.00) for members, or one-hundred twenty-five dollars ($125.00) for non-members at www.aafco.org/publications. You may also contact the North Carolina Department of Agriculture and Consumer Services Food and Drug Protection Division at 919-733-7366.

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Readopted Eff. March 1, 2017.

02 NCAC 09E .0103 COMMODITIES DECLARED EXEMPT

The following commodities are hereby declared exempt from the definition of commercial feed, under the provisions of G.S. 106-284.33(4):

(1) hay,

(2) straw,

(3) stover,

(4) silages,

(5) cobs,

(6) husks,

(7) hulls when unground and when not mixed or intermixed with other materials;

provided that these commodities are not adulterated within the meaning of G.S. 106-284.38(1).

History Note: Authority G.S. 106-284.33(4); 106‑284.41;

Eff. February 1, 1976;

Amended Eff. October 1, 1987;

Readopted Eff. March 1, 2017.

02 NCAC 09E .0104 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:

(1) Net weight;

(2) Product name and brand name, if any;

(3) If drugs are used, the following shall appear:

(a) 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;

(b) The purpose of medication (claim statement);

(c) The required direction for use and precautionary statements required by 02 NCAC 09E .0108 and 02 NCAC 09E .0109 appear elsewhere on the label;

(d) An active drug ingredient statement listing the active drug ingredients by their established name and the amounts in accordance with 02 NCAC 09E .0106(d);

(4) The guaranteed analysis of the feed as required under the provisions of Section 106‑284.35(1)(c) of the North Carolina Commercial Feed Law of 1973 include the following items, unless exempted in (h) of this Subparagraph, and in the order listed:

(a) Minimum percentage of crude protein;

(b) Maximum or minimum percentage of equivalent protein from non‑protein nitrogen as required in 02 NCAC 09E .0106(e);

(d) Maximum percentage of crude fiber;

(e) Minerals, to include, in the following order:

(i) minimum and maximum percentages of calcium (Ca),

(ii) minimum percentages of phosphorus (P),

(iii) minimum and maximum percentages of salt (NaCl),

(iv) other minerals;

(f) Vitamins in such terms as specified in 02 NCAC 09E .0106(c);

(g) Total sugars as invert on dried molasses products or products being sold primarily for their molasses content;

(h) Exemptions for guarantees will be as follows:

(i) Guarantees for minerals are not required when there are no specific label claims and when the commercial feed contains less than six and one‑half percent of mineral elements.

(ii) Guarantees for vitamins are not required when the commercial feed is neither formulated for nor represented in any manner as a vitamin supplement.

(iii) 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;

(5) Feed ingredients or collective terms for the grouping of feed ingredients as provided under the provisions of Section 106‑284.35(1)(d) of the North Carolina Commercial Feed Law of 1973 shall be described as follows:

(a) 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 Board;

(b) collective terms for the grouping of feed ingredients as defined in the Official Definitions of Feed Ingredients published in the Official Publications of the Association of American Feed Control Officials in lieu of the individual ingredients; provided that:

(i) 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.

(ii) The manufacturer shall provide the feed control official upon request, with a listing of individual ingredients, within a defined group, that are to be or have been used at manufacturing facilities distributing in or into the state;

(6) 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;

(7) The information required in Section 106‑284.35(1)(a) to (e) of the North Carolina Commercial Feed Law of 1973 must appear in its entirety on one side of the label or on one side of the container. The information required by Section 106‑284.35(1)(f) to (g) of the North Carolina Commercial Feed Law of 1973 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 106‑284.35(1)(f) to (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 106‑284.35 of the North Carolina Commercial Feed Law of 1973 shall be subordinated or obscured by other statements or designs.

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Amended Eff. December 20, 1980;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

02 NCAC 09E .0105 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 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 listing.

(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 Board of Agriculture 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 02 NCAC 09E .0106(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.

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Amended Eff. December 20, 1980;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

02 NCAC 09E .0106 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 six and one‑half percent 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 percentages 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 percent or less, the maximum shall not exceed the minimum by more than one percentage point.

(2) When the minimum is above 5.0 percent, the maximum shall not exceed the minimum by more than 20 percent and in no case shall the maximum exceed the minimum by more than five 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 with the following exceptions:

(1) Vitamin A, other than precursors of vitamin A, shall be stated in USP units per pound or International Units (IU) 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 guarantee 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, with the following exceptions:

(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 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 non‑protein nitrogen and containing more than five percent protein from natural sources shall be guaranteed as follows:

"Crude Protein, minimum,.............. percent"

(This includes not more than ............ percent equivalent protein from non‑protein nitrogen) .

(2) Mixed feed concentrates and supplements containing less than five percent protein from natural sources may be guaranteed as follows:

"Equivalent Crude Protein from Non‑Protein Nitrogen, minimum, .............. percent."

(3) Ingredient sources of non‑protein nitrogen such as urea, di‑ammonium 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, .......... percent Equivalent Crude Protein from Non‑Protein Nitrogen, minimum, ........ percent."

(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.

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

02 NCAC 09E .0107 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 Board of Agriculture.

(b) The name of each ingredient must be shown in letters or type of the same size.

(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 required 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 percent iodine, uniformly distributed.

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

02 NCAC 09E .0108 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 conform to the following:

(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 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 02 NCAC 09E .0109.

(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.

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

02 NCAC 09E .0109 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 percent 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 which reads as follows:

"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) The labeling of all feeds containing non‑protein nitrogen ingredients, additional to other required feed labeling, shall bear the caution statement "Feed Only To Ruminants"; provided that, 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.

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

02 NCAC 09E .0110 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 efficacy of a commercial feed may be as follows:

(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 106‑284.33(8) of the North Carolina Commercial Feed Law of 1973 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).

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

02 NCAC 09E .0111 ADULTERANTS

(a) For the purpose of Section 106‑284.38(1) of the North Carolina Commercial Feed Law of 1973, the terms "poisonous or deleterious substances" include but are not limited to the following:

(1) fluorine and any mineral mixture which is to be used directly for the feeding of domestic animals and in which the fluorine exceeds 0.30 percent for cattle; 0.35 percent for sheep; and 0.45 percent for swine and 0.60 percent 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 percent for cattle; 0.01 percent for sheep; 0.014 percent for swine; and 0.035 percent 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 B‑1 (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 contains no more than four whole prohibited weed seeds per pound and not more than 100 whole restricted weed seeds per pound.

(1) For the purpose of Subsection (c)(2) of 02 NCAC 09E .0111, the terms "prohibited weed seed" and "restricted weed seed" shall conform to the definitions in Section 106‑277.2(22)(a) and (b) of the North Carolina Seed Law. Notwithstanding the above mentioned tolerances, the presence of any seed in concentrations which are harmful to poultry or livestock shall be dealt with under Section 106‑284.38 of the North Carolina Commercial Feed Law.

(2) Prohibited weed seed shall include the following:

(A) Crotalaria‑‑Crotalaria spp.;

(B) Johnson grass‑‑sorghum halepense;

(D) Witchweed‑‑Striga asiatica.

(3) Restricted weed seed shall include the following:

(A) Cocklebur (Xanthium spp.);

(B) Blessed thistle‑‑Cnicus benedictus;

(D) Wild onions and/or wild garlic‑‑Allium spp.;

(E) Wild radish‑‑Raphanus raphanistrum;

(F) Bermuda grass‑‑Cynodon dactylon;

(G) Canada thistle‑‑Cirsium arvense;

(H) Corncockle‑‑Agrostemma githago;

(I) Field bindweed‑‑Convolvulus arvensis;

(J) Quackgrass‑‑Agropyron repens;

(K) Giant foxtail‑‑Setaria faberi;

(L) Dodders‑‑Cuscuta spp.;

(M) Dock‑‑Rumex crispus and/or obtusifolius;

(N) Horsenettle‑‑Solanum carolinense;

(O) Bracted plantain‑‑Plantago aristata;

(P) Buckhorn plantain‑‑Plantago lanceolata;

(Q) Wild mustard et al‑‑Brassica spp.

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Amended Eff. October 1, 1987;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

02 NCAC 09E .0112 GOOD MANUFACTURING PRACTICES

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Amended Eff. April 8, 1977;

Repealed Eff. January 1, 1987.

02 NCAC 09E .0113 PERMITTED ANALYTICAL VARIATION

Under the provisions of Section 106‑284.42(h) of the North Carolina Commercial Feed Law of 1973, the Board of Agriculture adopts the following as permitted analytical variation (PAV) values, unless the Board of Agriculture by resolution specifically determines that a particular PAV value is not appropriate and not in the interest of the consumer; in such cases, the Board shall establish appropriate PAV values:

(1) the PAV values as recommended by the Association of American Feed Control Officials (AAFCO) and published in the AAFCO Official Publication;

(2) assay control limitations for new drugs and for a combination of drugs in medicated feeds as established by FDA, recommended by AAFCO and published in the AAFCO Official Publication.

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Amended Eff. October 1, 1987; December 20, 1980;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

02 NCAC 09E .0114 BAG OR PACKAGE WEIGHTS

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Pursuant to G.S. 150B-21.3A, rule Expired April 1, 2015.

02 NCAC 09E .0115 CHANGES IN GUARANTEES AFTER REGISTRATION

A guarantee and label for a brand of feed having been registered may not be subsequently modified in a way that permits the lowering of the quality of feed, unless it can be clearly shown that the modification sought to be made is consistent with the interest of the feeder. It is provided, however, that the ingredients of a feed mixture may be changed after registration on presentation of satisfactory reasons if such a change does not necessitate a lowering of the guaranteed analysis or the quality of the feed.

History Note: Authority G.S. 106‑284.41;

Eff. February 1, 1976;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

02 NCAC 09E .0116 CURRENT GOOD MANUFACTURING PRACTICE OF THE NORTH CAROLINA COMMERCIAL ANIMAL FEED AND PET FOOD PROGRAM

Any person that engages in activities regulated by the North Carolina Commercial Feed Law of 1973, G.S. 106, Article 31C, shall comply with the standards set forth under Subpart B of 21 C.F.R. Part 507, titled "Current Good Manufacturing Practice," as incorporated under 02 NCAC 09B .0116(o)(130).

History Note: Authority G.S. 106-284.41;

Eff. March 1, 2020.