University of KentuckyCollege of Agriculture
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Complete Kentucky Administrative Regulations

12 KAR 2:006. Definitions.

RELATES TO: KRS 250.491 to 250.631
STATUTORY AUTHORITY: KRS 250.571

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1)(a) requires the Director of the Agricultural Experiment Station to promulgate an administrative regulation adopting the official definitions of feed ingredients and official feed terms adopted by the Association of American Feed Control Officials. KRS 250.501(4) defines "commercial feed" and authorizes the director to promulgate an administrative regulation exempting commodities meeting established criteria. This administrative regulation incorporates by reference the definitions adopted by the Association of American Feed Control Officials and exempts certain commodities from the definition of commercial feed.

Section 1. The names and definitions for commercial feeds shall be the "Official Definition of Feed Ingredients" adopted by the Association of American Feed Control Officials and published in its Official Publication, except as exempted by an administrative regulation promulgated by the director.

Section 2. The terms used in reference to commercial feeds shall be the official feed terms adopted by the Association of American Feed Control Officials and published in its Official Publication, except as exempted by an administrative regulation promulgated by the director.

Section 3. Pursuant to KRS 250.501(4), the following commodities shall be exempt from the definition of commercial feed: raw meat; and hay, straw, stover, silages, cobs, husks, and hulls when unground if the ingredient is not:

1. Mixed or intermixed with other materials; or

2. Adulterated within the meaning of KRS 250.541(1).

Section 4. "Quantity statement" means the net weight (mass), net volume (liquid or dry), or count.

Section 5. Incorporation by Reference. (1) "Official Publication", 1996 Edition, Association of American Feed Control Officials is incorporated by reference.

It may be inspected, copied, or obtained at the Division of Regulatory Services, 103 Regulatory Services Building, College of Agriculture, University of Kentucky, Lexington, Kentucky 40546 0275, Monday through Friday, 8 a.m. to 4:30 p.m. (AES-2 (1973)-1; 1 Ky.R. 998; eff. 6-11-75; Am. 23 Ky.R. 1604; 2703; eff. 1-10-97.)

12 KAR 2:011. Label format.

RELATES TO: KRS 250.491 to 250.631
STATUTORY AUTHORITY: KRS 250.571

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631, regarding commercial feeds. This administrative regulations establishes a uniform format for presentation of labeling to the purchaser of animal feeds.

Section 1. A commercial feed, other than customer formula feed, shall be labeled with the information prescribed in this administrative regulation on the principal display panel of the product and in the following format:

1. Product name and brand name, if any, in conformance with 12 KAR 2:016;

2. If a drug is used the word "medicated" shall appear directly following and below the product name in type size no smaller than one-half (1/2) the type size of the product name;

3. Product purpose statement as required by 12 KAR 2:017;

4. If a drug is used:

A. The purpose of medication (claim statement); and

B. An active drug ingredient statement listing the active drug ingredients by their established name and the amounts in accordance with 12 KAR 2:021, Section 4;

5. The guaranteed analysis of the feed as required by KRS 250.521(1)(b) and 12 KAR 2:018;

6. The listing of feed ingredients as required by 12 KAR 2:026;

7. Directions for use and precautionary statements as required by 12 KAR 2:031 and 12 KAR 2:036;

8. 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 of the city or county wherein the manufacturer or distributor maintains his principal place of business; and

9. The quantity statement of the net weight, net volume or count.

Section 2.

1. The information required by Section 1 of this administrative regulation shall appear in its entirety on one (1) side of the label or container, except the information required by Section 1(7) of this administrative regulation may be placed on a different side of the label or container if it is displayed in a prominent place on the label or container. If the information is placed on a different side, it shall be referenced on the front side with a statement indicating where the information is located.

2. The information required by Section 1 of this administrative regulation shall not be subordinated or obscured by other statements or designs.

Section 3. Customer-formula feed shall be accompanied by a label, 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 directions for use and precautionary statements as required by 12 KAR 2:031 and 12 KAR 2:036; and

7. If a drug-containing product is used:

A. The purpose of the medication (claim statement); and

B. The established name of each active drug ingredient and the level of each drug used in the final mixture as required by 12 KAR 2:021. (AES-2 (1973)-2; 1 Ky.R. 998; eff. 6-11-75; Am. 23 Ky.R. 1604; 2703; eff. 1-10-97.)

12 KAR 2:016. Brand and product names.

RELATES TO: KRS 250.491 to 250.631
STATUTORY AUTHORITY: KRS 250.571

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631, regarding commercial feeds. This administrative regulation establishes uniformity in the use of brand and product names to inform and not mislead the purchaser.

Section 1. The brand or product name shall be appropriate for the intended use of the feed and shall not be misleading. If the name indicates the feed is made for a specific use, the character of the feed shall conform to that use.

Section 2. Commercial, registered brand or trade names:

1. Shall not be used in guarantees or ingredient listings; and

2. May be used in the product name of a feed produced by or for the firm holding the rights to the name.

Section 3.

1. The name of a commercial feed shall not:

A. Be derived from one (1) or more ingredients of a mixture to the exclusion of other ingredients; and

B. Represent a component of a mixture unless all components are included in the name.

2. The name of an ingredient or combination of ingredients that is intended to impart a distinctive characteristic to the product which would be of significance to a purchaser may be used as a part of the brand name or product name if:

A. The ingredient or combination of ingredients is quantitatively guaranteed in the guaranteed analysis; and

B. The brand name or product name is not otherwise false or misleading.

Section 4. The word "protein" shall not be used in the product name of a feed that contains added nonprotein nitrogen.

Section 5.

1. If the name carries a percentage value, the percentage value shall signify the protein or equivalent protein content, and the name may explicitly modify the percentage with the word "protein".

2. If another percentage value is used, the value shall be followed by the proper description without false or misleading labeling.

3. If 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.

4. A digital number shall not be used in a manner that is misleading or confusing to the purchaser.

Section 6. A single ingredient feed shall have a product name that conforms to the definitions of feed ingredients in 12 KAR 2:006.

Section 7. The word "vitamin," a contraction thereof, or word suggesting vitamin may be used in the name of a feed which is:

1. Represented to be a vitamin supplement; and

2. Labeled with the minimum content of each vitamin declared, as specified in 12 KAR 2:021, Section 3.

Section 8.

1. The term "mineralized" shall not be used in the name of a feed, except for "trace mineralized salt."

2. A product including "trace mineralized salt" in its name shall contain significant amounts of trace minerals which are recognized as essential for animal nutrition by an authority on animal nutrition such as the National Research Council.

Section 9. The term "meat" or "meat by-products" shall designate the animal from which the meat or meat by-products is derived unless the meat or meat by-products are from cattle, swine, sheep, and goats. (AES-2 (1973)-3; 1 Ky.R. 999; eff. 6-11-75; Am. 23 Ky.R. 1606; 2704; eff. 1-10-97.)

12 KAR 2:017. Product purpose statement.

RELATES TO: KRS 250.491 to 250.631
STATUTORY AUTHORITY: KRS 250.571

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631, regarding commercial feeds. This administrative regulation establishes uniformity in the product purpose statement that is a required part of the label for commercial feed.

Section 1. The statement of purpose shall contain the specific species and animal class(es) for which the feed is intended as defined in 12 KAR 2:018.

Section 2. The manufacturer may describe in more specific and common language the defined animal class, species and purpose if the description is consistent with the category of animal class established in 12 KAR 2:018, including the weight range(s), sex, or ages of the animal(s) for which the feed is manufactured.

Section 3. 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.

Section 4. The indication for animal class(es) and specie(s) may be omitted on single ingredient products if the ingredient is not intended, represented, or defined for a specific animal class(es) or specie(s).

Section 5. 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:

1. The nutrients contained in the premix are guaranteed and sufficient for formulation into various animal species feeds; and

2. Premix specifications are provided by the end user.

Section 6. The purpose statement of a single purpose ingredient blend, including a blend of animal protein products, 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.

Section 7. The purpose statement of a direct fed microbial product shall state "Contains a Source of Live (Viable) Naturally Occurring Microorganisms". This statement may appear elsewhere on the label provided it is sufficiently conspicuous as to render it easily read by the purchaser.

Section 8. The purpose statement of a product shall include a statement of enzyme functionality if enzymatic activity is represented. (23 Ky.R. 1805; Am. 2705; eff. 1-10-97.)

12 KAR 2:018. Guaranteed analysis.

RELATES TO: KRS 250.491 TO 250.631
STATUTORY AUTHORITY: KRS 250.571

NECESSITY, FUNCTION, and CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631, regarding commercial feeds. KRS 250.521(1)(b) requires that a commercial feed label contain a guaranteed analysis stated in terms the director by administrative regulation determines are required to advise the user of the composition of the feed or to support claims made in the labeling. This administrative regulation establishes a uniform format for the nutritional guarantees required as a part of the commercial feed label.

Section 1. The nutritional guarantees shall be listed in the following order: crude protein, equivalent crude protein from nonprotein nitrogen, amino acids, crude fat, crude fiber, acid detergent fiber, calcium, phosphorus, salt and sodium. Other guarantees shall follow in a general format with the units of measure used to express guarantees (percentage, parts per million, international units, etc.) listed in a sequence that provides a consistent grouping of the units of measure.

Section 2. Required Guarantees for Swine Formula Feeds.

1. The animal classes for swine shall be:

A. Prestarter - two (2) to eleven (11) pounds;

B. Starter - eleven (11) to forty-four (44) pounds;

C. Grower - forty-four (44) to 110 pounds;

D. Finisher - 110 to 242 pounds or market weight;

E. Gilts, sows and adult boars; and

F. Lactating gilts and sows.

2. The guaranteed analysis for swine complete feeds and supplements (all animal classes) shall include the:

A. Minimum percentage of crude protein;

B. Minimum percentage of lysine;

C. Minimum percentage of crude fat;

D. Maximum percentage of crude fiber;

E. Minimum and maximum percentage of calcium;

F. Minimum percentage of phosphorus;

G. Minimum and maximum percentage of salt (if added);

H. Minimum and maximum percentage of total sodium, if the total sodium exceeds that furnished by the maximum salt guarantee;

I. Minimum selenium in parts per million (ppm); and

J. Minimum zinc in parts per million (ppm).

Section 3. Required Guarantees for Formula Poultry Feeds (Chicken and Turkey).

1. The animal classes for layer chickens that are grown to produce eggs for food shall be:

A. Starting and growing - from day of hatch to approximately ten (10) weeks of age;

B. Finisher - from approximately ten (10) weeks of age to time first egg is produced (approximately twenty (20) weeks of age);

C. Laying - chickens from time first egg is laid throughout the time of egg production; and

D. Breeders - chickens that produce fertile eggs to hatch replacement layers that produce eggs for food.

2. The animal classes for broiler chickens that are grown for human food shall be:

A. Starting and growing - from day of hatch to approximately five (5) weeks of age;

B. Finisher - from approximately five (5) weeks of age to market, (forty-two (42) to fifty-two (52) days); and

C. Breeders - hybrid strains of chickens whose offspring are grown for human food (broilers), any age and either sex.

3. The animal classes for breeder chickens whose offspring (broilers) are grown for human food shall be:

A. Starting and growing - from day of hatch until approximately ten (10) weeks of age;

B. Finishing - from approximately ten (10) weeks of age to time first egg is produced, approximately twenty (20) weeks of age; and

C. Laying - fertile egg producing chickens (broilers/roasters) from day of first egg throughout the time fertile eggs are produced.

4. The animal classes for turkeys shall be:

A. Starting and growing - turkeys that are grown for human food from day of hatch to approximately thirteen (13) weeks of age (females) and sixteen (16) weeks of age (males);

B. Finisher - turkeys that are grown for human food, females from approximately thirteen (13) weeks of age to approximately seventeen (17) weeks of age, males from sixteen (16) weeks of age to twenty (20) weeks of age, or desired market weight;

C. Laying - female turkeys that are producing eggs, from time first egg is produced, throughout the time they are producing eggs; and

D. Breeder - turkeys that are grown to produce fertile eggs, from day of hatch to time first egg is produced (approximately thirty (30) weeks of age), both sexes.

5. The guaranteed analysis for poultry complete feeds and supplements (all animal classes) shall include the:

A. Minimum percentage of crude protein;

B. Minimum percentage of lysine;

C. Minimum percentage of methionine;

D. Minimum percentage of crude fat;

E. Maximum percentage of crude fiber;

F. Minimum and maximum percentage of calcium;

G. Minimum percentage of phosphorus;

H. Minimum and maximum percentage of salt (if added); and

I. Minimum and maximum percentage of total sodium, if the total sodium exceeds that furnished by the maximum salt guarantee.

Section 4. Required Guarantees for Beef Cattle Formula Feeds.

1. The animal classes for beef cattle shall be:

A. Calves (birth to weaning);

B. Cattle on pasture (may be specific as to production stage; e.g., stocker, feeder, replacement heifers, brood cows, bulls, etc); and

C. Feedlot cattle.

2. The guaranteed analysis for beef complete feeds and supplements (all animal classes) shall include the:

A. Minimum percentage of crude protein;

B. Maximum percentage of equivalent crude protein from nonprotein nitrogen (if added);

C. Minimum percentage of crude fat;

D. Maximum percentage of crude fiber;

E. Minimum and maximum percentage of calcium;

F. Minimum percentage of phosphorus;

G. Minimum and maximum percentage of salt (if added);

H. Minimum and maximum percentage of total sodium, if the total sodium exceeds that furnished by the maximum salt guarantee;

I. Minimum percentage of potassium; and

J. Minimum vitamin A, other than precursors of vitamin A, in international units per pound (if added).

3. The guaranteed analysis for beef mineral feeds (if added) shall include the:

A. Minimum and maximum percentage of calcium;

B. Minimum percentage of phosphorus;

C. Minimum and maximum percentage of salt;

D. Minimum and maximum percentage of total sodium, if the total sodium exceeds that furnished by the maximum salt guarantee;

E. Minimum percentage of magnesium;

F. Minimum percentage of potassium;

G. Minimum copper in parts per million (ppm);

H. Minimum selenium in parts per million (ppm);

I. Minimum zinc in parts per million (ppm); and

J. Minimum vitamin A, other than precursors of vitamin A, in international units per pound.

Section 5. Required Guarantees for Dairy Formula Feeds.

1. The animal classes for dairy cattle shall be:

A. Veal milk replacer - milk replacer fed to calves for veal production;

B. Herd milk replacer - milk replacer fed to calves for herd replacement and other uses;

C. Starter - calf from approximately three (3) days to three (3) months of age;

D. Growing heifers, bulls and dairy beef:

1. Grower 1 - three (3) months to twelve (12) months of age; and

2. Grower 2 - more than twelve (12) months of age;

E. Lactating dairy cattle; and

F. Nonlactating dairy cattle.

2. The guaranteed analysis for veal and herd milk replacer shall include the:

A. Minimum percentage of crude protein;

B. Minimum percentage of crude fat;

C. Maximum percentage of crude fiber;

D. Minimum and maximum percentage of calcium;

E. Minimum percentage of phosphorus; and

F. Minimum vitamin A, other than precursors of vitamin A, in international units per pound (if added).

3. The guaranteed analysis for dairy cattle complete feeds and supplements shall include the:

A. Minimum percentage of crude protein;

B. Maximum percentage of equivalent crude protein from nonprotein nitrogen (if added);

C. Minimum percentage of crude fat;

D. Maximum percentage of crude fiber;

E. Maximum percentage of acid detergent fiber (ADF);

F. Minimum and maximum percentage of calcium;

G. Minimum percentage of phosphorus;

H. Minimum selenium in parts per million (ppm); and

I. Minimum vitamin A, other than precursors of vitamin A, in international units per pound (if added).

4. The guaranteed analysis for dairy mixing and pasture mineral (if added) shall include the:

A. Minimum and maximum percentage of calcium;

B. Minimum percentage of phosphorus;

C. Minimum and maximum percentage of salt;

D. Minimum and maximum percentage of total sodium, if the total sodium exceeds that furnished by the maximum salt guarantee;

E. Minimum percentage of magnesium;

F. Minimum percentage of potassium;

G. Minimum selenium in parts per million (ppm); and

H. Minimum vitamin A, other than the precursors of vitamin A, in international units per pound.

Section 6. Required Guarantees for Equine Complete Feeds and Supplements (All Classes).

1. The equine animal classes shall be:

A. Foal;

B. Mare;

C. Breeding; and

D. Maintenance.

2. The guaranteed analysis for equine complete feeds and supplements (all animal classes) shall include the:

A. Minimum percentage of crude protein;

B. Minimum percentage of crude fat;

C. Maximum percentage of crude fiber;

D. Minimum and maximum percentage of calcium;

E. Minimum percentage of phosphorus;

F. Minimum copper in parts per million (ppm);

G. Minimum selenium in parts per million (ppm);

H. Minimum zinc in parts per million (ppm); and

I. Minimum vitamin A, other than the precursors of vitamin A, in international units per pound (if added).

3. The guaranteed analysis for equine mineral feed shall include the:

A. Minimum and maximum percentage of calcium;

B. Minimum percentage of phosphorus;

C. Minimum and maximum percentage of salt (if added);

D. Minimum and maximum percentage of total sodium, if the total sodium exceeds that furnished by the maximum salt guarantee;

E. Minimum copper in parts per million (ppm);

F. Minimum selenium in parts per million (ppm);

G. Minimum zinc in parts per million (ppm); and

H. Minimum vitamin A, other than the precursors of vitamin A, in international units per pound (if added).

Section 7. Required Guarantees for Goats and Sheep Formula Feeds.

1. The animal classes for goats and sheep shall be:

A. Starter;

B. Grower;

C. Finisher;

D. Breeder; and

E. Lactating.

2. The guaranteed analysis for goat and sheep complete feeds and supplements (all animal classes) shall include the:

A. Minimum percentage of crude protein;

B. Maximum percentage of equivalent crude protein from nonprotein nitrogen (if added);

C. Minimum percentage of crude fat;

D. Maximum percentage of crude fiber;

E. Minimum and maximum percentage of calcium;

F. Minimum percentage of phosphorus;

G. Minimum and maximum percentage of salt (if added);

H. Minimum and maximum percentage of total sodium, if the total sodium exceeds that furnished by the maximum salt guarantee;

I. Minimum and maximum copper in parts per million (ppm) (if added, or if total copper exceeds twenty (20) ppm);

J. Minimum selenium in parts per million (ppm); and

K. Minimum vitamin A, other than precursors of vitamin A, in international units per pound (if added).

Section 8. Required Guarantees for Ducks and Geese Formula Feeds.

1. The duck animal classes shall be:

A. Starter - zero to three (3) weeks of age;

B. Grower - three (3) to six (6) weeks of age;

C. Finisher - six (6) weeks to market;

D. Breeder developer - eight (8) to nineteen (19) weeks of age; and

E. Breeder - twenty-two (22) weeks to end of lay.

2. The geese animal classes shall be:

A. Starter - zero to four (4) weeks of age;

B. Grower - four (4) to eight (8) weeks of age;

C. Finisher - eight (8) weeks to market;

D. Breeder developer - ten (10) to twenty-two (22) weeks of age; and

E. Breeder - twenty-two (22) weeks to end of lay.

3. The guaranteed analysis for duck and geese complete feeds and supplements (for all animal classes) shall include the:

A. Minimum percentage of crude protein;

B. Minimum percentage of crude fat;

C. Maximum percentage of crude fiber;

D. Minimum and maximum percentage of calcium;

E. Minimum percentage of phosphorus;

F. Minimum and maximum percentage of salt (if added); and

G. Minimum and maximum percentage of total sodium, if the total sodium exceeds that furnished by the maximum salt guarantee.

Section 9. Required Guarantees for Fish Complete Feeds and Supplements.

1. The following animal species shall be declared in lieu of an animal class:

A. Trout;

B. Catfish; and

C. Species other than trout or catfish.

2. The guaranteed analysis for all fish complete feeds and supplements shall include the:

A. Minimum percentage of crude protein;

B. Minimum percentage of crude fat;

C. Maximum percentage of crude fiber; and

D. Minimum percentage of phosphorus.

Section 10. Required Guarantees for Rabbit Complete Feeds and Supplements.

1. The rabbit animal classes shall be:

A. Grower - four (4) to twelve (12) weeks of age; and

B. Breeder - twelve (12) weeks of age and over.

2. The guaranteed analysis for rabbit complete feeds and supplements (all animal classes) shall include the:

A. Minimum percentage of crude protein;

B. Minimum percentage of crude fat;

C. Minimum and maximum percentage of crude fiber (the maximum crude fiber shall not exceed the minimum by more than five (5.0) units);

D. Minimum and maximum percentage of calcium;

E. Minimum percentage of phosphorus;

F. Minimum and maximum percentage of salt (if added);

G. Minimum and maximum percentage of total sodium, if the total sodium exceeds that furnished by the maximum salt guarantee; and

H. Minimum vitamin A, other than precursors of vitamin A, in international units per pound (if added).

Section 11. The required guarantees of grain mixtures and formula feeds and ingredients that are not specifically described in Sections 2 through 10 of this administrative regulation, or exempted under Section 12 of this administrative regulation, shall include the following items in the order listed:

1. Minimum percentage of crude protein;

2. Minimum or maximum percentage of equivalent crude protein from nonprotein nitrogen as required in 12 KAR 2:021 (if added);

3. Minimum percentage of crude fat;

4. Maximum percentage of crude fiber;

5. Minerals in formula feeds in the following order:

A. Minimum and maximum percentage of calcium;

B. Minimum percentage of phosphorus;

C. Minimum and maximum percentage of salt (if added);

D. Minimum and maximum percentage of total sodium, if the total sodium exceeds that furnished by the maximum salt guarantee; and

E. Other minerals;

6. Minerals in feed ingredients as specified by the official definition of the Association of American Feed Control Officials;

7. Vitamins in the terms required by 12 KAR 2:021;

8. Total sugars as invert on dried molasses products or products being sold primarily for their sugar content;

9. Viable lactic acid producing microorganisms when used in silage products and direct fed microbial products guaranteed in terms specified in 12 KAR 2:021;

10. Enzymatic activity for enzyme products and formula feeds represented as a source of enzymes guaranteed in terms specified in 12 KAR 2:021; and

11. If the item is a commercial feed (e.g., vitamin and mineral premix, base mix, etc.) intended to provide a specialized nutritional source for use in the manufacture of other feeds, its intended purpose and guarantee of those nutrients relevant to the stated purpose.

Section 12. Exemptions.

1. 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, shall not be required if:

A. The feed or feed ingredient is not intended or represented or does not serve as a principle source of that mineral to the animal; or

B. The feed or feed ingredient is intended for nonfood producing animals and contains less than six and five-tenths (6.5) percent total mineral.

2. Guarantees for vitamins shall not be required if the commercial feed is neither formulated for nor represented as a vitamin supplement.

3. Guarantees for crude protein, crude fat and crude fiber shall not be required if 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 a Type A drug article, mineral or vitamin supplements and molasses.

4. Guarantees for microorganisms and enzymes shall not be required if 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.

Section 13. Incorporation by Reference.

1. "Official Publication", 1996 Edition, Association of American Feed Control Officials is incorporated by reference.

2. It may be inspected, copied, or obtained at the Division of Regulatory Services, 103 Regulatory Services Building, College of Agriculture, University of Kentucky, Lexington, Kentucky 40546-0275, Monday through Friday, 8 a.m. to 4:30 p.m. (23 Ky.R. 1806; Am. 2706; eff. 1-10-97.)

12 KAR 2:021. Guarantees.

RELATES TO: KRS 250.491 to 250.631
STATUTORY AUTHORITY: KRS 250.571

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631, regarding commercial feeds. KRS 250.521(1)(b) requires that a commercial feed label contain a guaranteed analysis stated in terms the director by administrative regulation determines are required to advise the user of the composition of the feed or to support claims made in the labeling. This administrative regulation establishes a uniform format for the expression of nutritional guarantees required as a part of the commercial feed label.

Section 1. The guarantees for crude protein, equivalent crude protein from nonprotein nitrogen; lysine, methionine, and other amino acids; crude fat; crude fiber; and acid detergent fiber shall be in terms of percentage.

Section 2. Mineral Guarantees.

1. If the calcium, salt, and sodium guarantees are given in the guaranteed analysis, the guarantee shall be stated and conform to the following:

A. If the minimum is below two and one-half (2.5) percent, the maximum shall not exceed the minimum by more than one-half (0.5) percentage point.

B. If the minimum is two and one-half (2.5) percent but five (5) percent, the maximum shall not exceed the minimum by more than one (1) percentage point.

C. If the minimum is above five (5) percent, the maximum shall not exceed the minimum by more than twenty (20) percent and in no case shall the maximum exceed the minimum by more than five (5) percentage points.

2. If stated, guarantees for minimum and maximum total sodium; minimum potassium, magnesium, sulfur, and phosphorus; and maximum fluoride shall be stated in terms of percentage. Other minimum mineral guarantees shall be stated in parts per million (ppm) if the concentration is less than 10,000 ppm and in percentage if the concentration is 10,000 ppm (one (1) percent) or greater.

3. Products labeled with a quantity statement (tablets, capsules, granules, or liquids) shall state mineral guarantees in milligrams (mg) per unit (tablets, capsules, granules, or liquids) consistent with the quantity statement and directions for use.

Section 3. Guarantees for minimum vitamin content of commercial feeds in the following general order in the unit of measure per weight specified or expressed in terms of a quantity (tablets, capsules, granules or liquid volume) consistent with the quantity statement and directions for use shall be stated:

1. Vitamin A, other than precursors of vitamin A, shall be stated in international units per pound.

2. Vitamin D3, 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 international units per pound.

4. Vitamin E shall be stated in international units per pound.

5. Vitamin B-12 shall be stated in milligrams or micrograms per pound.

6. All other vitamin guarantees shall express the vitamin activity in milligrams per pound for 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, except that concentrate feed additive sources used for further manufacturing purposes may, at the option of the distributor, express the vitamin guarantee in grams per pound or other unit of weight when this expression is more meaningful and consistent with its use.

7. Concentrated oils and feed additive premixes containing vitamin A, vitamin D or vitamin E may, at the option of the distributor, state guarantees in international units per gram.

Section 4. 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. The term "milligrams per pound" may be used for drugs or antibiotics if a dosage is given in "milligrams" in the feeding directions.

Section 5. Commercial feeds containing added nonprotein nitrogen shall be labeled as follows:

1. For ruminants:

A. Complete feeds, supplements, and concentrates containing added nonprotein nitrogen and containing more than five (5) percent protein from natural sources shall be guaranteed as follows: Crude Protein, minimum ____% (this includes not more than ____% equivalent protein from nonprotein nitrogen.

B. Mixed feed concentrates and supplements containing five (5) percent or less protein from natural sources shall be guaranteed as follows: Equivalent Crude Protein from Nonprotein Nitrogen, minimum ____%.

C. Ingredient sources of nonprotein nitrogen including Urea, Di-Ammonium Phosphate, Ammonium Polyphosphate Solution, Ammoniated Rice Hulls, or other basic nonprotein nitrogen ingredients defined by the Association of American Feed Control Officials shall be guaranteed as follows: Nitrogen, minimum ____%. Equivalent Crude Protein from Nonprotein Nitrogen, minimum ____%.

2. For nonruminants:

A. Complete feeds, supplements and concentrates containing crude protein from all forms of nonprotein nitrogen from ammonium polyphosphate solution, diammonium phosphate, or monoammonium phosphate, 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 nonruminants containing more than 1.25 percent equivalent crude protein added from all forms of nonprotein nitrogen shall contain adequate directions for use and this prominent statement:

WARNING: This feed must be used only in accordance with directions furnished on the label.

Section 6. Guarantees for microorganisms shall be stated in colony forming units per gram (CFU/g) if directions are for using the product in grams, or in colony forming units per pound (CFU/lb) if directions are for using the product in pounds. A parenthetical statement following the guarantee shall list each species in order of predominance.

Section 7. 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 in the format followed in this example: Protease (Bacillus subtilis) five and five-tenths (5.5) mg amino acids liberated/min./milligram. If two (2) 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.

Section 8. 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. (AES-2 (1973)-4; 1 Ky.R. 999; eff. 6-11-75; Am. 23 Ky.R. 1607; 2709; eff. 1-10-97.)

12 KAR 2:026. Ingredients.

RELATES TO: KRS 250.491 to 250.631
STATUTORY AUTHORITY: KRS 250.571

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631, regarding commercial feeds. KRS 250.521(1)(c) requires that a commercial feed label list the common or usual name of each ingredient used in the manufacture of the commercial feed, unless the director promulgates an administrative regulation permitting the use of a collective term for a group of ingredients. This administrative regulation establishes the requirements for listing the ingredients on the commercial feed label.

Section 1. Commercial feeds, other than customer formula feeds, shall have an ingredient statement listing the feed ingredients, collective terms for the grouping of feed ingredient or other appropriate statement as provided under provisions of KRS 250.521(1)(c).

1. The name of each ingredient or collective term for the grouping of ingredients, if required to be listed, shall be the name as defined in the "Official Definitions of Feed Ingredients" as published in the Official Publication of the Association of American Feed Control Officials, the common or usual name, or one approved by the director.

2. The ingredient statement may list the 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 rather than the individual ingredients.

A. If 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 Director of Regulatory Services, upon written or oral request, with a listing of individual ingredients within a defined group that are or have been used in manufacturing facilities distributing in Kentucky. The manufacturer shall be specific in its response when the request is made of a particular facility or production.

Section 2. The name of each ingredient shall be shown in letters or type of the same size.

Section 3. A reference to quality or grade of an ingredient shall not appear in the ingredient statement of a feed.

Section 4. The term "dehydrated" may precede the name of a product that has been artificially dried.

Section 5. A single ingredient product defined by the Association of American Feed Control Officials shall not be required to have an ingredient statement.

Section 6. Tentative definitions for ingredients shall not be used until adopted as official by the Association of American Feed Control Officials unless an official definition does not exist.

Section 7. Commercial, registered brand or trade names shall not be permitted in the ingredient listing.

Section 8. The percentage of rice hulls shall be listed in the ingredient statement of a formula feed intended to supply energy to the animal if the amount added exceeds three (3) percent by weight. This shall not apply to feed products where rice hulls are used as a carrier including in dried molasses products, Type A medicated articles, vitamins, trace mineral and other premix additives. The percentage of rice hulls contributed from carrier sources shall be excluded from the determination of percentage of rice hulls in formula feeds.

Section 9. A product that is labeled, represented or intended to provide a substantial amount of magnesium to cattle shall be formulated utilizing magnesium ingredients with a biological value of seventy (70) percent or greater when compared to standard reference of feed grade magnesium oxide with a biological value of 100 percent; however, dolomitic limestone shall not be an acceptable source of magnesium unless data substantiates the source of dolomitic limestone has a biological value of seventy (70) percent or greater.

Section 10. If 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.

Section 11. Incorporation by Reference.

1. "Official Publication", 1996 Edition, Association of American Feed Control Officials, is incorporated by reference.

2. It may be inspected, copied, or obtained at the Division of Regulatory Services, 103 Regulatory Services Building, College of Agriculture, University of Kentucky, Lexington, Kentucky 40546-0275, Monday through Friday, 8 a.m. to 4:30 p.m. (AES-2 (1973)-5; 1 Ky.R. 999; eff. 6-11-75; Am. 1608; 2710; eff. 1-10-97.)

12 KAR 2:031. Directions and precautionary statements for feed containing additives.

RELATES TO: KRS 250.501, 250.531, 250.551(1), (2), 21 CFR 225.80, 225.180
STATUTORY AUTHORITY: KRS 250.521(2)(e), (f), 250.571(1)

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.490 to 250.631. This administrative regulation requires that directions for feeding and precautionary statements be provided with feed containing additives to ensure safe and effective use of the product.

Section 1. Directions for use and precautionary statements on the labeling of a commercial feed and customer-formula feed containing an additive, such as a drug, a special purpose additive, or nonnutritive additive shall:

1. Be stated in a manner that informs of the safe and effective use of the product for its intended purpose; and

2. Include all information prescribed by:

A. Applicable federal regulations under the Federal Food, Drug and Cosmetic Act, which is codified as 21 USC 301 to 397; and

B. 12 KAR 2:036, for feed containing nonprotein nitrogen.

Section 2. Adequate directions and precautionary statements necessary for safe and effective use shall be placed on commercial feeds distributed to supply particular dietary needs or for supplementing or fortifying the usual diet or ration with a vitamin, mineral, or other dietary nutrient or compound. (AES-2 (1973)-6; 1 Ky.R. 1000; eff. 6-11-75; Am. 25 Ky.R. 892; 2355; eff. 4-14-99.)

12 KAR 2:036. Nonprotein nitrogen.

RELATES TO: KRS 250.491 to 250.631
STATUTORY AUTHORITY: KRS 250.571

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631, regarding commercial feeds. This administrative regulation establishes requirements for the safe use of nonprotein nitrogen in ruminant ration.

Section 1. Urea and other nonprotein nitrogen products defined in the Official Publication of the Association of American Feed Control Officials shall be acceptable ingredients in commercial feeds for ruminant animals as a source of equivalent crude protein.

Section 2. A label shall bear adequate directions for the safe use of a feed and the precautionary statement "Caution: Use as Directed", if:

1. The commercial feed contains more than 8.75 percent of equivalent crude protein from all forms of nonprotein nitrogen; or

2. The equivalent crude protein from all forms of nonprotein nitrogen exceeds one-third (1/3) of the total crude protein.

Section 3. Nonprotein nitrogen defined in the Official Publication of the Association of American Feed Control Officials, if so indicated, shall be acceptable ingredients in commercial feeds distributed to nonruminant animals as a source of nutrients other than equivalent crude protein. The maximum equivalent crude protein from nonprotein nitrogen sources when used in nonruminant rations shall not exceed 1.25 percent of the total daily ration.

Section 4. The directions for use and the caution statement shall be typed and placed on the label in a manner that can be read and understood by ordinary persons under customary conditions of purchase and use.

Section 5. On labels that bear adequate feeding directions or warning statements, the presence of added nonprotein nitrogen shall not require a duplication of the feeding directions or the precautionary statements if the statements include sufficient information to ensure the safe and effective use of this product due to the presence of nonprotein nitrogen. (AES-2 (1973)-7; 1 Ky.R. 1000; eff. 6-11-75; Am. 23 Ky.R. 1609; 2711; eff. 1-10-97.)

12 KAR 2:041. Additives.

RELATES TO: KRS 250.501, 250.511, 250.541(1)(a), (b), (c), (d), (e), (f), (j), (2)(c), (d), (e), 21 CFR 570.3(1), 570.30, 582, 21 USC 151 to 158, 360(b)
STATUTORY AUTHORITY: KRS 250.571(1)

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631 regarding commercial feeds. KRS 250.541 provides that a commercial feed or a material exempted from the definition of commercial feed shall be considered adulterated if it meets the conditions established in KRS 250.541. KRS 250.551(1) and (2) prohibit the manufacture or distribution of an adulterated product as animal feed. This administrative regulation establishes the requirements to ensure the safe and effective use of commercial feeds containing additives.

Section 1. Before approval of a registration application or label for commercial feed containing an additive, including a drug, another special purpose additive, or nonnutritive additive, the distributor shall, upon request by the director, submit evidence to prove the safe and effective use of the commercial feed when used according to the directions furnished on the label.

Section 2. Satisfactory evidence of safe and effective use of a commercial feed shall be one (1) of the following:

1. The use of an additive that:

A. Conforms to the requirements of 21 CFR 570.3(1), 570.30, or Part 582; or

B. Is considered prior sanctioned, informal review sanctioned, or generally recognized as safe (GRAS) by the Food and Drug Administration;

2. A commercial feed that is a drug as defined in KRS 250.501(7) if it:

A. Is generally recognized by the Food and Drug Administration as safe and effective for its labeled use according to 21 CFR 570.30 and Part 582; or

B. Is marketed subject to an application approved by the Food and Drug Administration under 21 USC 360(b);

3. A commercial feed used to impart immunity if the constituents have been approved for that purpose through the Federal Virus, Serum and Toxins Act, which is codified as 21 USC 151 to 158;

4. A direct-fed microbial product if:

A. The product is defined as a fermentation product in the Official Publication of the Association of American Feed Control Officials; and

B. The microbial content statement:

1. Appears on the label; and

2. States "Contains a source of live (viable), naturally occurring microorganisms"; or

5. An enzyme product if the product is:

A. Defined as an enzyme in the Official Publication of the Association of American Feed Control Officials; and

B. Guaranteed according to the provisions of 12 KAR 2:018.

Section 3. Incorporation by Reference.

1. "Official Publication", 1998 Edition, Association of American Feed Control Officials, is incorporated by reference.

2. This material may be inspected, copied, or obtained at the Division of Regulatory Services, 103 Regulatory Services Building, College of Agriculture, University of Kentucky, Lexington, Kentucky 40546-0275, Monday through Friday, 8 a.m. to 4:30 p.m. (AES-2 (1973)-8; 1 Ky.R. 1000; eff. 6-11-75; Am. 23 Ky.R. 1610; eff. 1-10-97; 25 Ky.R. 1087; 2355; eff. 4-14-99.)

12 KAR 2:046. Poisonous or deleterious substances.

RELATES TO: KRS 250.501(4), (5), (6), (7), (8), (24), 250.541, 250.551(1), (2), (3)
STATUTORY AUTHORITY: KRS 250.571(1)

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631, regarding commercial feeds. This administrative regulation establishes the requirements for the safe use of substances that might have deleterious effects if not fed according to the following standards.

Section 1. For the purpose of KRS 250.541(1)(a), poisonous or deleterious substances include shall:

1. Fluorine and a mineral or mineral mixture that is fed directly to a domestic animal if the fluorine exceeds:

A. 0.20 percent for breeding or dairy cattle;

B. 0.30 percent for slaughter cattle;

C. 0.30 percent for sheep;

D. 0.35 percent for lambs;

E. 0.45 percent for swine; and

F. 0.60 percent for poultry.

2. A fluorine-bearing ingredient if used in an amount that raises the fluorine content of the total ration, excluding roughage, above:

A. 0.004 percent for breeding or dairy cattle;

B. 0.009 percent for slaughter cattle;

C. 0.006 percent for sheep;

D. 0.01 percent for lambs;

E. 0.015 percent for swine; and

F. 0.03 percent for poultry.

3. A fluorine-bearing ingredient mixed in feed that:

A. Is fed directly to cattle, sheep, or goats that consume roughage regardless of the amount of grain consumed; and

B. Results in a daily intake of more than fifty (50) milligrams of fluorine per 100 pounds of body weight.

4. Soybean meal, flakes or pellets or another vegetable meal, flake, or pellet that have been extracted with trichloroethylene or other chlorinated solvent.

5. Sulfur dioxide, sulfurous acid, and salts of sulfurous acid that are used in or on feeds or feed ingredients that are considered or labeled a significant source of vitamin B1 (thiamine).

Section 2. A screening or by-product of grains and seeds containing weed seeds used in commercial feed or sold as commercial feed to the ultimate consumer shall be ground fine enough or otherwise treated to destroy the viability of the weed seeds so the finished product contains:

1. No viable prohibited noxious weed seeds; and

2. Not more than 480 viable restricted weed seeds per pound. (AES-2 (1973)-9; 1 Ky.R. 1000; eff. 6-11-75; Am. 23 Ky.R. 1611; eff. 1-10-97; 25 Ky.R. 893; 2356; eff. 4-14-99.)

12 KAR 2:051. Manufacturing conditions.

RELATES TO: KRS 250.501, 250.511, 250.541, 250.551, 250.581(1), 21 CFR 225.1 to 225.202, 226.1 to 226.115
STATUTORY AUTHORITY: KRS 250.541(c), 250.571(1), 21 CFR 225.1 to 225.202, 226.1 to 226.115

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631, regarding commercial feeds. KRS 250.541(2)(c) requires the promulgation of an administrative regulation that establishes the current good manufacturing practices for the manufacturing, processing, and packaging of commercial feed. This administrative regulation establishes current good manufacturing practices for feeds containing drugs or antibiotics.

Section 1. The current good manufacturing practices published in the Code of Federal Regulations for Type B and Type C medicated feeds are governed by:

1. 21 CFR Part 225.1, Subpart A, 51 Federal Register 7389, March 3, 1986;

2. 21 CFR Part 225.10, Subpart A, 42 Federal Register 12426, March 4, 1977;

3. 21 CFR Parts 225.20, 225.30, 225.35, Subpart B, 41 Federal Register 52618, November 30, 1976;

4. 21 CFR Part 225.42, Subpart C, 41 Federal Register 52618, November 30, 1976;

5. 21 CFR Part 225.58, Subpart C, 55 Federal Register 11577, March 29, 1990;

6. 21 CFR Part 225.65, Subpart C, 41 Federal Register 52618, November 30, 1976;

7. 21 CFR Part 225.80, Subpart D, 41 Federal Register 52618, November 30, 1976;

8. 21 CFR Parts 225.102 and 225.110, Subpart E, 41 Federal Register 52618, November 30, 1976;

9. 21 CFR Part 225.115, Subpart E, 57 Federal Register 6475, February 25, 1992;

10. 21 CFR Parts 225.120, 225.130 and 225.135, Subpart F, 41 Federal Register 52618, November 30, 1976;

11. 21 CFR Parts 225.142, 225.158 and 225.165, Subpart G, 41 Federal Register 52618, November 30, 1976;

12. 21 CFR Part 225.180, Subpart H, 51 Federal Register 7390, March 3, 1986; and

13. 21 CFR Part 225.202, Subpart I, 51 Federal Register 7390, March 3, 1986.

Section 2. The current good manufacturing practices published in the Code of Federal Regulations for Type A medicated articles are governed by:

1. 21 CFR Parts 226.1 and 226.10, Subpart A, 40 Federal Register 14031, March 27, 1975;

2. 21 CFR Parts 226.20 and 226.30, Subpart B, 40 Federal Register 14031, March 27, 1975;

3. 21 CFR Parts 226.40 and 226.42, Subpart C, 40 Federal Register 14031, March 27, 1975;

4. 21 CFR Part 226.80, Subpart D, 40 Federal Register 14031, March 27, 1975; and

5. 21 CFR Parts 226.102, 226.110 and 226.115, Subpart E, 40 Federal Register 14031, March 27, 1975. (AES-2 (1973)-10; 1 Ky.R. 1001; eff. 6-11-75; Am. 23 Ky.R. 1612; eff. 1-10-97; 25 Ky.R. 894; 2357; eff. 4-14-99.)

12 KAR 2:056. List of manufacturers.

RELATES TO: KRS 250.491 to 250.631
STATUTORY AUTHORITY: KRS 250.571

NECESSITY, FUNCTION, AND CONFORMITY: To provide a current listing of facilities manufacturing commercial feed in the state. This will aid in the exchange of correspondence and collections of official feed samples.

Section 1. For the purpose of maintaining current files of feed manufacturers under KRS 250.511(1) of the Kentucky Feed Law, the list of manufacturers on file will be purged on January 1 of each year of all facilities not having current tonnage reports.

Section 2. Firms purged will be notified at the address of record and will be given the opportunity of being reinstated if the division is notified that reinstatement is desired. (AES-2 (1973)-11; 1 Ky.R. 1001; eff. 6-11-75.)

12 KAR 2:061. Registration.

RELATES TO: KRS 250.501, 250.511(3), 250.521(2), 250.561(3)
STATUTORY AUTHORITY: KRS 250.571(1)

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631, regarding commercial feeds. KRS 250.511(1) and (2) require a manufacturer or distributor of commercial feed in Kentucky to register with the director each facility that manufactures customer-formula feed and each commercial feed except customer-formula feed. This administrative regulation establishes the procedure for the registration of commercial feed and manufacturers of customer-formula feed and the requirements for an exemption

Section 1.

1. Except as provided in subsection (2) of this section, a manufacturer shall submit a completed Application for Registration of Commercial Feeds to register each feed other than a customer-formula feed.

2. The director shall grant an exemption to the registration requirement if the owner or other responsible individual with authority to register feed for the manufacturer:

A. Has a record of satisfactory compliance with the labeling requirements established in KRS 250.521 and 12 KAR 2:011; and

B. Submits to the director a notarized affidavit certifying the following:

1.a. Name and mailing address of the manufacturer; and

b. A statement acknowledging the manufacturer's responsibility to comply with KRS 250.491 to 250.631 including payment of the inspection fee required by KRS 250.561(1);

2.a. That the person requesting the exemption has knowledge of the labeling requirements of KRS 250.521 and 12 KAR 2:011; or

b. That a qualified individual is employed to ensure that commercial feed is labeled according to KRS 250.521 and 12 KAR 2:011. The name and address of the person responsible for product labeling shall be provided, if different than the affiant;

3. A commercial feed distributed in Kentucky is suitable for its intended purpose in accordance with the requirements established in 12 KAR 2:066, Sections 1, 2, and 6;

4. Within thirty (30) days of notification the affiant agrees to provide a label for each commercial feed, a specifically designated feed or feed type distributed in Kentucky for the purpose of determining compliance with the labeling requirements established in KRS 250.521 and 12 KAR 2:011. The request and compliance with the request shall not be construed as a registration process; and

5. That the affiant agrees to resume registration of each commercial feed if notified by the director of unsatisfactory compliance with the labeling requirements of KRS 250.521 and 12 KAR 2:011 or of the failure to provide a requested label within thirty (30) days. The manufacturer shall have thirty (30) days from receipt of the notice to complete registration of a commercial feed product offered for sale in Kentucky. During this period the affiant may request a meeting with the director to resolve a labeling violation or seek reinstatement or modification of registration exemption.

Section 2. A registration exemption shall not prevent the enforcement of KRS 250.491 to 250.631. A manufacturer granted a registration exemption shall be considered registered for a commercial feed, other than a customer-formula feed.

Section 3. A distributor of customer-formula feed shall register as a customer-formula feed distributor by submitting a completed Registration of Customer-Formula Feed Distributor Form. Registration as a customer-formula feed distributor shall be dependent upon agreement by the manufacturer to:

1. Abide by the labeling requirements of KRS 250.521(2); and

2. Maintain at the facility where customer-formula feed is manufactured, a file of customer-formula mixes.

Section 4. Registration of a customer-formula feed distributor shall be subject to cancellation under the same conditions established for registered feeds under KRS 250.511(3) and 250.561(3).

Section 5. For commercial feed that is distributed to the final purchaser exclusively in an immediate container package weight of ten (10) pounds or less, the person whose name appears on the label as the guarantor or distributor shall provide the director with:

1. The name of each product by submitting a completed Application for Registration of Commercial Feeds before distribution within Kentucky; and

2. Pay the fee required by KRS 250.561(1)(d).

Section 6. Incorporation by Reference.

1. "Application for Registration of Commercial Feeds", March 1999, Division of Regulatory Services, is incorporated by reference.

2. This material be inspected, copied, or obtained at the Division of Regulatory Services, University of Kentucky, 103 Regulatory Services Building, Lexington, Kentucky 40545-0275, Monday through Friday, 8 a.m. to 4:30 p.m. (AES-2 (1973)-12; 1 Ky.R. 1001; eff. 6-11-75; Am. 23 Ky.R. 1612; eff. 1-10-97; 25 Ky.R. 895; 2357; eff. 4-14-99.)

12 KAR 2:066. Suitability.

RELATES TO: KRS 250.541(2)(e)
STATUTORY AUTHORITY: KRS 250.541(2)(e), 250.571(1)

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631, regarding commercial feeds. This administrative regulation establishes criteria that commercial feed shall meet in order to be suitable for its intended purpose and establishes the procedure for an affidavit attesting to the nutritional adequacy of a commercial feed.

Section 1. The nutritional content of commercial feed shall be as stated by its labeling. The feed, its labeling and stated use shall be suitable for the intended purpose of the product.

Section 2.

1. Commercial feed for swine, poultry, or fish or milk replacer for veal or herd replacement calves, if fed according to directions, shall meet the applicable nutrient requirements established by the National Research Council, and incorporated by reference in this administrative regulation.

2. A signed affidavit of suitability attesting to the nutritional adequacy of the feed based upon valid scientific evidence shall be submitted to the director upon request as established in Section 6 of this administrative regulation.

Section 3. An affidavit of suitability certifying that the feed sponsor has valid scientific knowledge assuring suitability of the nutritional content of the feed shall be submitted to the director if the suitability of the feed is challenged.

Section 4. Submission of a completed Affidavit of Suitability shall serve as proof of suitability. The feed sponsor shall not be required to provide scientific information nor a reference thereto unless the director has reason to believe that the feed is not suitable for its intended use. The director shall have the authority to conduct a hearing requiring the feed sponsor to produce sufficient scientific evidence of the feed's suitability.

Section 5. Upon receipt by the director of a complete Affidavit of Suitability, the feed sponsor may continue to market the product. If an affidavit is not properly submitted, the director may pursuant to KRS 250.091(1) or 250.601(2) place or continue a stop-sale order on the feed and order its removal from the marketplace as well as all other feeds manufactured or distributed under the same product name.

Section 6. The Affidavit of Suitability shall contain the following information:

1. The feed manufacturer's name.

2. The feed's product name.

3. The name and title of the affiant submitting the document.

4. The statement that the affiant has knowledge of the nutritional content of the feed and is familiar with the nutritional requirements of the animal species and animal class for which the product is intended, as established by the National Research Council of the National Academy of Sciences.

5. The statement that the affiant has knowledge of valid scientific evidence that supports the suitability for the intended animal species and animal class(es) for which the feed is intended. If the manufacturer states on the label a nutrient guarantee below the minimum National Research Council nutrient recommendation, the manufacturer shall specify in the Affidavit of Suitability scientific evidence demonstrating that a feed with that nutrient content is suitable for its intended purpose.

6. The date of submission.

7. The signature of the affiant notarized by a notary public.

Section 7. Incorporation by Reference.

1. The following material is incorporated by reference:

A. Nutrient Requirements of Swine, Tenth Revised Edition, 1998, National Research Council;

B. Nutrient Requirements of Dairy Cattle, Sixth Revised Edition, 1988, National Research Council;

C. Nutrient Requirements of Fish, 1993, National Research Council; and

D. Nutrient Requirements of Poultry, Ninth Revised Edition, 1994, National Research Council.

2. This material may be inspected, copied, or obtained at the Division of Regulatory Services, University of Kentucky, 103 Regulatory Services Building, Lexington, Kentucky 40545-0275, Monday through Friday, 8 a.m. to 4:30 p.m. (23 Ky.R. 1809; eff. 1-10-97; Am. 25 Ky.R. 897; 2358; eff. 4-14-99.