20-013 Code Vt. R. 20-022-013-X

Current through August, 2024

Section 20 022 013 - VERMONT FEED REGULATIONS

PET FOOD REGULATIONS

Section I DEFINITIONS AND TERMS

A. When used in these regulations, definitions, terms and names relating to the manufacture and distribution of commercial feeds shall be those set out in 6 V.S.A. § 323. When a definition, name or term does not appear in 6 V.S.A. § 323, the definitions, terms and names adopted by the Association of American Feed Control Officials (AAFCO) shall apply unless the Commissioner prescribes otherwise.

B. For the purpose of these regulations, the following commodities are hereby exempt from the definition of "commercial feed" as set forth in § 323(2): hay, straw, stover, silage, cobs, husks, hulls, and individual chemical compounds or substances when such commodities, pounds or substances are not intended to be intermixed or mixed with other materials, and are not adulterated within the meaning of 6 V.S.A. § 327(a).

Section II REGISTRATION

A. Registration of Manufacturers. No person shall manufacture a commercial feed in this state prior to registering annually by January 31 with the Commissioner and providing the Commissioner with the following information:

1. the name of the manufacturer,

2. the manufacturer's principal place of business,

3. the location of each of the manufacturer's facilities within the state, and

4. the location of each of the manufacturer's facilities outside the state distributing feed or any feed ingredient within the state.

B. Notice of Change. The registrant shall notify the Commissioner within 30 days of any change in the above information.

C. Registration of Commercial Feeds. No person shall distribute a commercial feed product in this state prior to registering the same with the Commissioner, as specified in 6 V.S.A. § 324(b), and providing the Commissioner with the following information:

1. an official label as provided in 6 V.S.A. § 325(a), or, in the case of a customer-formula feed as provided in 6 V.S.A § 325(b).

D. Application Fee. The application for registration of each feed product shall be accompanied by the statutory fee as provided in 6 V.S.A. § 324(b), (c).

E. The registration year for commercial feeds shall commence on April 1 and expire on March 31 annually.

Section III LABEL FORMAT

A. Commercial feed, other than customer-formula feed, 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 a drug is used:

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. An active drug ingredient statement listing the active drug ingredients by their established name and the amounts in accordance with Section V. D.

d. The required directions for use and precautionary statements or reference to their location if the detailed feeding directions and precautionary statements required by regulations and appear elsewhere on the label.

4. The guaranteed analysis of the feed as required under the provisions of Section 325 of the Act include the following items, unless exempted in i. of this subsection, and in the order listed:

a. Minimum percentage of crude protein.

b. Maximum or minimum percentage of or equivalent protein from non-protein nitrogen as required in Section V. E.

c. Minimum percentage of crude fat.

d. Maximum percentage of crude fiber.

e. Minerals, to include in the following order:

(1) Minimum and maximum percentage of calcium (Ca),

(2) minimum percentages of phosphorus (P),

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

(4) other minerals

f. Vitamins in such terms as specified in Section V. C.

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

h. Viable lactic acid producing microorganisms for use in silages in terms specified in Section V. G.

i. Exemptions:

(1) Guarantees for minerals are not required when there are no specific label claims and when the commercial feed contains less than 6 1/2% of calcium, phosphorus, sodium and chloride.

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

(3) 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.

(4) 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 resisting to the primary purpose of the product, and no specific label claims are made.

5. Feed ingredients, collective terms for the grouping of feed ingredients, or appropriate statement as provided under the provisions of Section 325(a) 4 of the Act.

a. The name of each ingredient as defined in the Official Publication of the Association of American Feed Control Officials, common or usual name, or one approved by the Commissioner.

b. Collective terms for the grouping of feed ingredients as defined in the Official Definitions of Feed Ingredients published in the Official Publication of the Association of American Feed Control Officials in lieu of the individual ingredients provided that:

(1) 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.

(2) 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.

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.

7. The information required in Section 325(a) 1-5 of the Act must appear in its entirety on one side of the label or on one side of the container. The information required by Section 325(a) 6-7 of the Act shall be displayed in a prominent place on the label or container but not necessarily on the same side as the above information. When the information required by Section 325(a) 6-7 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 325 of the Act shall be subordinated or obscured by other statements or designs.

a. Customer-formula feed shall be accompanied with the information prescribed in this regulation 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 weight 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 VII. and VIII.

(7) If a drug containing product is used:

(a) The purpose of the medication (claim statement).

(b) The established name of each active drug ingredient and the level of each drug used in the final mixture expressed in accordance with Section V. D.

Section IV BRAND AND PRODUCT NAMES

A. The brand or product name must be appropriate for the intended use of the feed and must not be misleading. If the name indicates the feed is made for a specific use, the character of the feed must conform therewith. A mixture labeled "Dairy Feed," for example, must be suitable for that purpose.

B. Commercial, registered brand or trade names are not permitted in guarantees or ingredient listings and only in the product name of feeds produced by or for the firm holding the rights to such a name.

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 ingredients 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. Digital numbers shall not be used in such a manner as to be misleading or confusing to the customer.

F. Single ingredient feeds shall have a product name in accordance with the designated definition of feed ingredients as recognized by the Association of American Feed Control Officials unless the Commissioner designates otherwise.

G. The word "vitamin", or a contraction thereof, or any word suggesting vitamin can be used only in the name of a feed which is represented to be a vitamin supplement, and which is labeled with the minimum content of each vitamin declared, as specified in Section V. C.

H. The term "mineralized" shall not be used in the name of a feed expect 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 made from cattle, swine, sheep and goats.

Section V 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.

B. Commercial feeds containing 6 1/2% or more calcium, phosphorus, sodium and chloride shall include in the guaranteed analysis the minimum and maximum percentages of calcium (Ca), the minimum percentage of phosphorus (P), and if salt is added, the minimum and maximum percentage of salt (NaCl). Minerals, except salt (NaCl), shall be guaranteed in terms of percentage of the element. When calcium and/or salt guarantees are given in the guaranteed analysis such shall be stated and conform to the following.

1. When the minimum is 5.0% or less, the maximum shall not exceed the minimum by more than one percentage point.

2. When the minimum is above 5.0%, the maximum shall not exceed the minimum by more than 20% and in no case shall the maximum exceed the minimum by more than 5 percentage points.

C. Guarantees for minimum vitamin content of commercial feeds shall be listed in the order specified and are stated in milligrams per pound 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; thiamin; 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 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. 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 no more than .....% equivalent

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, 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,.....%

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.

Section VI INGREDIENTS

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

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

C. No reference to quality or grade of an ingredient shall appear in the ingredient statement of a feed.

D. The term "dehydrated" may precede the name of any product that has been artificially dried.

E. A single ingredient product defined by the Association of American Feed Control Officials is not required to have an ingredient statement.

F. Tentative definitions for ingredients shall not be used until adopted as official, unless no official definition exists or the ingredient has a common accepted name that requires no definition (i.e., sugar).

G. When the word "iodized" is used in connection with a feed ingredient, the feed ingredient shall contain not less than 0.007% iodine, uniformly distributed.

Section VII 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:

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 VIII.

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 VIII 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. 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 Publication of the Association of American Feed Control Officials, 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 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.

Section IX DRUG AND FEED ADDITIVES

A. Prior to approval of a registration application and/or approval of a label for commercial feed which contain additives (including drugs, other special purpose additives, or non-nutritive additives), the distributor may be required to submit evidence to prove the safety and efficacy of the commercial feed when used according to the directions furnished on the label.

B. Satisfactory evidence of safety and efficacy of a commercial feed may be:

1. When the commercial feed contains such additives, the use of which conforms to the requirements of the applicable regulation in the Code of Federal. Regulations, Title 21, or which are "prior sanctioned" or "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 323(6) of the Act and is generally recognized as safe and effective for the labeled use or is marketed subject to an application approved by the Food and Drug Administration under Title 21 U.S.C. 360(b).

Section X ADULTERANTS

A. For the purpose of Section 327(a) of the Act, the terms "poisonous or deleterious substances" include but are not limited to the following:

1. Fluorine and any mineral or mineral mixture which is to be used directly for the feeding of domestic animals and in which the fluorine exceeds 0.20% 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 result 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 B[1](Thiamine).

6. Mycotoxins, when present in levels that threaten animal health.

7. Pesticide residuals, when present in amounts greater than those listed in the Code of Federal Regulations, Title 40, Part 180.

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 found fine enough or otherwise treated to destroy the viability of such weed seeds so that the finished product contains no more than 10 viable weed seeds per pound or no more than 1% (by weight) viable weed seeds per ton finished product.

Section XI ADMINISTRATIVE PENALTY AND ANALYTICAL TOLERANCES

A. A commercial feed is deemed deficient for the purposes or the administrative penalty set forth in Section VIII B. if either of the following conditions is met:

1. If the analysis of any component varies from the guarantee by an amount exceeding the values in the following schedule:

a. Proximate Analysis Determination	AV %	Concentration Range
Moisture	12	3-40%
Protein	(20/x + 2)	10-85%
Fat	10	3-20%
Fiber	(30/x + 6)	2-30%
Ash	(45/x + 3)	2-88%
Pepsin Digest,
Protein	13
Total Sugar
as Invert	12	24-37%
NPN Protein	(80/x + 3)	7-60%

b. Minerals Determination	AV %	Concentration Range
(14/x + 6)
Calcium	10	.5 - 25%
12	10 - 25%
Phosphorus	(3/x + 8)	<10%
Salt	(7/x + 5)	.5 - 20%
(15/x + 9)	.5 - 14%
Fluorine	40	.5 - 14%
Cobalt	25
Iodine	40	0.01 - .16%
Copper	20
30	.03 - 1%
Magnesium	20	<.03%
Iron	25	.01 - 15%
Manganese	30	.01 - 5%
Potassium	15	.01 - 17%
Zinc	20	.04 - 8%
Selenium	25	.002 - 6%
ppm

c. Vitamins Determination	AV %	Concentration Range
Vitamin A	30	1200 -
		218,000 IU/lb
Vitamin B[12]	45
Riboflavin	30	1 - 1500 mg/lb
Niacin	25	3 - 500 mg/lb
Pantothenic Acid	25	4-190 mg/lb
Amprolium	20	.01 - .014%
Arsanilic Acid	20	.01 - .05%
Carbodox	20	.005 - .5%
Ethopabate	25	.004 - .04%
Furazolidone	25	.005 - .022%
Melengestrol Acetate	30	up to .07%
Nicarbazin	25	.01 - .02%
Nitarsone	30	.01 - .02%
Phenothiazine	20	.1 - .5%
Piperazine	25	.1 - .4%
Pyrantel Tartrate	25	.01%
Roxarsone	25	.005 - .5%
Sulfamethazine	20	.01 - .033%
Sulfaquinoxaline	25	.01 - .025%
Sulfathiazole	20	.008 - .034%
Thiabendazole	30	up to 1.5%
Zoalene	25	.004 - .0125%
Bacitracin	40	10 - 200 g/T
Chlortetracyline	30	10 - 260 g/T
Lincomycin	25	10 - 200 g/T
Monensin	30	10 - 200 g/T
Neomycin	45	20 - 250 g/T
Oxytetracyline	30	10 - 300 g/T
Penicillin	35	10 - 200 g/T
Streptomycin	45	10 - 75 g/T
Tylosin	30	10 - 150 g/T
Virginiamycin	40	80 g/T

2. If the weight of the feed is found not to be the net weight appearing on the label as required by Section III. (Label Format).

B. The registrant of a commercial feed deemed deficient under Section VIII A. shall be assessed an administrative penalty. A penalty shall not exceed:

1. $ 150.00 for the first violation for a particular product during the calendar year.

2. $ 300.00 for the second violation for the same product during the same calendar year.

3. $ 500.00 for the third or any subsequent violation for the same product during the same calendar year.

C. The Commissioner shall issue quarterly reports to registrants found to be in violation of this section. The quarterly report shall include an analysis of the deficient product or products and the proposed penalty. This quarterly report shall serve as written notice of deficiency as provided in 6 V.S.A. [331(c).

Section XII GOOD MANUFACTURING PRACTICES

A. For the purposes of enforcement of Section 327(b) 3 of the Act the Commissioner adopts the following as current good manufacturing practices:

1. The regulations prescribing good manufacturing practices for medicated feeds as published in the Code of Federal Regulations, Title 21, Part 225, Sections 225.1 - 225.202.

2. The regulations prescribing good manufacturing practices for medicated premixes as published in the Code of Federal Regulations, Title 21, Part 226, Sections 226.1 - 226.115.

Section XIII TONNAGE REPORTING

A. Annual tonnage reports shall be required of the following persons:

1. Registered manufacturers, and

2. Distributors within or without the state distributing feed products intended for use or sale within the state

B. Tonnage reports shall be made no later than January 30 and shall include the following information for the previous calendar year on forms to be supplied by the Commissioner:

1. The name of the registrant or distributor.

2. The tonnage of commercial feed or feed ingredients sold for use by consumers in this state.

3. The tonnage of customer-formula feed sold for use by consumers in this state.

C. Pet foods or feeds intended for use outside this state shall be exempt from the reporting requirements of this Section.

PET FOOD REGULATIONS

Section I. DEFINITIONS AND TERMS

A. "Principal display panel" means the part of a label that is most likely to be displayed, presented, shown or examined under normal and customary conditions of display for retail sale.

B. "Ingredient statements" means a collective and contiguous listing on the label of the ingredients of which the pet food is composed.

C. "Immediate container" means the unit, can, box, tin, bag, or other receptacle or covering in which a pet food is displayed for sale to retail purchasers, but does not include containers used as shipping containers.

Section II LABEL FORMAT AND LABELING

A. The statement of net content and product name must be shown on the principal display panel. All other required information may be placed elsewhere on the label but shall be sufficiently conspicuous as to render it easily read by the average purchaser under ordinary conditions of purchase and sale.

B. The declaration of the net content shall be made in conformity with the United States "Fair Packaging and Labeling Act" and the regulations promulgated thereunder.

C. The information which is required to appear in the "Guaranteed Analysis" shall be listed in the following order.

Crude protein (Minimum Amount)

Crude fat (Minimum Amount)

Crude fiber (Maximum Amount)

Moisture (Maximum Amount)

Additional guarantees shall follow moisture.

D. The label of pet food shall specify the name and address of the manufacturer, packer, or distributor of pet food. The statement of the place of business shall include an address that can be reached by mail.

E. If a person manufactures, packages, or distributes a pet food in a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where each package of such pet food was manufactured or packaged or is to be distributed, if such statement is not misleading in any particular.

F. A vignette, graphic, or pictorial representation of a product on a pet food label shall not misrepresent the contents of the package.

G. The use of the word "proven" in connection with label claims for a pet food is improper unless scientific or other empirical evidence establishing the claim represented as "proven" is available.

H. No statement shall appear upon the label of a pet food which makes false or misleading comparisons between that pet food and any other pet food. Personal or commercial endorsements are permitted on pet food labels where said endorsements are factual and not otherwise misleading.

J. When a pet food is enclosed in any outer container or wrapper which is intended for retail sale, all required label information must appear on such outside container or wrapper, unless legible through aperatures or transparencies.

K. The words "Dog Food," "Cat Food," or similar designations must appear conspicuously upon the principal panels of the pet food labels.

L. The label of a pet food shall not contain an unqualified representation of claim, directly or indirectly, that the pet food therein contained or a recommended feeding thereof, is or meets the requisites of a complete, perfect, scientific or balanced ration for dogs or cats unless such product or feeding:

1. Contains ingredients in quantities sufficient to provide the estimated nutrient requirements for all stages of the life of a dog or cat, as the case may be, which have been established by a recognized authority, on animal nutrition, or,

2. Contains a combination of ingredients which when fed to a normal animal as the only source of nourishment will provide satisfactorily for fertility of females, gestation and lactation, normal growth from weaning to maturity without supplementary feeding, and will maintain the normal weight of an adult animal whether working or at rest and has had its capabilities in this regard demonstrated by adequate testing.

M. Labels for products which are compounded for or which are suitable for only a limited purpose (i.e., a product designed for the feeding of puppies) may contain representations that said pet food product or recommended feed thereof, is or meets the requisites for a complete, perfect, scientific or balanced ration for dogs or cats only:

1. In conjunction with a statement of a limited purpose for which the product is intended or suitable (as, for example, in the statement "a complete food for puppies"). Such representations and such required qualification therefore shall be juxtaposed on the same panel and in the same size, style and color print; and

2. Such qualified representations may appear on pet food labels only if:

(a) The pet food contains ingredients in quantities sufficient to satisfy the estimated nutrient requirements established by a recognized authority, for such limited or qualified purpose; or

(b) The pet food product contains a combination of ingredients which when fed for such limited purpose will satisfy the nutrient requirements for such limited purpose and has had its capabilities in this regard demonstrated by adequate testing.

N. Except as specified by Section III. A. the name of any ingredient which appears on the label other than in the product name shall not be given undue emphasis so as to create the impression that such an ingredient is present in the product in a larger amount than is the fact, and if the names of more than one such ingredient are shown, they shall appear in the order of their respective predominance by weight in the product.

O. The label of a dog or cat food (other than one prominently identified as a snack or treat as part of the designation required upon the principal display panel under Section II. K.) shall bear, on either the principal display panel or the information panel (as those terms are defined in 21 C.F.R. 501.1 and 501.2 respectively), in type of a size reasonably related to the largest type on the panel, a statement of the nutritional adequacy or purpose of the product. Such statement shall consist of one of the following:

1. A claim that the pet food meets or exceeds the requirements of one or more of the recognized categories of nutritional adequacy: gestation, lactation, growth, maintenance, and complete for all life stages, as those categories are set forth in Section II. L. and M.

2. A nutrition or dietary claim for purposes other than those listed in Section II. L. and M. if the claim is scientifically substantiated.

3. The statement: "Use only as directed by your veterinarian", if it is a dietary animal food product intended for use by, or under the supervision or direction of a veterinarian.

4. The statement: "this product is intended for intermittent or supplemental feeding only," if a product does not meet either the requirements of Section II. L. and M. or any other special nutritional or dietary need and so is suitable only for limited or intermittent or supplementary feeding.

Section III BRAND AND PRODUCT NAMES

In addition to the requirements for commercial feed otherwise provided in this part, the following requirements shall apply to pet food and specialty pet food:

A. No flavor designation or claim shall be used on any pet food or specialty pet food label unless the designated flavor is detectable by a recognized test method. Any flavor designation or claim on any such label shall either conform to the name of its source as shown in the ingredient statement, or the ingredient statement shall show the source of the flavor. The word "flavor" shall be printed in the same size type and with an equal degree of conspicuousness as the ingredient term from which the flavor designation is derived. Distributors of pet food or specialty pet food employing such flavor designations or claims on the labels of such products shall, upon request by the Commissioner or his authorized representative, supply verification of the designated or claimed flavor.

B. The designation "100%" or "All" or words of similar connotation shall not be used in the brand name or product name of any pet food or specialty pet food if it contains more than one ingredient, provided, for the purpose of this subdivision only, water sufficient for processing, required decharacterizing agents and trace amounts of preservatives and condiments shall not be considered ingredients.

C. The terms "meat" and "meat by-products" may be used without a designation of the species from which the same was derived only if such meat or meat by-products have been derived from cattle, swine, sheep or goats; otherwise, the species shall be designated, for example, "horsemeat."

D. The name of any pet food or specialty pet food shall not be dervied 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 of any such product unless all components or ingredients are included in the name, except as provided in subdivisions A., E., or F. of this section; provided that the name of an ingredient or combination of ingredients may be used as part of the product name if:

1. the ingredient or combination of ingredients is present in sufficient quantity to impart a distinctive characteristic to the product or is present in amounts which have a material bearing upon acceptance of the product by the purchaser thereof; and

2. it does not constitute a representation that the ingredient or combination of ingredients is present to the exclusion of other ingredients; and

3. It is not otherwise false or misleading.

E. When an ingredient or a combination of ingredients derived from animals, poultry, or fish constitutes 95% or more of the total weight of all ingredients of any pet food or specialty pet food mixture, the name or names of such ingredient or ingredients may form a part of the product name of such food; provided, that where more than one ingredient is part of such product name, then all such ingredient names shall be in the same size, style, and color print.

F. When an ingredient or a combination of ingredients derived from animals, poultry or fish constitutes at least 25% but less than 95% of the total weight of all ingredients of any pet food or specialty pet food mixture, the name or names of such ingredient or ingredients may form a part of the product name of such food only if the product name also includes a primary descriptive term, such as "meatballs" or "fishcakes" so that the product name describes the contents of the product in accordance with an established law, custom or usage and so that the product name is not misleading. All such ingredient names and primary descriptive term shall be in the same size, style and color print.

G. Contractions of coined names referring to ingredients shall not be used in the brand name of any pet food or specialty pet food unless they are in compliance with subdivisions A., D., E., and F. of this section.

Section IV EXPRESSION OF GUARANTEES

In addition to the requirements for commercial feed otherwise provided in this part, the following requirements shall apply to pet food and specialty pet food:

A. The sliding scale method of expressing any guaranteed analysis (for example, "protein 15-18%") is prohibited.

B. The label of any pet food, which is formulated as and represented to be a vitamin supplement, shall include a guarantee of the minimum content of each vitamin declared in the ingredient statement. Such guarantees shall be stated in units of measurements established by a recognized authority on animal nutrition.

C. The vitamin potency of any pet food distributed in any container smaller than one pound may be guaranteed in such units per ounce as established by a recognized authority on animal nutrition.

D. If the label of any pet food does not represent the pet food to be either a vitamin or a mineral supplement, but does include a table of comparison of a typical analysis of the vitamin, mineral, or nutrient content of such food with levels recommended by a recognized animal nutrition authority, such comparison may be stated in the units of measurement used by such authority. Any table of comparison of any vitamin, mineral, or nutrient content shall constitute a guarantee, but need not be repeated in the guaranteed analysis. Such table of comparison may appear on the label separate and apart from the guaranteed analysis.

Section V INGREDIENTS

A. The maximum moisture in all pet foods shall be guaranteed and shall not exceed 78.00% or the natural moisture content of the constituent ingredients of the product, whichever is greater. Pet foods such as those consisting principally of stew, gravy, sauce, broth, juice, or a milk replacer which are so labeled, may contain moisture in excess of 78.00%.

B. Each ingredient of the pet food shall be listed in the ingredient statement, and the names of all ingredients in the ingredient statement must be shown in letters or type of the same size. The failure to list the ingredients of a pet food in descending order by their predominance by weight in non-quantitative terms may be misleading. Any ingredient for which the Association of American Feed Control Officials has established a name and definition shall be identified by the name so established. Any ingredient for which no name and definition has been so established shall be identified by the common or usual name of the ingredient. Brand or trade names shall not be used in the ingredient statement.

C. The term "dehydrated" may precede the name of any ingredient in the ingredient list that has been artificially dried.

D. No reference to quality or grade of an ingredient may appear in the ingredient statement of a pet food.

E. A reference to the quality, nature, form, or other attribute of an ingredient shall not be made unless such designation is accurate and unless the ingredient imparts a distinctive characteristic to the pet food because it possessess[possesses] that attribute.

F. Contractions of ingredient names shall be subject to the same regulation as the complete name of the ingredient.

Section VI DRUGS AND OTHER PET FOOD ADDITIVES

In addition to the requirements for commercial feed otherwise provided in this part, the following requirements shall apply to pet food.

A. An artificial color may be used in any pet food only if it has been satisfactorily shown to be harmless to pets or specialty pets, as the case may be. The permanent or provisional listing of any artificial color in the federal food and drug regulations as safe for use, together with the conditions, limitations, and tolerances, if any, incorporated therein, shall be deemed to be satisfactory evidence that the color is, when used pursuant to such regulations, harmless to pets.

B. Prior to approval of a registration application and/or approval of a label for pet food, 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 pet food, when used according to directions furnished on the label. Satisfactory evidence of the safety and efficacy of a pet food may be:

1. When the pet food 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 pet food itself is a drug as defined in § 323(6) of the Act and is generally recognized as safe and effective for label use or is marketed subject to an application approved by the Food and Drug Administration under Title 21, U.S.C. 360(b).

C. The use of mold inhibitors and anti-oxidants, in pet foods, shall be permissible, provided:

1 They are not harmful to pets in the concentration employed; the permanent or provisional listing of a mold inhibitor or an anti-oxidant in the United States Food and Drug Regulations as safe for use, together with the conditions, limitations and tolerances, if any, incorporated therein, shall be deemed to be satisfactory evidence that the substance is, when used pursuant to such regulations, not harmful to pets; and

2. The specific material used shall be listed in the ingredient statement by its common, usual or chemical name.

Section VII DIRECTIONS FOR USE

A. Each commercial pet food product intended by the distributor for intermittent or supplemental feeding shall:

1. Clearly so indicate by name or specific written statement to that effect; or

2. In the event the product is not so marked or identified, then specific feeding directions shall be a part of the label of said product.

Section VIII ADMINISTRATIVE PENALTY AND ANALYTICAL TOLERANCES

A. A commercial feed is deemed deficient for the purposes of the administrative penalty set forth in Section VIII B. if either of the following conditions is met: