PROPOSED RULES
Original Notice.
Preproposal statement of inquiry was filed as WSR 02-22-094.
Title of Rule: As a result of an Executive Order 97-02 rule review, the department is proposing to adopt a new, clearly written rule chapter created to specifically meet the needs of Washington state's commercial manufacturers and distributors of pet food and specialty pet food. Chapter 16-252 WAC, Commercial feed rules: Pet food and specialty pet food combines current pet food/specialty pet food regulates [regulations] contained in WAC 16-200-750 through 16-200-887 with appropriate requirements from the Association of American Feed Control Officials (AAFCO) model regulations.
Purpose: The purpose of the proposed new chapter 16-252 WAC is to create a set of regulations that are easy to understand and use, reflect current national standards, safeguard the health of man and animals, establish a structure for orderly commerce, and provide protection for consumers and the regulated industry. Specifically, chapter 16-252 WAC:
• Addresses the specific needs of Washington state pet food/specialty pet food manufacturers and distributors.
• Is written in a clear and readable style that allows users to more easily understand and apply WSDA pet food/specialty pet food rules.
• Presents pet food/specialty pet food rule requirements in shorter, more focused rule sections rather than the traditional practice of presenting a wide range of information in very long, tediously subdivided sections.
• Uses tables to clearly and succinctly present information wherever possible and appropriate.
• Incorporate applicable parts of the AAFCO model regulations to help increase the flow of trade and information and promote regulatory consistency between Washington's commercial pet food/specialty pet food industry and the pet food/specialty pet food industry in our sister states.
• Adopts regulations that safeguard public health and the health of animals and that provide increased protection for consumers and industry.
Statutory Authority for Adoption: Chapters 15.53 and 34.05 RCW.
Statute Being Implemented: Chapter 15.53 RCW.
Summary: The proposed new chapter 16-252 WAC creates a set of regulations that are easy to understand and use, reflect current national standards as expressed in the AAFCO model regulations, safeguard public health and the health of animals, establish a structure for orderly commerce with other states by ensuring that WSDA pet food/specialty pet food rules are consistent with AAFCO model regulations, and provide protection for consumers and the regulated industry.
Many of the requirements in the proposed new pet food/specialty pet food chapter are either identical or substantially the same as the pet food/specialty pet food requirements in the current rule sections (WAC 16-200-750 through 16-200-887). However, we have added several new requirements to increase the protection of pets, consumers and industry. We have also written the proposed new chapter more clearly and organized it in a more "user friendly" way than the current rules.
Specifically, the new pet food/specialty pet food chapter:
(1) Safeguards public health, pet health and provides increased protection for consumers and the pet food/specialty pet food manufacturers and distributors operating in Washington state.
To achieve this, we have strengthened commercial pet food/ specialty pet food labeling requirements in WAC 16-252-025 to:
• Improve our ability to track pet food from the manufacturer to the final distributor (WAC 16-252-025(11). In the event of a recall, this lot identifier will increase the effectiveness of the recall and improve pet food safety. Also, by adding this lot identifier requirement, the department voluntarily complies with federal regulations. Now, under the Federal Bio-terrorism Act, the Food and Drug Administration is requiring that all animal food be traceable from the manufacturer through final distribution.
• Prevent misleading labeling (WAC 16-252-025 (4), (12), (13), (14), (15), (17), (18), (19), (20) and (21)).
• Prevent someone from using a statement based on data from an outdated study that fails to recognize changes made to comparison products (WAC 16-252-025 (18)(d)).
• Prevent old products from being called "new," which would be misleading (WAC 16-252-025(20).
• Prevent a product label from being designed so it appears that the product contains an ingredient, when in fact it only contains a flavor of a certain ingredient (WAC 16-252-025 (21)(b) and (c)).
• Make companies aware that when the term "organic" is used on a label it has a specific meaning and additional regulations apply (WAC 16-252-025(23)).
In addition, the department has proposed new requirements to:
• Prevent someone from using misleading product names (WAC 16-252-040). For example, the requirement prevents a product name from being "Lamb, with Rice" when there is actually only a small amount of lamb in the pet food or specialty pet food.
• Ensure uniform labeling of the nutritional value of pet food products thus enabling product purchasers to make good nutrition and health decisions for their companion animals (WAC 16-252-061 and 16-252-062).
• Prevent the possibility of cross contamination of products (WAC 16-252-150). Certain ingredients and feed additives are only safe for certain species of animals. Proper cleaning of bags, totes and nonporous containers decreases the likelihood of cross contamination. Requiring documentation of the cleanout procedures used will remind an operator of the possibility of cross-contamination and the importance of preventing it.
(2) Addresses the specific needs of pet food/specialty pet food manufacturers and distributors operating in Washington state.
Current department rules regulating pet food and specialty pet food are embedded in fifteen rule sections of chapter 16-200 WAC, Feeds, fertilizers and livestock remedies. The new chapter 16-252 WAC, Commercial feed rules: Pet food and specialty pet food is devoted specifically to the commercial pet food/specialty pet food industry and contains only regulations that are pertinent to that industry. In addition, the new rule chapter for pet food/specialty pet food contains a number of "pet food/specialty pet food specific" definitions to better understand its contents.
(3) Is written in a clear and readable style that allows users to more easily understand and apply WSDA pet food and specialty pet food regulations.
Compare the following two examples. Both the current and new rule contains substantially the same requirements but the new rule because of format changes and the use of plain English is easier to read and understand.
| Current Rule | Proposed New Rule |
| WAC 16-200-755(2) (d) Guarantees for microorganisms are not required when the commercial feed is intended for a purpose other than to furnish these substances or they are of minor significance relating to the primary purpose of the product, and no specific label claims are made. |
WAC 16-252-051 (4) Guarantees for microorganisms are not required when: (a) The pet food or specialty pet food is intended for a purpose other than to furnish microorganisms; or (b) The microorganisms are insignificant to the primary purpose of the product, and no specific label claims are made. |
| WAC 16-200-885
Commercial feed label
submission. Pursuant to RCW 15.53.9013, license applicants or licensees shall submit copies of commercial feed labels and labeling, when requested by the department with just cause, in order to determine compliance with the provisions of laws and rules. |
WAC 16-252-170 Label
submission requirements. Pet food and specialty pet food registrants must submit copies of their labels and labeling to the department when: (1) Applying for a registration; or (2) The label is revised by the registrant; or (3) When requested by the department for reasonable cause. |
Notice how the current WAC 16-200-770 Expression of guarantees, presents how certain mineral guarantees must be stated:
WAC 16-200-770(3):
(b) When required, guarantees for minimum potassium, magnesium, sulfur and maximum fluoride shall be stated in parts per million (ppm) when the concentration is less than 10,000 ppm and in percentage when the concentration is 10,000 ppm (1%) or greater.
Now, notice how the same information is presented in the new section, WAC 16-252-072 Expression of guarantees -- Minerals in specialty pet food. Not only is the information in the table easier to read and digest, but also it is consistent with AAFCO (Regulation 4 (b)(2)) whereas WAC 16-200-770(3) is not.
WAC 16-252-072(1):
(b) When stated, certain mineral guarantees must be expressed as follows:
| Sodium, Salt, Potassium, Magnesium, Sulfur, Phosphorus, Fluorine, Other | |
| Mineral Guarantee: | Expressed as: |
| Minimum and maximum total sodium | Percentage (%) |
| Minimum and maximum salt | Percentage (%) |
| Minimum potassium | Percentage (%) |
| Minimum magnesium | Percentage (%) |
| Minimum sulfur | Percentage (%) |
| Minimum phosphorus | Percentage (%) |
| Maximum fluorine | Percentage (%) |
| Other minimum mineral guarantees | Parts per million (ppm) when the concentration is less than 10,000 ppm |
| Other minimum mineral guarantees | Percentage when the concentration is 10,000 ppm (1%) or greater |
Comparing the table of contents of the current rule with the table of contents of the proposed rule, you can see how the longer sections in the current rule have generally been divided into shorter, more focused sections in the new chapter. Also, notice how the new rule section titles are more descriptive than those in the current rule.
| Current Rule Sections | Proposed Rule Sections |
| WAC 16-252-001 Effective date. | |
| WAC 16-252-005 Commercial feed regulated by this chapter. | |
| WAC 16-200-750 Definitions and terms. | WAC 16-252-010 Commercial feed terms and definitions. |
| WAC 16-252-015 Feed ingredient names and definitions. | |
| WAC 16-200-755 Label format. | WAC 16-252-025 Label information and record-keeping requirements. |
| WAC 16-200-760 Brand and product names. | WAC 16-252-040 Product or brand name label information required. |
| WAC 16-252-042 Label information required when a drug is used. | |
| WAC 16-252-051 Exemptions from the guarantees required in WAC 16-252-061 and 16-252-062. | |
| WAC 16-200-770 Expression of guarantees. | WAC 16-252-061 Guarantees for pet food. |
| WAC 16-252-062 Guarantees for specialty pet food. | |
| WAC 16-252-065 Guarantees for grain mixture specialty pet food, with or without molasses. | |
| WAC 16-252-069 Expression of guarantees -- Expressed as is. | |
| WAC 16-252-070 Expression of guarantees -- Sliding-scale method prohibited. | |
| WAC 16-252-071 Expression of guarantees -- Protein, amino acids, fat, and fiber in specialty pet food. | |
| WAC 16-252-072 Expression of guarantees -- Minerals in specialty pet food. | |
| WAC 16-252-073 Expression of guarantees -- Minimum vitamin content in specialty pet food. | |
| WAC 16-252-074 Expression of guarantees -- Drugs. | |
| WAC 16-252-075 Expression of guarantees and special requirements -- Pet food and specialty pet food containing any added nonprotein nitrogen. | |
| WAC 16-252-076 Expression of guarantees -- Microorganisms and enzymes. | |
| WAC 16-252-080 Substantiating nutritional suitability. | |
| WAC 16-200-790 Ingredient statement. | WAC 16-252-090 Ingredient statement terms. |
| WAC 16-252-095 Drug and feed additive requirements. | |
| WAC 16-200-795 Directions for use and precautionary statements. | WAC 16-252-100 "Directions for use" and "precautionary statement" requirements. |
| WAC 16-200-805 Tonnage fees. | WAC 16-252-155 Tonnage reporting and fee requirements. |
| WAC 16-200-815 Adulteration. | WAC 16-252-120 Adulteration of pet food and specialty pet food. |
| WAC 16-200-820 Screenings. | WAC 16-252-110 Screenings. |
| WAC 16-200-830 Nonprotein nitrogen. | |
| WAC 16-200-840 Artificial color. | WAC 16-252-140 Use of artificial coloring. |
| WAC 16-200-860 Used sacks and containers. | WAC 16-252-150 Reusing bags, totes, and containers. |
| WAC 16-200-865 Commercial feed license. | WAC 16-252-165 Registration requirements. |
| WAC 16-200-885 Commercial feed label submission. | WAC 16-252-170 Label submission requirements. |
| WAC 16-200-887 Good manufacturing practices. | WAC 16-252-180 Good manufacturing practices adopted. |
In several sections of the proposed new chapter 16-252 WAC, language has been added to ensure that the WSDA rule is consistent with AAFCO's pet food/specialty pet food model regulations requirements. For example:
• Many of the new requirements in WAC 16-252-025 Label information and record-keeping requirements, were added to further protect consumers, pets and industry and also make the department's pet food/specialty pet food rules more consistent with AAFCO and the regulations of our sister states.
• Similarly, WAC 16-252-040 Product or brand name label information, is much more consistent with AAFCO's Model Regulations than the current WAC 16-200-760 Brand and product names.
• Again, WAC 16-252-061 Guarantees for pet food, 16-252-062 Guarantees for specialty pet food, and 16-252-065 Guarantees for grain mixture specialty pet food, with or without molasses, are much more consistent with AAFCO than the current regulations in WAC 16-200-755 Label format.
• Finally, WAC 16-252-080 Substantiating nutritional suitability, and 16-252-095 Drug and feed additive requirements, were added to strengthen the department's pet food/specialty pet food rules in a way that is consistent with AAFCO.
Reasons Supporting Proposal: See Summary above.
Name of Agency Personnel Responsible for Drafting: Neil Lanning, Olympia, Washington, (360) 902-2052; Implementation and Enforcement: Ali Kashani, Olympia, WA, (360) 902-2028.
Name of Proponent: Washington State Department of Agriculture, governmental.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: See Summary above.
Proposal Changes the Following Existing Rules: See Summary above.
No small business economic impact statement has been prepared under chapter 19.85 RCW. In order to mitigate any potential adverse economic impact of its proposed new pet food/specialty pet food requirements, the department is delaying the effective date of the new chapter until July 1, 2004. In addition, because the department could not determine the potential cost impact of its proposed new pet food/specialty pet food requirements, it conducted an economic impact survey. A survey, cover letter and a stamped envelope addressed was mailed (June 25, 2003) to all pet food/specialty pet food registrants registered by the department (142 surveys). All registrants were given until August 1, 2003, to complete and return the survey. On July 11, 2003, the department mailed a follow-up memo to all pet food/specialty pet food registrants reminding them to complete and return the economic impact survey to the department.
The survey response rate was 19.3%. As a result of the cost, sales and employee figures reported by the respondents, the department calculated that the average annual new cost imposed by the proposed new pet food/specialty pet food regulations is $0.05 per each hundred dollars of sales and $15.82 per employee. The department does not consider these costs to be "more than minor" and, therefore, has not prepared a formal small business economic impact statement as described in chapter 19.85 RCW.
RCW 34.05.328 does not apply to this rule adoption. The Washington State Department of Agriculture is not a listed agency in RCW 34.05.328 (5)(a)(i).
Hearing Location: Spokane County Extension Center, Room 106E, 222 North Havana, Spokane, on October 21, 2003, at 6:00 p.m.; at the WSDA office, Main Conference Room, 21 North 1st Avenue, Yakima, on October 22, 2003, at 6:00 p.m.; and at the WSU Research and Extension Center, 7612 Pioneer Way East, Puyallup Conference Room, Puyallup, on October 23, 2003, at 6:00 p.m.
Assistance for Persons with Disabilities: Contact Laurie Mauerman by October 13, 2003, TDD (360) 902-1996 or (360) 902-2012.
Submit Written Comments to: Laurie Mauerman, Washington State Department of Agriculture, P.O. Box 42560, Olympia, WA 98504-2560, fax (360) 902-2093, e-mail lmauerman@agr.wa.gov, by 5:00 p.m. on October 24, 2003.
Date of Intended Adoption: November 19, 2003.
September 17, 2003
Bob Arrington
Assistant Director
OTS-6458.3
COMMERCIAL FEED RULES -- PET FOOD AND SPECIALTY PET FOOD
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(1) Where a conflict occurs between the provisions of this chapter and those of chapter 16-250 WAC (commercial feed rules), the regulations in this chapter take precedence.
(2) Where a commercial pet food and/or specialty pet food issue arises on which this chapter is silent and a provision in chapter 16-250 WAC addresses the issue, then chapter 16-250 WAC must be followed. The department expects such situations will be rare.
| Note: | • Pet food is food for dogs and cats. |
| • Specialty pet food is food for specialty pets such as, but not limited to, gerbils, hamsters, canaries, psittacine birds, mynahs, finches, tropical fish, goldfish, snakes, and turtles. | |
| • Commercial feed for beef cattle, dairy cattle, equine, goats and sheep, ducks and geese, fish, rabbits, swine, chickens, turkeys, and other animals not specifically regulated under this chapter is regulated under chapter 16-250 WAC. | |
| • Customer-formula feed (food) for all species is regulated under chapter 16-250 WAC. | |
| • Ingredients meeting the definition of commercial feed, that are used to make a pet food or specialty pet food, are regulated under chapter 16-250 WAC, unless the ingredient meets the definition of pet food or specialty pet food in which case the ingredient is regulated under this chapter. |
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| Note: | A copy of the official publication is on file with the department. Copies may be purchased from AAFCO Assistant Secretary-Treasurer; P.O. Box 478 Oxford, IN 47971. |
"All life stages" means gestation/lactation, growth, and adult maintenance life stages of a domesticated dog or cat.
"Canned" means feed that has been processed, packaged, sealed, and sterilized for preservation in cans, pouches, or similar containers.
"Commercial feed" means all materials or combination of materials that are distributed or intended for distribution for use as feed or for mixing in feed, unless such materials are specifically exempted.
The following commodities are exempted and are not considered "commercial feed" if they are not adulterated (see RCW 15.53.902 for a list of conditions that cause commercial feeds to be adulterated):
• Unmixed whole seeds and physically altered entire unmixed seeds when such seeds are not chemically changed.
• Raw meat, hay, loose salt, straw, stover, silage, cobs, husks, and hulls when such commodities are not ground, mixed or intermixed with other materials.
"Customer-formula feed" means commercial feed that is a mixture of commercial feeds or feed ingredients, or both, each batch of which is manufactured according to the instructions of the final purchaser.
"Department" means the Washington state department of agriculture (WSDA).
"Director" means the director of the Washington state department of agriculture or the director's designee.
"Distressed pet food" means pet food (dog and cat) in distribution that is no longer available for retail sale. Examples of distressed pet food include, but are not limited to, dented cans, torn bags, or pet food past its sell-by date.
"Distressed specialty pet food" means specialty pet food in distribution that is no longer available for retail sale. Examples of distressed specialty pet food include, but are not limited to, dented cans, torn bags, or specialty pet food past its sell-by date.
"Distribute" means to:
(a) Offer for sale, sell, exchange or barter, commercial feed; or
(b) Supply, furnish, or otherwise provide commercial feed to a contract feeder.
"Distributor" means a person who distributes.
"Drug" means:
(a) Any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals other than man; and
(b) Articles other than feed intended to affect the structure or any function of the animal body.
"Enzyme" means a protein made up of amino acids or their derivatives, which catalyses a defined chemical reaction. Required cofactors should be considered an integral part of the enzyme.
"Facility" means any place where a commercial feed is manufactured, repackaged, sold, transloaded, or stored for later distribution.
"Family" means a group of pet food products, which are nutritionally adequate for any or all life stages based on their nutritional similarity to a lead product, which has been successfully test-fed according to an AAFCO feeding protocol(s).
"Feed ingredient" means each of the constituent materials making up a commercial feed.
"Grain mixture specialty pet food" means mixed or intermixed whole or physically altered grains, that:
(a) Are not chemically altered;
(b) May or may not contain molasses; and
(c) Except for molasses, contain no other additives.
"Guarantee" means a listing of specified nutrients or nonnutritive substances contained in a commercial feed that the manufacturer or distributor named on the feed label warrants as specified in these rules.
"Guaranteed analysis" means a listing of the minimum, maximum or both minimum and maximum concentrations of specified nutrients contained in a commercial feed that the manufacturer or distributor named on the feed label warrants. Both minimum and maximum concentrations of specified nutrients contained in a commercial feed are stated on an "as is" basis rather than on a "one hundred percent moisture free" basis in units specified by these rules.
"Initial distributor" means a person who first distributes a commercial feed in or into Washington state.
"Ingredient statement" means a contiguous listing on the label of all ingredients of which the commercial feed is composed.
"Label" means a display of written, printed, or graphic matter upon or affixed to the container in which a commercial feed is distributed, or on the invoice or delivery slip with which a bulk commercial feed is distributed.
"Labeling" means all labels and other written, printed, or graphic matter:
(a) Upon a commercial feed or any of its containers or wrappers; or
(b) Accompanying such commercial feed.
"Lot identifier" means a unique identifier for each lot, batch or production run that enables the manufacturer to accurately trace the complete manufacturing and distribution history of the product. A lot identifier is an individual lot, batch or production run number, code, date, or other suitable identification applied to the label, container, or package. In the case of bulk feed, the lot identifier is on a label, invoice, or shipping document accompanying the feed.
"Net weight" means the weight of a commodity excluding any materials, substances, or items not considered to be part of the commodity. Examples of materials, substances, or items not considered to be part of a commodity include, but are not limited to, containers, conveyances, bags, wrappers, packaging materials, labels, individual piece coverings, decorative accompaniments, and coupons. (See RCW 19.94.010 (1)(i).)
"Nutritionally adequate" means the feed, when fed according to directions on the label, will meet the nutritional requirements of the class of animals for which the feed was manufactured.
"Nutritionally suitable" means nutritionally adequate.
"Person" means an individual, firm, partnership, corporation, or association.
"Pet food" means a commercial feed prepared and distributed for consumption by domesticated dogs or cats.
"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.
"Prohibited mammalian protein" means any protein-containing portion of mammalian animals, excluding:
• Blood and blood products;
• Gelatin;
• Inspected meat products that have been cooked and offered for human food and further heat processed for feed (such as plate waste and used cellulose food casings);
• Milk products (milk and milk proteins); and
• Products whose only mammalian protein is porcine or equine protein.
"Processed," as applied to animal waste, means thermally dehydrated, dry-stacked, ensiled, oxidized, chemically treated, microbiologically digested, chemically or physically fractionated, or treated by other processes that enable an animal waste product to comply with the standards established in this chapter.
"Quantity statement" means the part of the label expressing net weight (mass), net volume (liquid or dry) or count.
"Salvage pet food" means pet food still under control of the original manufacturer and will not be offered for sale at retail. Examples include, but are not limited to, start-up and over-run product, unpelletted pet food, pet food fines, and other products not suitable for packaging for retail sale.
"Sell" or "sale" includes exchange.
"Specialty pet" means a domesticated animal pet normally maintained in a cage or tank, such as, but not limited to, gerbils, hamsters, canaries, psittacine birds, mynahs, finches, tropical fish, goldfish, snakes, and turtles.
"Salvage specialty pet food" means specialty pet food still under control of the original manufacturer and will not be offered for sale at retail. Examples include, but are not limited to, start-up and over-run product, unpelletted specialty pet food, specialty pet food fines, and other products not suitable for packaging for retail sale.
"Specialty pet food" means a commercial feed prepared and distributed for consumption by specialty pets.
"Transload" means to transfer commercial feed from one carrier to another carrier without processing or blending the ingredients. For example, transferred from rail cars to trucks or shipping containers.
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"Dehydrated grass meal" means the aerial portion of a grass plant that is:
• Cut before the formation of seed;
• Reasonably free of other crop plants, weeds, and mold;
• Finely ground; and
• Dried by artificial thermal means.
| Note: | If a dehydrated grass meal product is identified by a species name, the product must be made from that species. |
"Grass seed screenings meal or pellets" means a product comprised chiefly of hulls obtained from the cleaning of various grass seeds.
"Pea bran" means a product consisting primarily of the various components from a pea splitting operation. Pea bran must contain at least ten percent crude protein and not more than thirty-eight percent crude fiber.
"Pea by-products meal" means a product containing light and broken peas, and offal from pea cleaning, which includes chips, pea powder, pea hulls, and screenings. Pea by-products meal must contain at least fifteen percent crude protein and not more than thirty percent crude fiber.
"Pea meal" means a pea product resulting from the grinding of whole peas that are reasonably free of other crop seeds, weeds, and mold. Pea meal must contain at least twenty percent crude protein and not more than eight percent crude fiber.
"Pea screenings meal" means a product consisting primarily of the various components from the screening and cleaning of peas. Pea screenings meal must contain at least ten percent crude protein and not more than thirty-eight percent crude fiber.
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| Note: | Subsections (12) through (15) of this section apply to pet food only. All other sections apply to both pet food and specialty pet food. |
(3) Information required by WAC 16-252-042 if the product contains a drug.
(4) The species of pet (dog or cat), or specialty pet, for which the food is intended conspicuously stated in words on the principal display panel.
(5) A quantity statement on the principal display panel.
(6) If enzymatic activity related to the product is represented in any manner, the principal display panel must include a statement explaining the purpose of that enzymatic activity.
(7)(a) Guaranteed analysis consistent with requirements in WAC 16-252-061 for pet food; or
(b) Guaranteed analysis consistent with requirements in WAC 16-252-062 or 16-252-065 for specialty pet food.
(8) An ingredient statement that is consistent with the requirements in WAC 16-252-090.
(9) Feeding directions and precautionary statements if required under WAC 16-252-100.
(10)(a) The label of a pet food or specialty pet food must specify the name and address of the manufacturer or person responsible for distributing the feed. The statement of the place of business must include the street address, city, state, and zip code. However, the street address may be omitted if the street address is shown in a current city directory or telephone directory for the city listed on the label.
(b) When a person manufactures or distributes a pet food or specialty pet food in a place other than the principal place of business, the label may state the principal place of business in lieu of the actual place where each package was manufactured, packaged or distributed.
(11)(a) Lot identifier that is sufficient to allow the manufacturer to accurately trace the complete manufacturing and distribution history of the product.
(b) Records relating the lot identifier to the manufacture, processing, packing, distribution, receipt, or holding of the product must be kept for one year after the last date of distribution.
| Note: | Subsections (12) through (15) of this section apply to pet food only. All other subsections apply to both pet food and specialty pet food. |
(b) The nutritional adequacy statement must read as shown in (b)(i), (ii), or (iii) of this subsection with the blanks filled in with the stage or stages of the pet's life, such as, "gestation/lactation," "growth," "maintenance," or "all life stages."
(i) "(Name of product) is formulated to meet the nutritional levels established by the AAFCO dog (or cat) food nutrient profiles for. . . . . . "; or
(ii) "Animal feeding tests using AAFCO procedures substantiate that (name of product) provides complete and balanced nutrition for. . . . . . "; or
(iii) "(Name of product) provides complete and balanced nutrition for. . . . . . and is comparable in nutritional adequacy to a product that has been substantiated using AAFCO feeding tests."
(13) The use of the word "proven" in connection with a label claim for a pet food is not permitted unless the claim is substantiated by scientific or other empirical evidence.
(14) The label of a pet food intended for all life stages may include an unqualified claim, directly or indirectly, such as "complete and balanced," "perfect," "scientific" or "one hundred percent nutritious" if at least one of the following apply:
(a) The product meets the nutrient requirements for all life stages established by an AAFCO-recognized nutrient profile published in the Association of American Feed Control Officials official publication; or
(b) The product meets the criteria for all life stages as substantiated by completion of the appropriate AAFCO-recognized animal feeding protocols published in the Association of American Feed Control Officials official publication; or
(c) The product is a member of a product family, which is nutritionally similar to a lead product containing a combination of ingredients that has been fed, as the sole source of nourishment, to a normal animal according to testing procedures published in the Association of American Feed Control Officials official publication.
(i) The nutritional similarity of the family product can be substantiated according to the Procedures for Establishing Pet Food Product Families developed by AAFCO; and
(ii) The family product meets the criteria for all life stages; and
(iii) Under circumstances of reasonable doubt, the department may require the manufacturer to perform additional testing of the family product in order to substantiate the claim of nutritional adequacy.
(15) A pet food, intended for a limited purpose or specific life stage (but not all life stages), may include a direct or indirect qualified claim such as "complete and balanced," "perfect," "scientific" or "one hundred percent nutritious" when the product and claim comply with all of the following:
(a) A statement qualifying the claim must clearly identify the limited purpose or life stage for which the product is intended or suitable. For example, when the label reads "complete and balanced for puppies (or kittens)."
(b) The claim and the qualification must be next to each other, on the same label panel and in the same size, style, and color print; and
(c) The product must comply with at least one of the following:
(i) The nutrient requirements, established by an AAFCO-recognized nutrient profile, for the limited purpose or specific life stage; or
(ii) The criteria for a limited purpose or a specific life stage that are substantiated by completion of an appropriate AAFCO-recognized animal feeding protocol(s); or
(iii) The requirement of a product family that is nutritionally similar to a lead product and contains a combination of ingredients, which by adequate testing has demonstrated they satisfy the nutrient requirements for such a limited purpose.
(A) The nutritional similarity of the family product must be substantiated according to the Procedures for Establishing Pet Food Product Families developed by AAFCO; and
(B) The family product meets the criteria for such limited purpose; and
(C) If it has reasonable doubt, the department may require the manufacturer perform additional testing on the family product to substantiate the claim of nutritional adequacy.
(16) When pet food or specialty pet food enclosed in an outer container or wrapper is intended for retail sale, all required label information must appear on the outer container or wrapper.
(17) Graphic or pictorial representation or design (for example, pictures of animals or birds) of any kind must not be attached to, appear on, or distributed with pet food or specialty pet food if the material or design is misleading, incorrect, or at variance in any respect with the information required on the label.
(18)(a) Statements referring to a competitive product or comparing the properties of a packaged food to those of a competitive product must not appear on a label unless the competitive product is specifically identified.
(b) Negative statements regarding a competitive product must not appear on a label unless the director determines that the information provided by the statements is beneficial to the product's purchaser.
(c) False or misleading comparisons with other products must not appear on the label or labeling of any pet food product.
(d) A statement on a pet food or specialty pet food label stating preference or comparative attribute claims must be substantiated and limited to one year production, after which the claim must be removed or resubstantiated.
(19) A personal or commercial endorsement is permitted on a pet food or specialty pet food label, provided the endorsement is not false or misleading.
(20) A statement on a pet food or specialty pet food label stating "improved," "new," or similar designation must be substantiated and limited to six months production.
(21) When a flavor designation is included as part of the product name, or elsewhere on the label of a pet food or specialty pet food, it must meet the requirements in (a), (b), and (c) of this subsection.
(a) The flavor designation must:
(i) Conform to the name of the ingredient as listed in the ingredient statement; or
(ii) Be identified by the source of the flavor in the ingredient statement.
(b) The word "flavor" must be printed in the same size type and with an equal degree of conspicuousness as the name of the flavor designation.
(c) Substantiation of the flavor designation, the flavor claim, or the ingredient source must be provided to the department upon request.
(22) Distressed or salvage pet food or specialty pet food that contains, or may contain, prohibited mammalian protein must be labeled with the Bovine Spongiform Encephalopathy precautionary statement "do not feed to cattle or other ruminants."
(23) In addition to the requirements of this chapter, if the term "organic" is used on labels of any pet food or specialty pet food, it must be produced under conditions that comply with the 2001 National Organic Program final rule standards for the production and handling of organic crops, livestock and processed food products. The 2001 National Organic Program final rule may be obtained from the department, or on the Internet at http://www.ams.usda.gov/nop/NOP/standards.html.
(24) All required label information must be stated in English. In addition, label information may be translated into other languages. However, if the label is translated into another language, then the translation must give the same information as the English version of the label.
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(1) The brand or product name must be appropriate for the intended use of the pet food or specialty pet food, and must not be misleading. If the name indicates the pet food or specialty pet food is made for a specific use, the character of the pet food or specialty pet food must conform to that use. For example, a mixture labeled "dog food" must be suitable for dogs.
(2) When reviewing product names for single ingredient pet foods or specialty pet foods, the department will be guided by the definitions of feed ingredients and feed terms established by the Association of American Feed Control Officials official publication unless those definitions and terms are specifically defined in chapter 15.53 RCW, WAC 16-252-010, or 16-252-015.
(3) Except for the circumstances described in subsection (4) of this section, the name of a pet food or specialty pet food must not be derived from:
(a) One or more ingredients of a mixture to the exclusion of the other ingredients; or
(b) One component of a mixture unless all components are included in the name.
(4) When a pet food or specialty pet food contains any ingredient or combination of ingredients for the purpose of imparting a distinct characteristic to the product that is significant to the purchaser, the name of that ingredient or combination of ingredients may be used as part of the brand name or product name if the department determines that the:
(a) Ingredient or combination of ingredients is present in sufficient quantity to impart a distinctive characteristic to the product;
(b) Product name does not constitute a representation that the ingredient or combination of ingredients is present to the exclusion of other ingredients; and
(c) Product name is not otherwise false or misleading.
(5) The words "one hundred percent" or "all," or words of similar meaning, must not be used in the brand or product name of a pet food or specialty pet food if the product contains more than one ingredient other than:
(a) Water sufficient for processing;
(b) Decharacterizing agents;
(c) A trace amount of preservatives; or
(d) A trace amount of condiments.
(6) An ingredient or a combination of ingredients may form a part of the product name of a pet food or specialty pet food when the product conforms with one of the following options:
(a) The ingredient(s) derived from animals, poultry, or fish constitutes at least ninety-five percent of the total product weight, including water sufficient for processing. If processing water is excluded, then the ingredient(s) derived from animals, poultry, or fish must constitute at least seventy percent of the total product weight.
| Note: | Example 1: A product may be called "beef dog food" if beef makes up at least ninety-five percent of the total product weight, including water sufficient for processing. If processing water has been excluded from the calculation, then beef must make up at least seventy percent of the total product weight. |
| Example 2: A product may be called "beef and chicken dog food" if the combination of beef and chicken makes up at least ninety-five percent of the total product weight, including water sufficient for processing. If processing water has been excluded from the calculation, then beef and chicken must make up at least seventy percent of the total product weight. |
(i) A descriptor is used with the ingredient name(s). This descriptor must imply other ingredients are included in the product formula. Examples of descriptors include "dinner," "platter," "entree," "formula," and "recipe"; and
(ii) The descriptor must be in the same size, style and color print as the ingredient name(s).
| Note: | Example 1: A product may be called "beef dinner dog food" if beef makes up at least twenty-five percent of the total product weight, including water for processing and meets the conditions stated in (i) and (ii). |
| Example 2: If water for processing is excluded from the calculation, then a product may be called "beef dinner dog food" if beef makes up at least ten percent of the total product weight, and meets conditions stated in subsections (i) and (ii). |
(i) Each ingredient constitutes at least three percent of the product weight, excluding water sufficient for processing;
(ii) The names of the ingredients listed in the product name appear in the order of their respective predominance by weight in the product; and
(iii) The names of the ingredients listed in the product name appear on the label in the same size, style, and color print.
| Note: | Example 1: A product may be called "beef and chicken dog food" if: |
| (a) Including water for processing, the combination of beef and chicken total at least ninety-five percent of the product weight; and | |
| (b) Excluding water for processing, at least three percent of the product weight is chicken. | |
| Example 2: A product may be called "beef and chicken dog food" if, excluding processing water, the combination of beef and chicken total at least seventy percent of the product weight and at least three percent of the product weight is chicken. | |
| Example 3: A product may be called "beef and chicken dinner" if: | |
| (a) Including water for processing, the combination of beef and chicken total at least twenty-five percent of the product weight; and | |
| (b) Excluding water for processing, at least three percent of the product weight is chicken. | |
| Example 4: A product may be called "beef and chicken dinner" if the combination of beef and chicken, excluding water for processing total at least ten percent of the product weight and at least three percent of the product weight is chicken. |
(b) The three percent minimum level does not apply to claims for condiments or nutrients. Condiments include, but are not limited to, flavorings and spices. Nutrients include, but are not limited to, vitamins, minerals, and fatty acids.
(c) If the names of more than one ingredient are shown, they must appear in their respective order of predominance by weight in the product.
(d) The word "with" (or similar designation) and all named ingredients must appear in the same size, style, color and case print and be of no greater size than:
| Panel Size | Maximum "with claim" Type Size | |
| < 5 sq. in. | 1/8" | |
| 5-25 sq. in. | 1/4" | |
| 25-100 sq. in. | 3/8" | |
| 100-400 sq. in. | 1/2" | |
| 400 sq. in. + | 1" | |
| Note: | Example 1: A product may be called "beef with rice dog food" if: |
| (a) Including water for processing, the product contains at least ninety-five percent beef; and | |
| (b) Excluding water for processing, at least three percent of the product weight is rice. | |
| Example 2: A product may be called "beef and chicken dinner with rice dog food" if: | |
| (a) Including water for processing, the product contains enough beef and chicken so that these two ingredients total at least twenty-five percent of the product weight; and | |
| (b) Excluding water for processing, at least three percent of the product weight is rice. |
(9)(a) If a brand name includes a single percentage value without explanation, the percentage value must signify the feed's crude protein content. For example, "BLUE BIRD PET FOOD eighteen percent cat food" means that the feed contains eighteen percent crude protein.
(b) If a brand name includes a single percentage value and the percentage does not represent crude protein content, the brand name must indicate what the percentage represents. For example, "BLUE BIRD PET FOOD twenty-two percent calcium concentrate premix."
(c) If a brand name includes more than one percentage value, the percentage must be followed by a corresponding description. For example, "BLUE BIRD PET FOOD forty-two percent crude protein - twenty-five percent fat cat milk replacer."
(d) If the brand name contains either a percentage value that signifies crude protein or the word "protein," then the pet food or specialty pet food must contain no more than one and one-quarter percent nonprotein nitrogen.
(10) Pet food and/or specialty pet food must be considered a distinct brand if it differs in guaranteed analysis, trademark name, or any other characteristic method of marking. However, this requirement does not prevent a brand from being distributed in various physical forms.
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(1) The word "medicated" in a type size that is at least one-half the type size of the product name.
(2) Information stating the purpose of the medication.
(3) An active ingredient statement listing the:
(a) Active drug ingredients by established name; and
(b) Amount of active drug ingredient per unit (for example mg/lb, g/ton) consistent with requirements in WAC 16-252-074.
(4) Directions for use and precautionary statements, or a statement of where on the label the directions for use and precautionary statements can be found.
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(1) Guarantees for crude protein, crude fat, and crude fiber are not required when:
(a) The pet food or specialty pet food is intended for purposes other than to furnish these substances; or
(b) These substances are insignificant to the primary purpose of the product, such as drug premixes, mineral or vitamin supplements, and molasses.
(2) A mineral guarantee is not required when the food or food ingredient is:
(a) Not intended or represented or does not serve as a principal source of that mineral to the animal; or
(b) Contains less than six and one-half percent total minerals.
(3) Guarantees for vitamins are not required when the pet food or specialty pet food is neither formulated for nor represented in any manner as a vitamin supplement.
(4) Guarantees for microorganisms are not required when:
(a) The pet food or specialty pet food is intended for a purpose other than to furnish microorganisms; or
(b) The microorganisms are insignificant to the primary purpose of the product, and no specific label claims are made.
(5) Information on animal species is not required on single ingredient products if the ingredient is not intended, represented, or defined for a specific animal species.
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(2)(a) Guaranteed analysis for all pet food must include the following nutrients on the label in the order listed below unless exempted under WAC 16-252-051:
(i) Minimum percentage of crude protein;
(ii) Minimum percentage of crude fat;
(iii) Maximum percentage of crude fat when required by subsection (8) of this section;
(iv) Maximum percentage of crude fiber;
(v) Maximum percentage of moisture;
(vi) Maximum percentage of ash if listed;
(vii) Additional guarantees as required in this section and any voluntary guarantees.
(b) Additional required or voluntary guarantees must be listed in the same order and units as the nutrients in the AAFCO dog (or cat) food nutrient profiles.
(i) Guarantees for nutrients not listed in the AAFCO dog (or cat) food nutrient profiles, or otherwise provided for in this section, must:
(A) Be listed immediately following the entire list of nutrients found in the AAFCO dog (or cat) food nutrient profiles; and
(B) All nutrients of a similar class must be listed together. For example, amino acids not found in the AAFCO dog (or cat) food nutrient profile must be grouped together;
(ii) The concentration of nutrients and/or substances not found in an AAFCO dog (or cat) nutrient profile must be in the units that the nutrient or substance is normally associated with;
(iii) Guarantees for microorganisms and enzymes must be stated as required in WAC 16-252-076;
(iv) Any nutrients or substances that are guaranteed and are not listed in an AAFCO dog (or cat) food nutrient profile, must be immediately followed by an asterisk that refers to the appropriate disclaimer:
(A) "*Not recognized as an essential nutrient by the AAFCO dog food nutrient profiles"; or
(B) "*Not recognized as an essential nutrient by the AAFCO cat food nutrient profiles."
(3) The maximum moisture allowed is seventy-eight percent or the natural moisture content of the ingredients, whichever is higher. However, the moisture in products labeled as, and consisting principally of, items like stew, gravy, sauce, broth, aspic, juice, or a milk replacer may exceed these maximum moisture allowances.
(4) The use of commercial, copyrighted brand, or trade names in the guarantee statement is prohibited.
(5)(a) If a pet food is represented as a mineral supplement, then all minerals from sources listed in the ingredient statement that are also found in an AAFCO-recognized pet food nutrient profile must be guaranteed.
| Note: | AAFCO pet food nutrient profiles can be found in the Association of American Feed Control Officials official publication. |
(i) Listed in the order they appear in the AAFCO-recognized pet food nutrient profile; and
(ii) As the element in units specified in the AAFCO-recognized nutrient pet food profile.
(c) Mineral guarantees may be stated in milligrams (mg) per unit (for example, tablets, capsules, granules, or liquids) consistent with the units stated in the quantity statement and directions for use.
(d) All liquid mineral pet food must have a weight equivalent on the label following the guarantees for the minerals. For example, 1 fl. oz = 28 grams.
(6)(a) If a pet food is represented as a vitamin supplement, then all vitamins from sources listed in the ingredient statement that are also found in an AAFCO-recognized dog food or cat food nutrient profile must be guaranteed.
(b) When vitamins are listed, they must be:
(i) Listed in the order they appear in the AAFCO-recognized pet food nutrient profile; and
(ii) In units specified in the AAFCO-recognized pet food nutrient profile.
(c) Vitamin guarantees may be stated in approved units (for example, IU, mg, g) per unit (for example, tablets, capsules, granules, or liquids) consistent with those employed in the quantity statement and directions for use.
(d) All liquid vitamin pet food must have a weight equivalent on the label following the guarantees for the vitamins. For example, 1 fl. oz = 28 grams.
(7) If a pet food is not represented as a supplement for any mineral or vitamin, but the label does list guarantees for any mineral or vitamin, these are "voluntary" guarantees. These voluntary guarantees must meet the order and unit requirements for those pet foods that are represented as a mineral or vitamin supplement.
(8)(a) A dog food label, which contains the terms "lean," "low fat," or words of similar meaning, must:
(i) List the maximum crude fat percentage immediately following the minimum crude fat percentage in the guaranteed analysis; and
(ii) Contain no more crude fat than allowed at the different moisture levels stated in the table below.
| Maximum Allowed Percentage of Crude Fat at Different Moisture Ranges in Dog Food | |
| Maximum Allowed Percentage of Crude Fat | Moisture Range |
| 9% | Less than 20% |
| 7% | 20% or more but less than 65% |
| 4% | 65% or more |
(i) List the maximum crude fat percentage immediately following the minimum crude fat percentage in the guaranteed analysis; and
(ii) Contain no more crude fat than allowed at the different moisture levels stated in the table below.
| Maximum Allowed Percentage of Crude Fat at Different Moisture Ranges in Cat Food | |
| Maximum Allowed Percentage of Crude Fat | Moisture Range |
| 10% | Less than 20% |
| 8% | 20% or more but less than 65% |
| 5% | 65% or more |
(i) List the maximum crude fat percentage immediately following the minimum crude fat percentage in the guaranteed analysis;
(ii) Be compared to another product in the same moisture range (for example, "less than twenty percent," "twenty percent or more but less than sixty-five percent," "sixty-five percent or more"); and
(iii) Name the product of comparison and explicitly state the percentage of fat reduction expressed on an equal weight basis.
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| Note: | Guarantee requirements for grain mixture specialty pet food are stated in WAC 16-252-065. |
(a) Minimum percentage of crude protein;
(b) Minimum percentage of crude fat;
(c) Maximum percentage of crude fiber;
(d) Maximum percentage of moisture;
(e) Maximum percentage of ash if listed;
(f) Minimum and maximum percentages of calcium;
(g) Minimum percentage of phosphorus;
(h) Minimum and maximum percentage of salt (if added);
(i) Minimum and maximum percentage of total sodium must be guaranteed only when total sodium exceeds that furnished by the maximum salt guarantee;
(j) Other minerals.
(3) Minerals must be identified and listed consistent with requirements in WAC 16-252-072.
(4) Vitamins must be identified and listed consistent with requirements in WAC 16-252-073.
(5) The maximum moisture allowed is seventy-eight percent or the natural moisture content of the ingredients, whichever is higher. However, the moisture in products labeled as, and consisting principally of, items like stew, gravy, sauce, broth, aspic, juice, or a milk replacer may exceed these maximum moisture allowances.
(6) The use of commercial, copyrighted brand, or trade names in the guarantee statement is prohibited.
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(a) Minimum percentage of crude protein;
(b) Minimum percentage of crude fat; and
(c) Maximum percentage of crude fiber.
(2) The use of commercial, copyrighted brand, or trade names in the guarantee statement is prohibited.
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(a) When the calcium, salt, and sodium guarantees are given in the guaranteed analysis, they must be stated and conform to the following:
(i) When the minimum is below two and one-half percent, the maximum must not exceed the minimum by more than one-half percentage point.
(ii) When the minimum is two and one-half percent but less than five percent, the maximum must not exceed the minimum by more than one percentage point.
(iii) When the minimum is five percent or greater, the maximum must not exceed the minimum by more than twenty percent of the minimum and in no case may the maximum exceed the minimum by more than five percentage points.
(b) When stated, certain mineral guarantees must be expressed as follows:
| Sodium, Salt, Potassium, Magnesium, Sulfur, Phosphorus, Fluorine, Other | |
| Mineral Guarantee: | Expressed as: |
| Minimum and maximum total sodium | Percentage (%) |
| Minimum and maximum salt | Percentage (%) |
| Minimum potassium | Percentage (%) |
| Minimum magnesium | Percentage (%) |
| Minimum sulfur | Percentage (%) |
| Minimum phosphorus | Percentage (%) |
| Maximum fluorine | Percentage (%) |
| Other minimum mineral guarantees | Parts per million (ppm) when the concentration is less than 10,000 ppm |
| Other minimum mineral guarantees | Percentage when the concentration is 10,000 ppm (1%) or greater |
(d) Products labeled with a quantity statement (for example, tablets, capsules, granules, or liquid) may state mineral guarantees in milligrams (mg) per unit (for example, milligrams per tablet or milligrams per capsule) consistent with the quantity statement and the directions for use.
(2) All mineral phosphatic materials used for specialty pet food must be labeled with the guarantee for:
(a) Minimum and maximum percentage of calcium (when present);
(b) Minimum percentage of phosphorus; and
(c) Maximum percentage of fluorine.
(3) Specialty pet food that is a single mineral product that is defined in the "mineral products" section of the Association of American Feed Control Officials official publication must guarantee the minerals included in the mineral products definition. For example, bone charcoal must guarantee calcium and phosphorous; calcium iodate must guarantee calcium and iodine.
(4) All liquid mineral guarantees for specialty pet foods must have a weight equivalent on the label following the guarantees for the minerals. For example, 1 fl. oz = 28 grams.
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(a) Milligrams per pound; or
(b) Per unit consistent with the units on the quantity statement; or
(c) For the vitamins listed in the following table, the units must be consistent with those in the table:
| Vitamins | |
| Type of Vitamin and Listing Order: | Stated in: |
| Vitamin A, other than precursors of Vitamin A | International Units per pound (IU/lb) |
| Vitamin D, for other uses | International Units per pound (IU/lb) |
| Vitamin E | International Units per pound (IU/lb) |
| 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 (g) instead of units per pound (lb) |
| Vitamin B-12 | Milligrams (mg) or micrograms (µg) per pound (lb) |
| Menadione, riboflavin, d-pantothenic acid, thiamine, niacin, vitamin B-6, folic acid, choline, biotin, inositol, p-amino benzoic acid, ascorbic acid, and carotene | Milligrams per pound (mg/lb) |
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| Drugs | |
| Antibiotics, present at less than 2,000 grams per ton (total) of commercial feed | Grams per ton of commercial feed (g/ton) |
| Antibiotics, present at 2,000 or more grams per ton (total) of commercial feed | Grams per pound of commercial feed (g/lb) |
| Note: | The term "milligrams per pound" (mg/lb) may be used for drugs or antibiotics in those cases where a dosage is given in "milligrams" in the feeding directions. |
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Crude protein, minimum . . . . . . %
This includes not more than . . . . . . % equivalent crude protein, which is not nutritionally available as protein to (species of animal for which feed is intended).
(2) Pet food or specialty pet food, premixes, concentrates or supplements containing more than one and one-quarter percent crude protein from any form of added nonprotein nitrogen must contain adequate directions for use and a prominent statement on the principal display panel, such as the following:
WARNING: This food must be used only in accordance with directions furnished on the label.
(3) In pet food and specialty pet food, nonprotein nitrogen sources defined in the Association of American Feed Control Officials official publication are acceptable sources of nutrients other than crude protein, as long as the maximum crude protein from all nonprotein nitrogen sources does not exceed one and one-quarter percent of the pet's or specialty pet's total daily ration.
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(b) A parenthetical statement following the guarantee must list each species in order of predominance.
(2)(a) Guarantees for enzymes must be stated in units of enzymatic activity per unit weight or volume, consistent with label directions.
(b) The source organism for each type of enzymatic activity must be specified, for example: Protease (Bacillus subtilis) 5.5 mg amino acids liberated/minute/milligram.
(c) If two or more sources have the same type of activity, they must be listed in order of predominance based on the amount of enzymatic activity provided.
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(2) If the department has reasonable cause to believe a pet food or specialty pet food is not nutritionally suitable, the department may require that the manufacturer either submit an "affidavit of suitability" or a department approved alternative procedure, certifying that the food is nutritionally adequate for its intended purpose. The affidavit of suitability or alternate procedure substantiates the food's suitability but does not preclude the department from requiring additional evidence of nutritional suitability.
(3) If an affidavit of suitability, or department approved alternative procedure, is not submitted by the pet food or specialty pet food manufacturer within thirty days of written notification, the department may declare that the pet food or specialty pet food composition or quality is less than or differs from what is represented by its labeling (see RCW 15.53.902(8)) and order the pet food or specialty pet food removed from the marketplace.
(4) An affidavit of suitability must contain the following information:
(a) The pet food or specialty pet food registrant's name;
(b) The product name;
(c) The name and title of the affiant submitting the document;
(d) A statement from the affiant that they know the nutritional content of the pet food or specialty pet food and that the pet food or specialty pet food, based on valid scientific evidence, is nutritionally adequate for its intended purpose;
(e) The date the affidavit of suitability is submitted to the department; and
(f) The signature of the affiant notarized by a certified notary public.
(5) For dog food, a claim of nutritional adequacy must be based on one of the following:
(a) The AAFCO dog food nutrient profiles;
(b) One of the AAFCO dog food feeding protocols; or
(c) Other scientific substantiation acceptable to the department.
(6) For cat food, a claim of nutritional adequacy must be based on one of the following:
(a) The AAFCO cat food nutrient profiles; or
(b) One of the AAFCO cat food feeding protocols;
(c) Other scientific substantiation acceptable to the department.
(7) A specialty pet food nutritional adequacy claim must be based on:
(a) The corresponding species nutrient requirements as published in the 1995 National Research Council Nutrient Requirements of Laboratory Animals, by the National Academy of Sciences; or
(b) Other scientific substantiation acceptable to the department.
| Note: | • The only species included in the 1995 National Research Council Nutrient Requirements of Laboratory Animals are gerbils, guinea pigs, hamsters, mice, and rats. All other specialty pet species will require other methods of scientific substantiation for claims of nutritional adequacy. |
| • A copy of Nutrient Requirements of Laboratory Animals is on file with the department. Copies may be purchased from Office of Publications, National Academy of Sciences, 2101 Constitution Avenue, N.W., Washington, D.C. 20418. |
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(1) The name of each ingredient must conform to one of the following:
(a) Ingredients must have an official definition in the AAFCO official publication;
(b) If there is no official definition for an ingredient in the AAFCO official publication, then an ingredient with an AAFCO tentative definition may be used;
(c) The ingredient is defined in WAC 16-252-015; or
(d) The ingredient has a commonly accepted name that requires no definition, for example, sugar.
(2) Each ingredient of a pet food or specialty pet food must be listed separately. Collective terms may not be used on pet food or specialty pet food labeling.
(3) Ingredients in the ingredient statement must not list specific ingredient weights or concentrations, but must be listed in descending order by weight.
(4) A single ingredient product, as defined by the Association of American Feed Control Officials official publication, does not need an ingredient statement.
(5) The names of all listed ingredients must be shown in the same size of letters and type.
(6) Commercial, copyrighted, brand, or trade names must not be used in the ingredient statement.
(7) No reference to quality or grade of an ingredient may appear in the ingredient statement.
(8) The term "dehydrated" may precede the name of any product that has been artificially dried.
(9) When the word "iodized" is used in connection with a feed ingredient, the ingredient must contain at least 0.007% iodine, uniformly distributed.
(10) The term "degermed" must precede the name of any product from which germs were wholly or partially removed.
(11) If a drug is used, it does not have to be listed in the ingredient statement. However, the drug name is required to be listed on the label (see WAC 16-252-025 and 16-252-042).
(12) Unless meat and meat by-products are made from cattle, swine, sheep or goats, the terms "meat" and "meat by-products" must specifically identify the animal from which they are derived.
(13) When water is added in the preparation of canned pet food or specialty pet food, the water must be listed as an ingredient.
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(2) Satisfactory evidence of the safety and effectiveness of a pet food or specialty pet food that contains additives (including drugs, other special purpose additives, or nonnutritive additives) is established if one or more of the following apply:
(a) When the use of a pet food or specialty pet food containing such additives either:
(i) Conforms to the requirements of the applicable regulation in 21 CFR, 2002 edition; or
(ii) Are "prior sanctioned"; or
(iii) Are "informal review sanctioned"; or
(iv) "Generally recognized as safe" (GRAS) for such use.
(b) When the pet food or specialty pet food is itself a drug, and is:
(i) Generally recognized as safe (GRAS) and effective for the labeled use; or
(ii) Marketed subject to an application approved by the Food and Drug Administration under Title 21 U.S.C. 360 b as amended effective on the date these rules were adopted.
(c) When one purpose for feeding a pet food or specialty pet food is to immunize through some immunological process and the immunizing drugs or additives have been approved for the purpose through the Federal Virus, Serum and Toxins Act of 1913, as amended in 1985.
(d) When the pet food or specialty pet food is a directly fed microbial product and the:
(i) Product meets the particular fermentation product definition as listed in the Association of American Feed Control Officials official publication; and
(ii) Required microbial content statement on the label is limited to the following: "Contains a source of live (viable) naturally occurring microorganisms"; and
(iii) Source is stated with a corresponding guarantee expressed according to WAC 16-252-076 requirements.
(e) When the pet food or specialty pet food is an enzyme product and the:
(i) Product meets the particular enzyme definition listed in the Association of American Feed Control Officials official publication; and
(ii) Enzyme is stated with a corresponding guarantee expressed according to WAC 16-252-076 requirements.
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(a) Be adequate to enable users with no special knowledge of the purpose and use of the feed to use it safely and effectively for its intended purposes; and
(b) Include all information described by all applicable regulations of 21 CFR, Parts 500-599 under the Federal Food, Drug and Cosmetic Act, 2002 edition.
| Note: | The Food and Drug Administration's regulations are published in the Code of Federal Regulations, and are available in book format from the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402. They are also available on the Internet at http://www.access.gpo.gov/nara/cfr/cfr-retrieve.html#page1. A copy of the 2002 edition Parts 500-599 are also on file with the department. |
(a) Supply particular dietary needs; or
(b) Supplement or fortify the usual diet or ration with any vitamin, mineral, or other dietary nutrient or compound.
(3)(a) When a pet food or specialty pet food is intended for use by or under the supervision of a veterinarian, the statement "use only as directed by your veterinarian" must be on the label. When such a statement is on a pet food label, feeding instructions are not required, but may appear on the label. This regulation takes precedence over other regulations in this subsection.
(b) Pet food, including snacks or treats, labeled as "complete and balanced" for any or all life stages, must list feeding directions on the label. Any pet food labeled as "snacks" or "treats" that contains a drug, must list feeding directions on the label. These directions must:
(i) Be expressed in common terms;
(ii) Appear prominently on the label;
(iii) State the frequency of feeding; and
(iv) At a minimum state, "feed (weight or other measure of product) per (weight only) of dog (or cat)."
(c) Directions must be consistent with the intended use(s) indicated in the nutritional adequacy statement, unless a limited use or more limited life stage designation is declared elsewhere (for example, "adult formula").
(d) Directions must be given for each life stage stated on the label.
(4)(a) Pet food and specialty pet food snacks and treats do not require feeding directions on the label except when they:
(i) Are labeled as "complete and balanced"; or
(ii) Contain a drug.
(b) Feeding directions may be on the label for snacks and treats even when not required.
(5) Pet food and specialty pet food labels must contain the statement "This product is intended for intermittent or supplemental feeding only," if the product does not meet the nutrient requirements of the appropriate AAFCO recognized nutrient profile, feeding protocol, or any other special nutritional or dietary need, thus making it suitable only for limited, intermittent, or supplementary feeding.
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(a) Not contain any seed, pesticide, or other product that renders it adulterated within the meaning of RCW 15.53.902; and
(b) Be ground fine enough or otherwise treated to destroy the viability of the noxious weed seeds contained in the screening so that the finished product contains no more than one viable prohibited noxious weed seed per pound and not more than twenty-five viable restricted noxious weed seeds per pound.
(2) For purposes of this pet food and specialty pet food, commercial feed rule, prohibited noxious weed seeds are those listed in WAC 16-301-045 (Prohibited noxious weed seeds) and restricted noxious weed seeds are those listed in WAC 16-301-050 (Restricted noxious weed seeds).
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(a) Any ingredient, pet food or specialty pet food that contains more than twenty parts per billion aflatoxin B1, B2, G1, G2, individually or in total.
(b) Soybean meal, flakes or pellets or other vegetable meals, flakes or pellets that have been extracted with trichlorethylene or other chlorinated solvents.
(c) Sulfur dioxide, sulfurous acid, and salts of sulfurous acid when used in or on pet food or pet food ingredients that are considered or reported to be a significant source of vitamin B1 (thiamine).
(d) Any substance that is prohibited by 21 CFR, Part 589, 2002 edition.
(2) When screenings are used in a pet food or specialty pet food, the screenings and the finished product must comply with the requirements in WAC 16-252-110 or the pet food will be considered adulterated.
(3) Pet food or specialty pet food containing raw or unprocessed animal waste will be considered adulterated.
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Reviser's note: The spelling error in the above section occurred in the copy filed by the agency and appears in the Register pursuant to the requirements of RCW 34.08.040.
NEW SECTION
WAC 16-252-140
Use of artificial coloring.
(1)
Artificial coloring may be used in pet food if it is harmless
to animals.
(2) Any pet food or specialty pet food ingredient or pet food or specialty pet food product must not contain materials that enhance the natural color of a food if it conceals inferiorities.
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| Note: | "Appropriate cleaning procedures" are procedures that prevent cross contamination of products that would create a safety concern. Examples of safety concerns include: |
| (1) Medicated products contaminating nonmedicated products; | |
| (2) Prohibited mammalian protein contaminating ruminant feed; and | |
| (3) Feed containing minerals, or other additives, intended for one species contaminating feed intended for another species that is more sensitive to a mineral or other additive. |
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(2) The application for pet food and specialty pet food registration, to be completed by applicants and registrants, must include:
(a) The company name (registrant);
(b) Complete business mailing address;
(c) Complete physical address of the business, if different than the mailing address;
(d) Telephone number;
(e) Company name on label if different than the registrant;
(f) Number of products sold in small packages of less than ten pounds;
(g) Number of products sold in large packages of ten pounds or more;
(h) Company registrar's name;
(i) Company registrar's title;
(j) Registrar's signature; and
(k) Date signed.
| Note: | The application for registration of pet food and specialty pet food products may be downloaded from the Internet at http://www.wa.gov/agr/FoodAnimal/AnimalFeed/Forms/Form4307.pdf. |
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(1) Applying for a registration; or
(2) The label is revised by the registrant; or
(3) When requested by the department for reasonable cause.
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(1) Regulations prescribing current good manufacturing practices for Type B and Type C medicated feeds as published in 21 CFR, Part 225, Sections 225.1-225.202, 2002 edition.
(2) Regulations prescribing good manufacturing practices for Type A Medicated Articles as published in 21 CFR, Part 226, Sections 226.1-226.115, 2002 edition.
(3) Regulations pertaining to animal proteins prohibited in ruminant feed as published in 21 CFR, Part 589.2000, 2002 edition.
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OTS-6460.1
REPEALER
The following sections of the Washington Administrative Code are repealed:
| WAC 16-200-750 | Definitions and terms. |
| WAC 16-200-755 | Label format. |
| WAC 16-200-760 | Brand and product names. |
| WAC 16-200-770 | Expression of guarantees. |
| WAC 16-200-790 | Ingredient statement. |
| WAC 16-200-795 | Directions for use and precautionary statements. |
| WAC 16-200-805 | Tonnage fees. |
| WAC 16-200-815 | Adulteration. |
| WAC 16-200-820 | Screenings. |
| WAC 16-200-830 | Nonprotein nitrogen. |
| WAC 16-200-840 | Artificial color. |
| WAC 16-200-860 | Used sacks and containers. |
| WAC 16-200-865 | Commercial feed license. |
| WAC 16-200-885 | Commercial feed label submission. |
| WAC 16-200-887 | Good manufacturing practices. |
| WAC 16-200-890 | Definitions -- Animal waste products. |
| WAC 16-200-900 | Registration requirements. |
| WAC 16-200-910 | Refusing or cancelling registration -- Procedure. |
| WAC 16-200-920 | Quality standards. |
| WAC 16-200-930 | Labeling requirements of animal waste products. |
| WAC 16-200-940 | Testing required. |
| WAC 16-200-950 | Records required. |