PERMANENT RULES
Purpose: These adopted amendments are necessary to ensure that chapter 16-250 WAC, Commercial feed rules, is consistent with current commercial feed law requirements, chapter 15.53 RCW, Commercial feed. Also, they are necessary to ensure that the references in chapter 16-250 WAC are correct so users of the chapter will find it easier to follow and comply with its requirements.
The following table identifies and explains the specific changes to chapter 16-250 WAC, Commercial feed rules, adopted by the Washington State Department of Agriculture with this filing. As the table illustrates, the changes are necessary to ensure that chapter 16-250 WAC:
| • | Is consistent with recent changes in Washington state commercial feed law, chapter 15.53 RCW, Commercial feed, requirements adopted by the legislature; |
| • | Contains correct references; |
| • | Is free of redundant references; and |
| • | States requirements clearly so compliance is easier. |
| Rule Section | Adopted Change | Rationale | |
| WAC 16-250-001 Effective date. | Repealed | Repealed because stating the effective date of the original rule is no longer necessary. | |
| WAC 16-250-007 The code of federal regulations. | New | Added a new section stating that all references to the code of federal regulations refers to the 2002 edition. This allows the department to delete several references to "2002 edition" throughout the rule. | |
| WAC 16-250-010 Commercial feed terms and definitions. | Amended | Numbered the definitions for quick reference. | |
| WAC 16-250-035 Format required for all commercial labels except customer formula feed. | Amended | Updated internet reference in subsection (3). | |
| WAC 16-250-050 Guarantee requirements that apply to WAC 16-250-052 through 16-250-065. | Amended | Added WAC reference to "Note" for clarity. | |
| WAC 16-250-090 Feed ingredient statement terms and record-keeping requirements. | AMENDED? | I don't see that we did anything to this section. If we didn't do anything then it should not be included on the CR-103. If we proposed something on the CR-105 and then changed our mind, we should not include it on the CR-103 and send a memo to the code reviser formally withdrawing the proposed changes on the CR-105. | |
| WAC 16-250-095 Drug and feed additive requirements. | Amended | • | Deleted the "2002 edition" reference in subsection (1)(a) because it is redundant with the addition of new WAC 16-250-007. |
| • | Added "21 U.S.C. 151 et seq." to subsection (3) for clarity. | ||
| WAC 16-250-100 Directions for use and precautionary statement requirements. | Amended | • | Corrects a grammatical error in subsection (1)(a). |
| • | Deleted the "2002 edition" reference in subsection (1)(b) because it is redundant with the addition of new WAC 16-250-007. | ||
| • | Updated internet reference in subsection (1)(b) note. | ||
| • | Replaced "2002 edition" with "21 CFR" in subsection (1)(b) note for clarity. | ||
| WAC 16-250-120 Adulteration of feed. | Amended | • | Corrects a spelling error in subsection (1)(e). |
| • | Deleted the "2002 edition" reference in subsection (1)(g) because it is redundant with the addition of new WAC 16-250-007. | ||
| WAC 16-250-155 Tonnage fee requirements. | Amended | Deletes the word "penalty" to make the section consistent with RCW 15.53.9018. | |
| WAC 16-250-160 Commercial feed license application requirements. | Amended | • | Added language to subsection (1) to make the section consistent with chapter 15.53 RCW. |
| • | Updated internet reference in subsection (2) note. | ||
| WAC 16-250-180 Good manufacturing practices adopted. | Amended | Deleted all references to "2002 edition" because they are redundant with the addition of new WAC 16-250-007. | |
Citation of Existing Rules Affected by this Order: Repealing WAC 16-250-001; and amending WAC 16-250-007, 16-250-010, 16-250-035, 16-250-050, 16-250-090, 16-250-095, 16-250-100, 16-250-120, 16-250-155, 16-250-165, and 16-250-180.
Statutory Authority for Adoption: Chapters 15.53 and 34.05 RCW.
Adopted under notice filed as WSR 05-14-149 on July 6, 2005.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 2, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 1, Amended 8, Repealed 1.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 1, Amended 10, Repealed 1.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 1, Amended 10, Repealed 1.
Date Adopted: September 7, 2005.
Valoria H. Loveland
Director
OTS-7950.1
NEW SECTION
WAC 16-250-007
The code of federal regulation.
Throughout these rules where the code of federal regulation is
referred to, the reference is to the 2002 edition.
[]
| 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. |
(2) "Canned" means feed that has been processed, packaged, sealed, and sterilized for preservation in cans, pouches, or similar containers.
(3) "Commercial feed" means all materials or combinations 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.
(4) "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.
(5) "Department" means the Washington state department of agriculture (WSDA).
(6) "Director" means the director of the Washington state department of agriculture or the director's designee.
(7) "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.
(8) "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.
(9) "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.
(10) "Distributor" means a person who distributes.
(11) "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.
(12) "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.
(13) "Facility" means any place where a commercial feed is manufactured, repackaged, sold, transloaded, or stored for later distribution.
(14) "Feed ingredient" means each of the constituent materials making up a commercial feed.
(15) "Grain mixture feed" 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.
(16) "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.
(17) "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.
(18) "Initial distributor" means a person who first distributes a commercial feed in or into Washington state.
(19) "Ingredient statement" means a contiguous listing on the label of all ingredients of which the commercial feed is composed.
(20) "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.
(21) "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.
(22) "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.
(23) "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).)
(24) "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.
(25) "Nutritionally suitable" means nutritionally adequate.
(26) "Person" means an individual, firm, partnership, corporation, or association.
(27) "Pet food" means a commercial feed prepared and distributed for consumption by domesticated dogs or cats.
(28) "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.
(29) "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.
(30) "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.
(31) "Quantity statement" means the part of the label expressing net weight (mass), net volume (liquid or dry) or count.
(32) "Repackage" means taking commercial feed from packages (no larger than one hundred pounds for dry feed or fifty-five gallons for liquid feed) and placing it into smaller packages for resale.
(33) "Salvage pet food" means pet food (dog and cat 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.
(34) "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.
(35) "Sell" or "sale" includes exchange.
(36) "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.
(37) "Specialty pet food" means a commercial feed prepared and distributed for consumption by specialty pets.
(38) "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.
[Statutory Authority: Chapters 15.53 and 34.05 RCW. 03-23-128, § 16-250-010, filed 11/19/03, effective 7/1/04.]
(i) Product name and brand name, if any;
(ii) Drug used, if any drug is used;
(iii) Purpose of feed statement;
(iv) Guaranteed analysis;
(v) Feed ingredients;
(vi) Directions for use and precautionary statements or reference to their location if they appear elsewhere on the label;
(vii) Name and principal mailing address of the manufacturer or person responsible for distributing the feed; and
(viii) Quantity statement.
(b) A lot identifier must appear on the label of all commercial feed, but may be in a different location than the information required by (a) of this subsection.
(2)(a) If a reference to the location of the directions for use and precautionary statements is made on the principal label, the directions for use and precautionary statements must be displayed in a prominent place on the label or container but not necessarily on the same side as the information required in subsection (1)(a) of this section.
(b) When directions for use or precautionary statements are placed on a different side of the label or container than the information required in subsection (1)(a) of this section, there must be a statement on the same side of the label or container that the information required in subsection (1)(a) of this section is printed such as "see back of label for directions for use."
(3) When the Bovine Spongiform Encephalopathy
precautionary statement "do not feed to cattle or other
ruminants" is required by 21 CFR, Part 589.2000 (((2002
edition))), it must appear in a prominent place on the label.
| Note: | A copy of 21 CFR, Part 589.2000 is available from the department. It is also available on the internet at
(( |
(5) Printed or written material or design (for example, pictures of animals or birds) of any kind must not be attached to, appear on, or distributed with commercial feed if the material or design is misleading, incorrect, or at variance in any respect with the information required on the label.
(6)(a) Statements referring to a competitive product or comparing the properties of a packaged feed 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.
[Statutory Authority: Chapters 15.53 and 34.05 RCW. 03-23-128, § 16-250-035, filed 11/19/03, effective 7/1/04.]
| Note: | "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. See WAC 16-250-010(16). |
(1) Complete feeds and feeds intended to be mixed with grain to produce complete feed for the following animal classes and/or species always require a mineral guarantee:
(a) Swine;
(b) Poultry;
(c) Fish; and
(d) Veal and herd milk replacers.
(2) When stated on a commercial feed label, nutritional guarantees must be listed in the following order:
(a) Crude protein;
(b) Crude protein from nonprotein nitrogen;
(c) Amino acids;
(d) Crude fat;
(e) Crude fiber;
(f) Acid detergent fiber;
(g) Calcium;
(h) Phosphorus;
(i) Salt;
(j) Sodium.
(3) Other required and/or voluntary guarantees should follow those listed in subsection (2) of this section grouped by the unit (percentage, parts per million, International Units, etc.) of measure used to express the guarantees. For example, all guarantees measured by parts per million should be grouped together.
(4) The use of commercial, copyrighted brand, or trade names in the guarantees statement is prohibited.
(5) The following requirements apply to WAC 16-250-052 through 16-250-063:
(a) Commercial feed must be labeled for the animal class or classes for which it is intended.
(b) Commercial feed must also be nutritionally suitable for each and every class for which it is labeled.
(c) WAC 16-250-052 through 16-250-063 contains a series of animal class tables. When a manufacturer uses the class terms in the tables, the feed must be suitable for the class as defined in the table.
(d) Instead of the class terms used in the tables, a manufacturer may use more specific and common language to describe animal classes, especially when describing attributes such as the weight range, sex, or age of the animal for which the feed is manufactured.
[Statutory Authority: Chapters 15.53 and 34.05 RCW. 03-23-128, § 16-250-050, filed 11/19/03, effective 7/1/04.]
(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 16-250-015; or
(d) The ingredient has a commonly accepted name that requires no definition, for example, sugar.
(2) Collective terms for the grouping of feed ingredients must be those defined in the Association of American Feed Control Officials official publication. However, when a collective term for a group of ingredients is used on a label:
(a) Individual ingredients within that group must not be listed on the label; and
(b) When requested the manufacturer must give the department a list of individual ingredients, within a defined group, that are or have been used at manufacturing facilities distributing the commercial feed in Washington state. These records must be available to the department for inspection and copying for at least one year after the last date of distribution of the commercial feed.
(3) Ingredients on labels must be listed in descending order by weight.
(4) The specific amount of each ingredient does not need to be listed on the label.
(5) A single ingredient product, as defined by the Association of American Feed Control Officials official publication, does not need an ingredient statement.
(6) The names of all listed ingredients must be shown in the same size of letters and type.
(7) Commercial, copyrighted, brand, or trade names must not be used in the ingredient statement.
(8) No reference to quality or grade of an ingredient may appear in the ingredient statement.
(9) The term "dehydrated" may precede the name of any product that has been artificially dried.
(10) When the word "iodized" is used in connection with a feed ingredient, the ingredient must contain at least 0.007% iodine, uniformly distributed.
(11) The term "degermed" must precede the name of any product from which germs were wholly or partially removed.
(12) If a drug is used, the drug does not have to be listed in the ingredient statement. However, the drug name is required to be listed on the label (see WAC 16-250-030 and 16-250-035).
(13) 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.
[Statutory Authority: Chapters 15.53 and 34.05 RCW. 03-23-128, § 16-250-090, filed 11/19/03, effective 7/1/04.]
Satisfactory evidence of the safety and effectiveness of a commercial feed that contains additives (including drugs, other special purpose additives, or nonnutritive additives) is established if one or more of the following apply:
(1) When the use of a commercial feed containing such additives either:
(a) Conforms to the requirements of the applicable
regulation in 21 CFR((, 2002 edition)); or
(b) Are "prior sanctioned"; or
(c) Are "informal review sanctioned"; or
(d) "Generally recognized as safe" (GRAS) for such use.
(2) When the commercial feed is itself a drug, and
(a) Is generally recognized as safe (GRAS) and effective for the labeled use; or
(b) Is 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.
(3) When one purpose for feeding a commercial feed 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 (21 U.S.C. 151 et seq.).
(4) When the commercial feed is a directly fed microbial product and the:
(a) Product meets the particular fermentation product definition as defined in the Association of American Feed Control Officials official publication; and
(b) Required microbial content statement in the label is limited to the following: "Contains a source of live (viable) naturally occurring microorganisms"; and
(c) Source is stated with a corresponding guarantee expressed according to WAC 16-250-076 requirements.
(5) When the commercial feed is an enzyme product and the:
(a) Product meets the particular enzyme definition in the Association of American Feed Control Officials official publication; and
(b) Enzyme is stated with a corresponding guarantee expressed according to WAC 16-250-076 requirements.
[Statutory Authority: Chapters 15.53 and 34.05 RCW. 03-23-128, § 16-250-095, filed 11/19/03, effective 7/1/04.]
(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 ((it's)) 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
(( |
(3) Adequate directions for use and precautionary statements identified in subsection (1) of this section are required for commercial feeds that are distributed to:
(a) Supply particular dietary needs; or
(b) For supplementing or fortifying the usual diet or ration with any vitamin, mineral, or other dietary nutrient or compound.
[Statutory Authority: Chapters 15.53 and 34.05 RCW. 03-23-128, § 16-250-100, filed 11/19/03, effective 7/1/04.]
(a) A commercial feed or feed ingredient that contains more than twenty parts per billion aflatoxin B1, B2, G1, G2, individually or in total.
(b) Fluorine and any mineral or mineral mixture that is used directly to feed domestic animals and in which the fluorine exceeds:
| Maximum Allowed Percentage of Fluorine in Minerals | Type of Animal | |
| 0.20% | Breeding and dairy cattle | |
| 0.30% | Slaughter cattle | |
| 0.30% | Sheep | |
| 0.35% | Lambs | |
| 0.45% | Swine | |
| 0.60% | Poultry | |
| Maximum Allowed Percentage of Fluorine in Ration Excluding Roughage | Type of Animal | |
| 0.004% | Breeding and dairy cattle | |
| 0.009% | Slaughter cattle | |
| 0.006% | Sheep | |
| 0.01% | Lambs | |
| 0.015% | Swine | |
| 0.03% | Poultry | |
(e) Soybean meal, flakes or pellets or other vegetable
meals, flakes or pellets that have been extracted with
((trichlorethylene)) trichloroethylene or other chlorinated solvents.
(f) Sulfur dioxide, sulfurous acid, and salts of sulfurous acid when used in or on feeds or feed ingredients that are considered or reported to be a significant source of vitamin B1 (thiamine).
(g) Any substance that is prohibited by 21 CFR, Part
589((, 2002 edition)).
(2) When screenings are used in a commercial feed, the labeling and screenings must comply with the requirements in WAC 16-250-110 or the commercial feed will be considered adulterated.
(3) Feed containing raw or unprocessed animal waste will be considered adulterated.
[Statutory Authority: Chapters 15.53 and 34.05 RCW. 03-23-128, § 16-250-120, filed 11/19/03, effective 7/1/04.]
[Statutory Authority: Chapter 15.53 RCW, 2003 1st sp.s. c 25, and chapter 34.05 RCW. 04-14-076, § 16-250-155, filed 7/6/04, effective 1/1/05. Statutory Authority: Chapters 15.53 and 34.05 RCW. 03-23-128, § 16-250-155, filed 11/19/03, effective 7/1/04.]
(a) The company name and ((business)) mailing address of
the applicant; ((and))
(b) The physical address of the facility;
(c) The name, contact information, and signature of the applicant;
(d) Information regarding the types of business the firm is engaged in (feed manufacturer, dealer, broker); and
(((c))) (e) The type of commercial feed distributed
(medicated feed, complete feed, feed supplement, or animal
by-products).
(2) A commercial feed license is not required for facilities that only:
(a) Sell food processing by-products from fruit, vegetable, or potato processing plants, freezing or dehydrating facilities, or juice or jelly preserving plants;
(b) Sell bona fide experimental feed on which accurate records and experimental programs are maintained;
(c) Makes retail sales of bagged, or packaged commercial feed bearing labeling or other approved indicators showing that the commercial feed is from a licensed manufacturer, guarantor, or distributor who has assumed full responsibility for the required tonnage inspection fees.
| Note: | The commercial feed license application form is available from the department. This form may also be
downloaded from the internet at (( |
[Statutory Authority: Chapters 15.53 and 34.05 RCW. 03-23-128, § 16-250-160, filed 11/19/03, effective 7/1/04.]
(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)), even if interstate commerce is not involved.
[Statutory Authority: Chapters 15.53 and 34.05 RCW. 03-23-128, § 16-250-180, filed 11/19/03, effective 7/1/04.]
The following section of the Washington Administrative Code is repealed:
| WAC 16-250-001 | Effective date. |