The purpose of the following rules is to:

(1) Establish an inspection criteria and a rating system that will be used to determine whether food processing establishments which process, handle or store food in intrastate commerce, are in compliance with chapters 16.49, 69.07, 69.10, and 15.130 RCW, and regulations adopted thereunder, including Title 21 C.F.R.

(2) Identify steps leading to enforcement actions by the department.

(3) Establish criteria for licensing food establishments under chapters 69.07 and 69.10 RCW.

To qualify for a new food processing plant license issued under chapter 69.07 RCW, the Washington Food Processing Act, a food processing facility must first make application to the department. After the department receives a complete application, the department will inspect the facility. The facility must be in compliance with the following requirements prior to issuance of a license:

The food processing facility must achieve a score of ninety points or higher on the prelicensing inspection AND be in compliance with licensing criteria. Refer to WAC 16-165-140 for the inspection criteria. For the purposes of licensing, a food processing facility may incur a one-point debit of a licensing criteria that has sliding scale.

(1) Definitions for terms used in this chapter may be found in chapters 69.07, 69.10, and 15.130 RCW, and Title 21 C.F.R. as adopted, unless otherwise provided in this chapter.

(2) For the purposes of this chapter, the following definitions apply:

(a) "Adequate" means that which is needed to accomplish the intended purpose in keeping with good public health practice.

(b) "Critical violation" means a violation of the inspection criteria that is a direct violation of RCW 15.130.200 with respect to adulterated food or a violation that results in food adulteration that could cause injury or illness in consumers, or that has the potential to contribute to conditions resulting in such adulteration.

(c) "Department" means the department of agriculture of the state of Washington (WSDA).

(d) "Director" means the director of agriculture.

(e) "Establishment or food establishment" means any premise, plant, building, room, area, or facility which processes, prepares, handles or stores food or food products for sale in intrastate commerce including food processors, food storage warehouses, custom slaughter operations, refrigerated lockers, and dairy manufacturing plants.

(f) "Licensing criteria violation" means any violation of the inspection criteria required to be in compliance prior to the issuance of a food processor's license under chapter 69.07 RCW.

(g) "Sanitize" means to adequately treat food contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.

(h) "Significant violation" means any violation of the inspection criteria not deemed to be a critical violation as defined in WAC 16-165-140(2).

WSDA will use the definitions and interpretations in this section to determine if a food establishment inspection complies with the inspection criteria.

(1) "Clean and adequate protective clothing and hair restraints" means the clothing or the outside layer of clothing, which can occasionally or incidentally contact food, either directly or indirectly, is:

(a) Clean at the start of the work shift; and

(b) Changed when the clothing becomes so soiled during the course of the work shift that contamination of food, food packaging or food contact surfaces becomes imminent; and

(c) Suitable to the specific food processing operation for protection against the contamination of food, food packaging, and food contact surfaces.

Clean and effective hair restraints, such as hairnets, or beard nets if appropriate, are worn for the protection of food from contamination. Hats, caps, scarves or other head cover are acceptable if the hair is properly contained to protect food from contamination. Hair spray and/or tying back the hair in ponytails, etc., are not considered effective hair restraints.

(2) "Adequate washing and sanitizing of hands as necessary" means washing and sanitizing hands thoroughly to protect against contamination of food from undesirable microorganisms in an adequate handwash facility by:

(a) Using proper handwashing methods which consist of:

(i) Applying soap to hands;

(ii) Using warm water;

(iii) Scrubbing hands thoroughly;

(iv) Rinsing and drying hands using methods that prevent food contamination;

(b) Washing hands before beginning work, after each absence from the work station, and any time hands become soiled or contaminated; and

(c) Sanitizing hands when appropriate in addition to, but not in place of, the proper handwashing methods.

(3) "Garments and personal belongings stored appropriately; not a source of contamination" means personal belongings and garments, either personal or plant supplied, are stored or kept separately from food processing, handling and storage operations such as in an area, locker, cupboard, or other closeable unit that is dedicated to the storing or hanging of personal belongings and clothing so not to become a source of contamination to food, food packaging or food contact surfaces; and

No food, packaging materials, utensils or equipment used in the food processing operation are kept, stored or commingled with personal belongings or garments.

(4) "Processes separated as required" means there is a separation of processes for the purpose of reducing potential contamination in food processing operations where contamination is likely to occur. One or more of the following means may accomplish this:

(a) Location;

(b) Time;

(c) Partition;

(d) Air flow;

(e) Enclosed systems; or

(f) Other effective method.

(5) "Adequate light" means a minimum of 25 foot candles at the working surfaces of food processing areas and a minimum of 10 foot candles at the floor level in all other food processing areas.

(6) "Detergents, sanitizers and toxic materials properly identified" means:

(a) Labeling any container containing detergent, sanitizer or toxic material with the:

(i) Product name;

(ii) Chemical description;

(iii) Directions for use;

(iv) Any required precautionary and warning statements;

(v) First-aid instructions;

(vi) Name and address of the manufacturer or distributor; and

(vii) Any other additional information required by the federal Environmental Protection Agency or other laws or rules; or

(b) Small transport or use containers for detergents, sanitizers or toxic materials are used only under the following conditions:

(i) The contents are properly identified on the container. Labeling the container with the common name is acceptable if the original storage container is on hand and properly identified;

(ii) No food container is used as a container for detergents, sanitizers or toxic materials;

(iii) No container used for detergents, sanitizers or toxic materials, is used as a food container.

(7) "Product contact surfaces clean and maintained in a sanitary condition, cleaned and sanitized prior to each use or as essential" means:

(a) Product contact surfaces of equipment, utensils, containers and other articles used in the processing of food, when its continued use is apparent, are not soiled with any residue or contaminant that could adulterate food products as defined in RCW 15.130.200; and

(b) Food residues are removed from food product contact surfaces frequently enough to prevent residues from becoming unwholesome or unfit for food, decomposed, filthy, putrid, or injurious to health; and

(c) The food product contact surfaces are sanitized prior to use and after cleaning.

(8) "Product contact surfaces clean and maintained in a sanitary condition, cleaned and sanitized prior to each use or as essential: Critical violation" means it is a critical violation if a food product contact surface comes into contact with potentially hazardous food and the surface is not sanitized after cleaning or prior to use.

Product contact surfaces that become contaminated, but are cleaned and sanitized prior to use are not considered a critical violation.

(9) "Nonproduct contact surfaces of equipment cleaned and maintained in a sanitary condition" means nonproduct contact surfaces of equipment used in the processing of food are kept reasonably free from dirt, old food residues, foreign material, dust, mold, mildew, slime and other accumulations that occur because of day-to-day food processing operations.

(10) "In-use food contact equipment and utensils appropriately stored: Protected from contamination between uses" means the utensils used in the processing of foods, such as knives, scrapers, scoops, shovels, cutters, and other hand tools and equipment, are placed or stored in a manner to prevent food contact surfaces from being contaminated with filth. Filth includes, but is not limited to, microorganisms, unsuitable toxic chemicals, and microscopic physical contaminants.

Storage and placement of utensils or equipment in the following manner is considered inappropriate storage:

(a) In contact with the floor, dirty equipment frames, other insanitary nonfood contact surfaces;

(b) In contact with containers of nonpotable water (other than sterilizing solutions); and

(c) In contact with other contaminants.

(11) "In-use food contact equipment and utensils appropriately stored: Protected from contamination between uses: Critical violation" means that it is a critical violation when a utensil or piece of equipment is or has been stored in such a manner that it becomes obviously contaminated with filth and its continued use is apparent.

Utensils and equipment that become contaminated are not considered a critical violation if the utensils and equipment are cleaned and sanitized prior to the next use.

(12) Water supply—"Safe and of sanitary quality" means the water supply used in the processing of food is potable from an approved source and is monitored in accordance with applicable laws and rules. Water from an approved source and monitored in accordance with applicable laws and rules means:

(a) Food processors who produce bottled water meet the requirements of 21 C.F.R., Part 129 and comply with the state department of health, division of drinking water requirements for a group A water system (chapter 246-290 WAC).

(b) Food processors who produce ice comply with the state department of health, division of drinking water requirements for a group A water system (chapter 246-290 WAC).

(c) Food processors with twenty-five or more employees and operating sixty days or more annually comply with the state department of health, division of drinking water requirements for a group A water system (chapter 246-290 WAC).

(d) Processors with less than twenty-five employees or operating less than sixty days annually, except single-family residences employing only household members, comply with the state department of health, division of drinking water requirements for a group B water system (chapter 246-291 WAC).

(e) Processors that operate from single-family residences on private water supplies meet the department of health, division of drinking water requirements for a group B water system (chapter 246-291 WAC) with respect to monitoring for bacteriological, chemical and physical properties. Processors that do not use water as an ingredient or incorporate water into their product need only meet the bacteriological testing requirements.

(f) Water used for certain purposes within the food processing operation (such as circulated water used in the washing of soil from raw agricultural commodities or fluming) is acceptable if:

(i) The water does not impart harmful or deleterious substances or additives to food products; and

(ii) The food products in contact with the water undergo a final potable water wash/rinse; and

(iii) The water meets the requirements of the good manufacturing practices under 21 C.F.R., Part 117.

(13) "Current satisfactory water test" means analysis verifying the bacteriological, physical and chemical safety of the water has been conducted according to appropriate group A or B water system monitoring schedules or, in the case of bottled water operations, according to the requirements of Title 21 C.F.R., Part 129 and that reports of such analysis are on file at the processing facility and available for review by WSDA during routine facility inspection.

(14) "Ice from an approved source" means:

(a) Ice is manufactured on the premises of a food establishment with water that is safe and of sanitary quality; or

(b) Ice is supplied by an establishment that is under license and inspection of a federal, state or local government agency, and proof of the water's potability is on file with the food processing plant using the ice.

(15) "Ice properly handled" means ice is processed, handled and held according to sanitary practices provided in 21 C.F.R., Part 117, and ice used in the processing of food is protected from contamination by taking the necessary precautions during its manufacture, storage, transport and use. Necessary precautions include, but are not limited to:

(a) Storage bins and containers of water are covered;

(b) All storage and packaging containers, including ice house or storage room contact surfaces, are sanitary, readily cleanable, and do not impart deleterious materials to the ice. Wooden totes are not to be used for the transporting or holding of ice;

(c) Scoops, shovels and other utensils used in the handling of ice are in a sanitary condition, properly stored, readily cleanable, and do not impart deleterious materials to the ice;

(d) The ice does not come into contact with floor areas where foot traffic is possible; and

(e) Equipment used to manufacture ice is in a sanitary condition, readily cleanable and does not impart any deleterious or other foreign substances to the ice.

(16) "No cross connections, no back siphonage" means there is no backflow from or cross connection between piping systems that discharge waste water sewage and piping systems that carry water for food manufacturing. This includes any cross connection between a potable water system and:

(a) A system in which the water contains boiler additives; or

(b) A CIP (clean in place) system; or

(c) A recirculating system used to wash or flume food products, such as raw fruits or vegetables.

(17) "Adequate floor drains and plumbing to convey wastes and sewage from the plant, into approved sewage disposal system" means:

(a) Plumbing is designed, sized, installed and maintained in accordance with applicable state and local plumbing codes so that sewage and liquid disposable waste is readily conveyed from the plant;

(b) Floor drainage is sufficient to prevent excessive pooling of water or other disposable waste;

(c) Plumbing and drains do not provide a source of contamination to food, potable water, food contact surfaces or food packaging material or create any insanitary condition; and

(d) Sewage is disposed into a municipal sewer system or other system approved by a federal, state or local agency having jurisdiction.

(18) "Adequate, readily accessible toilet facilities" means:

(a) A food establishment provides its employees with toilet facilities that are located within a reasonable distance to the work area, and the toilet facilities are maintained in accordance with 21 C.F.R., Part 117, and:

(i) Toilet facilities are located on the premises of a licensed food establishment; or

(ii) If the food establishment shares space in a multiple building complex, toilet facilities are located within the complex and within a reasonable distance from the work area; or

(iii) A domestic toilet facility is sufficient if the food processing operation is a family operation where only family members are employed and if the domestic toilet facility meets applicable requirements provided in 21 C.F.R., Part 117.

(b) Outhouses, chemical toilets or other nonflush toilets may not be used in a food establishment.

(19) "Toilets clean, in good repair, not opening directly into process areas, self-closing doors" means toilet rooms are kept clean, free of trash and litter, in good repair and all toilet room doors are self-closing and do not open directly into a food processing area.

(20) "Handwash facilities adequate and convenient, with hot and cold or tempered water" means food handlers in a food establishment have access to one or more handwashing facilities with hot, cold, or tempered running water, and:

(a) There is at least one handwash facility located in the food processing area in a location convenient to each food handling area when hands come into contact with or manipulate unwrapped or unpackaged ready to eat food. (Hand sanitizing stations may be required if appropriate); or

(b) Handwash facilities are located in rest rooms or other areas in operations where food is not manipulated by hand and hands do not contact the food; or

(c) Handwash facilities are located in rest rooms or other areas and hand sanitizing stations are located in food processing areas in operations where food would normally undergo further preparation (for example washing, cleaning, cooking or other processing) either in the plant or by the consumer that would adequately eliminate physical, chemical and microbiological contaminants introduced by handling.

(21) "Hand dips provided as necessary" means hand sanitizing stations are provided, and properly positioned and maintained in all food operations as provided in subsection (20)(c) of this section.

(a) For the purposes of this subsection "properly positioned" means:

(i) Food handlers have ready access to hand sanitizing stations when returning from the toilet, handwash stations, lunch and breaks and whenever necessary while working; and

(ii) At least one hand sanitizing station is inside the process room entryways on each side of the processing table, lines and equipment where food is manipulated by hand, and at least one hand sanitizing station for every ten food handlers at processing tables, lines and equipment.

(b) For the purposes of this subsection "properly maintained" means sanitizing solutions are checked and recharged to a strength equal to 10 PPM chlorine or 25 PPM iodine, and changed every four hours while in use.

(c) Hand sanitizing stations are recommended for all food operations provided for in subsection (20)(c) of this section.

(22) "Food protected from contamination in storage" means food is stored under conditions that protect food against physical, chemical and microbial contamination, as well as against deterioration of the food and the container.

(23) "Food protected from contamination in storage: Critical violation" means it is a critical violation when:

(a) A storage situation allows potential contamination of products. This includes, but is not limited to, the storing of raw materials in such a fashion that they cross-contaminate finished food products, particularly ready to eat food. For example, the storage of raw fish and seafood, meat, poultry and other food which inherently contains pathogenic and spoilage microorganisms, as well as soil and other foreign material, is in direct contact with other food in the same container or in any other cross-contaminating circumstance with finished food products; or

(b) Raw materials or food products from unapproved or uncertified sources are used that are inherently associated with food-borne illnesses. Raw products include, but are not limited to:

(i) Unpasteurized milk and dairy products;

(ii) Unpasteurized eggs used in products which are not heated to pasteurization temperatures during processing;

(iii) Home canned low-acid foods;

(iv) Raw uncertified shellfish; and

(v) Uninspected meat products.

(24) "Adequate records maintained as required" means all records are maintained as provided under Title 21 C.F.R., Part 113 Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Part 114, Acidified Foods; Part 129, Processing and Bottling of Bottled Drinking Water; and any other law or rule requiring recordkeeping, except that water tests under Part 129 are covered under subsection (13) of this section, "Current satisfactory water test."

(25) "Adequate records maintained as required: Critical violation" means it is a critical violation when a record is not maintained on any food process and/or controls as provided for in subsection (24) of this section, or so poorly maintained that the information intended to be conveyed by the record is lacking or cannot be determined.

(26) "Products coded as required" means all products are coded as provided under Title 21 C.F.R., Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Part 114, Acidified Foods; Part 129, Processing and Bottling of Bottled Drinking Water; and any other law or rule requiring that products be coded.

(27) "Products coded as required: Critical violation" means it is a critical violation when a product is not coded as required in subsection (26) of this section, or so inadequately coded with respect to the food product, the plant where manufactured, the date manufactured, time or batch manufactured, cannot be readily identified.

(28) "Packaging material properly handled and stored" means:

A food contact surface of food packaging material is protected from potential sources of contamination during handling and storage. This includes, but is not limited to:

(a) Boxes, liners and other primary containers are stored off floors or other insanitary surfaces;

(b) Top containers in a nested stack of lined or primary containers are inverted or otherwise protected;

(c) All single service containers, caps, roll stock, liner jars, bottles, jugs and other preformed containers are stored in closed sanitary tubes, wrappings, boxes or cartons prior to use;

(d) The forming, make-up or other package assembly is conducted in a manner that precludes contamination; and

(e) The handling of packaging material and containers prior to filling or wrapping is conducted so not to expose them to contamination by dust, foreign material or other contaminants.

(29) "Potentially hazardous food" means any food, whole or in part, capable of supporting the germination, growth and/or toxin production by infectious or toxic microorganisms is at temperatures between 38°F and 145°F, and/or food is otherwise harmful to health.

The food inspection criteria shall be in accordance with the following table for determining:

(1) If a food establishment is in compliance with chapters 16.49, 69.07, 69.10, and 15.130 RCW, and rules adopted thereunder;

(2) The debit value for each significant violation; and

(3) Whether a violation is critical, or a licensing requirement:

(1) A food establishment is rated as follows at the completion of an inspection conducted by the department:

(a) A food establishment will be debited the point value assigned to the inspection item listed in WAC 16-165-140 for each violation found during an inspection.

(b) The sum of the points debited for an inspection are subtracted from the maximum point value of one hundred. The remaining sum is the establishment's score for that inspection.

(c) When the department on a food establishment inspection identifies a critical violation, no score will be listed unless the critical violation is satisfactorily corrected during the inspection.

(2) An establishment is considered in substantial compliance with the inspection criteria if:

(1) The department may issue a notice of correction for:

(a) Food establishments that score less than ninety points on an inspection; or

(b) Critical violations found during an inspection of a food establishment.

(2) The department may review and consider initiating enforcement action, such as license suspension, civil penalties, and/or other penalties provided in chapters 16.49, 69.07, 69.10, or 15.130 RCW when:

(a) Food establishments score less than ninety points on two separate inspections within a consecutive three-year period; or

(b) Food establishments fail to correct critical violations during an inspection.

(3) Nothing herein shall prevent the department from:

(a) Choosing not to pursue a case administratively.

(b) Issuing a notice of correction in lieu of pursuing administrative action.

(c) Negotiating settlement(s) of cases on such terms and for such reasons as it deems appropriate.