WSR 99-23-088

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed November 16, 1999, 3:41 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 99-19-031.

Title of Rule: WAC 246-215-010 and 246-215-040, food service.

Purpose: The proposal amends WAC 246-215-040 to require notification to consumers when unpasteurized juices are offered for sale or service. It also amends WAC 246-215-010 to include a definition of unpasteurized juice.

Statutory Authority for Adoption: RCW 43.20.050 (2) and (3).

Statute Being Implemented: RCW 43.20.050.

Summary: The amendments add unpasteurized juice to WAC 246-215-040 a list of items that require notification such as raw or undercooked meats, eggs, or shellfish. A definition of unpasteurized juice is also added to WAC 246-215-010.

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Dave Gifford, Tumwater, (360) 236-3074.

Name of Proponent: [Department of Health], governmental.

Rule is not necessitated by federal law, federal or state court decision.

Explanation of Rule, its Purpose, and Anticipated Effects: The rule will require businesses that serve unpasteurized juice by the glass to provide notification to consumers. Recent foodborne illness outbreaks in Washington have been linked to unpasteurized juice. The proposal is intended to provide notice to customers when unpasteurized juice is being served so that those people at greatest risk from foodborne illnesses will have this information.

Proposal Changes the Following Existing Rules: The proposal adds unpasteurized juice to a list of items that currently require notification such as undercooked meat, eggs, or shellfish.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

Background: As a result of several foodborne disease outbreaks linked to unpasteurized juice in Washington, the governor and the State Board of Health (SBOH) have directed the Department of Health to begin the rule revision process requiring notification to consumers when unpasteurized juices are offered for unpackaged retail sale. Although federal regulations require a warning to be printed on packaged juice, it does not apply to juices or smoothies sold by the glass. The purpose of the rule is to provide information to consumers so that persons at greatest risk of severe or fatal outcomes from foodborne disease may make an informed choice when purchasing juice beverages at the retail level.

Chapter 246-215 WAC, Food service, currently requires notification about the service of raw or undercooked meats, eggs, and shellfish. The amendment adds unpasteurized or unprocessed juice to the list of items. Businesses will have a variety of ways of meeting the notification requirement including signs, table tents, or menus.

Small Business Economic Impact Statements: Pursuant to requirements of the Regulatory Fairness Act (act),1 state agencies must prepare a small business economic impact statement (SBEIS) prior to proposing a new regulation. The impetus for this legislation was a concern that regulatory mandates could "...threaten the very existence of some small businesses" (RCW 19.85.011). The act defines a small business as "any business entity, including a sole proprietorship, corporation, partnership, or other legal entity, that is owned and operated independently from all other businesses, that has the purpose of making a profit, and that has fifty or fewer employees" (RCW 19.85.020).

The Department of Health prepared this SBEIS on behalf of the SBOH as required by the Regulatory Fairness Act. The department used the following process to determine whether the act mandates that the proposed rule include regulatory relief for small businesses.


Step I Determine the categories of businesses affected by the proposed regulations
Step II Determine the employment profile for each business category
Step III Determine the "more than minor" cost threshold
Step IV Determine whether the estimated cost exceeds the "more than minor" cost threshold for each category of business
Step V Determine whether the proposed regulations imposes a disproportionate cost burden on small businesses
Step VI Determine whether regulatory relief is legal and feasible
Step VII Describe the regulatory relief provided to small businesses
Step VIII Miscellaneous SBEIS requirements

This process need not result in the provision of regulatory relief. At several steps along this process the department could determine that regulatory relief is not warranted or even that an SBEIS is not necessary. For example, if in Step II all businesses found within an industrial category had more (or less) than 50 employees, the regulation could not, by definition, disproportionately affect small businesses. Such a finding would obviate the need to provide regulatory relief. Or, if the cost to businesses determined in Step IV were below the "more than minor" cost threshold, then, by law, a SBEIS is not required. Similarly, department could determine that it could not legally provide regulatory relief in Step VI.

Step I: What Businesses are Affected by the Proposed Regulation? The proposed rule only affects those businesses selling or serving to the public juice that does not meet the federal standards for pasteurization (which allow other processes that reduce or eliminate pathogens). The department has identified three types of businesses and their associated "standard industrial codes" (SIC) that could be affected by the proposed rule.

Full Service Restaurants (SIC No. 5812) - While some restaurants could be affected by this rule, the Department of Health believes that the vast majority only serve pasteurized juice.

Juice Bars (SIC Nos. 5812, 5411, 5499 and 5431) - Juice bars serving specialty juice drinks could be significantly affected by the proposed rule. Juice bars are run as independent businesses and also as part of retail food establishments (grocery stores and health food stores) and fruit and vegetable markets.

Juice Producers (SIC No. 2033) - Businesses that specialize in making unpasteurized/unprocessed juice and wholesaling it to restaurants may lose some customers as a result of the proposed rule.

Step II: What is the Employment Profile of Businesses Affected by the Proposed Regulation? The department turned to United States Department of Commerce reports to determine employment patterns in the affected business categories. Table 1 presents employment data on the affected business categories -- employment data for independent juice bars was not separated from the larger category of restaurants. Unfortunately, the SIC codes do not distinguish between businesses producing or serving unpasteurized juice and those in similar but unrelated activities. For example, included in SIC 5812 are beaneries, box lunch stands, buffets, cafes, cafeterias, carryout restaurants caterers, coffee shops, as well as 35 other types of businesses. It is clear to the department that most of these businesses do not serve unpasteurized juice and will not be affected by the proposed rule. Nevertheless, the department concludes that in all likelihood, the proposed regulation will affect both large and small businesses. Therefore, the proposed regulation has the potential to impose disproportionate costs on small businesses.

TABLE 1


Type of

Establishment

Total Number of Establishments Number of

Establishments by

employment-size

Total number of Employees
1 to 49 50+
Restaurants 9,011 8,397 614 150,403
Juice Bars, independent N/A N/A N/A N/A
Juice Bars, groc. Store 2,634 2,183 451 65,686
Juice Bars, fruit/veg. market 74 73 1 338
Health Food Stores 282 281 1 1,683
Juice Producers 32 20 12 2,047

† U.S. Department of Commerce, Economics and Statistics Administration, Bureau of the Census, County Business Patterns, 1996, Washington, CBP/96-49.


Step III: What are the "more than minor" Cost Thresholds for Businesses Affected by the Proposed Regulation? An SBEIS is required whenever a regulation imposes "more than minor" costs on a regulated business. The "more than minor" thresholds were developed by the Washington State Business Assistance Center (Department of Community, Trade and Economic Development) and range from $50 to $300 depending on a businesses SIC code2. Of the business categories potentially affected by the proposed regulations, No. 5812 and 5431 both had a "more than minor" cost threshold of $50.

Step IV: Do the Costs Imposed by the Proposed Rule Exceed the "more than minor" Cost Thresholds? To estimate the cost of this proposed rule, the department considered how businesses would comply with the proposed requirements, the cost to comply and whether compliance would cause businesses to lose sales or revenue. The department anticipates both a direct and an indirect cost associated with the proposed rule. The direct cost will be the cost of the notices, signs or stickers for menus. The indirect costs will be incurred if the notices cause businesses to lose sales.

Direct Cost: There is a range of possible costs for notification. Each restaurant will have a choice to either comply with the notification requirement or switch to juice that is processed or pasteurized. For those choosing to continue serving unpasteurized juice there will be many options. The Department of Health anticipates that depending on the type of establishment the rule will be implemented in various ways.

Large Restaurants: The lowest cost alternative is a handwritten sign that is clearly visible to customers. This option would likely cost under $1.00. Most restaurants will probably prefer to provide the notification in a format other than a handwritten sign. They might print labels to add to their menus or add the information to their menus if they reprint frequently. The department believes printing labels may cost $25-$35. At the opposite end of the spectrum is a business going to a print shop with a concept for the notice and asking for design and printing of 75 table tents. Local printers estimate a job like this could cost $150. In between these estimates would be the cost to add a notice to menus (probably in the form of a sticker).

Juice Bars: The department anticipates that juice bars would employ the lowest cost alternative -- a handwritten sign visible to customers. This option would likely cost under $1.00. As an alternative some juice bars may want to add the notice to their reader board menus. This could cost $10-$35 depending on the medium used in making the board.

Juice Producers: Juice producers will not incur a direct cost from this rule unless they sell juice by the glass directly to the public. In this case, the department anticipates they will also use the lowest cost alternative.

Indirect Cost: The indirect costs associated with the proposed rule will be loss of revenue if consumers demand pasteurized juice products as a result of the notification. The consideration of whether or not the rule will cause businesses to lose sales requires the department to make some assumptions regarding the effectiveness of the notification as well as predicting behavior of consumers and businesses. The department anticipates different scenerios for the different types of businesses affected.

Full Service Restaurants: The Department of Health believes that the vast majority of restaurants will not lose revenue because consumers who believe they are at risk from unpasteurized juice will likely substitute some other beverage (i.e., another juice that is pasteurized, coffee or soft drink).

Juice Bars: Of restaurants, juice bars serving specialty juice drinks have the greatest potential to lose revenue. However, when the Department of Health posed the question of whether the rule would cause them to lose sales, some said they were not sure and some said no. One reason for this is that the clientele of juice bars purchase unpasteurized juice for the perceived health benefits and so it is unlikely that a notice identifying the juice as unpasteurized would cause them not to buy it. Most juice bars also serve a variety of juices, some of which are pasteurized, and so customers could easily substitute one product for another if they considered themselves at risk. Nevertheless, the department can only assume that juice bars may lose some sales as a result of consumers at highest risk opting not to purchase juice beverages. The amount is indeterminate at this time.

Juice Producers: Businesses who specialize in making unpasteurized/unprocessed juice and wholesaling it to restaurants may lose revenue if restaurants find it easier to comply with the rule by only serving pasteurized juice. It is important to note however, that juice producers are already being affected by federal rules requiring a warning label on packaged juice that is unpasteurized/unprocessed. It is also anticipated that federal rules requiring all juice to be pasteurized or processed will be adopted within the next five years. Given the changing regulatory environment for juice producers, it is difficult for the department to separate the impact associated with the specific rule being analyzed here. The department assumes there is an indirect cost for juice producers, however it is indeterminate.

As a result of this cost analysis the department concluded that the proposed rule has a potential to exceed the more than minor cost threshold for juice bars and juice producers because of the indeterminate indirect costs. Therefore, the department will move to the next step of a small business economic impact statement - consideration of whether there is a disproportionate burden on small businesses.

Step V: Does the Proposed Regulation Impose a Disproportionate Cost Burden on Small Businesses? To determine whether the proposed rule will disproportionately affect small businesses, the act requires a comparison of "the cost of compliance for small business with the cost of compliance for the ten percent of [the largest] businesses... using one or more of the following as a basis for comparing costs: (a) Cost per employee; (b) cost per hour of labor; or (c) cost per $100 of sales" (RCW 19.85.040).

Of the alternative ways to compare costs, the preferable approach is "cost per $100 of sales." By providing a measure of the effect of the proposed rule on the profits of affected businesses, this approach best indicates the likelihood that the businesses will continue (or fail). Thus, this approach most directly addresses the legislature's concern of ensuring that a proposed rule does not threaten the existence of some small businesses.

Even though this rule has a potential to pose more than minor impacts to small businesses, the department does not anticipate that there will be a disproportionate impact. The direct cost is minimal for small businesses at $1.00 - $10.00. As noted above, larger businesses may feel it is necessary to spend over $100 to develop notices. The indirect costs are also anticipated to be proportionate between large and small businesses. Although the extent to which the notice will cause consumers to change their behavior is indeterminate at this time, the department anticipates that any change would affect the sales of small and large businesses at the same rate. Therefore, larger businesses with a higher volume of sales stand to lose more if consumers stop buying unpasteurized juice. This is also true for juice producers. If restaurants stop buying wholesale unpasteurized juice, larger businesses have more potential sales to lose.

Step VI: Is Regulatory Relief for Small Businesses Necessary, Legal and Feasible? Because the agency finds that there are no disproportionate cost impacts associated with the proposed rule, no special relief is required. During the development of the rule however, the department carefully considered the Regulatory Fairness Act along with its statutory mandate to protect human health. The department considered suggestions including a total ban on unpasteurized juice or that a warning be required instead of a notice. These suggestions were rejected, in part, because businesses both large and small thought this would have a much greater negative impact on their sales. Also, the department purposely left the notification options very flexible, allowing businesses the choice to implement the rule at a very low cost if desired. The department feels that any further efforts to mitigate the impact would undermine the purpose of the rule to provide consumers with information about juice products they purchase.

Step VII: Miscellaneous SBEIS Requirements: How did the department involve affected businesses and other interested parties in the development of the rule? The department worked with the Restaurant Association to gather input about how this rule would affect its members. More specifically, juice bars were interviewed because they have the greatest potential impact. Throughout the development of this rule, the department worked to balance the needs of businesses with protecting public health. Workshops were held around the state for businesses, the public and local health jurisdiction to discuss the rule.


1 The Regulatory Fairness Act is codified at RCW 19.85.

2 Facilitating Regulatory Fairness, Washington State Department of Community, Trade and Economic Development, Washington State Business Assistance Center, 1995.

A copy of the statement may be obtained by writing to Dave Gifford, Office of Food Safety and Shellfish Programs, P.O. Box 47824, Olympia, WA 98507-7824.

RCW 34.05.328 applies to this rule adoption. This is a significant legislative rule because if notification is not provided a business may be subject to a penalty.

Hearing Location: First Floor Conference Room, 1102 Quince Street S.E., Olympia, WA 98504, on December 21, 1999, at 10:00.

Assistance for Persons with Disabilities: Contact Dave Gifford, (360) 236-3074, by December 16, 1999, TDD (800) 833-6388.

Submit Written Comments to: Dave Gifford, P.O. Box 47824, Olympia, WA 98504-7824, fax (360) 236-2257, by December 21, 1999.

Date of Intended Adoption: December 21, 1999.

November 12, 1999

M. C. Selecky

Secretary

OTS-3309.1


AMENDATORY SECTION(Amending Order 261B, filed 4/1/92, effective 5/2/92)

WAC 246-215-040
Public health labeling.

(1) Food service establishment owners shall label all food products offered for sale if enclosed in a package or container; except:

(a) Food products produced on-site;

(b) Nonpotentially hazardous bakery products from approved sources; or

(c) Single service portions or other packaged foods which are shipped to the food service establishment enclosed within a properly labeled master carton.

(2) Food service establishment owners shall label modified atmosphere packaged foods in compliance with WAC 246-215-060.

(3) Food service establishment owners shall ensure labels include:

(a) The common name of the food;

(b) All ingredients, including food additives, in descending order of predominance;

(c) The name, city, state, and zip code of the manufacturer; and

(d) A packaging date code, when required by law or when the food is potentially hazardous.

(4) Food service establishment owners shall ensure information contained on labels is:

(a) Accurate;

(b) Easily readable; and

(c) In the English language, except that duplicate labeling in foreign languages is allowed.

(5) When labels, menus, or other printed or graphic materials are inaccurate or misleading and a report of illness or injury is associated with the food product, the health officer may:

(a) Stop sale of the product until correctly labeled;

(b) Require relabeling of the product; and

(c) Issue public health advisories.

(6) Whenever raw milk or raw milk cheese or similar raw milk products are offered for sale in a food service establishment, the health officer shall:

(a) Require conspicuous labeling of raw milk or products containing raw milk as "raw milk" or "contains raw milk";

(b) Require conspicuous posting of signs near the product that state: "Warning: Raw milk or foods prepared from raw milk, such as unripened or fresh cheese, may be contaminated with dangerous bacteria capable of causing severe intestinal illnesses.  Contact your local health department for advice or to report a suspected illness";

(c) Exempt properly fermented raw milk cheeses from the labeling requirements contained in this subsection, provided the cheeses are produced using a flash heating process and they meet the following cheese composition requirements:

(i) Moisture content of 40% or less;

(ii) Saline-in-moisture content of 3.75% or greater;

(iii) Water activity (Aw) of 0.96 or less; and

(iv) pH of 5.40 or less.

(7) Food service establishment owners shall label packaged or bulk foods containing sulfiting agents at detectable levels as follows:

(a) Accept accurate labels placed on packaged foods by the manufacturer;

(b) Place a label on prepackaged foods stating, "This food contains a sulfiting agent";

(c) Place a sign or label on the bulk food container or in a conspicuous place nearby stating, "The following food or foods contain a sulfiting agent,. . . . . . . . ";

(d) Except these foods may be sold without labeling:

(i) Wine by the glass;

(ii) Salad bars; and

(iii) Delicatessens and similar take-out food facilities when food is prepared on-site.

(8) Food service establishment owners shall provide prominent and conspicuous labels on bulk food display units with at least one of the following:

(a) Manufacturer's or processor's container label plainly in view;

(b) A card, sign, or other appropriate device stating the common name of the food; or

(c) A list of ingredients and any food additives contained in the product.

(9) Food service establishment owners shall ensure accurate labels are present on bulk containers of chemicals and pet foods.

(10) When raw or undercooked meats, eggs, or aquatic foods, or unpasteurized fruit or vegetable juices, are offered for immediate service or for sale as ready-to-eat, the health officer shall require these foods to be identified, as such:

(a) On the menu;

(b) On the label; or

(c) On a sign clearly visible to the patrons.

(11) The health officer may approve alternate wording on signs required in subsections (6) and (7) of this section.

[Statutory Authority: RCW 43.20.050.  92-08-112 (Order 261B), § 246-215-040, filed 4/1/92, effective 5/2/92.]

OTS-3566.1


AMENDATORY SECTION(Amending Order 261B, filed 4/1/92, effective 5/2/92)

WAC 246-215-010
Definitions.

(1) "Abbreviations":

(a) "FDA" means United States Food and Drug Administration.

(b) "HACCP" means hazard analysis, critical control point.

(c) "PPM" means parts per million.

(d) "USA" means United States of America.

(e) "USDA" means United States Department of Agriculture.

(f) "WSDA" means Washington state department of agriculture.

(2) "Adulterated" means the altered condition of food including:

(a) Bearing or containing any poisonous or deleterious substance in a quantity rendering food injurious to health;

(b) Bearing or containing any added poisonous or deleterious substance where no safe tolerance has been established by regulation, or exceeding such tolerance if one has been established;

(c) Consisting in whole or in part of any filthy, putrid, or decomposed substance, or otherwise being unfit for human consumption;

(d) Processing, preparing, packing, or holding potentially hazardous foods under improper time-temperature conditions or under other conditions increasing the probability of food contamination with excessive microorganisms or physical contaminants;

(e) Processing, preparing, packing, or holding food under insanitary conditions increasing the probability of food contamination or cross-contamination;

(f) Holding or packaging food in containers composed, in whole or in part, of any poisonous or deleterious substance rendering the contents potentially injurious to health; or

(g) Containing any product of a diseased animal, or an animal dying by means other than by slaughter, except as permitted under WAC 246-215-020(6).

(3) "Approved" means acceptable to the health officer based on his/her determination regarding conformance with appropriate standards and public health practice.

(4) "Approved source" means foods which are obtained by the food service establishment owner from persons who comply with applicable federal, state and local laws, ordinances and regulations.

(5) "Aquatic foods" means foods grown in or harvested from water, including all types of fish, shellfish and mollusks, edible crustacea, reptiles, amphibians, and mixtures containing aquatic foods and synthetic foods, such as surimi.

(6) "Base of operation" means an approved site for servicing, cleaning, sanitizing, supplying, and maintaining a mobile food unit.

(7) "Bed and breakfast" means a private home or inn offering lodging on a temporary basis to travelers, tourists, and transient guests which provides food service only to registered guests.

(8) "Bulk food" means processed or unprocessed food in containers where consumers withdraw desired quantities.

(9) "Caterer" means a person or food service establishment contracted to prepare food in an approved facility for final cooking or service at another location.

(10) "Commissary" means an approved food service establishment where food is stored, prepared, portioned, or packaged for service elsewhere.

(11) "Corrosion-resistant" means a material maintaining original surface characteristics under prolonged contact with food, cleaning compounds, or sanitizing solutions.

(12) "Critical control point" means a location where exercising a preventive measure or procedure eliminates, prevents, or minimizes a hazard or hazards from occurring after that point.

(13) "Cross-contamination" means the process where disease causing organisms are transferred from raw or other foods to equipment or ready-to-eat foods.

(14) "Department" means the Washington state department of health.

(15) "Durable" means capable of withstanding expected use and remaining easily cleanable.

(16) "Easily cleanable" means readily accessible with materials and finish fabricated to permit complete removal of residue by normal cleaning methods.

(17) "Equipment" means all stoves, ovens, ranges, hoods, slicers, mixers, meat blocks, tables, counters, refrigerators, sinks, dish machines, steam tables, and similar items used in the operation of a food service establishment.

(18) "Extensive remodel" means construction in a food service establishment requiring a building permit or plumbing permit, except for signs and fences.

(19) "Food" means any raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale, in whole or in part, for human consumption.

(20) "Food additive" means substances added directly or indirectly to food.

(21) "Food contact surfaces" means those surfaces of equipment and utensils normally contacting food, and those surfaces where food may drain, drip, or splash back onto surfaces normally in contact with food.

(22) "Food service establishment" means:

(a) A place, location, operation, site, or facility where food is manufactured, prepared, processed, packaged, dispensed, distributed, sold, served, or offered to the consumer regardless of whether or not compensation for food occurs, including but not limited to:

(i) Restaurants, snack bars, cafeterias, taverns, bars;

(ii) Retail food stores, supermarkets, retail meat markets, retail fish markets, retail bakeries, delicatessens;

(iii) Institutional operations licensed by the department or local health officer, such as schools, hospitals, jails, prisons, and child care facilities;

(iv) Central preparation sites, including caterers;

(v) Satellite servicing locations;

(vi) Temporary food service establishments or mobile food units;

(vii) Bed and breakfast operations;

(viii) Remote feeding sites; and

(ix) Vending machines dispensing potentially hazardous foods.

(b) Except for the following:

(i) Private homes where food is prepared or served for consumption by household members and/or their guests;

(ii) Establishments offering only commercially prepackaged nonpotentially hazardous foods;

(iii) Commercial food processing establishments, licensed and regulated by the USDA, FDA, or WSDA; and

(iv) Farmers exempt from licensure under RCW 36.71.090.

(23) "Food service worker" means the permit holder, an individual having supervisory or management duties, and any other person working in a food service establishment.

(24) "Frozen" means the condition of a food when it is continuously stored at or below 10° F.

(25) "Game meat" means warm-blooded and cold-blooded animals, excluding fish and meat food animals as defined by USDA, noncommercially raised and processed without continuous regulatory surveillance, including, but not limited to:

(a) Mammals such as deer, elk, antelope, buffalo, and bear;

(b) Birds; and

(c) Reptiles such as alligator.

(26) "Hazard analysis critical control point (HACCP)" means a method used to reduce the risk of foodborne illness by:

(a) Identifying hazards of high risk foods;

(b) Assessing the hazards posed by each preparation step;

(c) Determining the critical points for controlling hazards;

(d) Monitoring a critical control point or points; and

(e) Implementing immediate and appropriate corrective action when control criteria are not met.

(27) "Health officer" means the city, county, city-county, or district health officer defined under RCW 70.05.010(2), or his/her authorized representative, or the representative of the department.

(28) "Hermetically sealed container" means a properly designed container, intended to keep the contents free of contamination by microorganisms and to maintain the commercial sterility of its contents after thermal processing.

(29) "Imminent or actual health hazard" means:

(a) A breakdown or lack of equipment or power causing improper temperature control for potentially hazardous foods; and/or

(b) Lack of water preventing adequate handwashing or equipment cleaning and sanitizing; and/or

(c) Emergency situations including fire, flood, building collapse, or similar accident or natural disaster; and/or

(d) A sewage backup or sewage contamination within a food service establishment; and/or

(e) An occurrence of an outbreak of foodborne illness linked to the food service establishment.

(30) "Immediate service" means foods served to the public within thirty minutes of preparation.

(31) "Menu" means a written or graphic description of foods prepared and offered for sale or service by a food service establishment.

(32) "Mislabeled" means the presence of any false or misleading written, printed, or graphic material upon or accompanying food or food containers.

(33) "Mobile food unit" means a readily movable food service establishment.

(34) "Modified atmosphere packaging" means a process that completely encases food in an impermeable or partially permeable membrane, with either a partial or complete vacuum; or a gas or mixture of gases surrounding the food.  Hermetically sealed containers are not considered to be modified atmosphere packaging.

(35) "Owner" means a person owning and/or responsible for the operation of a food service establishment.

(36) "Perishable food" means foods, other than potentially hazardous foods, where deterioration or spoilage due to loss of moisture or growth of molds and bacteria may occur.

(37) "Person" means any individual, partnership, corporation, association, or other legal entity or agency of state, county, or municipal government, or agency of the federal government which is subject to the jurisdiction of the state.

(38) "Person in charge" means the individual present in a food service establishment and designated supervisor of the food service establishment at the time of inspection or any food service worker present when a designated supervisor is absent.

(39) "pH" means a measure of the amount of acid in a food product.

(40) "Potentially hazardous food" means any natural or synthetic edible item, material, or ingredient in a form supporting rapid and progressive growth of infectious or toxigenic microorganisms or the slower growth of Clostridium botulinum.  Potentially hazardous food:

(a) Includes any food of animal origin, raw, cooked, or processed;

(b) Includes certain cooked or prepared foods of plant origin, including but not limited to:

(i) Potato products;

(ii) Dry legumes;

(iii) Rice;

(iv) Sprouts; and

(v) Cut melons and cut cantaloupes.

(c) Excludes foods:

(i) With a water activity (Aw) value of 0.90 or less;

(ii) With a pH level of 4.6 or below;

(iii) Enclosed in unopened hermetically sealed containers commercially processed to achieve and maintain commercial sterility under nonrefrigerated storage and distribution conditions; and

(iv) Where laboratory evidence acceptable to the health officer indicates no likelihood of rapid or progressive growth of infectious or toxigenic microorganisms or the slower growth of Clostridium botulinum.

(41) "Restructured" means potentially hazardous foods processed and formed so surface contaminants may become incorporated inside the final product.

(42) "Sanitary design" means smooth, nonabsorbent, and easily cleanable.

(43) "Sanitized" means effective bactericidal treatment by a process providing enough accumulative heat or concentration of chemicals for enough time to reduce the bacterial count, including pathogens, to a safe level on food contact surfaces.

(44) "Sealed" means free of cracks or other openings permitting entry or passage of moisture or air.

(45) "Self-service" means any site within a food service establishment where customers dispense their own food or beverages.

(46) "Served" means offered to a person for consumption.

(47) "Single service articles" means utensils designed, fabricated, and intended by the manufacturer for one time use.

(48) "Sulfiting agents" means chemicals used to treat food to increase shelf life and enhance appearance including:

(a) Sulfur dioxide;

(b) Sodium sulfite;

(c) Sodium bisulfite;

(d) Potassium bisulfite;

(e) Sodium metabisulfite; and

(f) Potassium metabisulfite.

(49) "Temporary food service establishment" means a food service establishment operating at a fixed location for not more than twenty-one consecutive days in conjunction with a single event or celebration.

(50) "Time/temperature" means the relationship between the length of time and the specific temperatures to which potentially hazardous foods are subjected during storage, transportation, preparation, cooking, reheating, dispensing, service, or sale.

(51) "Unpasteurized juice" means fruit or vegetable juice that has not been specifically processed to prevent, reduce, or eliminate the presence of pathogens, either through heat pasteurization or in another manner allowed under 21 CFR 101.17 (g)(7). This includes any beverage containing juice where neither the juice ingredient nor the beverage has been processed in the above manner.

(52) "Utensil" means any food contact implement used in storing, preparing, transporting, dispensing, serving, or selling of food.

(((52))) (53) "Water activity (Aw)" means a measure of the amount of moisture available for bacterial growth in a food.

(((53))) (54) "Wholesome" means in sound condition, clean, free from adulteration, and otherwise suitable for use as human food.

[Statutory Authority: RCW 43.20.050.  92-08-112 (Order 261B), § 246-215-010, filed 4/1/92, effective 5/2/92.]

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