HAR §11-50-31. with broken shells

Dead shellstock with badly broken shells shall be discarded. (o) Molluscan shellfish, packaging and identification. ( 1) Except as specified in paragraph (2) (A), molluscan shellfish shall be obtained in nonreturnable packages or containers which bear a legible tag or label that identifies the: (A) Source, and are affixed by a dealer that depurates, packs, ships or reships the molluscan shellfish, as specified in the National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish; and (B) "Sell by" or "best if used by" date for shucked shellfish packages with a capacity of less than one-half gallon or the date shucked for packages with a capacity of one-half gallon or more; (2) When a two-tag harvester or dealer system is used, the dealer tag shall meet the requirements identified in paragraph ( 1) (A) ; (A) When both the dealer and harvester tags appear on the container, the dealer's tag is not required to duplicate the information on the harvester's tag; (3) A container of raw molluscan shellfish that does not bear a tag or label or which bears a tag or label which does not contain all the information as specified under the National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish shall be subject to a hold order, as allowed by law, or seizure and destruction in accordance with 21 CFR Subpart D, entitled "Specific administrative decisions regarding interstate shipments", Section 1240.60(d). (p) Juice treated. Prepackaged juice shall: (1) Be obtained from a processor with a HACCP system as specified in 21 CFR Part 120, entitled "Hazard analysis and critical control (HACCP) systems"; and (2) Be obtained pasteurized or otherwise treated to attain a five-log reduction of the most resistant microorganism of public health significance as 50-71 §11-50-31 (q) (1) (2) (3) (4) (5) specified in 21 CFR Part 120.24, entitled "Process controls". Molluscan shellfish, original container. Except as specified in paragraphs (3) to (5), molluscan shellfish may not be removed from the container in which they are received other than immediately before sale or preparation for service; Molluscan shellfish from one tagged or labeled container shall not be commingled with molluscan shellfish from another container with different certification numbers, different harvest dates, or different growing areas identified on the tag or label before being ordered by the consumer; For display purposes, shellstock or in-shell product may be removed from the container in which they are received, displayed on drained ice, or held in a display container, and a quantity specified by a consumer may be removed from the display or display container and provided to the consumer if: (A) The source of the shellstock or in-shell product on display is identified as specified in subsection (o) and recorded as (B) specified in subsection (r); and The shellstock or in-shell product are protected from contamination; Shucked shellfish may be removed from the container in which they were received and held in a display container from which individual servings are dispensed upon a consumer's request if: (A) (B) The labeling information for the shellfish on display as specified in subsection (o) is retained and correlated to the date when, or dates during which, the shellfish are sold or served; and The shellfish are protected from contamination; Shucked shellfish may be removed from the container in which they were received and repacked in consumer self service containers where allowed by law if: (A) The labeling information for the shellfish is on each consumer self service container 50-72 §11-50-31 as specified in subsection (o) and section 11-50-35 (b) (1) and (2) (A) to (E); (B) The labeling information as specified in subsection (o) is retained and correlated with the date when, or dates during which, the shellfish are sold or served; (C) The labeling information and dates specified in paragraph (5) (B) are maintained for ninety days; and (D) The shellfish are protected from contamination. (r) Molluscan shellfish, maintaining identification. (1) Except as specified in paragraph (3) (B), molluscan shellfish tags or labels shall remain attached to the container in which the shellstock are received until the container is empty; and (2) The date when the last molluscan shellfish from the container is sold or served shall be recorded on the tag, label, or invoice; and (3) The identity of the source of molluscan shellfish that are sold or served shall be maintained by retaining product tags, labels, or invoices for ninety calendar days from the date that is recorded on the tag, label, or invoice as specified in paragraph (2), by: (A) Using an approved record keeping system that keeps the tags, labels, or invoice in chronological order correlated to the date that is recorded on the tag, label, or invoice as specified in paragraph (2); and (B) If shellstock, shucked shellfish or in- shell product are removed from its tagged or labeled container the source identification will be preserved by using a record keeping system as specified in paragraph (3) (A). 50-73 §11-50-31 (s) Food donation. Food stored, prepared, packaged, displayed, and labeled in accordance to law and this chapter may be offered for donation. [Eff 2/24/2014; am and comp AUG 24 2025 (Auth: HRS §321-11) (Imp: HRS §321-11) §11-50-32 Protection from contamination after receiving. (a) Preventing contamination from hands. (1) Food employees shall wash their hands as specified in section 11-50-22(b); (2) Except when washing fruits and vegetables as specified in subsection (g) or as specified in paragraphs (4) and (5), food employees may not contact exposed, ready-to-eat food with their bare hands and shall use suitable utensils such as deli tissue, spatulas, tongs, single-use gloves, or dispensing equipment; (3) Food employees shall minimize bare hand and arm contact with exposed food that is not in a ready- to-eat form; (4) Paragraph (2) does not apply to a food employee that contacts exposed, ready-to-eat food with bare hands at the time the ready-to-eat food is being added as an ingredient to a food that: (A) Contains a raw animal food and is to be cooked in the food establishment to heat all parts of the food to the minimum temperatures specified in section 11-50- 33(a) (1) to (2) or 11-50-33(b); or (B) Does not contain a raw animal food but is to be cooked in the food establishment to heat all parts of the food to a temperature of at least one hundred forty-five degrees Fahrenheit. (5) Food employees not serving a highly susceptible population may contact exposed, ready-to-eat food with their bare hands if: (A) The owner or operator obtains prior approval from the department; (B) Written procedures are maintained in the food establishment and made available to the department upon request that include: (i) For each bare hand contact procedure, a listing of the specific ready-to-eat foods that are touched by bare hands; 50-74 §11-50-32 (ii) Diagrams and other information showing that handwashing facilities, installed, located, equipped, and maintained as specified in sections 11-50-61 (g), (1), (o) and 11-50-72 (b), (c), and (e), are in an easily accessible location and in close proximity to the work station where the bare hand contact procedure is conducted; (C) A written employee health policy that details how the food establishment complies with section 11-50-21 (a), (b), and (c) including: (i) Documentation that food employees and conditional employees acknowledge that they are informed to report (ii) (iii) information about their health and activities as they relate to gastrointestinal symptoms and diseases that are transmittable through food as specified in section 11-50-21 (a) (1); Documentation that food employees and conditional employees acknowledge their responsibilities as specified in section 11-50-21 (a) (5) and (6); and Documentation that the person in charge acknowledges the responsibilities as specified in sectionll-50-21(a)(2) to (4), (b), and ( c); (D) Documentation that food employees acknowledge that they have received training in: (i) The risks of contacting the specific ready-to-eat foods with bare hands; (ii) Proper handwashing as specified in section 11-50-22(b); (iii) (iv) When to wash their hands as specified in section 11-50-22(c); Where to wash their hands as specified in section 11-50 22(d); (v) Proper fingernail maintenance as specified in section 11-50-22(f); (vi) Prohibition of jewelry as specified in section 11-50-22(g); and 50-75 §11-50-32 (vii) Good hygienic practices as specified in section ll-50-23(a) and (b); (E) Documentation that hands are washed before food preparation and as necessary to prevent cross contamination by food employees as specified in section ll-50- 22(a) to (d) during all hours of operation when the specific ready-to-eat foods are prepared; (F) Documentation that food employees contacting ready-to-eat food with bare hands use two or more of the following control measures to provide additional safeguards to hazards associated with bare hand contact: (i) Double handwashing; (ii) Nail brushes; (iii) A hand antiseptic after handwashing as specified in section ll-50-22(e); (iv) Incentive programs such as paid sick leave that assist or encourage food employees not to work when they are ill; or (v) Other control measures approved by the director; and (G) Documentation that corrective action is taken when subparagraphs (A) to (F) are not followed. (b) A food employee may not use a utensil more than once to taste food that is to be sold or served. (c) Packaged and unpackaged food - separation, packaging, and segregation. (1) Food shall be protected from cross contamination by: (A) Except as specified in clause (iv), or when combined as ingredients, separating raw animal foods during storage, preparation, holding, and display from: (i) Raw ready-to-eat food including other raw animal food such as fish for sushi or molluscan shellfish, or other raw ready-to-eat food such as fruits and (ii) (iii) vegetables; Cooked ready-to-eat food; and Fruits and vegetables before they are washed; 50-76 §11-50-32 (iv) Frozen, commercially processed and packaged raw animal food may be stored or displayed with or above frozen, commercially processed and packaged, ready-to eat food; (B) Except when combined as ingredients, separating types of raw animal foods from each other such as beef, fish, lamb, pork, and poultry during storage, preparation, holding, and display by: (i) Using separate equipment for each type; or (ii) Arranging each type of food in equipment so that cross contamination of one type with another is prevented; and (iii) Preparing each type of food at different times or in separate areas; (C) Cleaning equipment and utensils as specified in section 11-50-50 (b) (1) and sanitizing as specified in section 11-50-51(c); (D) Except as specified in section 11-50-34 (e) (2) (B) and in paragraph (2), storing the food in packages, covered containers, or wrappings; (E) Cleaning hermetically sealed containers of food of visible soil before opening; (F) Protecting food containers that are received packaged together in a case or overwrap from cuts when the case or overwrap is opened; (G) Storing damaged, spoiled, or recalled food being held in the food establishment as specified in section 11-50-73(d); and (H) Separating fruits and vegetables, before they are washed as specified in subsection (g) from ready-to-eat food; (2) Paragraph (1) (D) does not apply to: (A) Whole, uncut, raw fruits and vegetables and nuts in the shell, that require peeling or hulling before consumption; (B) Primal cuts, quarters, or sides of raw meat or slab bacon that are hung on clean, sanitized hooks or placed on clean, sanitized racks; 50-77 §11-50-32 (C) Whole, uncut, processed meats such as country hams, and smoked or cured sausages that are placed on clean, sanitized racks; (D) Food being cooled as specified in section 11-50-34 (e) (2) (B); or (E) Shells tock. (d) Except for containers holding food that can be readily and unmistakably recognized, such as dry pasta, working containers holding food or food ingredients that are removed from their original packages for use in the food establishment, such as cooking oils, flour, herbs, potato flakes, salt, spices, and sugar shall be identified with the common name of the food. (e) Pasteurized eggs or egg products shall be substituted for raw eggs in the preparation of foods such as Caesar salad, hollandaise or Bearnaise sauce, mayonnaise, meringue, eggnog, ice cream, and egg-fortified beverages that are not: (1) Cooked as specified in section 11-50-33 (a) (1) (A) or (B); or (2) Included in section 11-50-33 (a) (4). (f) Protection from unapproved additives. (1) Food shall be protected from contamination that may result from the addition of, as specified in section ll-50-3l(i): (A) Unsafe or unapproved food or color additives; and (B) Unsafe or unapproved levels of approved food and color additives; (2) A food employee may not: (A) Apply sulfiting agents to fresh fruits and vegetables intended for raw consumption or to a food considered to be a good source of vitamin Bl; or (B) Except for grapes, serve or sell food specified in subparagraph (A) that is treated with sulfiting agents before receipt by the food establishment. (g) Washing fruits and vegetables. (1) Except as specified in paragraph (2) and except for whole, raw fruits and vegetables that are intended for washing by the consumer before consumption, raw fruits and vegetables shall be thoroughly washed in water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served, or 50-78 §11-50-32 offered for human consumption in ready-to-eat form; (2) Fruits and vegetables may be washed by using chemicals approved by the department. (h) Ice used as exterior coolant, prohibited as ingredient. After use as a medium for cooling the exterior surfaces of food such as melons or fish, packaged foods such as canned beverages, or cooling coils and tubes of equipment, ice may not be used as food. (i) Storage or display of food in contact with water or ice. (1) Packaged food may not be stored in direct contact with ice or water if the food is subject to the entry of water because of the nature of its packaging, wrapping, or container or its positioning in the ice or water; (2) Except as specified in paragraphs (3) and (4), unpackaged food may not be stored in direct contact with undrained ice; (3) Whole, raw fruits or vegetables; cut, raw vegetables such as celery or carrot sticks or cut potatoes; and tofu may be immersed in ice or water; (4) Raw poultry and raw fish that are received immersed in ice in shipping containers may remain in that condition while in storage awaiting preparation, display, service, or sale. (j) Food shall only contact surfaces of: (1) Equipment and utensils that are cleaned as specified in section 11-50-50 and sanitized as specified in section 11-50-51; (2) Single-service and single-use articles; or (3) Linens, such as cloth napkins, as specified in subsection (1) that are laundered as specified in section 11-50-52. (k) During pauses in food preparation or dispensing, food preparation and dispensing utensils shall be stored: (1) Except as specified in paragraph (2), in the food with their handles above the top of the food and the container; (2) In food that is not time/temperature control for safety food with their handles above the top of the food within containers or equipment that can be closed, such as bins of sugar, flour, or cinnamon; 50-79 §11-50-32 (3) On a clean portion of the food preparation table or cooking equipment only if the in-use utensil and the food-contact surface of the food preparation table or cooking equipment are cleaned and sanitized at a frequency specified in sections 11-50-50(b) and 11-50-51(b); (4) In running water of sufficient velocity to flush particulates to the drain, if used with moist food such as ice cream or mashed potatoes; (5) In a clean, protected location if the utensils, such as ice scoops, are used only with a food that is not time/temperature control for safety food; (6) In a container of water if the water is maintained at a temperature of at least one hundred thirty-five degrees Fahrenheit and the container is cleaned at a frequency specified in section 11-50-50 (b) ( 4) (G); or (7) In any other manner approved by the department. (1) Linens, such as cloth napkins, may not be used in contact with food unless they are used to line a container for the service of foods and the linens and napkins are replaced each time the container is refilled for a new consumer. (m) Wiping cloths, use limitation. (1) Cloths in-use for wiping food spills from tableware and carry-out containers that occur as food is being served shall be: (A) Maintained dry; and (B) Used for no other purpose; (2) Cloths in-use for wiping counters and other equipment surfaces shall be: (A) Held between uses in a chemical sanitizer solution at a concentration specified in section 11-50-49(n); and (B) Laundered daily as specified in section 11-50-52 (b) (4); (3) Cloths in-use for wiping surfaces in contact with raw animal foods shall be kept separate from cloths used for other purposes; (4) Dry wiping cloths and the chemical sanitizing solutions specified in paragraph (2) (A) in which wet wiping cloths are held between uses shall be free of food debris and visible soil; (5) Containers of chemical sanitizing solutions specified in paragraph ( 2) (A) in which wet wiping 50-80 ( 6) (n) ( 1) (2) (3) ( 4) (o) refills. (1) (2) §11-50-32 cloths are held between uses shall be stored off the floor and used in a manner that prevents contamination of food, equipment, utensils, linens, single-service, or single-use articles; Single-use disposable sanitizer wipes shall be used in accordance with EPA-approved manufacturer's label use instructions. Gloves, use limitation. If used, single-use gloves shall be used for only one task such as working with ready-to-eat food or with raw animal food, used for no other purpose, and discarded when damaged or soiled, or when interruptions occur in the operation; Except as specified in paragraph (3), slash- resistant gloves that are used to protect the hands during operations requiring cutting shall be used in direct contact only with food that is subsequently cooked as specified in section 11-50-33 such as frozen food or a primal cut of meat; Slash-resistant gloves may be used with ready-to- eat food that will not be subsequently cooked if the slash-resistant gloves have a smooth, durable, and nonabsorbent outer surface; or if the slash-resistant gloves are covered with a smooth, durable, nonabsorbent glove, or a single- use glove; Cloth gloves may not be used in direct contact with food unless the food is subsequently cooked as required in section 11-50-33 such as frozen food or a primal cut of meat. Using clean tableware for second portions and Except for refilling a consumer's drinking cup or container without contact between the pouring utensil and the lip-contact area of the drinking cup or container, food employees may not use tableware, including single-service articles, soiled by the consumer, to provide second portions or refills; Except as specified in paragraph (3), self- service consumers may not be allowed to use soiled tableware, including single-service articles, to obtain additional food from the display and serving equipment; 50-81 §11-50-32 (3) Drinking cups and containers may be reused by self-service consumers if refilling is a contamination-free process as specified in section 11-50-46 (p) (1), (2), and (4). (p) Refilling returnables. (1) Except as specified in paragraphs (2) to (5), empty containers returned to a food establishment for cleaning and refilling with food shall be cleaned and refilled in a regulated food processing plant; (2) A take-home food container returned to a food establishment may be refilled at a food establishment with food if the food container is: (A) Designed and constructed for reuse and in accordance with the requirements specified in sections 11-50-45 and 11-50-46; (B) One that is initially provided by the food establishment to the consumer, either empty or filled with food by the food establishment, for the purpose of being returned for reuse; (C) Returned to the food establishment by the consumer after use; (D) Subject to the following steps before being refilled with food: (i) Cleaned as specified in section 11-50- 50, (ii) Sanitized as specified in section 11- 50-51, and (iii) Visually inspected by a food employee to verify that the container, as returned, meets the requirements specified in sections 11-50-45 and 11- 50-46. (3) A take-home food container returned to a food establishment may be refilled at a food establishment with beverage if: (A) The beverage is not a time/temperature control for safety food; (B) The design of the container and of the rinsing equipment and the nature of the beverage, when considered together, allow effective cleaning at home or in the food establishment; (C) Facilities for rinsing before refilling returned container with fresh, hot water 50-82 §11-50-32 that is under pressure and not recirculated are provided as part of the dispensing system; (D) The consumer-owned container returned to the food establishment for refilling is refilled for sale or service only to the same consumer; and (E) The container is refilled by: (i) An employee of the food establishment; or (ii) The owner of the container if the beverage system includes a contamination-free transfer process as specified under section 11-50- 46 (p) (1), (2), and (4) that cannot be bypassed by the container owner; (4) Consumer-owned, personal take-out beverage containers, such as thermally insulated bottles, nonspill coffee cups, and promotional beverage glasses, may be refilled by employees or the consumer if refilling is a contamination-free process as specified under section 11-50- 4 6 (p) ( 1) , ( 2) , and ( 4) ; (5) Consumer-owned containers that are not food- specific may be filled at a water vending machine or system. (q) Food storage. (1) Except as specified in paragraphs (2) and (3), food shall be protected from contamination by storing the food: (A) In a clean, dry location; (B) Where it is not exposed to splash, dust, or other contamination; and (C) At least six inches above the floor; (2) Food in packages and working containers may be stored less than six inches above the floor on case lot handling equipment; (3) Pressurized beverage containers, cased food in waterproof containers such as bottles or cans, and milk containers in plastic crates may be stored on a floor that is clean and not exposed to floor moisture. (r) Food may not be stored: ( 1) In locker rooms; (2) In toilet rooms; (3) In dressing rooms; 50-83 §11-50-32 (4) In garbage rooms; (5) In mechanical rooms; (6) Under sewer lines that are not shielded to intercept potential drips; (7) Under leaking water lines, including leaking automatic fire sprinkler heads, or under lines on which water has condensed; (8) Under open stairwells; or (9) Under other sources of contamination. (s) Time/temperature control for safety food dispensed through a vending machine shall be in the package in which it was placed at the food establishment or food processing plant at which it was prepared. (t) During preparation, unpackaged food shall be protected from environmental sources of contamination. (u) Except for nuts in the shell and whole, raw fruits and vegetables that are intended for hulling, peeling, or washing by the consumer before consumption, food on display shall be protected from contamination by the use of packaging; counter, service line, or salad bar food guards; display cases; or other effective means. (v) Condiments, protection. (1) Condiments shall be protected from contamination by being kept in dispensers that are designed to provide protection, protected food displays provided with the proper utensils, original containers designed for dispensing, or individual packages or portions; (2) Condiments at a vending machine location shall be in individual packages or provided in dispensers that are filled at an approved location, such as the food establishment that provides food to the vending machine location, a food processing plant that is regulated by the agency that has jurisdiction over the operation, or a properly equipped facility that is located on the site of the vending machine location. (w) Consumer self-service operations. (1) Raw, unpackaged animal food, such as beef, lamb, pork, poultry, and fish may not be offered for consumer self-service. This paragraph does not apply to: (A) Consumer self-service of ready-to-eat foods at buffets or salad bars that serve foods such as sushi, sashimi, poke, or raw shellfish; 50-84 §11-50-32 (B) Ready-to-cook individual portions for immediate cooking and consumption on the premises such as consumer-cooked meats or consumer-selected ingredients for Mongolian barbecue or yakiniku; (C) Raw, frozen, shell-on shrimp, or lobster; or (D) Raw, whole, unprocessed fish that are naturally protected from contamination by a shell or skin; (2) Consumer self-service operations for ready-to-eat foods shall be provided with suitable utensils or effective dispensing methods that protect the food from contamination; (3) Consumer self-service operations such as buffets and salad bars shall be monitored by food employees trained in safe operating procedures. (x) When food sample demonstrations and food promotions are authorized in the establishment, the person in charge shall ensure that those activities comply with the applicable sanitation provisions of this chapter. (y) Returned food and re-service of food. (1) Except as specified in paragraph (2), after being served or sold and in the possession of a consumer, food that is unused or returned by the consumer may not be offered as food for human consumption; (2) Except as specified in section section 11-50- 37(7), a container of food that is not time/temperature control for safety food may be re-served from one consumer to another if: (A) The food is dispensed so that it is protected from contamination and the container is closed between uses, such as a narrow-neck bottle containing catsup, steak sauce, or wine; or (B) The food, such as crackers, salt, or pepper, is in an unopened original package and is maintained in sound condition. (z) Food shall be protected from contamination that may result from a factor or source not specified in subA~'tcz\02n525(a) to (y). [Eff 2/24/2014; am and comp U ] (Auth: HRS §321-11) (Imp: HRS §321-11) 50-85 §11-50-33 §11-50-33 Destruction of organisms of public health concern. (a) Cooking raw animal foods. (1) Except as specified in paragraphs (2), (3) and (4), raw animal foods such as eggs, fish, meat, poultry, and foods containing these raw animal foods, shall be cooked to heat all parts of the food to a temperature and for a time that complies with one of the following methods based on the food that is being cooked: (A) One hundred forty-five degrees Fahrenheit or above for fifteen seconds for: (i) Raw eggs that are broken and prepared in response to a consumer's order and for immediate service; and (ii) Except as specified in subparagraphs (B) and (C) and paragraphs (2) and (3), fish and intact meat including game animals commercially raised for food as specified in section 11-50-31 (g) (1) (A) and game animals under a voluntary inspection program as specified in section 11-50-31 (g) (1) (B); (B) One hundred fifty-five degrees Fahrenheit for seventeen seconds or the temperature specified in Table 33-1 that corresponds to the holding time for ratites, and nonintact meats; the following if they are comminuted: fish and game animals commercially raised for food as specified in section 11-50-31 (g) (1) (A), and game animals under a voluntary inspection program as specified in section 11-50- 31 (g) (1) (B); and raw eggs that are not prepared as specified in subparagraph (A) (i): Table 33-1 Minimum Temperature Minimum Time 145°F 3 minutes 150°F 1 minute 158°F <1 second ( instantaneous) or 50-86 §11-50-33 (C) One hundred sixty-five degrees Fahrenheit or above for more than one second (instantaneous) for poultry, baluts, wild game animals as specified in section 11-50- 31 (g) (1) (C) and (D), stuffed fish, stuffed meat, stuffed pasta, stuffed poultry, stuffed ratites, or stuffing containing fish, meat, poultry, or ratites; (2) Whole meat roasts. including beef, corned beef, lamb, pork, and cured pork roasts such as ham shall be cooked: (A) As specified in Table 33-2 and Table 33-3, to heat all parts of the food to a temperature and for the holding time that corresponds to that temperature: Table 33-2 Temperature ( OF) Time1 in Minutes 130 112 131 89 133 56 135 36 136 28 138 18 140 12 142 8 144 5 145 4 1Holding time may include postoven heat rise. Table 33-3 Temperature ( OF) Time1 in Seconds 147 134 149 85 151 54 153 34 155 22 157 14 158 0 1Holding time may include postoven heat rise. ; and 50-87 §11-50-33 (B) If cooked in an oven, use an oven that is preheated to the temperature specified for the roast's weight in Table 33-4 and that is held at that temperature: Table 33-4 Oven Type Oven Temperature Based on Roast Weight Less than 10 lbs 10 lbs or More Still Dry 350°F or more 250°F or more Convection 325°F or more 250°F or more High Humidity1 250°F or less 250°F or less 1Relative humidity greater than ninety per cent for at least one hour as measured in the cooking chamber or exit of the oven; or in a moisture-impermeable bag that provides one hundred per cent humidity. (3) A raw or undercooked whole-muscle, intact beef steak may be served or offered for sale in a ready-to-eat form if: (A) The food establishment serves a population that is not a highly susceptible population, except as specified in section 11-50-37 (4); (B) The steak is prepared so that it remains intact; and (C) The steak is cooked on both the top and bottom to a surface temperature of one hundred forty-five degrees Fahrenheit or above and a cooked color change is achieved on all external surfaces; (4) A raw animal food such as raw egg, raw fish, raw- marinated fish, raw molluscan shellfish, or steak tartare; or a partially cooked food such as lightly cooked fish, soft cooked eggs, or rare meat other than whole-muscle, intact beef steaks as specified in paragraph (3), may be served or offered for sale upon consumer request or selection in a ready-to-eat form if: (A) As specified in section 11-50-37(3) (A) and (B), the food establishment serves a population that is not a highly susceptible population, except as specified in section 11-50-37(4); 50-88 §11-50-33 (B) The food, if served or offered for service by consumer selection from a children's menu, does not contain comminuted meat; and (C) The consumer is informed as specified in section 11-50-35(d) that to ensure its safety, the food should be cooked as specified in paragraph (1) or (2); or (D) The department grants a variance from paragraph (1) or (2) as specified in section ll-50-13(a) based on a HACCP plan that: (i) Is submitted by the owner or operator (ii) (iii) and approved as specified in section 11-50-13 (b); Documents scientific data or other information showing that a lesser time and temperature regimen results in a safe food; and Verifies that equipment and procedures for food preparation and training of food employees at the food establishment meet the conditions of the variance. (b) Raw animal foods cooked in a microwave oven shall be: (1) Rotated or stirred throughout or midway during cooking to compensate for uneven distribution of heat; (2) Covered to retain surface moisture; (3) Heated to a temperature of at least one hundred sixty-five degrees Fahrenheit in all parts of the food; and (4) Allowed to stand covered for two minutes after cooking to obtain temperature equilibrium. (c) Plant foods that are cooked for hot holding shall be cooked to a temperature of one hundred thirty-five degrees Fahrenheit. (d) Raw animal foods that are cooked using a non- continuous cooking process shall be: (1) Subject to an initial heating process that is no longer than sixty minutes in duration; (2) Immediately after initial heating, cooled according to the time and temperature parameters specified for cooked time/temperature control for safety food in section 11-50-34 (d) (1); 50-89 §11-50-33 (3) After cooling, held frozen or cold, as specified for time/temperature control for safety food in section 11-50-34 (f) (1) (B); (4) Prior to sale or service, cooked using a process that heats all parts of the food to a temperature and for a time as specified under section subsection (a) (1) to (3); (5) Cooled according to the time and temperature parameters specified for cooked time/temperature control for safety food in section 11-50-34 (d) (1) if not either hot held as specified in section 11-50-34 ( f) ( 1) , served immediately, or held using time as a public health control as specified in section 11-50-34(i) after complete cooking; and (6) Prepared and stored according to written procedures that: (A) Have obtained prior approval from the department; (B) Are maintained in the food establishment and are available to the department upon request; (C) Describe how the requirements specified in paragraphs (1) to (5) are to be monitored and documented by the owner or operator and the corrective actions to be taken if the requirements are not met; (D) Describe how the foods, after initial heating, but prior to complete cooking, are to be marked or otherwise identified as foods that must be cooked as specified in paragraph (4) prior to being offered for sale or service; and (E) Describe how the foods, after initial heating but prior to cooking as specified in paragraph (4), are to be separated from ready-to-eat foods as specified in section 11-50-32 (c) (1). (e) Manufacturer cooking instructions. (1) Commercially packaged food that bears a manufacturer's cooking instructions shall be cooked according to those instructions before use in ready-to-eat foods or offered in unpackaged form for human consumption, unless the manufacturer's instructions specify that the food may be consumed without cooking; 50-90 §11-50-33 (2) Food for which the manufacturer has provided information that it has not been processed to control pathogens, when used in ready-to-eat foods or offered for human consumption, shall be cooked according to a time and temperature appropriate for the food; (f) Parasite destruction. (1) Except as specified in paragraph (2), before service or sale in ready-to-eat form, raw, raw- marinated, partially cooked, or marinated- partially cooked fish shall be: (A) Frozen and stored at a temperature of minus four degrees Fahrenheit or below for a minimum of one hundred sixty-eight hours (seven days) in a freezer; (B) Frozen at minus thirty-one degrees Fahrenheit or below until solid and stored at minus thirty-one degrees Fahrenheit or below for a minimum of fifteen hours; or (C) Frozen at minus thirty-one degrees Fahrenheit or below until solid and stored at minus four degrees Fahrenheit or below for a minimum of twenty-four hours; (2) Paragraph (1) does not apply to: (A) Molluscan shellfish; (B) A scallop product consisting only of the shucked adductor muscle; (C) Tuna of the species Thunnus alalunga (Albacore tuna), Thunnus albacares (Yellowfin tuna), Thunnus atlanticus (Blackfin tuna), Thunnus maccoyii (Bluefin tuna, Southern), Thunnus obesus (Bigeye tuna), Thunnus orientalis (Bluefin tuna, Pacific), Thunnus thynnus (Bluefin tuna, Northern), Katsuwonus Pelamis (Skipjack tuna), Makaira nigricans (Pacific blue marlin), Tetrapturus audax (Striped marlin), Istiophorus platypterus (Sailfish), Xiphias gladius (Swordfish); or (D) Aquacultured fish, such as salmon, that: (i) If raised in open water, are raised in net-pens; or (ii) Are raised in land-based operations such as ponds or tanks; and 50-91 §11-50-33 (iii) Are fed formulated feed, such as pellets, that contains no live parasites infective to the aquacultured fish; (E) Fish eggs that have been removed from the skein and rinsed. (g) Records, creation, and retention. ( 1) Except as specified in subsection ( f) ( 2) and paragraph (2), if raw, raw-marinated, partially cooked, or marinated-partially cooked fish are served or sold in ready-to-eat form, the person in charge shall record the freezing temperature and time to which the fish are subjected and shall retain the records of the food establishment for ninety calendar days beyond the time of service or sale of the fish; (2) If the fish are frozen by a supplier, a written agreement or statement from the supplier stipulating that the fish supplied are frozen to a temperature and for a time specified in subsection (f) may substitute for the records specified in paragraph (1); (3) If raw, raw-marinated, partially cooked, or marinated-partially cooked fish are served or sold in ready-to-eat form, and the fish are raised and fed as specified in subsection (f) (2) (D), a written agreement or statement from the supplier or aquaculturist stipulating that the fish were raised and fed as specified in subsection (f) (2) (D) shall be obtained by the person in charge and retained in the records of the food establishment for ninety calendar days beyond the time of service or sale of the fish. (h) Cooked and refrigerated food that is prepared for immediate service in response to an individual consumer order, such as a roast beef sandwich au jus, may be served at any temperature. (i) Reheating for hot holding. (1) Except as specified in paragraphs (2), (3), and (5), time/temperature control for safety food that is cooked, cooled, and reheated for hot holding shall be reheated so that all parts of the food reach a temperature of at least one hundred sixty-five degrees Fahrenheit for fifteen seconds; 50-92 §11-50-33 (2) Except as specified in paragraph (3), time/temperature control for safety food reheated in a microwave oven for hot holding shall be reheated so that all parts of the food reach a temperature of at least one hundred sixty-five degrees Fahrenheit and the food is rotated or stirred, covered, and allowed to stand covered for two minutes after reheating; (3) Ready-to-eat time/temperature control for safety food that has been commercially processed and packaged in a food processing plant that is inspected by the regulatory authority that has jurisdiction over the plant, shall be heated to a temperature of at least one hundred thirty-five degrees Fahrenheit when being reheated for hot holding; (4) Reheating for hot holding as specified in paragraphs (1) to (3) shall be done rapidly and the time the food is between forty-one degrees Fahrenheit and the temperatures specified in paragraphs (1) to (3) may not exceed two hours; (5) Remaining unsliced portions of meat roasts that are cooked as specified in subsection (a) (2) may be reheated for hot holding using the oven parameters and minimum time and temperature conditions specified in subsection (a) (2). (j) Juice packaged in a food establishment shall be: (1) Treated under a HACCP plan as specified in section 11-50-4 (h) (2) (B} to (F) to attain a five- log reduction, which is equal to a 99.999 per cent reduction, of the most resistant microorganism of public health significance; or (2) Labeled, if not treated to yield a five-log reduction of the most resistant microorganism of public health significance: (A) As specified in section ll-50-35(b); and (B) As specified in 21 CFR 101.17(g), juices that have not been specifically processed to prevent, reduce, or eliminate the presence of pathogens with the following, "Warning: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious 50-93 §11-50-33 illness in children, the elderly, and persons with weakened immune systems". [Eff 2/24/2014; am and comp AUG 2 4 2025 (Auth: HRS §321-11) (Imp: HRS §321-11) §11-50-34 Limitation of growth of organisms of public health concern. (a) Stored frozen foods shall be maintained frozen. (b) Frozen time/temperature control for safety food that is slacked to moderate the temperature shall be held: (1) Under refrigeration that maintains the food temperature at forty-one degrees Fahrenheit or less; or (2) At any temperature if the food remains frozen. (c) Except as specified in paragraph (4), time/temperature control for safety food shall be thawed: (1) Under refrigeration that maintains the food temperature at forty-one degrees Fahrenheit or less; or (2) Completely submerged under running water: (A) At a water temperature of seventy degrees Fahrenheit or below; (B) With sufficient water velocity to agitate and float off loose particles in an overflow; and (C) For a period of time that does not allow thawed portions of ready-to-eat food to rise above forty-one degrees Fahrenheit; or (D) For a period of time that does not allow thawed portions of a raw animal food requiring cooking as specified in section 11-50-33 (a) (1) or (2) to be above forty-one degrees Fahrenheit, for more than four hours including: (i) The time the food is exposed to the running water and the time needed for preparation for cooking; or (ii) The time it takes under refrigeration to lower the food temperature to forty-one degrees Fahrenheit; (3) As part of a cooking process if the food that is frozen is: (A) Cooked as specified in section 11-50- 33 (a) (1) or (2), (b) or (e); or 50-94 §11-50-34 (B) Thawed in a microwave oven and immediately transferred to conventional cooking equipment, with no interruption in the process; (4) Using any procedure if a portion of frozen ready- to-eat food is thawed and prepared for immediate service in response to an individual consumer's order; or (5) Reduced oxygen packaged fish that bears a label indicating that it is to be kept frozen until time of use shall be removed from the reduced oxygen environment: (A) Prior to its thawing under refrigeration as specified in paragraph (1); or (B) Prior to, or immediately upon completion of, its thawing using procedures specified in paragraph (2). (d) Cooling. (1) Cooked time/temperature control for safety food shall be cooled: (A) Within two hours from one hundred thirty- five degrees Fahrenheit to seventy degrees Fahrenheit; and (B) Within a total of six hours from one hundred thirty-five degrees Fahrenheit to forty-one degrees Fahrenheit or less; (2) Time/temperature control for safety food shall be cooled within four hours to forty-one degrees Fahrenheit or less if prepared from ingredients at ambient temperature, such as reconstituted foods and canned tuna; (3) Except as specified in paragraph (4), a time/temperature control for safety food received in compliance with laws allowing a temperature above forty-one degrees Fahrenheit during shipment from the supplier as specified in section 11-50-31(h) (2), shall be cooled within four hours to forty-one degrees Fahrenheit or less; (4) Raw eggs shall be received as specified in section 11-50-31(h) (3) and immediately placed in refrigerated equipment that maintains an ambient air temperature of forty-five degrees Fahrenheit or less; 50-95 §11-50-34 (e) Cooling methods. (1) Cooling shall be accomplished in accordance with the time and temperature criteria specified in subsection (d) by using one or more of the following methods based on the type of food being cooled: (A) Placing the food in shallow pans; (B) Separating the food into smaller or thinner portions; (C) Using rapid cooling equipment; (D) Stirring the food in a container placed in an ice water bath; (E) Using containers that facilitate heat transfer; (F) Adding ice as an ingredient; or (G) Other effective methods; (2) When placed in cooling or cold holding equipment, food containers in which food is being cooled shall be: (A) Arranged in the equipment to provide maximum heat transfer through the container walls; and (B) Loosely covered, or uncovered if protected from overhead contamination as specified in section 11-50-32 (q) (1) (B), during the cooling period to facilitate heat transfer from the surface of the food. (f) Time/temperature control for safety food, hot and cold holding. (1) Except during preparation, cooking, or cooling, or when time is used as the public health control as specified in subsection (i), and except as specified in paragraphs (2) and (3), time/temperature control for safety food shall be maintained: (A) At one hundred thirty-five degrees Fahrenheit or above, except that roasts cooked to a temperature and for a time specified in section 11-50-33 (a) (2) or reheated as specified in section 11-50- 33(i) (5) may be held at a temperature of one hundred thirty degrees Fahrenheit or above; or (B) At forty-one degrees Fahrenheit or less; (2) Eggs that have not been treated to destroy all viable Salmonellae shall be stored in 50-96 ( 3) (g) food, date (1) (2) (3) §11-50-34 refrigerated equipment that maintains an ambient air temperature of forty-five degrees Fahrenheit or less; Time/temperature control for safety food in a homogenous liquid form may be maintained outside of the temperature control requirements, as specified in paragraph (1), while contained within specially designed equipment that complies with the design and construction requirements as specified in section 11-50-46 (p) (5). Ready-to-eat, time/temperature control for safety marking. Except when packaging food using a reduced oxygen packaging method as specified in subsection (1), and except as specified in paragraphs (5) and (6), refrigerated, ready-to-eat, time/temperature control for safety food prepared and held in a food establishment for more than twenty-four hours shall be clearly marked to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded when held at a temperature of forty-one degrees Fahrenheit or less for a maximum of seven days. The day of preparation shall be counted as Day 1; Except as specified in paragraphs (5) to (7), refrigerated, ready-to-eat, time/temperature control for safety food prepared and packaged by a food processing plant shall be clearly marked, at the time the original container is opened in a food establishment and if the food is held for more than twenty-four hours, to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded, based on the temperature and time combinations specified in paragraph (1) and: (A) The day the original container is opened in the food establishment shall be counted as day one; and (B) The day or date marked by the food establishment may not exceed a manufacturer's use-by date if the manufacturer determined the use-by date based on food safety; A refrigerated, ready-to-eat, time/temperature control for safety food ingredient or a portion of a refrigerated, ready-to-eat, time/temperature 50-97 §11-50-34 control for safety food that is subsequently combined with additional ingredients or portions of food shall retain the date marking of the earliest-prepared or first-prepared ingredient; (4) A date marking system that meets the criteria stated in paragraphs (1) and (2) may include: (A) Using a method approved by the department for refrigerated, ready-to-eat time/temperature for control safety food that is frequently rewrapped, such as lunchmeat or a roast, or for which date marking is impractical, such as soft serve mix or milk in a dispensing machine; (B) Marking the date or day of preparation, with a procedure to discard the food on or before the last date or day by which the food must be consumed on the premises, sold, or discarded as specified in paragraph (1); (C) Marking the date or day the original container is opened in a food establishment, with a procedure to discard the food on or before the last date or day by which the food must be consumed on the premises, sold, or discarded as specified in paragraph (2); or (D) Using calendar dates, days of the week, color-coded marks, or other effective marking methods, provided that the marking system is disclosed to the department upon request; (5) Paragraphs (1) and (2) do not apply to individual meal portions served or repackaged for sale from a bulk container upon a consumer's request; (6) Paragraphs (1) and (2) do not apply to shell stock; (7) Paragraph (2) does not apply to the following foods prepared and packaged by a food processing plant inspected by a regulatory authority: (A) Deli salads, such as ham salad, seafood salad, chicken salad, egg salad, pasta salad, potato salad, and macaroni salad, manufactured in accordance with 21 CFR 117, entitled "Current good manufacturing practice in manufacturing, packing, or holding human food"; 50-98 §11-50-34 (B) Hard cheeses containing not more than 39 per cent moisture as defined in 21 CFR 133, entitled "Cheeses and related cheese products", such as cheddar, gruyere, parmesan and reggiano, and romano; (C) Semi-soft cheeses containing more than thirty-nine per cent moisture, but not more than fifty per cent moisture, as defined in 21 CFR 133, entitled "Cheeses and related cheese products", such as blue, edam, gorgonzola, gouda, and monterey jack; (D) Cultured dairy products as defined in 21 CFR 131, entitled "Milk and cream", such as yogurt, sour cream, and buttermilk; (E) Preserved fish products, such as pickled herring and dried or salted cod, and other acidified fish products defined in 21 CFR 114, entitled "Acidified foods"; (F) Shelf stable, dry fermented sausages, such as pepperoni and Genoa; and (G) Shelf stable salt-cured products such as prosciutto and Parma (ham). (h) Ready-to-eat, time/temperature control for safety food, disposition. (1) A food specified in subsection (g) (1) or (2) shall be discarded if it: (A) Exceeds the temperature and time combination specified in subsection ( g) ( 1) , except time that the product is frozen; (B) Is in a container or package that does not bear a date or day; or (C) Is appropriately marked with a date or day that exceeds a temperature and time combination as specified in subsection (g) ( 1); (2) Refrigerated, ready-to-eat, time/temperature control for safety food prepared in a food establishment and dispensed through a vending machine with an automatic shutoff control shall be discarded if it exceeds a temperature and time combination as specified in subsection ( g) ( 1) ; (i) Time as a public health control. (1) Except as specified in paragraph (4), if time without temperature control is used as the public health control for a working supply of time/temperature control for safety food before 50-99 §11-50-34 cooking, or for ready-to-eat time/temperature control for safety food that is displayed or held for sale or service: (A) Written procedures shall be prepared in advance, maintained in the food establishment and made available to the department upon request that specify: (i) Methods of compliance with paragraph (2) (A) to (D) or (3) (A) to (E); and (ii) Methods of compliance with subsection (d) for food that is prepared, cooked, and refrigerated before time is used as a public health control; (2) If time without temperature control is used as the public health control up to a maximum of four hours: (A) Except as specified in subparagraph (B), the food shall have an initial temperature of forty-one degrees Fahrenheit or less when removed from cold holding temperature control or one hundred thirty-five degrees Fahrenheit or greater when removed from hot holding temperature control; (B) The food may have an initial temperature of seventy degrees Fahrenheit or less if; (i) It is a ready-to-eat fruit or vegetable that upon cutting is rendered a time/temperature control for safety food as defined in 11-50-2; or (ii) (iii) (iv) It is a ready-to-eat hermetically sealed food that upon opening is rendered a time/temperature control for safety food as defined in 11-50-2; The food temperature does not exceed seventy degrees Fahrenheit within a maximum time period of four hours from the time it was rendered a time/temperature control for safety food; and The food is marked or otherwise identified to indicate the time that is four hours past the point in time when the food is rendered a time/temperature control for safety 50-100 §11-50-34 food as specified in subparagraphs (B) (i) and (ii); (C) The food shall be marked or otherwise identified to indicate the time that is four hours past the point in time when the food is removed from temperature control; (D) The food shall be cooked and served, served at any temperature if ready-to-eat, or discarded, within 4 hours from the point in time when the food is removed from temperature control; and (E) The food in unmarked containers or packages, or marked to exceed a four-hour limit shall be discarded; (3) If time without temperature control is used as the public health control up to a maximum of six hours: (A) The food shall have an initial temperature of forty-one degrees Fahrenheit or less when removed from temperature control and the food temperature may not exceed seventy degrees Fahrenheit within a maximum time period of six hours; (B) The food shall be monitored to ensure the warmest portion of the food does not exceed seventy degrees Fahrenheit during the six- hour period, unless an ambient air temperature is maintained that ensures the food does not exceed seventy degrees Fahrenheit during the six-hour holding (C) (D) period; The food shall be marked or otherwise identified to indicate: (i) The time when the food is removed from (ii) forty-one degrees Fahrenheit or less cold holding temperature control; and The time that is six hours past the point in time when the food is removed from cold holding temperature control; The food shall be: (i) Discarded if the temperature of the food exceeds seventy degrees Fahrenheit; or (ii) Cooked and served, served at any temperature if ready-to-eat, or discarded within a maximum of six 50-101 §11-50-34 ( 4) hours from the point in time when the food is removed from forty-one degrees Fahrenheit or less cold holding temperature control; and (E) The food in unmarked containers or packages, or marked with a time that exceeds the six-hour limit shall be discarded; A food establishment that serves a highly susceptible population may not use time as specified in paragraphs (1), (2) or (3) as the public health control for raw eggs. (j) A food establishment shall obtain a variance from the department as specified in section 11-50-13(a) and (b) before: (1) Smoking food as a method of food preservation rather than as a method of flavor enhancement; (2) Curing food; (3) Using food additives or adding components such as vinegar: (A) As a method of food preservation rather than as a method of flavor enhancement; or (B) To render a food so that it is not time/temperature control for safety food; (4) Packaging a time/temperature control for safety food using a reduced oxygen packaging method except where the growth of and toxin formation by Clostridium botulinum and the growth of Listeria monocytogenes are controlled as specified in subsection (l); (5) Operating a molluscan shellfish life-support system display tank used to store or display shellfish that are offered for human consumption; (6) Custom processing animals that are for personal use as food and not for sale or service in a food establishment; (7) Preparing food by another method that is determined by th~ department to require a variance; or (8) Sprouting seeds or beans. (k) A food processing plant may be exempt from this variance requirement. (1) Reduced oxygen packaging without a variance, criteria. (1) Except for a food establishment that obtains a variance as specified in subsection (j), a food 50-102 §11-50-34 establishment that packages time/temperature control for safety food using a reduced oxygen packaging method shall control the growth and toxin formation of Clostridium botulinum and the growth of Listeria monocytogenes; (2) Except as specified in paragraph (6), a food establishment that packages time/temperature control for safety food using a reduced oxygen packaging method shall implement a HACCP plan that contains the information specified in section 11-50-4 (h) (2) (B) and (C) and that: (A) Identifies the food to be packaged; (B) Except as specified in paragraphs (3) to (C) (D) (5), requires that the packaged food shall be maintained at forty-one degrees Fahrenheit or less and meet at least one of the following criteria: (i) Has an Aw of 0.91 or less; (ii) Has a pH of 4.6 or less; (iii) Is a meat or poultry product cured at (iv) a food processing plant regulated by the USDA using substances specified in 9 CFR 424.21, entitled "Use of food ingredients and sources of radiation," and is received in an intact package; or Is a food with a high level of competing organisms such as raw meat, raw poultry, or raw vegetables; Describes how the package shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to: (i) (ii) Maintain the food at forty-one degrees Fahrenheit or below; and Discard the food if within thirty calendar days of its packaging if it is not served for on-premises consumption, or consumed if served or sold for off-premises consumption; Limits the refrigerated shelf life to no more than thirty calendar days from packaging to consumption, except the time the product is maintained frozen, or the 50-103 §11-50-34 original manufacturer's "sell by" or "use by" date, whichever occurs first; (E) Includes operational procedures that: (F) (i) Prohibit contacting ready-to-eat food with bare hands as specified in section 11-50-32 (a) (2); (ii) Identify a designated work area and the method by which physical barriers or methods of separation of raw foods and ready-to-eat foods minimize cross contamination. Access to the processing equipment is limited to trained personnel familiar with the potential hazards of the operation; and (iii) Delineate cleaning and sanitization procedures for food-contact surfaces; and Describes the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the: (i) Concepts required for a safe (ii) (iii) operation; Equipment and facilities; and Procedures specified in subparagraph (E) and section 11-50-4 (h) (2) (B) and (C); (G) Is provided to the department before implementation; (3) Except for fish that is frozen before, during, and after packaging and bears a label indicating that it is to be kept frozen until time of use, a food establishment may not package fish using a reduced oxygen packaging method; (4) Except as specified in paragraphs (3) and (6), a food establishment that packages time/temperature control for safety food using a cook-chill or sous vide process shall: (A) Provide to the department prior to implementation, a HACCP plan that contains the information as specified in section 11-50-4 (h) (2) (B) and (C); (B) Ensure the food is: (i) Prepared and consumed on the premises, or prepared and consumed off the 50-104 (ii) (iii) (iv) (v) (vi) (vii) §11-50-34 premises but within the same business entity with no distribution or sale of the packaged product to another business entity or the consumer; Cooked to heat all parts of the food to a temperature and for a time as specified in section 11-50-33 (a) (1), ( 2 ) , and ( 3) ; Protected from contamination before and after cooking as specified in sections 11-50-32 and 11-50-33; Placed in a package with an oxygen barrier and sealed before cooking, or placed in a package and sealed immediately after cooking and before reaching a temperature below one hundred thirty-five degrees Fahrenheit; Cooled to forty-one degrees Fahrenheit in the sealed package or bag as specified in subsection (d) and cooled to thirty-four degrees Fahrenheit within forty-eight hours of reaching forty-one degrees Fahrenheit and held at that temperature until consumed or discarded within thirty days after the date of packaging; Cooled to forty-one degrees Fahrenheit in the sealed package or bag as specified in subsection (d) and held at forty-one degrees Fahrenheit or less for no more than seven days at which time the food must be consumed or discarded; or Cooled to forty-one degrees Fahrenheit in the sealed package or bag as specified in subsection (d) and cooled to thirty-four degrees Fahrenheit within forty-eight hours of reaching forty-one degrees Fahrenheit, removed from refrigeration equipment that maintains a thirty-four degrees Fahrenheit food temperature and then held at forty-one degrees Fahrenheit or less for no more than seven days, not to exceed thirty days from its 50-105 §11-50-34 (viii) date of packaging, at which time the food must be consumed or discarded; or Cooled to forty-one degrees Fahrenheit in the sealed package or bag specified in subsection (d) and held frozen with no shelf life restriction while frozen until consumed or used; (ix) Held in a refrigeration unit that is equipped with an electronic system that continuously monitors time and temperature and is visually examined for proper operation twice daily; (x) If transported off-site to a satellite location of the same business entity, equipped with verifiable electronic monitoring devices to ensure that times and temperatures are monitored during transportation; and (xi) Labeled with the produce name and the date packaged; and (C) Maintain the records required to confirm that cooling and cold holding refrigeration time/temperature parameters are required as part of the HACCP plan and: (i) Make such records available to the department upon request; and (ii) Hold such records for at least six months; and (D) Implement written operational procedures as specified in paragraph (2) (E) and a training program as specified in paragraph (2) (F); (5) Except as specified under paragraph (6), a food establishment that packages cheese using a reduced oxygen packaging method shall: (A) Limit the cheeses packaged to those that are commercially manufactured in a food processing plant with no ingredients added in the food establishment and that meet the Standards of Identity as specified in 21 CFR 133.150, entitled "Hard cheeses", 21 CFR 133.169, entitled "Pasteurized process cheese" or 21 CFR 133.187, entitled "Semisoft cheeses"; (B) Have a HACCP plan that contains the information specified in section 50-106 §11-50-35 11-50-4 (h) (2) (B} and (C) and as specified in paragraphs (2) (A), (2) (C) (i}, (2) (E), and (2) (F); (C) Labels the package on the principal display panel with a "use by" date that does not exceed thirty calendar days from its packaging or the original manufacturer's "sell by" or "use by" date, whichever occurs first; and (D) Discards the reduced oxygen packaged cheese if it is not sold for off-premises consumption or consumed within thirty calendar days of its packaging; (6) A HACCP Plan is not required when a food establishment uses a reduced oxygen packaging method to package time/temperature control for safety food, that is always: (A) Labeled with the production time and date, (B) Held at forty-one degrees Fahrenheit or less during refrigerated storage, and (C) Removed from its package in the food establishment within forty-eight hours after packaging. [Eff 2/24/2014; am and comp AUG 24 2025 ] (Auth: HRS §321-11) (Imp: HRS §321-11) §11-50-35 Food identity, presentation, and on-premises labeling. (a) Honestly presented. (1) Food shall be offered for human consumption in a way that does not mislead or misinform the consumer; (2) Food or color additives, colored overwraps, or lights may not be used to misrepresent the true appearance, color, or quality of a food. (b) Food labels. (1) Food packaged in a food establishment, shall be labeled as specified in law, including 21 CFR 101, entitled "Food labeling", and 9 CFR 317, entitled "Labeling, marking devices, and containers"; (2) Label information shall include: (A) The common name of the food, or absent a common name, an adequately descriptive identity statement; 50-107 §11-50-35 (B) If made from two or more ingredients, a list of ingredients and subingredients in descending order of predominance by weight, including a declaration of artificial colors, artificial flavors, and chemical preservatives, if contained in the food; (C) An accurate declaration of the net quantity of contents; (D) The name and place of business of the manufacturer, packer, or distributor; and (E) The name of the food source for each major food allergen contained in the food unless the food source is already part of the common or usual name of the respective ingredient; (F) Except as exempted in the Federal Food, Drug, and Cosmetic Act §403 (q) (3) to (5), nutrition labeling as specified in 21 CFR 101, entitled "Food labeling" and CFR 317 Subpart B, entitled "Nutrition labeling"; (G) For any salmonid fish containing canthaxanthin or astaxanthin as a color additive, the labeling of the bulk fish container, including a list of ingredients, displayed on the retail container or by other written means, such as a counter card, that discloses the use of canthaxanthin or astaxanthin; (3) Bulk food that is available for consumer self- dispensing shall be prominently labeled with the following information in plain view of the consumer: (A) The manufacturer's or processor's label that was provided with the food; or (B) A card, sign, or other method of notification that includes the information specified in paragraph (2) (A), (B), (E), and (F); (4) Bulk, unpackaged foods such as bakery products and unpackaged foods that are portioned to consumer specification need not be labeled if: (A) A health, nutrient content or other claim is not made; (B) There are no state or local laws requiring labeling; and 50-108 §11-50-35 (C) The food is manufactured or prepared on the premises of the food establishment or at another food establishment or a food processing plant that is owned by the same person and is regulated by the food regulatory agency that has jurisdiction. (c) Other forms of information. (1) If required by law, consumer warnings shall be provided; (2) Food establishment or manufacturers' dating information on foods may not be concealed or altered; (3) The permit holder shall notify consumers by written notification of the presence of major food allergens as an ingredient in unpackaged food items that are served or sold to the consumer; (4) Homemade food products shall bear a label with the following information: (A) A statement that reads "Made in a home kitchen not routinely inspected by the Department of Health"; (B) The common name of the food or, if no common name exists, an adequately descriptive identity statement; (C) If made from two or more ingredients, a list of ingredients and subingredients in descending order of predominance by weight; (D) Notification of the presence of major food allergens; (E) Name and contact information of the homemade food product producer; (5) Hand-pounded poi shall bear a label that contains the following information: (A) A statement that reads "This hand-pounded poi was prepared in a facility not inspected by the Department of Health"; (B) Name and contact information of the producer. (d) Consumption of animal foods that are raw, undercooked, or not otherwise processed to eliminate pathogens. (1) Except as specified in sections 11-50-33 (a) (3) and (4) (D) and 11-50-37 (3), if an animal food such as beef, eggs, fish, lamb, milk, pork, poultry, or shellfish is served or sold raw, 50-109 §11-50-35 undercooked, or without otherwise being processed to eliminate pathogens, either in ready-to-eat form or as an ingredient in another ready-to-eat food, the owner or operator shall inform consumers of the significantly increased risk of consuming such foods by way of a disclosure and reminder, as specified in paragraphs (2) and (3) using brochures, deli case or menu advisories, label statements, table tents, placards, or other effective written means; (2) Disclosure shall include: (A) A description of the animal-derived foods, such as "oysters on the half shell (raw oysters)", "raw-egg Caesar salad", and "hamburgers (can be cooked to order)"; or (B) Identification of the animal-derived foods by asterisking them to a footnote that states that the items are served raw or undercooked, or contain (or may contain) raw or undercooked ingredients; (3) Reminder shall include asterisking the animal- derived foods requiring disclosure to a footnote that states: (A) Regarding the safety of these items, written information is available upon request; (B) Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness; or (C) Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness especially if you have certain medical UG 2 4 2025 conditions. [Eff 2/24/2014; am and comp A. ... ] (Auth: HRS §321-11) (Imp: HRS §321-11)