In this chapter, all provisions of 21 CFR 113 and 114 are incorporated by reference. In this chapter, the following terms have the meanings indicated. Terms Defined. “Acid foods” means foods that have a natural pH of 4.6 or below. Acidified Foods. “Acidified foods” means low-acid foods to which acid or acids or acid food or acid foods are added and that have a: Water activity (aw) greater than 0.85; and Finished equilibrium pH of 4.6 or below. “Acidified foods” includes, but is not limited to: Beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in combination; and Foods that are called, or may purport to be, “pickles” or “pickled”. “Acidified foods” does not include: Carbonated beverages, jams, jellies, or preserves; Acid foods that contain small amounts of low-acid food or foods and have a resultant finished equilibrium pH that does not significantly differ from that of the predominate acid or acid food, including such foods as standardized and nonstandardized food dressings and condiment sauces; and Foods that are stored, distributed, and retailed under refrigeration. “Canned foods” means foods that are heat treated and hermetically sealed in a container for preservation. “Commercially sterile” means the condition achieved by the: Application of heat that renders the food free of: Microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; and Viable microorganisms, including spores, that cause disease; or Control of water activity and the application of heat that renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution. “Culinary grade steam” means steam that is free of deleterious or harmful matter that might adulterate food. “Department” means the Maryland Department of Health or the Department's designee. “Lot” means the product produced during a time period indicated by a specific code. Low-Acid Foods. “Low-acid foods” means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85. “Low-acid foods” does not include tomatoes and tomato products having a finished equilibrium pH less than 4.7. “Person-in-charge” means the licensee or other individual responsible for the overall conditions and operation of a cannery or acidified food processing plant. “Process authority” means an individual having knowledge acquired through training about and experience with thermal processing requirements or the acidification and processing of acidified foods. “Scheduled process” means the process selected by the processor as adequate under the conditions of manufacture that: Is at a minimum equivalent to the process established by a process authority; For thermally processed low-acid foods packaged in hermetically sealed containers: Achieves a commercially sterile product; and May be in excess of that necessary to ensure destruction of microorganisms that cause disease; For acidified foods: Achieves and maintains a food that will not permit the growth of microorganisms that cause disease; and Includes the control of pH and other critical factors; and For thermally processed acid foods packaged in hermetically sealed containers: Achieves a commercially sterile product; or Ensures the destruction of microorganisms that cause disease and prevents spoilage during the product's shelf life. “Thermal process validation study” means a scientific study conducted by a process authority to determine critical factors and establish and validate a food process. “Water activity (aw)” means the measure of the free moisture in a product and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature. The person-in-charge shall ensure that a food processing plant is in compliance with this chapter and COMAR 10.15.04: In the design, operation, and maintenance of the plant, its facilities, and equipment; and When the plant is canning foods or manufacturing acidified foods, or both. If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 regarding canning or acidified food manufacturing, this chapter takes precedence. In order to operate a cannery or acidified food processing plant, a person shall obtain a food processing license pursuant to the provisions of Health-General Article, §21-305, Annotated Code of Maryland, COMAR 10.15.04, and this chapter. The Department shall specify on a food processing license issued to a cannery or acidified food processing plant the following type or types of food the licensee is approved to produce: Low-acid canned foods; Acidified foods; Acid canned foods; or A combination of these types. The person-in-charge shall ensure that: Foods are not canned and acidified foods are not manufactured in the plant without the license required by Health-General Article, §21-305, Annotated Code of Maryland; The required food processing license is conspicuously posted in the plant during operations; and The food canned or manufactured is limited to the type or types of foods stated on the license. The person-in-charge shall provide and properly maintain, in good working and sanitary condition, the equipment and facilities needed to can food and manufacture acidified foods in accordance with applicable regulations. The person-in-charge shall ensure that: The water supplied to a fixture is potable and meets the requirements of the Environment Article, Annotated Code of Maryland; The sewerage system for the plant meets all applicable State and local codes and properly disposes of all wastewater; Individuals in the plant: Practice good personal hygiene; While working with food, wash their hands frequently and directly after an activity that is likely to soil their hands; Wear clean outerwear and no jewelry; and Do not smoke or engage in any activity that might contaminate food; Food contact surfaces are effectively cleaned and sanitized: As often as needed to prevent food contamination; and At a minimum: Following processing; Between an interruption in processing of greater than 2 hours; and After a continuous use of 6 hours; When a time greater than 8 hours separates the start of processing from previous cleaning and sanitizing, food contact surfaces are sanitized again before work resumes; Non-food contact surfaces that: Receive splash or waste are cleaned and sanitized: As necessary to maintain a sanitary condition; and At a minimum following each day's use; and Do not receive splash or waste are cleaned as often as necessary to maintain a sanitary condition; Cleaning procedures are effective in removing soil and in preparing the surface for sanitizing when sanitizing is required; The sanitization of surfaces is effective in killing pathogens that may be present on the surface; and Clean equipment and utensils are stored to prevent their contamination. The person-in-charge shall ensure that: Processing equipment used to heat or cool food in hermetically sealed containers is: Designed to provide even and adequate processing; Provided adequate instrumentation and recording devices to allow process control, monitoring, and verification; Durable and impervious to water; Maintained in a sanitary and working condition; Monitored to verify that process requirements are met; and Calibrated according to a schedule approved by the Department; Food equipment other than that used for heating and cooling food in hermetically sealed containers is: Non-toxic and does not impart any toxic or deleterious matter to the food; Corrosion resistant; Durable; Impervious; and Smooth and easily cleanable; Non-food contact equipment that receives splash or waste is smooth and easily cleanable; and Steam that might contact food is culinary grade steam. The person-in-charge shall ensure that: Low-acid foods are processed and labeled in accordance with 21 CFR 113; Acidified foods are processed and labeled in accordance with 21 CFR 114; When canning is taking place, a scheduled process is used that takes into account the critical factors and limits that are likely to influence the food’s safety, stability, or shelf life, such as: Food characteristics; Spoilage organisms; Time and temperature of thermal process; Cooling parameters; Acidification; Storage conditions; Design and performance of the processing equipment; and Batch size and configuration; Before a food processing plant processes food in a closed vessel, such as a retort or steam cabinet, a process authority performs a thermal process validation study that includes: Heat penetration tests; Heat distribution tests; Cooling parameters; and Any other measurements, observations, or calculations needed to ensure that the process is effective and reliable; The scheduled thermal process and validation study are re-established each time there is a change in the processing system; and All thermal processes and validation studies being used are available for inspection by the Department. The person-in-charge shall ensure that: The canning process is monitored and controlled as necessary to ensure the food's safety, stability, and shelf life; The cook time, cook temperatures, and pH of each batch of canned food are measured and recorded; Through strict processing criteria, monitoring, record keeping, and corrective action, a container of food processed as an acidified food is not distributed if the final pH measurement of the food is greater than 4.6 (4.7 for tomatoes and tomato products) when the food’s water activity is greater than 0.85; Sealing and seaming closure inspections are conducted to verify that containers are properly hermetically sealed; When a deviation from the scheduled process occurs: The food manufactured during the deviation is: Held for evaluation by a process authority; and Completely reprocessed, destroyed, released, or otherwise disposed of in accordance with the decision of the process authority; and The deviation and associated corrective action is documented in a record; Records are maintained to identify the initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use; and The records required in §§B, C, E, and F of this regulation are retained for at least 3 years from the date of manufacturing and are available for inspection by the Department. The person-in-charge shall ensure that: Canned food is conspicuously and prominently labeled or marked with the following information: The common name of the food; The list of ingredients in descending order of prominence by weight; The name and address of the manufacturer or distributor; and The net weight of the container; For a container marked with the name of the distributor, the name of the distributor is: Preceded by the words “packed for” or “distributed by”; or Followed by the word “distributor”; A container of canned low acid or acidified food is marked with a permanently visible identifying code that is: Embossed or inked on the container; or Perforated or otherwise marked on a label securely affixed to the product container, if the container does not allow embossing or inking; The identifying code required in §C of this regulation: Specifies the following: The establishment where the product was packed; The product contained in the container; and The year, day, and time period during which the product was packed; and Is changed: Every 4 to 5 hours; With a personnel shift change; With each batch, as long as the containers that constitute a batch do not extend over a period of more than one personnel shift; or Otherwise often enough to enable ready identification of a lot during its sale and distribution; A container of product that needs to be refrigerated after opening to provide safety, stability, or shelf life is prominently and conspicuously marked with the statement “refrigerate after opening” or an equivalent statement; and False or misleading information is not placed on a container. Health-General Article, §§18-102, 21-211, 21-234, 21-304, 21-321, 21-340, and 21-350, Annotated Code of Maryland Effective date: April 18, 1957 Chapter, Canneries, repealed effective January 22, 2001 (28:1 Md. R. 26) Regulations .01 — .10, Canning and Acidified Food Manufacturing, adopted effective January 22, 2001 (28:1 Md. R. 26) Chapter, Canning and Acidified Food Manufacturing, renamed, Low Acid and Acidified Food Canning, effective February 15, 2016 (43:3 Md. R. 272) Regulation .02B amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .05B amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .06A, B amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .07 amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .08 repealed effective February 15, 2016 (43:3 Md. R. 272) Regulation .09 amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .10 amended effective February 15, 2016 (43:3 Md. R. 272) In this chapter, the following terms have the meanings indicated. Terms Defined. “Back” means to remove a crab's outer shell. “Boiled” means cooked by boiling in water that is bubbling rapidly, greatly agitated, and at a temperature of 212°F at sea level. “Chum” means the parts of a cooked crab that are not eaten, and that are disposed of as waste material. “Crab meat” means the edible meat of cooked crabs. “Crab meat plant” means: A picking plant; or A place where crab meat is heat-treated to improve the keeping quality of the crab meat. “Culinary grade steam” means steam that is free of deleterious or harmful matter that might adulterate food. “Department” means the Maryland Department of Health or the Department's designee. “Fresh crab meat” means cooked crab meat that has not been pasteurized or frozen. “HACCP plan” means a Hazard Analysis Critical Control Point (HACCP) plan as specified in COMAR 10.15.10. “Pasteurized crab meat” means cooked crab meat that is sealed in a container and further heat processed to improve the keeping quality of the meat. “Person-in-charge” means the licensee or other person responsible for the operation of the crab meat plant. “Picking plant” means a place where: Crabs are cooked; Crab meat is picked from crabs; and Crab meat is packed for sale. “Process authority” means an individual having knowledge acquired through training about and experience with thermal processing requirements for crabs and crab meat. “Repack crab meat” means to pack crab meat by taking it from a container or package, when the crab meat has been picked from a crab at another location, and placing that crab meat in another container or package. “Scheduled process” means a method or set of procedures determined by a process authority for processing crabs and crab meat, which takes into account the critical factors that may impact the food's safety or stability. “Steamed” means cooked by exposure to steam in a cooker with the steam: Under pressure, so that the temperature of the steam is greater than 212°F at sea level; or At atmospheric pressure in a non-pressurized cooker. The person-in-charge shall process crab meat and design, operate, and maintain a crab meat plant, its facilities, and equipment in compliance with this chapter and COMAR 10.15.04 and 10.15.10. If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 or 10.15.10 regarding crab meat plants or the processing of crab meat, this chapter takes precedence. In order to operate a crab meat plant, a person shall obtain a food processing license pursuant to the provisions of: Health-General Article, §21-305, Annotated Code of Maryland; COMAR 10.15.04; and This chapter. The Department shall specify on a food processing license it issues to a person operating a crab meat plant that the licensee is approved to process: Fresh crab meat; Pasteurized crab meat; Repacked crab meat; or Any combination of the above types of crab meat. The person-in-charge shall ensure that: Crab meat is not processed without the license required by Health-General Article, §21-305, Annotated Code of Maryland; The required food processing license is conspicuously posted in the plant; and The operations in the plant are limited to the type of crab meat operation specified on the license pursuant to §B of this regulation. The person-in-charge shall ensure that the equipment and facilities needed to process crab meat in accordance with the requirements of this chapter are provided and maintained in a sanitary and working condition. The person-in-charge shall ensure that: The water supplied to a fixture is potable and meets the requirements of the Environment Article, Annotated Code of Maryland; The sewage disposal system for the plant meets all applicable State and local codes and properly disposes of all wastewater; Ice used in the manufacture of crab meat is produced from water that is potable and meets the requirements of the Environment Article, Annotated Code of Maryland; The plant design and the flow of food through the plant minimize the potential for cross-contamination; If uncooked crabs will be stored at the plant for more than 4 hours before cooking, a separate cooler is provided for uncooked crabs; Partitions or linear distances are used to separate cooking areas, picking areas, and packing areas; Floors in all processing areas and in refrigerated rooms are sloped to accessible floor drains that dispose of wastewater, in compliance with applicable plumbing codes; Toilet rooms: Are provided at the rate of one toilet for every 20 employees; Do not open directly into a food processing or storage area; and Are: Separate for men and women; or Designed for use by not more than one person at a time. A hand sink is: Provided in the picking area at the rate of one hand sink for each 15 pickers; Provided in the packing area; Equipped with soap and paper towels for drying hands; Accompanied by sanitizer in the picking and packing rooms for the sanitizing of hands; and Equipped with hot and cold water under pressure; A picking table is: Adequate in size so that a picker does not contaminate crab meat during the picking of cooked crabs; and Provided with sanitary paper towels in a dispenser within reach of a picker while at the table; A three-compartment sink is: Designed to allow immersion of utensils or equipment that will be cleaned and sanitized in the sink; Provided in the plant for washing, rinsing, and sanitizing equipment and utensils; and Equipped with hot and cold water under pressure; and Waste containers are: Provided inside the facility to be accessible to the workers; Made to be easily cleanable; Large enough to hold waste until the waste is taken off-site if the containers are outside waste containers; and Vermin-proof, insect-proof, and placed on a hard and impermeable surface if the containers are outdoor waste containers, except in the case of chum containers that are removed daily. The person-in-charge may use a two-compartment sink instead of the three-compartment sink required in §B(11)(b) of this regulation, if the two-compartment sink: Was installed before the effective date of this chapter; Complies with all regulations applicable before the effective date of this chapter; Performs the intended function; Is maintained in a sanitary condition; and When replaced, is replaced with a hand sink or three-compartment sink in full compliance with this chapter. The person-in-charge shall ensure that: Individuals in the plant: Practice good personal hygiene; Are excluded from working with food when the individuals are sick with an illness that is transmittable through food; While working with food, wash the individuals' hands frequently and after an activity that is likely to soil the hands; Wear clean outerwear, hair coverings, and no jewelry; If handling crabs or crab meat, maintain trim and clean fingernails, and do not wear false fingernails; Store personal items in a designated non-food area; and Do not smoke or engage in an activity that might contaminate food; Picking trays, knives, and gloves are washed, rinsed, and sanitized before use and after each delivery of crab meat to the packing room; Except as provided in §B of this regulation, food contact surfaces are cleaned and sanitized: As often as needed to prevent food contamination; and At a minimum: Following processing; and Between an interruption in processing of greater than 2 hours; During processing, gross soil is removed from food contact surfaces and the surfaces are sanitized: After a continuous use of 6 hours; and After an interruption in processing of greater than 30 minutes; When a time greater than 8 hours separates the start of processing from previous cleaning and sanitizing, food contact surfaces are sanitized again before work resumes; Non-food contact surfaces that receive splash or waste are cleaned and sanitized: As often as necessary to maintain a sanitary condition; and At a minimum following each day's use; Cleaning procedures: Include the use of detergents or other cleaning chemicals; and Remove soils; The sanitization of surfaces is effective in killing pathogens on the treated surface; Non-food contact surfaces that do not receive splash or waste are cleaned as often as necessary to maintain a sanitary condition; Before cleaning, all food and food packaging is removed from the area being cleaned; Cleaning and sanitizing occur in a manner that protects food from contamination; In-use and cleaned equipment and utensils are stored to prevent contamination of the equipment and utensils; Waste, including chum, is held in a sanitary manner and disposed of to maintain the plant grounds in a sanitary condition; and Outdoor containers for chum that are not vermin-proof or insect-proof are removed daily and transported to a disposal site. The person-in-charge shall ensure that: Processing equipment is: Designed to provide even and effective processing; Provided with instrumentation to allow process control, monitoring, and verification; Durable and impervious to water; Maintained in a sanitary and working condition; Monitored to verify that process requirements are met; and Calibrated to ensure accuracy; Pasteurization equipment is provided with: Temperature sensors: For controlling and documenting the thermal process; and That are located to give an accurate representation of the heating medium's temperature; An automatic recording device of time and temperature that is: Equipped with a reliable clock, so that a recorded interval does not exceed the elapsed time indicated by an accurate time piece; and Equipped with a temperature measuring device that is scaled at a maximum of 2°F intervals within the operating temperature range of the pasteurization equipment and accurate to within ±1°F within the range spanning ±15°F of the target processing temperature; An indicating thermometer scaled at a maximum of 2°F intervals within the operating range of the pasteurization equipment with an accuracy of ±1°F within the range spanning ±15°F of the target processing temperature; Adequate agitation for even heating and cooling; and Cooling water that contains residual free chlorine throughout the cooling process; A vessel for steaming crabs is provided with: An indicating thermometer scaled at a maximum of 2°F intervals within the operating range of the vessel and accurate to within ±1°F within the range spanning ±15°F of the target processing temperature; Vents to exhaust air thoroughly; A bottom drain; Steam pipe inlets or spreaders for even steam distribution; and Culinary grade steam of sufficient volume for processing; In addition to what is required in §C of this regulation, a pressurized vessel is provided with: When pressure is part of a standardized process, a pressure gauge; and A pressure relief valve as required for safety; An accurate clock or timer is provided in the immediate vicinity of a heat-processing vessel to allow the accurate measurement of process time; Equipment used to process crab meat has food contact surfaces that are: Non-toxic and do not impart toxic or deleterious matter to the food; Corrosion resistant; Durable; Impervious; and Smooth and easily cleanable; Tables used to back and pick crabs, and pack crab meat and food are made of stainless steel of American Iron and Steel Institute Type 304, or the equivalent; and Non-food contact equipment that receives splash or waste is smooth and easily cleanable. The person-in-charge shall ensure that: Crab meat is processed using sanitary practices, process controls, and a HACCP plan in compliance with COMAR 10.15.10; A process used for crab cooking or pasteurization is at least equivalent to a scheduled process; The scheduled process: Is maintained in writing and available on-site; Provides the heat lethality and rate of cooling prescribed in this chapter; Establishes the time and temperature requirements for the processing system, which may include the: Minimum time for exhausting air from the cooking or pasteurization vessel and a target temperature and pressure at the end of the exhaust; Minimum processing temperature; Minimum processing time after the cooking or pasteurization vessel reaches processing temperature; and Cooling parameters; Takes into account factors in the process that are likely to affect the lethality of the thermal process and the rate of cooling, which for pasteurization may include the: Design and performance of the processing equipment; Initial food temperature; Batch size and configuration; and Size and the shape of the crab meat container; Is re-standardized each time there is a change in the processing system; and Allows process monitoring; A thermometer used in conjunction with a cooking or pasteurization vessel is calibrated at least annually, or is certified by the National Institute of Standards and Technology with a valid certificate; and If pressure is part of the scheduled process, a pressure gauge, used in conjunction with a cooking or pasteurization vessel is calibrated at least annually. The person-in-charge shall ensure that: Live crabs received at the plant are stored in a manner that enhances the crab's survival and prevents decomposition; Crabs are steamed using a standardized process: For a heat lethality equivalent to F(235°F) = 1 minute with z = 15°F, which is equivalent to bringing the internal temperature of the crabs instantaneously to 235°F, holding the internal temperature at 235°F for 1 minute, and then instantaneously cooling the crabs; or Other than the one set forth in §B(1) of this regulation, if the alternative process has been shown through scientific study to provide: Pathogen lethality; and Equivalent conformance with the bacteriological standards set forth in Regulation .15 of this chapter; The cooling of cooked crabs conforms with the following: Except as provided in Regulation .10C of this chapter, air cooling of cooked crabs at ambient air temperatures does not exceed more than 4 hours in length; When cooked crabs are refrigerated before picking, the cooked crabs are placed in refrigeration at 40°F or below after cooling at ambient air temperatures; and Except as provided in §D of this regulation, cooked crabs are: Cooled and held before picking with the outer shell in place; and Backed immediately before picking; and In order to provide a cold water rinse to remove sediment, when cooked dredged crabs are backed: Before refrigeration, the crabs are air cooled, backed, and refrigerated within 4 hours after cooking; After refrigeration, the crabs are backed, rinsed, and picked and the crab meat packed in: A continuous process; and Accordance with Regulation .10B of this chapter; or With no refrigeration and directly before picking the cooked crabs are cooled, backed, and picked and the crab meat packed in: A continuous process; and Accordance with Regulation .10C of this chapter. The person-in-charge shall ensure that: Cooked crabs are transferred to the pickers in containers dedicated to that purpose; For cooked crabs that are refrigerated before picking, within 3.5 hours after the crabs are removed from refrigeration, the: Crabs are picked; and Packed crab meat is cooled by: Surrounding the packed crab meat with ice; or Another effective and sanitary cooling method; For cooked crabs that are not refrigerated before picking, within 6 hours after the crabs are cooked, the: Crabs are picked; and Packed crab meat is cooled by: Surrounding the packed crab meat with ice; or Another effective and sanitary cooling method; The corrective action for crab meat that is not picked, packed, and iced or otherwise cooled within HACCP critical limits is documented in records; Containers in which crab meat is picked and packed are: Made of suitable food-grade materials; Protected from contamination; and Rinsed in a bactericidal solution and completely drained immediately before being filled with crab meat; and Crab meat picked in the plant is not removed from the container into which it was picked and placed into another container, except when specific written approval for the transfer of crab meat from the original container into another container is given by the Department, based on a review of a written proposal plan to transfer the crab meat that complies with this chapter and includes the: Type or types of crab meat to be placed from one container into another container; Procedures to maintain the crab meat at temperatures that prevent the growth of pathogens and retard spoilage; HACCP plan for the process, if a hazard analysis indicates that reasonably likely food safety hazards exist; Food-grade specifications of a crab meat container; Oxygen permeability of a crab meat container; Procedures to protect crab meat from contamination; and Labeling and marking of a crab meat container. The person-in-charge shall ensure that: Crab meat is repacked only in a licensed picking plant; Repacking does not occur except when written approval for the repacking is given by the Department, based on a review of a written proposal plan to repack that complies with this chapter, and includes the: Information in Regulation .10G of this chapter; If imported crab meat will be repacked, name of the person responsible for ensuring compliance with §H(7) of this regulation; and Source of the crab meat; Frozen crab meat is not repacked; Crab meat that is repacked into a container is: From a single plant; and Completely comprised of crab meat that was picked, packed, or pasteurized on the same day; Once repacked, crab meat is not repacked again; An empty container from which crab meat has been repacked is placed immediately into a waste disposal receptacle and is not kept on the premises for reuse; Repacking is done in a sanitary manner in accordance with the provisions of this chapter; Crab meat for repacking is: Processed in a licensed plant operating under a HACCP plan; Wholesome; Received in its original container and marked with the date of pasteurization as required in Regulation .14 of this chapter; Crab meat that meets the bacteriological standards in Regulation .15 of this chapter; If pasteurized, stored at 40°F or below before repacking; When fresh: Repacked within 72 hours of the original pick and pack; and Stored in ice or held at 40°F or less before repacking; and When imported crab meat, sampled and tested for Standard Plate Count and Escherichia coli by an accredited laboratory using a composite sample from 5 separate containers and standard methods approved by the Secretary based on the ability of the methods to provide accurate and repeatable results; Repacked crab meat not for pasteurization is: Maintained at 40°F or below during repacking; and Rapidly cooled after repacking by surrounding the packed crab meat in ice or some other sanitary and effective means; Repacked crab meat for pasteurization is: Maintained at 40°F or below during repacking and in storage before pasteurization; Pasteurized within 96 hours of the original pick and pack; and Pasteurized, cooled, and stored in accordance with Regulations .08, .12, and .13 of this chapter; and Repack records: Are maintained to allow crab meat to be traced to the original picking plant; Include the following information: The name, address, and plant number of the original picking plant; The type and quantity of the crab meat that is repacked; The original pick, pack, or pasteurization date and the repack date; and Results of the microbiological laboratory testing required in Regulation .11H(7) of this chapter; and Are available for inspection by the Department for 2 years following the date of repacking. The person-in-charge shall ensure that: When crab meat is picked in one plant for pasteurization at another: The crab meat is transported in the final container; A temporary cover that effectively protects the crab meat is placed on the can until seaming or sealing when the crab meat container will be seamed or sealed at a plant other than where it was filled; and The final product is labeled according to the requirements of Regulation .14 of this chapter; When a container is hermetically sealed: The container is covered or otherwise protected before sealing or seaming; and At a minimum, the seals or seams are inspected: At the start of sealing or seaming; At a minimum of every 4 hours during sealing and seaming; and When the sealing or seaming equipment malfunctions; Crab meat that has been placed in containers and the containers sealed or seamed for pasteurization: Is pasteurized within 48 hours of sealing or seaming; and Receives a standardized process for a heat lethality equivalent to F(185°F) = 31 minutes with z = 16°F; Immediately following pasteurization, pasteurized crab meat is continuously cooled to 55°F within 3 hours and to 40°F within an additional 15 hours; When a recording chart is used to record the time and temperature of pasteurization: A continuous inked record is made of process time and temperature during pasteurization; A new chart or section of chart is used for each pasteurization operation; The used charts that document a pasteurization process are kept on file in the plant, and available for inspection by the Department for a period of 2 years; and The following information is placed on the recorder chart form or another comparable form that documents that a pasteurization process is used: Process date; Plant name and number; Batch code; Quantity of each batch; Initial temperature of the crab meat when the temperature is a critical factor; Indicating thermometer reading after the target temperature has been reached and stabilized; Occurrence of any mechanical or power failure or the opening of the recording thermometer case for adjustments or repair during a thermal process cycle; and Written signature of the operator of the pasteurization equipment; and When a computer-based data logger or data acquisition device is used to record the time and temperature of pasteurization, the information required in §E(4) of this regulation is: Recorded; and Available as a permanent copy for inspection by the Department for a period of 2 years. The person-in-charge shall ensure that: After being picked and packed in ice, blast chilled, or otherwise cooled in a sanitary and effective way, fresh crab meat is kept in ice or in an ambient air temperature of 40°F or less; Except when pasteurized within 2.5 hours of weigh-up in the packing room, packed crab meat for pasteurization is kept in ice or in an ambient air temperature of 40°F or below until pasteurization; Pasteurized crab meat in hermetically sealed containers is kept in an ambient air temperature of 38°F or below; Reduced oxygen packaged non-pasteurized crab meat is kept frozen; and Crab meat is protected from contamination during storage. The person-in-charge shall ensure that: The information required on a container of crab meat is marked by: Embossing; Imprinting; Lithography; or Another method approved by the Department based on its: Durability; and Ability to remain on the container for the shelf life of the crab meat in a form that is: Conspicuous; and Legible; The following information is marked on a container of crab meat: The common name of the food; The name and address of the picking plant or distributor; If a chemical is added to the crab meat, a statement to that effect; The license number of the plant preceded by the State abbreviation applicable to the picking plant; and The net weight of the contents of the container; For a container marked with the name of the distributor, the name of the distributor is: Preceded by the words “packed for” or “distributed by”; or Followed by the word “distributor”; When the packing and pasteurization are completed at different plants, the label clearly states the license numbers of the packer and pasteurizer; For a container of pasteurized crab meat, whenever the term “crab meat” or its equivalent appears on the label, the word “pasteurized” is stated with equal prominence and in immediate conjunction with the term “crab meat”; A container of pasteurized crab meat is marked with a batch code that indicates the date of picking, packing, or pasteurization; Except when crab meat is frozen, the words “keep refrigerated” or equivalent words are placed on a container of fresh or pasteurized crab meat; The words “keep frozen” or equivalent words are prominently displayed on the label of a container of frozen crab meat; If crab meat is in a frozen state after being manufactured, processed, or packaged and it then is offered for sale in an unfrozen state, the container's labeling contains a clear and conspicuous statement that the crab meat was previously frozen and should not be refrozen; A container of crab meat containing crab meat picked from a crab, packed, repacked, or processed outside of the United States: Is marked with the words “This product contains crab meat from (name of country of origin)”; and The marking required in §J(1) of this regulation is prominently displayed in letters not smaller than 12-point type on the principal display panel; A container of crab meat containing crab meat picked from a crab other than a “blue crab” (C. sapidus) is marked with the common name and scientific name of the crab picked into the container; False or misleading information is not placed on a container of crab meat; and A container of repacked crab meat is marked: With the date of the repack, which may be a code date; With the crab meat plant numbers of both the original packer and repacker; and To allow the crab meat to be traced back to both the repacker and original packer. The person-in-charge: Shall ensure that crab meat is processed to meet the bacteriological standards set forth in this regulation; and May not distribute crab meat that does not meet these standards. To establish whether compliance is met with the bacteriological standards for crab meat set forth in §§C and D of this regulation, a person shall utilize the isolation, identification, and enumeration methods that are approved by the Secretary based on the ability of the methods to provide accurate and repeatable results. The bacteriological standards for crab meat that is not pasteurized are the following: Generic Escherichia coli may not exceed a Most Probable Number of 3.6 per gram of fresh crabmeat; Listeria monocytogenes and enterohemorrhagic Escherichia coli may not be present in fresh crab meat; and Standard Plate Count may not exceed 100,000 colony-forming units per gram of crab meat. The bacteriological standards for pasteurized crab meat are the following: Escherichia coli may not be present in pasteurized crab meat; Listeria monocytogenes may not be present in pasteurized crab meat; and Standard Plate Count may not exceed 25,000 colony-forming units per gram of crab meat. Health-General Article, §§18-102, 21-211, 21-234, 21-304, 21-321, 21-339, 21-340, and 21-350, Annotated Code of Maryland Effective date: March 15, 1955 Amended effective September 3, 1957 Regulations .01—.06 amended effective September 14, 1977 (4:19 Md. R. 1468) Regulation .03C amended and .05-1 adopted effective September 30, 1994 (21:9 Md. R. 751) Regulations .01—.06 repealed and new Regulations .01—.15 adopted effective August 5, 2002 (29:15 Md. R. 1142) Regulation .01B amended effective February 12, 2018 (45:3 Md. R. 157) Regulation .02 repealed effective February 12, 2018 (45:3 Md. R. 157) Regulation .05B, C amended effective February 12, 2018 (45:3 Md. R. 157) Regulation .07G amended effective February 12, 2018 (45:3 Md. R. 157) Regulation .08C—E amended effective February 12, 2018 (45:3 Md. R. 157) Regulation .09 amended effective February 12, 2018 (45:3 Md. R. 157) Regulation .10 amended effective February 12, 2018 (45:3 Md. R. 157) Regulation .11B amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .11H, J amended effective February 12, 2018 (45:3 Md. R. 157) Regulation .12 amended effective February 12, 2018 (45:3 Md. R. 157) Regulation .13B, D amended effective February 12, 2018 (45:3 Md. R. 157) Regulation .14 amended effective February 12, 2018 (45:3 Md. R. 157) Regulation .15B, C amended effective February 12, 2018 (45:3 Md. R. 157) Regulation .15C amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .15E repealed effective February 15, 2016 (43:3 Md. R. 272) This chapter: Governs food service facilities in Maryland; Along with COMAR 10.15.04, 15.04.01, and 15.11.11, establishes the standards for the control of Salmonella Enteritidis in shell eggs and egg-producing chickens as part of a program jointly administered by the Maryland Department of Health and the Maryland Department of Agriculture; and Is not intended to govern the food service operations in a child care center as defined in Family Law Article, §5-570, Annotated Code of Maryland, or a family day care home as defined in Family Law Article, §5-501, Annotated Code of Maryland, unless the food service operation is conducted in conjunction with another institution that is governed by this chapter. In this chapter, the following terms have the meanings indicated. Terms Defined. “Acceptable” means agreeable to the use or presence of equipment or a practice when standards are not developed or when developed standards are inappropriate, because the approving authority has determined that the equipment or practice conforms to principles, practices, and generally recognized standards that protect public health. Adulterated. “Adulterated” has the meaning stated in Health-General Article, §§21-207, 21-208, and 21-209, Annotated Code of Maryland. “Adulterated” includes food that: Contains any poisonous or deleterious substance; Is diseased, contaminated, filthy, putrid, or decomposed; or Is otherwise unfit as food for human beings. “Approved source” means a source of food or food ingredients accepted by the Department because the food or food ingredients from the source: Are not adulterated or misbranded; and Where required, are regulated by the approving authority. “Approving authority” means: Within the State, the Secretary of Health or the Secretary's designee; or Outside the State, the agency designated in the laws of another state or country to license or permit a food establishment. “aw” means water activity, which is: The ratio of the water vapor pressure of a food to the vapor pressure of pure water at the same temperature; and An index of the available, free moisture in food. Bake Sale. “Bake sale” means a place where only non-potentially hazardous bakery goods, including breads and pastries, are sold in conjunction with a fundraising event. “Bake sale” does not include a place: Where a person sells baked goods for individual profit; From which food is commercially distributed; or Where a potentially hazardous baked good is sold or distributed. “Barrier” means a physical, biological, or chemical factor that retards or prevents the growth of microorganisms that are infectious or toxigenic. “Base of operations” means a licensed food service facility that is used by the owner or operator of a mobile food service facility for food storage, potable water, safe disposal of waste and sewage, and, if necessary, utensil washing. “Bed and breakfast” means a lodging or rooming house as defined in Public Safety Article, §9-201, Annotated Code of Maryland, that has eight rooms or fewer for rent. “Bona fide nonprofit” means an organization having official documentation from the United States Internal Revenue Service that the organization has current tax-exempt nonprofit status. “Caterer” means a food service facility that: Offers catering services; or Identifies itself as a caterer. “Catering services” means the preparation or provision and the serving of food or drink by a food service facility for service at the provider's premises or elsewhere in connection with a: Specific public event; or Business or social function or affair. “Commercially sterile” means the condition achieved by the: Application of heat, pressure, or other energy or matter that renders a food free of: Microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; and Viable microorganisms, including spores, that may cause disease; or Control of water activity and the application of heat, pressure, or other energy or matter that renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution. Comminuted. “Comminuted” means reduced in size by methods including: Chopping; Flaking; Grinding; or Mincing. “Comminuted” includes fish, meat, or a mixture of products that are reduced in size and restructured or reformulated, such as: Gefilte fish; Formed roast beef; The meat used in gyros; Ground beef; and Sausage. “Condiment” means a food or seasoning used to enhance the flavor of another food, including: Mustard; Ketchup; Mayonnaise; Relish; Salt; Pepper; Sugar; or Chutney. “Consumer” means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food service facility or food processing plant, and does not offer the food for resale. “Consumer advisory” means a written notification to consumers that: Identifies food of animal origin that is served or sold as a ready-to-eat food or as an ingredient in a ready-to-eat food that is: Raw; Undercooked; or Not otherwise processed to eliminate pathogens; and Reminds consumers that consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase the risk of foodborne illness, especially if the consumer has certain medical conditions. Continental Breakfast. “Continental breakfast” means a meal that does not require major food preparation as specified in Regulation .28G(1) of this chapter. “Continental breakfast” includes foods such as: Coffee and tea; Juice; Cereal; Milk and cream; Whole fresh fruit; Pastries; Bread; Donuts; Butter and margarine; and Jams and jellies. “Continental breakfast” does not include foods such as: Eggs cooked outside of the shell; Meat; and Fruit salad prepared on premises. “Corrosion resistant” means the property that allows a material to maintain sanitary surface characteristics under the influence of prolonged contact with: Food; Cleaning compounds; Sanitizing solutions; and Other conditions of the environment. “Cottage food business” means a business that: Produces or packages cottage food products in a residential kitchen in Maryland; and Has annual revenues from the sale of cottage food products in an amount not exceeding $50,000. “Cottage food product” means: A non-potentially hazardous food as specified in Regulation .27 of this chapter that is offered for sale: Directly to a consumer from a residence, by personal delivery, by mail delivery, at a farmer’s market, or at a public event; or To a retail food store if the cottage food product remains in the original packaging; and A food that is not offered for sale through interstate commerce. “County of origin” means the county in which the base of operations of a mobile food service facility is located. “Critical control point (CCP)” means a point in the preparation or processing of food where there is a reasonable likelihood that improper control may cause, allow, or contribute to a hazard to public health. Critical Item. “Critical item” means a food safety requirement that if violated requires: Immediate correction; The cessation of some or all processing operations; or Plant closure. “Critical item” includes the following requirements: Obtaining food from an approved source; Protecting food from adulteration, spoilage, and contamination; Restricting food workers with infection or diarrhea in accordance with COMAR 10.06.01; Ensuring that all food workers wash hands thoroughly before touching food and utensils, and as often as needed to prevent food contamination from hand contact; Cooling potentially hazardous foods in accordance with the requirements of this chapter; Holding potentially hazardous foods at the hot and cold temperatures specified in this chapter; Cooking and reheating potentially hazardous foods in accordance with the requirements of this chapter; Providing potable hot and cold running water; and Discharging sewage from the facility in accordance with all applicable State and local codes. “Critical limit” means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to minimize the risk that an identified potential food safety hazard may occur. “Department” means the Maryland Department of Health or the Department's designee. “Detention order” means a written notification by the approving authority to the person-in-charge of a food service facility to detain food that may be adulterated or misbranded, pending a determination of the food's status and disposition in accordance with Health-General Article, §§21-253 and 21-254, Annotated Code of Maryland. “Easily cleanable” means the property of a surface that allows the surface to: Be readily accessible; and Have soil and residue removed by routine cleaning methods. “Egg carton” means a container holding up to 36 shell eggs, including overwrapped cartons and sleeves, that is used to pack shell eggs for distribution or sale to a consumer. “Egg case” means a container that: Is not a carton; Holds either loose shell eggs or cartons of eggs; and Is used to pack shell eggs for distribution or sale to a consumer. “Employee” means: The licensee; An individual having supervisory or management duties; An individual on the payroll; A volunteer; An individual performing work under contractual agreement; or Any other individual working in a food service facility. Equipment. “Equipment” means an item, other than a utensil, that is used in the operation of a food establishment for: Storage; Preparation; Display; Washing; or Transportation. “Equipment” includes a: Stove; Oven; Hood; Slicer; Grinder; Mixer; Scale; Meat block; Table; Food shelf; Refrigerator; Freezer; Sink; Ice maker; or Another item used in the operation of a food service facility. “Equipment” does not include a: Forklift truck; or Dolly. “Excluded organization” means a volunteer fire company or bona fide nonprofit fraternal, civic, war veterans’, religious, or charitable organization or corporation that does not serve food to the public more often than 4 days per week, except that once a year an organization may serve food to the public for up to 30 consecutive days. Farm. “Farm” means a place where agricultural commodities are grown, raised, or harvested for commercial purposes. “Farm” includes a place where, for commercial purposes: Crops are grown and harvested; Fruit, nuts, or other agricultural commodities are harvested from trees; or Animals are raised, fed, and managed for meat or other agricultural commodities. Farmer's Market. “Farmer's market” means a place where a person offers or sells one or more of the following food products directly to the public: Raw agricultural products; Products processed in a private home kitchen, as set forth in Regulation .27 of this chapter; Products that are not potentially hazardous and do not require refrigeration that are processed in a food processing plant licensed and operated according to COMAR 10.15.04.19; or Eggs in compliance with Regulation .05A(8) of this chapter. “Farmer's market” does not include a food service facility. “Food” means: A substance that is used as: Food or drink for human beings; or A component of food or drink for human beings; or Chewing gum or any substance that is a component of chewing gum. “Food-contact surface” means a surface: Of equipment and utensils with which food normally comes in contact; or From which food may drain, drip, or splash onto a: Food; or Surface normally in contact with food. “Food processing plant” has the meaning stated in COMAR 10.15.04.02B. Food Service Facility. “Food service facility” means: A place where food or drink is prepared for sale or service on the premises or elsewhere; or An operation where food is served to or provided for the public with or without charge. “Food service facility” includes: A restaurant, coffee shop, cafeteria, short order cafe, luncheonette, tavern, sandwich stand, soda fountain, retail market, or retail bakery outlet; A food operation in an industry, institution, health care facility, club, school, camp, church, catering kitchen, commissary, or a similar place in which food or drink is prepared for sale or for service on the premises or elsewhere; and A micro market licensed under Business Regulation Article, Title 17, Subtitle 17, Annotated Code of Maryland, and meeting the requirements of this chapter as a food service facility. “Food service facility” does not include a: Facility that offers only prepackaged foods that are not potentially hazardous as specified in §B(55)(c) of this regulation; Kitchen in a private home where food is prepared at no charge for guests in the home, for guests at a social gathering that is not a public event, or for service to unemployed, homeless, or another disadvantaged population; Food preparation or serving area where food is prepared or served only by an excluded organization; Hotel, lodging, or rooming house that serves only a continental breakfast; Farmer’s market or a public event where food products as specified in §B(30)(a) of this regulation are sold; Bake sale where only non-potentially hazardous bakery goods, including breads and pastries, are sold in conjunction with a fundraising event; or Cottage food business. Game Animal. “Game animal” means an animal: That is food for human beings; and That is not classified as cattle, sheep, swine, goat, mule, or other equine. “Game animal” includes: Reindeer; Elk; Deer; Antelope; Water buffalo; Bison; Rabbit; Squirrel; Opossum; Raccoon; Nutria; Muskrat; Bear; and Nonaquatic reptiles such as land snakes. “Game animal” does not include ratites such as: Ostrich; Emu; and Rhea. “Hazard” means a biological, chemical, or physical property that may be detrimental to public health. “Hazard analysis critical control point (HACCP) plan” means a written plan that delineates the procedures for maintaining control of potentially hazardous food at the critical control points of food preparation or processing. Health Care Facility. “Health care facility” means: A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland; A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland; An ambulatory surgical facility or center as defined in Health-General Article, §19-114, Annotated Code of Maryland; An inpatient facility that is organized primarily to help in the rehabilitation of disabled individuals, through an integrated program of medical and other services provided under competent professional supervision; A home health agency, as defined in Health-General Article, §19-401, Annotated Code of Maryland; A hospice facility, as defined in Health-General Article, §19-901, Annotated Code of Maryland; or Another health institution, service, or program for which Health-General Article, §19-114(d)(1)(ix), Annotated Code of Maryland, requires a certificate of need. “Health care facility” does not include the facilities, institutions, and offices set forth in Health-General Article, §19-114(d)(2), Annotated Code of Maryland. “Hermetically sealed container” means a container that: Is secure against the entry of microorganisms; and Maintains the commercial sterility of the contents after processing. “Juice” means: The aqueous liquid expressed or extracted from one or more fruits or vegetables; Purees of the edible portion of one or more fruits or vegetables; or Any concentrate of the liquid or puree as referenced in §B(40)(a) and (b) of this regulation. “License” means the authority to operate a food service facility within the State in accordance with this chapter and Health-General Article, Title 21, Subtitles 1, 2, and 3, Annotated Code of Maryland. “Loose eggs” means shell eggs not contained in a carton. “Lot designation” means a method of marking packed or packaged shell eggs to enable the packer and the approving authority to trace the eggs to the flock that produced the eggs. Major Food Allergen. “Major food allergen” means: Milk; Egg; Fish such as bass, flounder, or cod; Crustacea such as crab, lobster, or shrimp; Tree nuts such as almonds, pecans, or walnuts; Wheat; Peanuts; Soybeans; and A food ingredient that contains protein derived from milk, egg, fish, tree nuts, wheat, peanuts, or soybeans. “Major food allergen” does not include: A highly refined oil derived from a food specified in §B(44)(a) of this regulation and any ingredient derived from a highly refined oil; or An ingredient that is exempt in regard to food allergen labeling requirements under the petition or notification process specified in 21 U.S.C. §343(w)(6) and (7). “Micro market” means an unstaffed, self-checkout retail food service facility that: Includes one or more micro market displays; Has an automated payment kiosk or other device designed to accept electronic payments that is operated by the consumer; Is located indoors and within a separate business; and Is generally accessible only to individuals within the building in which the food service facility is located. “Micro market display” means the place where the food being sold by a micro market is displayed, including: An open rack; A refrigerator or a refrigerated cooler; A freezer; A vending machine; A beverage dispenser; or A single-serve coffee brewer. “Misbranded” has the meaning stated in Health-General Article, §21-210, Annotated Code of Maryland. Mobile Food Service Facility. “Mobile food service facility” means a food service facility that is a mechanically, electrically, manually, or otherwise propelled vehicle operating on land or water that moves as part of its routine operation to: Change location for sales; Obtain food and other supplies; Fill potable water supply holding tanks; Empty wastewater holding tanks; or Provide for the cleaning and sanitization of equipment and utensils. “Mobile food service facility” does not include a food service facility that is able to be moved but does not move routinely for a purpose set forth in §B(46)(a) of this regulation. “Mobile reciprocity license” means a license issued to a mobile food service facility that: Is operating in the jurisdiction; Is operating within 90 miles of its base of operations; and Holds a valid license from the county of origin. “Non-potentially hazardous food” means food named or described in §B(55)(c) of this regulation. “On-farm food service facility” means a temporary food service facility that: Is located on a farm; Serves only those foods approved by the Department, based on a: Review of the facility, equipment, and processing hazards; and Determination that these foods can be prepared safely and in a manner that conforms to applicable laws and regulations; and Operates during a period of time of not more than 30 consecutive days with up to two renewals in a 1-year period. “Package” means a bottle, can, carton, bag, or wrapped container. “Packer” means a person who places shell eggs in the original case, carton, or container that is used to hold eggs for: Distribution; or Sale to a consumer. “Person” has the meaning stated in Health-General Article, §§1-101 and 21-101, including: An operator of a facility that is owned by the State or local unit of government; or A State or local unit of government if the State or local unit of government is the operator of the facility. “Person-in-charge” means: The licensee; or Another person responsible for the operation of a food service facility. “pH” means the symbol for the negative logarithm of the hydrogen ion concentration in gram equivalents per liter of solution where: pH values from 0 to 7 indicate acidity; pH values from 7 to14 indicate alkalinity; and The pH value for pure distilled water, regarded as neutral, is 7. “Portable” means that equipment: Can be easily moved because the equipment is: Small in size and weighs 80 pounds or less; Mounted on casters, gliders, or rollers; or Provided with a mechanical means of safely tilting for cleaning; and Has one of the following: No utility connection; A utility connection that disconnects quickly; or A flexible utility connection line long enough to permit the equipment to be moved for thorough cleaning. Potentially Hazardous Food. “Potentially hazardous food” means a natural or synthetic food that requires temperature control because the food is in a form capable of supporting: The rapid and progressive growth of infectious or toxigenic microorganisms; The growth and toxin production of Clostridium botulinum; or In raw shell eggs, the growth of Salmonella Enteritidis. “Potentially hazardous food” includes: A food of animal origin that is raw or heat-treated; A food of plant origin that is heat-treated; Raw seed sprouts; Cut melons; Cut raw tomatoes; Garlic and oil mixtures that support growth as specified in §B(55)(a)(i) and (ii) of this regulation; and Cut leafy greens. “Potentially hazardous food” does not include a: Hard-boiled shell egg that has been air-cooled with the shell intact; Food with an aw value of 0.85 or less; Food with a pH level of 4.6 or below when measured at 75°F; Commercially sterile food in a hermetically sealed container; or Food for which laboratory evidence demonstrates that the rapid and progressive growth of infectious and toxigenic microorganisms or the growth of Salmonella Enteritidis in eggs or Clostridium botulinum cannot occur, such as a food that has an aw or a pH that is above the levels specified in §B(55)(c)(ii)and(iii) of this regulation or that may contain a preservative, other barrier to the growth of microorganisms, or a combination of barriers that inhibit the growth of microorganisms. “Poultry” means a: Domesticated bird whether live or dead including a: Chicken; Turkey; Duck; Goose; Guinea; Ratite; or Squab; and Migratory waterfowl or game bird whether live or dead, including a: Pheasant; Partridge; Quail; or Grouse. “Premises” means the physical food service facility and the contiguous land or property under the control of the operator or the licensee. “Principal display panel” means the part of a container that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. “Priority assessment” means an evaluation of risk in a food service facility using the parameters established by the Department in Regulation .33C of this chapter. Public Event. “Public event” means an event or festival that is a planned gathering that is: Open to the public; and Regulated by the State or local jurisdiction in which the planned gathering takes place. “Public event” includes an event or festival: Attended by individuals from the general public whether or not a fee is charged; or Advertised with fliers, banners, newspaper articles, radio or television announcements, or on an Internet website as being open to the public. “Public event” does not include a: Private party; An event restricted to organization members; or Another event that restricts the general public from attending. “Raw agricultural product” means a whole, unprocessed agricultural product supplied directly from the farm on which it was produced, including: Grains; Flowers; Herbs; Nuts; Fruits; Vegetables; and Honey. Ready-to-Eat Food. “Ready-to-eat food” means food in a form that is edible without washing, cooking, or additional preparation by the food service facility or the consumer. “Ready-to-eat food” includes: Potentially hazardous food that is cooked to the temperature and time required for a specific food as set forth in Regulation .10 of this chapter; Raw fruits and vegetables that are washed and cut; Whole, raw fruits and vegetables that are presented for consumption without need for further washing, such as at a buffet; and A food presented for consumption for which further washing or cooking is not required and from which rinds, peels, husks, or shells are removed. “Reconditioned” means reprocessing a food using an approved method that results in a food that is safe, wholesome, and free from contamination. “Reconstituted” means water or other liquid has been restored to a food that was previously dehydrated. Reduced Oxygen Packaged. “Reduced oxygen packaged” means that a food was packaged so that the amount of oxygen in the package is below that found in the surrounding atmosphere due to the: Mechanical evacuation of oxygen; Displacement of oxygen with one or more gases; or Reduction of the oxygen content by other means. “Reduced oxygen packaged” includes food that is: Vacuum packaged; Modified atmosphere packaged; and Controlled atmosphere packaged. “Refrigerated food” means a food that: Is not shelf stable; Must be refrigerated to: Retard the growth of spoilage or pathogenic microorganisms; and Prevent the production of microbial toxins; or Is labeled by the manufacturer with a statement indicating that the product is to be kept refrigerated. “Registration” means the process by which the Maryland Department of Agriculture grants the authority to a packer within the State to provide shell eggs for human consumption. “Registration number” means the number that the Maryland Department of Agriculture assigns a packer. “Retail food manufacturing” means the manufacturing of food in a food service facility for wholesale distribution. Retail Food Store. “Retail food store” means a licensed food service facility that sells prepackaged food items either fresh, refrigerated, frozen, or shelf-stable. “Retail food store” includes a grocery store, convenience store, retail market, retail bakery, or food cooperative. “Retail food store” does not include a restaurant, mobile food service facility, coffee shop, cafeteria, short order café, luncheonette, tavern sandwich shop, produce stand that only offers whole, uncut fresh fruits and vegetables, or establishment that offers only pre-packaged non-potentially hazardous foods. “Sanitization” means a heat or chemical treatment on cleaned food contact surfaces that is sufficient to yield a 99.999 percent reduction of the number of representative disease microorganisms of public health significance. “Seasonal farmer’s market producer sampling food service facility” means a facility that: Serves only foods that are prepared and offered as samples by a producer of a farm product at a farmer’s market or a public event, such as: Farm products as specified in §B(30)(a) of this regulation; or Farm products that have been inspected, licensed, or certified for food safety by the Maryland Department of Agriculture; Serves food only produced by the licensee; Serves only those foods approved by the Department, based on a: Review of the facility, equipment, and processing hazards; and Determination that these foods can be prepared safely and in a manner that conforms to applicable laws and regulations; and Operates during a period of time of not more than a 1-year period from the date of issuance or renewal of the license. “Secretary” means the Secretary of Health or the Secretary's designee. “Semi-permanent food service facility” means a facility that: Is built at a location other than where it operates; Is transported as a complete unit that does not require a building permit to install on the location at which it operates; Has no indoor seating for patrons; When serving cooked food, serves only foods cooked for immediate service; and Is not a mobile food service facility as specified in §B(46) of this regulation. “Service animal” has the meaning stated in Human Services Article, §7-701, Annotated Code of Maryland. “Shell eggs” means raw eggs produced by chickens for human consumption. “Shellfish” means all species of: Oysters, clams, or mussels, whether: Shucked or in the shell; Raw, including post-harvest processed; Frozen or unfrozen; and Whole or in part; and Scallops in any form, except when the final product is the adductor muscle only. Single Service Article. “Single service article” means an article designed, fabricated, and intended for one-time consumer use. “Single service article” includes a: Utensil; Cup; Plate; Stirrer; Napkin; Straw; Toothpick; Food container; Place mat; Food package; or Similar item. Single Use Article. “Single use article” means an article intended by the manufacturer for one-time use by the preparer of the food. “Single use article” includes a: Bulk food container; Utensil; Formed aluminum pie pan; Jar; Plastic bucket; or Similar item. Special Food Service Facility. “Special food service facility” means a food service facility for which the Department provides exceptions to certain regulations because of the nature of one or more of the following: Design and operation of the facility; Food preparation or service methods; or Limited length of time that the facility operates in association with special events. “Special food service facility” includes: A bed and breakfast that serves hot meals; A mobile unit; A temporary food service facility; A semi-permanent food service facility; An on-farm food service facility; or A seasonal farmer’s market producer sampling food service facility. Tableware. “Tableware” means multi-use eating, drinking, and serving utensils. “Tableware” includes: Knives; Forks; Spoons; Bowls; Cups; Serving dishes; Tumblers; and Plates. “Temporary food service facility” means a food service facility that operates at a fixed location for up to 30 consecutive days in conjunction with a: Fair; Carnival; Public exhibition; Construction project; Recreational facility; Fundraising event; or Similar gathering. “Time-only” means using time instead of time in conjunction with temperature as the sole means of food protection for a potentially hazardous food. “Undercooked” means a potentially hazardous food that is not cooked to the minimum internal temperature and for the specified holding time specified in Regulation .10A of this chapter. “Utensil” means tableware or a food-contact implement used in the storage, preparation, dispensing, or serving of food. “Vending machine” means a self-service device that dispenses either packaged or unpackaged food. “Warewashing” means the cleaning and sanitizing of food-contact surfaces of equipment or utensils. Whole Muscle, Intact Beefsteak. “Whole muscle, intact beefsteak” means a beefsteak cut from whole muscle beef that has not been penetrated in a way that may allow infectious or toxigenic microorganisms to be introduced into the interior of the meat. “Whole-muscle, intact beefsteak” does not include meat that has been: Injected; Mechanically tenderized; Reconstructed; or Scored. In this chapter, the following documents are incorporated by reference. Documents Incorporated. 21 CFR, as amended; 9 CFR, as amended; and 21 U.S.C. §343, as amended. The person-in-charge shall ensure that: Food served to the public is: Wholesome and free from contamination; Not adulterated; Safe for human consumption; Obtained from an approved source; and If in packaged form, labeled in accordance with: COMAR 10.15.01; COMAR 10.15.02; COMAR 10.15.04; and This chapter; Eggs and egg products comply with Regulation .05 of this chapter; Milk and milk products are not sold or served unless they are produced, processed, stored, transported, and distributed in accordance with COMAR 10.15.06 and COMAR 10.15.09, including: Fluid milk; Other fluid dairy products; Manufactured milk products; and Reconstituted dry milk or dry milk products used only for: Instant desserts; Whipped products; and Cooking and baking purposes; Frozen desserts including ice cream, soft frozen desserts, ice milk, sherbets, ices, gelato, and frozen dessert mix are manufactured and sold in accordance with COMAR 10.15.05; Shellfish: Are obtained from an approved source; Are from a firm listed in the “Interstate Certified Shellfish Shippers List”; Are processed, handled, packed, labeled, and identified in accordance with COMAR 10.15.07; Containers are identified with a tag or label as set forth in COMAR 10.15.07; and Tags are maintained on the premises for 90 calendar days after a container of shellfish is emptied to identify readily the source of the shellfish, by: Recording the date on the tag or label when the last shellfish from the container is sold or served; Using an approved record keeping system that: Keeps the tags or labels in chronological order; and Preserves source identification if tags or labels are removed from the container; and Ensuring that shellfish from one tagged or labeled container is not mixed with shellfish from another container if the tags or labels are removed from the container. Crab meat is processed, handled, and packed in accordance with COMAR 10.15.02; Seafood is processed, handled, and packed in accordance with COMAR 10.15.10; Meat and poultry have been inspected for wholesomeness by the approving authority; and Ice is: Made: From a potable water supply; In an ice-making machine that: Meets the standards in Regulation .15 of this chapter; and Is located, installed, operated, and maintained to prevent contamination; If not manufactured on site, obtained from an approved source; Handled, transported, and stored in a manner that precludes contamination; and Not reused. The person-in-charge shall ensure that: Only clean, whole Grade A or higher grade eggs with shell intact and without cracks, or pasteurized eggs or egg products, are used; An invoice or other equivalent record is obtained from the supplier for each delivery of shell eggs; The invoice or equivalent record required in §A(2) of this regulation contains the following information written in English: Name and address of the seller and buyer; Date of delivery; Grade and size of eggs delivered; and Quantity of eggs sold in number by grade and size; When loose eggs are distributed, offered for sale, or sold directly to a consumer in Maryland: A daily record is maintained that shows the lot designation of the shell eggs for each packer; A placard is displayed that: Is legible and printed in block letters not less than 3/8 inch in height; Is a minimum size of 4-1/4 inches by 6 inches; Plainly and conspicuously displays the eggs' grade term, size (weight), and lot designation; and Is placed on or near the eggs; and Egg cartons are labeled in accordance with §A(9), (10), and (12) of this regulation; All egg invoices, daily records, or other equivalent records are kept on file for a minimum of 90 days; Upon request, the approving authority is granted access to copy and verify, at any reasonable time, records relating to the sale and purchase of shell eggs; Except as provided in Regulation .10 of this chapter, only pasteurized eggs and egg products are used when serving eggs or foods prepared with eggs that have not been heated adequately to kill Salmonella Enteritidis; All shell eggs accepted for delivery, used, or provided to the consumer are: Produced by flocks that are certified to be in compliance with COMAR 15.11.11; Supplied by a registered packer as provided in COMAR 15.04.01; and Pasteurized or otherwise heat-treated to kill Salmonella Enteriditis if Salmonella Enteriditis is isolated from a flock in Maryland as determined by testing procedures contained in COMAR 15.11.11; All egg cartons of shell eggs accepted for delivery, used, or provided to the consumer are labeled on the principal display or information panel with: Legible stamping in permanent ink; The following information at a minimum type size of 1/16 of an inch: The packer's or distributor's name and address; The packer's registration number; The lot designation of the eggs; and A safe handling statement with the words “safe handling instructions” in bold capital letters and the statement “To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly.” set off in a box by hairlines; The following information at a minimum type size of 1/4 of an inch: The identity of the product as eggs; and The word “grade” and the grade term (AA or A) and size (weight) of the eggs; and The net quantity of eggs in weight or numerical count in at least the minimum type size permitted based on the space available for labeling as set forth in §B of this regulation, with the minimum type size measurement determined by: The height of type of printing by measuring the height of the lower case letter “o” or its equivalent when mixed upper and lower case letters are used; or The height of the upper case letters when only upper case letters are used; If the safe handling statement does not appear on the principal display panel or the front information panel, a separate statement that eggs be kept refrigerated is printed on either the principal display panel or the front of the information panel; The same information in at least the same minimum type size that is required on an egg carton is printed on the top of an egg case or any side of an egg case; and The grade term and size (weight) on an egg carton is not abbreviated. Table 1. The person-in-charge shall ensure that: At all times: Food is: Not adulterated; and Protected from contamination during storage, preparation, display, service, and transportation; The internal temperature of a food is maintained according to the requirements of this chapter to preclude the growth of pathogenic bacteria and other microorganisms that could cause spoilage; Except during necessary periods of preparation and service, a potentially hazardous food is refrigerated or held hot as set forth in §B(7) of this regulation; When storing and holding food: Facilities used for hot or cold potentially hazardous food are provided a temperature-measuring device that is: Graduated and accurate to plus or minus 2°F; Calibrated annually or more frequently; Located in the: Coldest area of equipment where hot foods are stored; and Warmest area of equipment where cold foods are stored; and Easily readable; Except for metal beverage containers and cased food packaged in cans, glass, or other waterproof containers stored as provided in §B(3) of this regulation, containers of food are stored: Off the floor; 18 inches above the floor or higher if food is exposed; On clean racks, dollies, or other clean surfaces; and In a manner that will protect from splash and other contamination; When metal beverage containers and cased food in cans, glass, or other waterproof containers are stored on the floor: The floor is maintained in a clean and sanitary condition; The storage: Is temporary such as for floor displays; Does not interfere with the flow of food or personnel; and Does not afford harborage for rodents or insects; In refrigeration units, the food is placed to permit free circulation of cold air; Except where food packaging prevents the entry of water, packaged food is not stored in contact with water or un-drained ice; Food is not stored in locker rooms, toilet rooms, dressing rooms, garbage rooms, or mechanical rooms; Except as provided in §B(8)—(13) of this regulation, the internal temperature of a potentially hazardous food is kept at 41°F or less or 135°F or greater; If pasteurized crab meat, the crab meat’s internal temperature is maintained at 41°F or less; If potentially hazardous reduced oxygen packaged products, the reduced oxygen packaged food's internal temperature is maintained at: 38°F or less if refrigeration is the only barrier to control the growth of Clostridium botulinum; or At a lower temperature if a lower temperature is specified by the food manufacturer; If shell eggs and shellfish, the eggs and shellfish are stored, displayed, and transported under refrigeration at an ambient temperature of 45°F or less; Except for the service of foods such as ice cream and frozen desserts, frozen food is received and stored frozen; If a whole roast cooked and cooled in accordance with Regulations .10 and .11 of this chapter, the roast is held at an internal temperature of 130°F or above; and Using holding temperatures and times other than those specified in this section, the holding temperatures and times are: Scientifically proven to be effective in preventing the growth of foodborne pathogens; Incorporated into an HACCP plan; and Submitted to and approved by the Department based on a review that indicates compliance with §B(13)(a) and (b) of this regulation; While displaying and serving food: Except as provided in §C(3) of this regulation, a potentially hazardous cold food that is placed on display is: Pre-chilled to an internal temperature of 41°F or below; Rapidly re-chilled to an internal temperature of 41ºF or below if the food has exceeded 41ºF for a verifiable period of not more than 4 hours; or Discarded if: The food has exceeded 41°F or more for more than 4 hours; or The time the food has been out of temperature is not verifiable; Except as provided in §§B(12) and (13) and C(3) of this regulation, a potentially hazardous hot food that is placed on display is: Cooked according to Regulation .10 of this chapter; Rapidly re-heated to an internal temperature of 165ºF or above if the food was below 135ºF for a verifiable period of not more than 4 hours; and Discarded if: The food was below 135°F for more than 4 hours; or The time the food has been out of temperature is not verifiable; A potentially hazardous bakery product that is stored at room temperature: Is manufactured, packaged, and labeled with a sell-by date only in an approved food processing plant meeting the requirements set forth in COMAR 10.15.04; Remains in the original package until sold to a consumer; and Is not offered for human consumption following expiration of the sell-by date; Except as provided in §C(5) of this regulation, raw unpackaged food of animal origin is not offered for consumer self-service; Raw unpackaged foods of animal origin offered for consumer self-service are offered only: At buffets or salad bars that serve foods of animal origin such as sushi or raw shellfish; When the foods of animal origin are ready-to-cook individual portions for immediate cooking and consumption on premises, such as for Mongolian barbecue; or Frozen if shell-on shrimp and lobster; When uncovered food is placed on display in food operations, including buffets and cafeterias, the ready-to-eat food is protected by: Physical guards; Separation from potential contaminants; or Other effective methods acceptable to the approving authority; During pauses in food preparation or dispensing, utensils such as scoops, spoons, and dippers are stored: In a running water dipper well that provides a volume of fresh potable water sufficient to maintain the utensil in a sanitary condition; In hot water that is maintained at 135°F or above; With the handles above the top of the food in an open container; On a clean portion of the food preparation or cooking equipment, which has been cleaned and sanitized as set forth in Regulation .16 of this chapter; or In a clean, protected location if the utensils are used with a food that is not potentially hazardous; Sugar, condiments, seasonings, and dressings are provided for self-service in individual packages or dispensed by methods that protect the food; Except for packaged non-potentially hazardous foods with the wrapping intact, portions of food once served to a customer are not served again; and Except for drinking cups reused by self-service consumers in a manner to prevent cross-contamination, employees and self-service customers do not reuse soiled tableware, including single service articles to: Provide second portions or refills; or Obtain additional food from display and serving equipment; During the transportation of food: Except as provided in §B(8)—(13) of this regulation, the internal temperature of a potentially hazardous food is maintained at 41°F or below or 135°F or above; From a food service facility to another location, the requirements set forth in §A(2) of this regulation are met; Frozen food is maintained frozen; and Food is in covered containers or completely wrapped or packaged to protect against contamination; and During the preparation, storage, or service of food: Unsafe or adulterated food is discarded or reconditioned according to an approved procedure by the approving authority; Food that is not from an approved source as specified under Regulation .04 of this chapter is discarded; Ready-to-eat food that may have been contaminated by an employee who has been restricted or excluded as specified under Regulation .14A or B of this chapter is discarded; and Food shall be discarded if it is contaminated by employees, consumers, or other persons through: Contact with their hands; Bodily discharges, such as nasal or oral discharges; or Other means. The person-in-charge shall ensure that: During the use of outdoor cooking equipment, such as a barbeque grill, at a food service facility: Equipment: Is used only at the food service facility for service to patrons; Is located: On an impermeable surface; In close proximity to the food preparation area of the food service facility; and Away from parking areas, dumpsters, and patron entrances; and Meets the requirements set forth in Regulation .15 of this chapter; Food is: Prepared for outdoor cooking inside the food service facility; and Protected from contamination during cooking and service; and When preparing beverages outdoors: Overhead protection is provided; Protection from contamination during storage is provided for ingredients, including: Ice; Drink mixes; and Condiments; Containers are protected from contamination during storage; and Other than when only beer, wine, or soda is offered, a hand washing sink is provided in accordance with Regulation .18K and L of this chapter. The approving authority may approve the use of time-only, rather than time in conjunction with temperature, for food protection as set forth in §B of this regulation. The person-in-charge shall ensure that: Before using time-only while holding or preparing a potentially hazardous food: A written request is submitted to and approved by the approving authority for a specific food under specific conditions of preparation and service that includes: A record-keeping procedure that can verify safety intervention steps; and Procedures for marking or otherwise identifying the food with the time by which it is to be either used or discarded; and The procedures for time-only are included in the food service facility's HACCP plan as a critical control point; Except as otherwise approved by the approving authority, the maximum time limit under time-only control is 4 hours for a: Raw, working supply of potentially hazardous food during preparation, after which time the food is cooked or discarded; and Ready-to-eat potentially hazardous food held for immediate consumption, after which time the food not served is discarded; Food has an initial temperature of: 41°F or less upon removal from refrigeration; or 135°F or more upon removal from cooking equipment; and Food that has been protected using time-only control is not served in a health care facility. The person-in-charge shall ensure that: Food temperature measuring devices are: Used to monitor the temperature of potentially hazardous foods; Graduated and accurate within plus or minus 2°F; Calibrated annually or more frequently; and Cleaned and sanitized between uses in different foods to prevent cross-contamination; The storage, thawing, cooking, cooling, reheating, and holding of a food: Are safe; and Comply with this chapter; When a recipe in which more than one egg is broken and the eggs are combined and not prepared for immediate service: The mixture is stored under refrigeration at all times before cooking; The process is included in the food service facility's HACCP plan as a critical control point; and The mixture containing eggs is cooked to a minimum internal temperature of 155°F for 15 seconds; Potentially hazardous food is thawed: In refrigerated units so that the temperature of the food does not exceed 41°F; Under potable running water that is at or below 70°F with sufficient force to agitate and float off loose particles; In a microwave oven only when the food will be immediately cooked in the microwave oven or immediately transferred to conventional cooking facilities as part of a continuous cooking process; If a potentially hazardous reduced oxygen packaged food: In the food’s airtight package at or below 41°F; At a lower temperature if specified by the manufacturer; or If fish or seafood, completely removed from the reduced oxygen environment or package prior to thawing; As part of a conventional cooking process; or By another method acceptable to the approving authority that has been scientifically proven to the approving authority to prevent the bacteriological, physical, or chemical contamination of food; Employees prevent contact of exposed, ready-to-eat food with their bare hands by using: Gloves as specified under Regulation .14J of this chapter; Utensils such as: Tongs; Spatulas; Deli tissue; or Automatic dispensing equipment; and Cross-contamination is prevented by: Not allowing contact between ready-to-eat and raw foods; Storing and holding food so that: Ready-to-eat food is located above or otherwise segregated from raw food; and A food is protected from plumbing leaks and condensate drippage; Using separate utensils and work surfaces for ready-to-eat food and foods requiring further preparation; Cleaning and sanitizing utensils and work surfaces between uses; Excluding sick workers from food handling in accordance with Regulation .14A and B of this chapter; and Washing raw fruits and vegetables thoroughly to remove soil and other contaminants before cutting, cooking, or serving, with: Water; or Chemicals intended specifically for washing or peeling whole fruits and vegetables as specified in 21 CFR §173.315. Except as provided in §§B—D of this regulation, the person-in-charge shall ensure that potentially hazardous food is cooked to the minimum internal temperature and for the specified holding time as follows: Chart 1. Summary of Minimum Cooking and Reheating Food Temperatures and Holding Times. A minimum internal temperature of 145°F for 15 seconds for: Shell eggs prepared for immediate service; Fish; Meat; and All other potentially hazardous food not specified in §A(3)—(7) of this regulation; A minimum internal temperature of 155°F for 15 seconds or as specified in §A(1) of this regulation for: Shell eggs not prepared for immediate service; Ratites; Comminuted fish and meats; Game animals commercially raised for food; and Injected meats; A minimum internal temperature of 130°F for 112 minutes or as specified in §A(1) of this chapter for: Whole or corned beef; and Pork and cured pork roasts; A minimum internal temperature of 165°F for 15 seconds for: Poultry; Stuffed meat, pasta, or poultry; Exotic bird species; Wild game animals; and Stuffing containing fish, meat, or poultry; A minimum internal temperature of 165°F and held for 2 minutes after removing from the oven for raw animal foods that are cooked in a microwave oven; and A minimum internal temperature of 135°F for fruits and vegetables cooked for hot holding. The Department may approve cooking times and temperatures other than those specified in §A of this regulation, if the cooking times and temperatures are scientifically proven to the Department to be as effective in killing foodborne pathogens as those specified in §A of this regulation. The person-in-charge may serve a consumer: Undercooked seared beefsteak when: Only whole muscle, intact beefsteak, is prepared; The meat is seared continuously on both top and bottom utilizing a heating environment that: Imparts a temperature at the surface of the intact steak of at least 145°F for 15 seconds; and Achieves a cooked color change on all external surfaces; and A HACCP plan specifically developed for undercooked seared beefsteak is submitted and approved by the approving authority; and A food that is cooked, cooled, and then refrigerated in accordance with this chapter, such as roast beef for a sandwich, cold or warmed to any desired temperature for immediate consumption. A health care facility may not serve a raw or undercooked animal food. Repealed. The person-in-charge shall ensure that a consumer advisory is issued when an animal food, such as beef, eggs, fish, lamb, pork, poultry, or shellfish, is served raw or undercooked by: Providing a written notification on: A menu or brochure; A deli case or menu board; A label statement; A table tent or placard; or Another written means that is visible and legible to the consumer; Identifying food items on the items set forth in §F(1) of this regulation with an asterisk to a footnote that states the item: Is served raw; Is served undercooked; May be cooked to order upon specific consumer request; or Contains raw or undercooked ingredients; and Providing this written statement: “Consuming raw or undercooked animal foods may increase your risk of contracting a foodborne illness, especially if you have certain medical conditions.” The person-in-charge shall ensure that: A potentially hazardous cooked food’s internal temperature is cooled from 135°F to 70°F within 2 hours and from 70°F to 41°F or less within an additional 4 hours; A potentially hazardous food for cold service, such as a reconstituted food, salad, or canned meat, is cooled to an internal temperature of 41°F within 4 hours; Cooling of potentially hazardous food is accomplished using one or a combination of the following methods: Refrigerate in shallow pans with food not over 3 inches deep; Reduce food mass by separating foods into smaller or thinner portions; Use rapid cooling equipment; Use ice water baths combined with frequent stirring; Use containers that facilitate heat transfer; Add ice made from potable water as an ingredient; Refrigerate loosely covered or allow the food to remain uncovered until cooled if the food is protected from overhead contamination; or Another effective method acceptable to the approving authority based on applicable state and local laws, regulations, and ordinances; and Potentially hazardous food is reheated: Within 2 hours to a minimum internal temperature of 165°F for 15 seconds for food that is cooked, cooled, and refrigerated before being placed into hot food holding equipment; Within 2 hours to a minimum internal temperature of 135°F for ready-to-eat food taken from a commercially processed, hermetically sealed container or from an intact package from a food processing plant that is inspected by a food regulatory authority for hot holding; Using the same time and temperature conditions specified in Regulation .10A of this chapter for initial cooking for remaining unsliced portions of roasts for hot holding; and Within 2 hours or less, to a minimum internal temperature of 165°F for 15 seconds in a microwave oven for hot holding and then stirred, covered, and allowed to stand covered for 2 minutes after reheating. The person-in-charge shall ensure that: Except as specified in §B of this regulation, each item of packaged food has a label containing the following information: The common name of the food or a descriptive identity statement; If made from two or more ingredients: A list of ingredients in descending order of prominence by weight; and A declaration of artificial color or flavor and chemical preservatives; An accurate declaration of the quantity of the package contents by weight in both metric and English units; The name and place of business of the manufacturer, packer, or distributor; Except as exempted in 21 U.S.C. §343(q)(3)—(5), the nutrition labeling specified in 21 CFR Part 101 and 9 CFR Part 317; and The name of the food source for each major food allergen that is contained in the food unless the food source is already part of the common or usual name of the respective ingredient; The use of canthaxanthin as a color additive in salmonid fish is disclosed by written means, such as a counter card; Bulk food available for consumer self-dispensing is prominently labeled with the following information in plain view of the consumer: The manufacturer's label that was provided with the food; or A card, sign, or other method of notification that includes the information specified in §A(1)(a), (b), and (f) of this regulation. A food service facility may offer for sale bulk, unpackaged foods such as bakery products and unpackaged foods that are portioned to consumer specification without a label if: A health, nutrient, or other claim relating to the unpackaged food is not made on a card or sign; and The food is manufactured or prepared on the premises of the food service facility or at another food service facility owned by the same person. The person-in-charge shall ensure that: Except for packaged poisonous or toxic products offered in their unopened original containers for retail sale, only poisonous or toxic materials needed to maintain sanitary conditions and to sanitize equipment and utensils are located in a food or food utensil area; A container of a poisonous or toxic material is: Kept in the original bulk container before use; Prominently and distinctively marked or labeled for easy identification; and Used according to the manufacturer's directions; When not in use, poisonous or toxic materials are stored in a: Cabinet used for no other purpose; or Room not used for food storage, food preparation, or equipment and utensil washing or storage; A bactericide, cleaning compound, or other compound intended for use on food-contact surfaces is not: Stored in the same cabinet with an insecticide, rodenticide, or other poisonous or toxic material; or Used or stored in a way that will leave a toxic residue on food-contact surfaces; A poisonous or toxic material is not used or stored in a way that will: Contaminate: Food; or Food equipment; or Constitute a potential hazard to: Employees; or Customers; A medication is not stored in a food storage, preparation, processing, or service area; First aid supplies are stored in a way that prevents contamination of: Food; or Food-contact surfaces; and A container previously used to store poisonous or toxic materials is not used to store, transport, or dispense: Food; or Items that will come into contact with food. The person-in-charge shall ensure that: As set forth in COMAR 10.06.01.06E, a food handler does not serve or handle food intended for public consumption if the food handler: Has any of the following diseases: Diarrhea caused by Entamoeba histolytica; Cholera; Disease causing diarrhea, unless physician-certified as noninfectious; E. coli O157:H7; Hepatitis A; Diarrhea caused by Salmonella; Shigellosis; Streptococcal infection caused by group A beta-hemolytic Streptococcus; or Typhoid fever; or Is a carrier of Salmonella Typhi; An employee experiencing persistent sneezing, coughing, or a runny nose that causes discharges from the eyes, nose, or mouth does not work with: Exposed food; Clean equipment, utensils, and linens; or Unwrapped single service or single use articles; An employee who has a disease that may be transmissible through food reports the condition to the person-in-charge; The approving authority is notified when an employee of a food service facility is known to have or is suspected of having a disease that is transmissible by food; An employee washes hands and exposed arm areas thoroughly with soap and warm water: Before handling: Exposed foods; or Food-contact surfaces; Before starting work; As often as required to remove soil and contamination; After using toilet facilities; and Before and between glove use; An employee washes hands, exposed portions of the arms, between the fingers, and underneath the fingernails: With a cleaning compound; At a hand washing facility that is equipped as specified in Regulation .18K and L of this chapter; and By: Vigorously rubbing together the surfaces of lathered hands and arms for at least 20 seconds; Cleaning under the nails with a brush if needed; and Thoroughly rinsing the hands and arms with clean water; An employee keeps hands clean while engaged in handling food and food-contact surfaces; An employee who handles exposed food and food-contact surfaces: Keeps fingernails clean and neatly trimmed; Unless wearing gloves that are in good repair, does not wear fingernail polish or artificial fingernails; Except for a plain, smooth ring such as a wedding band, does not wear jewelry; Wears outer garments that are clean; Uses hairnets, caps, or other effective hair restraints in order to keep hair from contacting food and food-contact surfaces; Maintains personal cleanliness; and Except as provided in §L of this regulation, does not eat, drink, or use tobacco in any form while working; An employee does not use bare hands for handling ready-to-eat foods, as set forth in Regulation .09E of this chapter; An employee using gloves to protect exposed food: Uses gloves only for one task; Does not use the same gloves while working with ready-to-eat food and raw food; and Discards used gloves when: The gloves are damaged or soiled; An interruption occurs in the operation; or After 2 hours of continuous use; An employee receives training in proper food handling and sanitation as it relates to assigned duties; and When in a food preparation or utensil washing area, an employee: Drinks only from a covered beverage container; and Handles the container in a way that prevents contamination of: The employee's hands; Exposed food; Clean equipment; Utensils; Linens; and Unwrapped single service and single use articles. The person-in-charge shall ensure that: Except as provided in §§A(2) and (14) and B of this regulation, food equipment meets one or more of the following design standards: National Sanitation Foundation (NSF) or equivalent sanitation certification from: The Etlsemko division of Intertek Group PLC (Intertek ETL SEMKO); Canadian Standards Association (CSA); or Underwriters Laboratories (UL); Baking Industry Sanitation Standards Committee; National Automation Merchandizing Association; International Association of Milk and Food Sanitarian's "3-A Sanitary Standards"; or Another applicable published standard acceptable to the approving authority; When design standards conflict with State laws, codes, or regulations, the State laws, codes, or regulations are followed; Equipment and utensils are designed, constructed, and maintained to: Accomplish the intended and required functions; Protect food from internal and external contamination; Be durable under normal conditions and operations; Be resistant to: Denting; Buckling; Pitting; Chipping; Crazing; and Excessive wear; Have non-food contact surfaces where exposed to splash, food debris, or other soils that are: Smooth; Washable; and Readily accessible; Withstand repeated scrubbing, scouring, corrosive action of food, cleansers, and sanitizing agents; and Prevent harboring of soils, bacteria, or pests: In or on the equipment; and Between the equipment and other equipment, floors, walls, or supports; Materials used as food contact surfaces of equipment are: Nontoxic; Unable to contaminate or be absorbed by food under the conditions of use; Non-porous and nonabsorbent; and Except for the use of cast iron as a food contact material if the surface is to be heated, corrosion resistant; Food contact surfaces of equipment and utensils are designed, constructed, and maintained to be: Smooth; Easily cleanable; In good repair; Free of difficult to clean internal corners and crevices; Self-emptying or self-draining if an interior surface; Visible or readily disassembled for inspection; and Readily: Accessible for manual cleaning without tools; or Disassembled with the use of simple tools kept available near the equipment; Equipment designed for pressurized cleaning-in-place is designed, constructed, and maintained to: Fully circulate cleaning and sanitizing solutions through a fixed system in which the solutions will contact all interior food contact surfaces; Self-drain or otherwise completely evacuate all cleaning solutions; and Effectively clean and sanitize all food contact surfaces without disassembly; Cutting blocks, bakers tables, and similar wood food contact surfaces are made from: Hard maple; or Another material that is: Nontoxic; Smooth; and Free of cracks, crevices, and open seams; Lubricants used on bearings and gears of equipment are food-grade; Except for equipment that is portable, equipment that is placed on tables or counters is: Sealed in place; Mounted on legs or feet at least 4 inches high; or Installed to allow cleaning of the equipment and adjacent areas; Floor-mounted equipment is: Elevated: At least 6 inches above the floor; and So that food contact surfaces are at least 18 inches above the floor; and Placed so that there is sufficient space for cleaning between: Adjoining units; and A unit and the adjacent walls; The spaces between adjoining equipment are closed and sealed if exposed to seepage; Aisles or working spaces between equipment and between equipment and walls are: Unobstructed and of sufficient width to permit employees to perform duties without contaminating food or food-contact surfaces by clothing or personal contact; and In a new facility or a facility that is remodeled, a minimum width of: 3 feet where food preparation occurs on only one side of the aisle; 4 feet where food preparation occurs on both sides of the aisle and employees work back to back; 5 feet where food preparation occurs on both sides of the aisle, employees work back to back, and other employees must pass through the area; or Another width approved by the approving authority based on a review that indicates compliance with §A(12)(a) of this regulation; Equipment is installed and located to limit the potential for cross-contamination of food; When an existing piece of equipment ceases to operate: Equipment intended for temporary use is: Acceptable to the approving authority; and In compliance with §A(3)—(8) of this regulation; Equipment is replaced: With equipment that meets the requirements of this regulation; and Within 30 working days from the date the permanent replacement plan required in §A(14)(c) of this regulation is accepted by the approving authority; and The approving authority is provided plans for permanent replacement of the failed unit within 10 working days after the failure of the unit; and A vending machine containing potentially hazardous foods has an automatic control that prevents the machine from vending food: If there is a power failure, mechanical failure, or other condition resulting in an internal machine temperature that cannot maintain food temperatures as specified in Regulation .06B(7) of this chapter; and Until serviced and working properly. The approving authority may allow the use of equipment that meets §A(3)—(10) of this regulation but fails to comply with §A(1) of this regulation if a review indicates the equipment and its use are: Not harmful to public health; and Consistent with industry standards and practice. The person-in-charge shall ensure that: Food contact surfaces of equipment and utensils are effectively cleaned and sanitized by: Removing soil and food particles by one or more of the following: Flushing; Soaking; Scraping; Cleaning with a suitable commercial detergent; Rinsing with potable water; and Sanitizing, using: Immersion in hot water of 170°F or higher temperature for at least 30 seconds; Immersion in a chemical sanitizer that is proven to kill pathogens effectively: In accordance with the manufacturer's label use instructions; or As set forth in §C(1) of this regulation; or For equipment that is not sanitized by the methods set forth in §C(1) of this regulation: Live steam from a hose, provided that the steam can be confined within the equipment; A rinse with boiling water; or A spray or swab with a chemical sanitizing solution of at least the minimum strength stated in §C(1) of this regulation; Cleaning and sanitization occur: As often as needed to prevent food contamination; After each use; Between an interruption in food preparation greater than 4 hours; and Except for food contact surfaces of equipment or utensils within holding units that are maintained at proper temperatures, after a continuous use of 4 hours; When sanitizer is used for the manual sanitization of food contact surfaces of equipment and utensils: The minimum level of sanitizer provided is: 50 parts per million chlorine with a minimum water temperature of 75°F and a minimum contact time of 7 seconds; 12.5—25 parts per million iodine with a minimum water temperature of 75°F and a minimum contact time of 30 seconds; or The concentration indicated on the manufacturer's label with a minimum contact time of 30 seconds for quaternary ammonium compound; and A test kit or other device that accurately measures concentration of the sanitizer in parts per million is provided and used to check that the minimum level of sanitizer is accurate; When hot water is used as the sanitizing agent in manual operations, a graduated thermometer is provided that is: Accurate within plus or minus 2°F; Calibrated annually or more frequently; Located near the sink; and Used frequently to check water temperature; A three-compartment sink is: Provided and used wherever warewashing is conducted manually; Adequate in length, width, and depth to accommodate the largest equipment items and utensils; Supplied with hot and cold running water at each sink compartment; and If used for tasks other than warewashing, such as washing wiping cloths or produce or thawing food: Is washed and sanitized before and after the sink is used for a different task; and Does not contain an automatic chemical dispenser; Dish tables or integral drainboards are: Of adequate size for proper handling of soiled utensils before washing and for cleaned utensils following rinsing or sanitization; Located and constructed so the tables or drainboards do not interfere with the proper use of the warewashing facilities; and Not required for cooks' and bakers' rinse sinks; When spray-type warewashing machines are used: The machines are installed: According to manufacturer's specifications; and To provide effective cleaning and sanitization of equipment and utensils; The manufacturer's specifications are listed on a data plate that is permanently affixed to the machine; If manufacturer's specifications for wash and rinse water temperature do not exist, the following standards are followed: For machines using chemical sanitization, the wash and final rinse water temperature is at least 120°F; or For machines using hot water sanitization, the wash water is at least: 160°F for single tank conveyor machines; and 150°F for other types of machines; For machines using hot water sanitization, the final or fresh rinse water temperature is at least: 180°F at the entrance of the manifold; or 160°F when a pumped rinse is provided; Wash water is kept clean and rinse water tanks are protected by: Distance; Baffles; or Other means to minimize the entry of wash water into the rinse water; The flow pressure is not less than 15 or more than 25 pounds per square inch on the water line immediately adjacent to the final rinse control valve; Except for a pumped or recirculated final rinse, a pressure gauge is provided immediately upstream from the final rinse control valve to check the flow pressure of the final rinse water; and An easily readable thermometer is provided to measure water temperature with an accuracy of plus or minus 2°F: In each tank of the warewashing machine; and As the final rinse water enters the manifold; Jets, nozzles, and all other parts of each machine are maintained free of: Chemical deposits; Debris; and Other soil; and If used, automatic detergent dispensers are maintained and operating; All warewashing machines are thoroughly cleaned as often as needed throughout the day to: Prevent recontamination of equipment and utensils; and Ensure that the equipment performs the equipment's intended function; A pre-rinse device is provided for all warewashing machines; Equipment and utensils are placed in racks, trays, baskets, or on conveyors after flushing, scraping, or soaking so that food contact surfaces are: Subject to unobstructed application of detergent wash; Rinsed thoroughly with clean rinse water to remove particulate matter and detergent residues; and Drained; Warewashing machines using chemicals for sanitization meet the following additional requirements: Chemicals added for sanitization purposes are automatically dispensed; and The chemical sanitizer used: Is listed in 21 CFR §178.1010; and Provides the equivalent bactericidal effect of a solution containing at least 50 parts per million of chlorine; and A test kit or other device that accurately measures the concentration of the sanitizing solution is used; Written approval is obtained from the approving authority when any other type of machine, device, or facilities and procedures for warewashing will be used based on a review that indicates compliance with §A of this regulation; Non-food contact surfaces of equipment are cleaned frequently enough to preclude the accumulation of soil residues; and Wiping cloths are: Used only for wiping food spills; Free of food debris when used dry for wiping food spills on tableware; and Rinsed and stored in one of the sanitizing solutions specified in §C(1) of this regulation when used wet for wiping spills from the surfaces of equipment. The person-in-charge shall ensure that: Contamination of food-contact surfaces of cleaned and sanitized equipment and utensils is prevented by handling: Cleaned spoons, knives, and forks by the utensil's handles only; and Cleaned cups, glasses, and bowls so that hands do not contact inside surfaces or mouth-contact surfaces; The food-contact surfaces of equipment are protected from: Splash; Dust; and Other contamination; Cleaned and sanitized food equipment, portable equipment, and utensils are stored: A minimum of 18 inches above the floor when not fully protected by an enclosure with doors; In a clean, dry location; and In a space that affords protection from splash, dust, and other contamination; Utensils are: Air dried before being stored; or Stored in a self-draining position on hooks or racks constructed of a corrosion resistant material; Stored containers and utensils are covered or inverted whenever possible; Flatware is stored in containers designed to present the handle to the employee or customer; Toilet rooms or vestibules are not used to store: Food equipment; Utensils; or Single service articles; and Single service articles are: Stored in closed cartons or containers to protect the articles from contamination; Handled and dispensed in a manner that prevents contamination of surfaces that come into contact with food or the mouth of the user; and Used only once. The person-in-charge shall ensure that: Potable water is: Obtained from a water supply system that complies with Environment Article, Title 9, Annotated Code of Maryland, and COMAR 26.04.04; and Meets the standards of quality specified in Environment Article, Title 9, Annotated Code of Maryland, and COMAR 26.04.01; Non-potable water for non-culinary purposes such as air conditioning or fire protection is used only if the system complies with §H(3) of this regulation; Except for a temporary food service facility where water under pressure is not available, hot and cold running water under pressure is provided: In all areas where: Food is prepared; and Equipment and utensils are washed; and With sufficient water capacity, pressure, and hot water generation and distribution to meet peak demands throughout the facility; Drinking water, if not dispensed through the water supply system of the food service facility, is potable and stored in a container that meets all applicable laws, ordinances, and regulations; Steam that contacts food is free from deleterious or harmful matter that might adulterate food; All water-carried sewage is disposed of by: A public sewerage system; or An approved sewage disposal system constructed and operated in conformance with applicable State and local laws, ordinances, and regulations; Where water-carried disposal methods are not possible, non-water-carried sewage disposal facilities are utilized if: The method has been approved by the approving authority as meeting State and local requirements; and The facilities are: In conformance with applicable State and local laws, ordinances, and regulations; and Located outside and not attached to the establishment; Plumbing is sized, installed, and maintained so that: The plumbing complies with applicable State and local plumbing laws, ordinances, and regulations; The potable water supply system is: Installed in a manner that prevents backflow or backsiphonage; and Not connected with a non-potable water system in a manner that would allow non-potable water to be drawn or discharged into the potable water supply system; The piping of a non-potable water system is: Marked so that the piping is readily distinguishable from piping that carries potable water, such as with distinctive yellow-colored paint; and Not connected to equipment or other outlets in the food preparation area; Indirect waste piping is provided to a: Food preparation or utensil washing sink; Refrigerator coil; Ice making machine; Steam kettle; Coffee urn or brewer; Hot or cold drink machine; Steam table; Potato peeler; Warewashing machine, unless: The machine is located within 5 feet of a trapped floor drain; and The waste piping is connected directly to the inlet side of a floor drain trap vented in conformance with applicable State and local laws, ordinances, and regulations; and Similar piece of equipment in which food, portable equipment, or utensils are placed; Each compartment of a multiple compartment sink is indirectly drained to a trapped and vented plumbing receptor through an air gap that complies with State and local laws, regulations, and ordinances: From a separate pipe through the air gap and into the plumbing receptor; or Through the air gap into a single manifolded branch and into the plumbing receptor; Plumbing receptors receiving the discharge of indirect waste pipes: Have a shape and capacity that will prevent splashing or flooding; and Are accessible for cleaning and inspection; Food waste grinders are connected and trapped separately from other fixtures or sink compartments; Floor drains subject to evaporation have: A water seal of at least 4 inches; Water fed from a plumbing fixture that complies with State and local laws, regulations, and ordinances; or An automatic priming device that complies with State and local laws, regulations, and ordinances; Floor drains in storerooms, refrigerated rooms, walk-in coolers, or other locations where food is stored, have indirect waste piping; Hand sinks in food preparation tables and counters discharge through an air gap into a floor sink or receptor that is trapped and vented; and Except when required by building design, waste pipes and fixtures are: Not located over food storage, preparation, or serving areas; and Where installed over food storage, preparation, or serving areas, food is protected by one or more of the following: Pipe joining methods that will preclude leakage; Using wall-mounted fixtures; Limiting the number of pipe joints; Pressure testing the piping; Thermally insulating pipes to prevent condensation; and Installing integral seepage pans or pipe sleeves; Toilet facilities are: Sufficient in number to serve the facility; Conveniently located; Accessible to employees at all times; Except as specified in Health-General Article, §21-325(b), Annotated Code of Maryland, for facilities established after January 1, 1979, provided for patrons whenever a food service facility: Prepares food and provides seating; or Is a carry-out facility with indoor tables used for dining; Installed in accordance with applicable State and local laws, ordinances, and regulations; Designed with fixtures that are: Of sanitary design; and Readily cleanable; Kept: Clean; In good repair; and Free of objectionable odor; and Supplied with: Toilet tissue at each toilet at all times; and Receptacles that are easily cleanable and covered for waste materials in toilet rooms for women; Toilet rooms: Are completely enclosed; Are equipped with self-closing doors except when a toilet room without doors is approved by the approving authority based on a review that shows that: Doors would impede the use of the toilet room; and The requirements in §J(3)—(6) of this regulation are met; Provide privacy; Are provided mechanical ventilation that: Exhausts air at the rate of 2 cubic feet per minute per square foot of floor area; and Allows the entrance of an equal amount of makeup air; Prevent the entry of insects and vermin; and Do not open directly into the kitchen or food preparation areas; Hand washing facilities are: Located: In each food preparation and processing area; In each utensil washing area; and Adjacent to all toilet rooms; Accessible at all times; Equipped with an adequate supply of hand-cleaning soap or detergent; Equipped with a means of drying hands, such as: Individual towels in dispensers; or An effective hand-drying device; Equipped with a waste receptacle; and Kept clean and in good repair; Hand sinks are: Installed in accordance with applicable State and local laws, ordinances, and regulations; Able to discharge: Hot and cold running water; or Tempered running water at a temperature of at least 100°F through: A mixing valve; A combination faucet; or Any slow closing or metering faucet that provides a flow of water for at least 15 seconds before the faucet has to be reactivated; and Utensil washing vats, food preparation sinks, or mop sinks are not used as hand sinks. The person-in-charge shall ensure that: Garbage is stored in the following ways as applicable to the facility: In containers that: Are sufficient in number to hold all of the garbage that accumulates between periods of removal from the premises; Do not leak or absorb liquids; Are constructed of durable metal or another approved type of material; and Are provided with tight-fitting lids or covers unless kept in a: Vermin-proofed room or enclosure; or Waste refrigerator; In storage areas that: Are clean; and Do not constitute a nuisance; In storage rooms or enclosures that: Are constructed of easily cleanable, grease resistant, washable materials; and Are vermin-proofed; In garbage containers outside the establishment that are located on a grease resistant, durable surface; and For damaged, adulterated, or recalled products, in designated areas separate from: Food; Equipment; Utensils; Linens; and Single service and single use articles that are held for credit, redemption, or return to the distributor; Garbage containers are cleaned as necessary to prevent a buildup of soil: In a manner that does not contaminate food, equipment, utensils, or food preparation areas; With: Brushes for washing that may not be used for any other purpose; Can-washing machines; Steam-cleaning devices; or Similar equipment; and In an area that enables waste water from cleaning operations to be disposed of as sewage; Food waste grinders are: Constructed and installed to comply with applicable State and local plumbing laws, ordinances, and regulations; and Not connected to a sink drain that is used for food or utensils; All garbage and rubbish is disposed of: Daily, or as often as necessary, to prevent a nuisance or insanitary condition; and By a method that complies with applicable State and local laws, regulations, and ordinances; and Used cooking grease and oils are stored, recycled, and disposed of in accordance with applicable State and local laws, regulations, and ordinances. The person-in-charge shall ensure that: A food service facility may operate with its outer doors and windows open unless, while the food service facility is operating with the outer doors or outer windows open, the approving authority: Finds evidence of vermin in food preparation or food storage areas; or Finds evidence of flying insects in food preparation or food storage areas that pose a significant threat to sanitation or public health. If the approving authority finds that a food service facility is operating in violation of §A of this regulation, the food service facility shall take immediate action to eliminate the vermin or flying insects. If the approving authority finds that a food service facility is operating in violation of §A of this regulation, the approving authority may: Close a food service facility; Order a temporary closure of the outer windows and outer doors, until the vermin or flying insects are eliminated from the food preparation or food storage areas; or Take another action to eliminate vermin or flying insects. A food service facility found to be operating in violation of §A of this regulation on three or more separate occasions shall keep the outer windows and outer doors closed at all times until: Modifications approved by the local approving authority are made to the food service facility to effectively protect against the entrance of vermin and flying insects; or Another action acceptable by the approval authority is taken. The person-in-charge shall ensure that: Effective control measures are used to eliminate rodents, flies, roaches, and other vermin from the building; The premises are kept clean and free of debris that will promote the harborage of vermin; Openings into the building are effectively protected against the entrance of insects and rodents by: Doors that are: Tight; and Self-closing; Screening on windows, doors, skylights, transoms, and other openings, which is: Tight-fitting; In good repair; and Made of material that is not less than 16-mesh to the inch or equivalent; Positive air pressure or controlled air currents; and Other means acceptable to the approving authority; and Insect control devices that are used to electrocute or stun flying insects are: Designed to retain the insects within the device; Not located over areas used to prepare food; and Located so that dead insects and insect fragments are prevented from being impelled or from falling onto: Exposed food; Clean equipment; Utensils; Linens; and Unwrapped single service and single use articles. The person-in-charge shall ensure that: A floor and floor covering is kept: Clean; and In good repair; The floor in a food preparation, food processing, food storage, utensil washing, dressing or locker, toilet, and walk-in refrigerator room or area is constructed of epoxy, sealed concrete, quarry tile, ceramic tile, commercial grade continuous sheet vinyl, or similar material that makes the floor: Smooth; Durable; Nonabsorbent, unless the floor is in a: Dry-food storage area; Dining area; or Mechanical or electrical room; Easily cleanable; and Grease resistant in areas subject to grease spillage or drippage; A floor installed in a food preparation, food processing, food storage, utensil washing, walk-in refrigerator, dressing or locker, and toilet room or area has a juncture between the floor and the wall that is: Coved; and Closed; A mat, floor covering, and duckboard is: Removable; Easily cleanable; and Kept clean; When carpeting is used, the carpeting is placed only on the floors of: Interior dining areas; Retail areas where liquid products are not displayed; and Areas not subject to water flushing, spraying, or drippage; When a floor receives water as a result of processing or cleaning, floor drains are provided at a minimum of one floor drain per 400 square feet of floor area; When floor drains are installed, floors are graded at not less than 1/8 inch per foot to direct wastewater to the floor drains; A floor in a room without floor drains that requires the removal of processing or wash-water, is drained by: Sloping the floor at least 1/8 inch per foot toward a doorway or another opening; and Directing the wastewater into a floor drain or other discharge point located outside the room in compliance with applicable State and local laws, regulations, and ordinances; The walking and driving surfaces of all exterior areas of food service facilities are: Kept clean and free of debris; and Surfaced with concrete, asphalt, gravel, or similar material to facilitate maintenance and minimize dusty or muddy conditions; A door on the building's exterior is equipped with a self-closing device; A wall, ceiling, door, window, skylight, and similar closure, is kept: Clean; and In good repair; The walls up to at least the highest level reached by splash or spray in all food preparation, food storage, utensil washing, and toilet rooms or areas have surfaces that are: Smooth; Washable; and Water and grease resistant; A wall covering material, such as tile, stainless steel, fiber reinforced plastic, sealed gypsum board, or a similar material, is attached and sealed to the wall or ceiling so that: There are no open spaces or cracks to permit accumulation of grease or soil; The surface is easily cleanable; and Harborage for vermin is prevented; Ceiling covering materials in food preparation and utensil washing areas: Have smooth, washable surfaces; and Do not contain fiberglass backing; Exposed construction, such as exposed floor and ceiling rafters, trusses or beams, utility ducts, and lighting, is: Used only in: A dry food storage area; A dining area; or Other areas with the approval of the approving authority based on applicable State and local laws, regulations, and ordinances; Not used in: A refrigerated food storage area; A food preparation area; An equipment and utensil washing area; and A toilet room; and Cleanable; and Piping, conduit, and similar construction located outside a wall is installed so that there is a minimum of 3/4 inch space between the piping, conduit, and similar construction and the wall. The person-in-charge shall ensure that: Light fixtures, decorative material, and similar equipment and material attached to walls or ceilings are kept clean; Lighting provides artificial light at: 50 footcandles at a surface where a food employee is working with food, utensils, or equipment; 20 footcandles at 30 inches from the floor in a: Storage area; Toilet room; Locker room; Garbage and rubbish storage area; Dining area during cleaning; Utensil washing area; Bar; Wait station; and Service area; or Another lighting level approved by the approving authority based on a review that indicates the lighting level is sufficient for cleaning, facility maintenance, and employee safety. Light bulbs and tubes are shielded to prevent broken glass from falling onto food and utensils; Infrared or other heat lamps are protected against breakage by a shield surrounding and extending beyond the bulb, leaving only the face of the bulb exposed; The facility is ventilated with ventilation equipment that is maintained and operated so that: All areas are kept reasonably free from: Excessive heat; Steam; Condensation; Vapors; Smoke; and Fumes; Outside air is supplied: Through: The HVAC system; A separate supply fan; or A combination of the HVAC system and a separate supply fan; So that the entry of outdoor contaminants is excluded by: Maintaining the building under a slight positive pressure; and Providing an air filtering system; and So that it does not reduce the effectiveness of the exhaust system; Mechanical exhaust and make-up air systems are connected by an interlocking switch in order to provide make-up air whenever the exhaust system is in operation; and Make-up air is tempered when necessary to: Prevent the build-up of condensation that could: Result in an unsanitary condition within the facility; and Contaminate food; Provide comfortable working conditions; and Comply with applicable building codes; Rooms, areas, and equipment from which aerosols, odors, fumes, or vapors may originate are effectively vented to the outside air by a system that does not create a harmful or unlawful discharge; A ventilation hood or other ventilation device or fixture is designed: To prevent grease or condensate from dripping onto food or onto food preparation surfaces; In compliance with NSF Standard 2; and So that interior and exterior parts are easily accessible for maintenance and cleaning; Intake air ducts are designed and maintained to prevent the entrance of: Dust; Dirt; Insects; or Other contaminating materials; A grease removing exhaust hood is provided when needed over commercial cooking equipment that produces grease-laden vapors or smoke, such as: Griddles; Fryers; Charbroilers; Ovens used to cook fatty foods at a temperature which exceeds the vaporization point of grease; and Solid fuel cooking equipment; A ventilation hood is provided over equipment where needed, for heat, fumes, and steam removal, including: High temperature ovens not cooking fatty foods or not emitting grease vapors; Steam kettles; and Warewashing machines using hot water sanitization; Overshelves are used over cooking equipment under a hood only if: Deflectors or the design of the overshelf prevents grease from condensing on the bottom of the overshelf and contaminating the food below; Deflectors meet NSF or equivalent standards for food zone materials; and The ability of the hood to capture grease vapors and smoke is not impaired; Equipment is not added or substituted under a hood that exceeds the capacity of the hood to remove: Heat; Steam; Smoke; Grease; Fumes; and Obnoxious odors; Except as provided in §N of this regulation, ventilation in toilet rooms is provided: So that 2 cubic feet of air per minute per square foot of floor space is mechanically exhausted to the outside; and With make-up air; When an existing building is converted for use as a food service facility and there is no feasible method to vent the toilet room to the exterior of the building, a ductless exhaust fan is used that: Is sized and installed so that it will move 2 cubic feet of air per minute per square foot of floor area; and Is serviced and maintained according to the manufacturer's specifications; and Required ventilation meets the provisions of this regulation: Initially; and For the life of the system. The person-in-charge shall ensure that: The facility and parts of the property associated with the operation of the facility are kept: Clean; and Free of litter and rubbish; Traffic through the food operation and utensil washing areas is limited to on-duty personnel conducting pertinent job-related functions; The facility is not used for living or sleeping quarters; Sufficient space to store all custodial equipment is provided; At least one utility sink or curbed cleaning facility with a floor drain is provided and used for: Cleaning mops or similar wet floor cleaning tools; and The disposal of mop water or similar liquid wastes; A hand sink, utensil washing, equipment washing, or food preparation sink is not used as a mop or utility sink; Except for emergency cleaning due to an accident or spill, all cleaning is done during periods when the least amount of food is exposed, such as after closing to the public; Cleaning and sanitizing occur in a manner that protects food from contamination; Vacuum cleaning, wet cleaning, other dustless methods of floor and wall cleaning, or dust-arresting sweeping compounds and brooms are used in a manner that: Removes dust and soils; and Prevents the contamination of food and food-contact surfaces; Linens and clothes are stored: Laundered and in a clean place until used; and In non-absorbent containers or laundry bags when damp or soiled until removed for laundering; Employee clothing and personal belongings are stored in: Dressing rooms or dedicated areas that are: Provided when employees change clothing within the facility; Located outside of food preparation, serving, and utensil washing areas; and Kept clean; and Lockers or other facilities within dressing rooms or areas; and Live birds and animals are not present on the premises of a food service facility except for: Edible fish, shellfish, crustacea, or decorative fish in aquariums or display tank systems; Service animals that are controlled by the individual with a disability; Pets in the common dining areas of health care facilities at times other than during meals if: Effective partitioning and self-closing doors separate the common dining areas from food storage and food preparation areas; Condiments, equipment, and utensils are stored in enclosed cabinets or removed from the common dining area when pets are present; and Dining areas including tables and countertops are cleaned and sanitized before the next meal service; and A patron’s dog in an outdoor dining area of a food service facility in conformance with applicable State and local laws, ordinances, and regulations. Patrons' Dogs in Outdoor Dining Areas. Subject to the requirements of §§B(2)—(5) of this regulation, an owner of a restaurant may allow a patron's dog to accompany the patron in the outdoor dining area during the hours designated by the restaurant. Before an owner may allow a patron's dog to accompany the patron in the outdoor dining area, the owner shall: Provide written notice to the approving authority or the local health department in the jurisdiction where the restaurant is located that the owner intends to allow patrons' dogs to accompany patrons in the outdoor dining area of the restaurant 30 days prior to the days dogs will be allowed; and Place on permanent display in the restaurant a written notice that: States the restaurant's policy of allowing patrons' dogs in an outdoor dining area; Is in a typeface that is large enough to be easily legible to the average person from a distance of 8 feet; and Is in a location that is plainly visible to the patrons of the restaurant. In establishing the restaurant's policy concerning patron's dogs in outdoor dining areas, the owner may: Determine the location and the amount of space designated for a patron accompanied by the patron's dog; and Establish a limit on the size and type of dogs and any other limitations relating to a patron's dog. At the owner's discretion, the owner may deny entry to the restaurant or eject from the restaurant any patron and the patron's dog. A patron accompanied by a dog: Shall: Be an adult who is responsible for the behavior of the dog; Keep the dog with the patron on a leash at all times at the table at which the patron is seated; and Be liable for any damages caused by the dog to the restaurant or any other patron of the restaurant; and May not: Allow the dog to travel through an indoor space of a restaurant to enter or exit an outdoor dining area; or Leave the dog unattended at any time. A person who is licensed to operate a food service facility may manufacture food for sale or distribution as provided in §§B, C, and E of this regulation. The person-in-charge shall ensure that before a food is manufactured in a food service facility: Plans for the manufacturing: Are submitted to the Department; Are approved in writing by the Department based on a review that indicates compliance with this regulation; Include: A list of foods proposed for manufacture; The proposed processing procedures for a food; Specifications for equipment items to be used for manufacture; Packaging and labeling information; Methods of shipment; Procedures for maintaining potentially hazardous food as set forth in Regulation .06B(7)—(13) of this chapter; and An HACCP plan in accordance with Regulation .34 of this chapter; and The facilities and equipment proposed for use in manufacturing are: Inspected by the Department; and Approved in writing by the Department based on a review that indicates compliance with this chapter. A person licensed only to operate a food service facility may not manufacture the following foods: Low-acid canned foods as defined in 21 CFR §113.3(n); Acidified foods as defined in 21 CFR §114.3(b); Hermetically sealed and ready-to-eat potentially hazardous foods that a hazard analysis indicates are associated with the outgrowth of Clostridium botulinum or Listeria monocytogenes, such as: Smoked fish; or Pasteurized crabmeat; Bottled water; or Soft drinks. The approving authority shall routinely inspect the food manufacturing conducted in the food service facility: During inspections of the retail food service facility; and At a frequency set forth in Regulation .30 of this chapter. The person-in-charge shall ensure that: All manufactured food is labeled in accordance with Regulation .12 of this chapter; and Records are: Made to allow the trace-back of distributed or sold food to the food service facility that manufactured the food; Made to identify the immediate source of the food and food ingredients stored and processed at the facility; For shell eggs, made to provide the information required in COMAR 15.04.01.03A(2)(a)—(e); Made to identify the initial distribution of the food to facilitate the segregation of food that may have become adulterated or otherwise unfit for human consumption; and Maintained at the facility for at least: 2 years for a shelf stable or preserved food; and 1 year for a fresh food. For a special food service facility that handles only potentially hazardous food that remains in the original container or wrapping and that does not prepare, wrap, or package the food at the facility, the person-in-charge shall ensure that: Compliance is maintained with Regulations .01—.06, .08, .12—.14, .15A(3)—(5), .19—.23, .25, .28—.33, and .35—.39 of this chapter; and When single service articles are used, the single service articles comply with Regulation .17H of this chapter. For a special food service facility that handles food that is removed from the original package or that prepares, packages, or wraps food at the facility, the person-in-charge shall ensure that: Compliance is maintained with Regulations .01—.06, .08—.14, .15A(3)—(10), .16—.25, and .28—.39 of this chapter; The premises are kept clean and free of litter or rubbish; If permanent toilet facilities are not required, temporary toilet facilities are made available and maintained in a sanitary manner; Except as provided in §D(2) of this regulation, adequate hand washing facilities are provided by: Where potable water under pressure is available, a hand sink as set forth in Regulation .18K and L of this chapter; or Another hand washing facility that has: Warm water; Soap; and Paper towels; and Wastewater from hand washing, food preparation, and cleaning is disposed of in accordance with State and local laws, regulations, and ordinances. For a special food service facility that is a mobile unit, the person-in-charge shall ensure that: Compliance is maintained with either §A or B of this regulation as applicable; Equipment components of the mobile unit are in compliance with Regulation .15A(1) and (2) or B of this chapter; A hand washing sink is provided as set forth in Regulation .18K and L of this chapter; Potable water tanks are used to provide water for hand washing and, where applicable, for food preparation and utensil cleaning; Wastewater tanks are used to hold wastewater pending disposal at a facility in a manner that conforms with State and local laws, regulations, and ordinances; Subject to §C(8) and (9) of this regulation, a base of operations is established that provides: A source of potable water, potable water hoses, and clean connections; A method for the disposal of sewage; Clean, adequate, and covered trash receptacles; A storage area for single serve food items; and If necessary: Refrigerated and dry food storage areas; and A utensil washing facility. The base of operation is located within 90 miles of the licensing county; For a mobile food service facility not seeking a mobile reciprocity license, a base of operations as set forth in §C(6) and (7) of this regulation is established by May 1, 2020; A base of operations is not required for a mobile food service facility that offers only prepackaged frozen desserts; A valid license from the county of origin is maintained; and Compliance is maintained with all applicable State and local laws and regulations in the jurisdiction in which it is operating. For a special food service facility that is a temporary food service facility, the person-in-charge shall ensure that: Compliance is maintained with either §A or B of this regulation as applicable, except that no compliance with Regulations .21 and .22 of this chapter is required; Where potable water under pressure is not available, sufficient containerized potable water is provided for: Hand washing; and Rinsing utensils; and The period of time that the facility operates is limited to the time stated in Regulation .02B(80) of this chapter. For a special food service that is a bed and breakfast, the person-in-charge shall ensure that: Compliance is maintained with either §A or B of this regulation as applicable; The facility serves hot meals only to renters; and The facility does not operate as a restaurant or caterer. For a special food service facility that is a semi-permanent food service facility, the person-in-charge shall ensure that: Compliance is maintained with either §A or B of this chapter as applicable; A connection to potable water is maintained as a critical item, as set forth in Regulation .18A of this chapter; Hand sinks are provided and maintained as set forth in Regulation .18K and L of this chapter; and A connection to a sewage disposal system is provided and maintained as a critical item that meets applicable State and local laws, regulations, and ordinances. For a special food service facility that is an on-farm food service facility, the person-in-charge shall ensure that: Compliance is maintained with either §A or B of this regulation as applicable, except that no compliance with Regulations .21 and .22 of this chapter is required; Hand washing stations are provided in close proximity to the food service facility for use by customers; Signs are displayed prominently at the hand washing stations stating “In the interests of public health, please wash your hands thoroughly before entering or handling food.”; and The period of time that the facility operates is limited to the time in Regulation .02B(48) of this chapter. For a special food service facility that is a seasonal farmer’s market producer sampling food service facility, the person-in-charge shall ensure that: Compliance is maintained with §B of this regulation when food is removed from the original package or food is prepared at the facility, except that no compliance with Regulations .21 and .22 of this chapter is required; Where potable water under pressure is not available, sufficient containerized potable water is provided for: Hand washing; and Rinsing utensils; and The period of time that the facility operates is limited to the time stated in Regulation .02B(70) of this chapter. Pursuant to Health-General Article, §21-304(a)(2), Annotated Code of Maryland, a volunteer fire company or bona fide nonprofit fraternal, civic, war veterans’, religious, or charitable organization or corporation that does not serve food to the public more often than 4 days per week, except that once a year an organization may serve food to the public for up to 30 consecutive days, may make: A rescindable decision to operate as a licensed food service facility and in full compliance with this chapter; or A decision to operate without a license and in compliance with §§B—E of this regulation, which establish the minimum requirements to ensure food safety at a food preparation or serving area operated by an excluded organization without a license. The person-in-charge shall ensure that a food preparation or service area operated by an excluded organization without a license complies with Regulations .01—.15A(3)—(10), .16—.23, .26—.27, and .29—.39 of this chapter. During the operation of a special food service facility, the person-in-charge of an unlicensed excluded organization shall ensure compliance with: Regulations .01—.06, .08, .12—.14, .15A(3)—(5), .19—.20, .22B—D, .23, .26, .29—.33, and .35—.39 of this chapter, if the unlicensed excluded organization is a special food service facility that: Handles only potentially hazardous food that remains within the original container or wrapping; and Does not prepare, wrap, or package food at the facility; or Regulations .01—.06, .08—.14, .15A(3)—(10), .16—.20, .22B—D, .23, .26, and .29—.39 of this chapter, if the unlicensed excluded organization is a special food service facility that: Handles food that is removed from the original container or wrapping; or Prepares, packs, or wraps potentially hazardous food at the facility. The person-in-charge shall ensure that an unlicensed excluded organization does not: Operate a bed and breakfast; Operate a semi-permanent food service; or Except as provided for in §G of this regulation, perform retail food manufacturing. The person-in-charge shall ensure that, when an unlicensed excluded organization plans a single event to prepare or serve potentially hazardous food to 200 or more individuals from the public: Written notification of the event is submitted to the approving authority not less than 30 days before the scheduled event; and The written notification required in §E(1) of this regulation contains: The date, place, and time of the event; The estimated number of individuals to be served at the event; A menu or list of foods to be served; The source of all potentially hazardous foods to be served; A list of foods to be prepared more than 12 hours in advance of service; If food is to be prepared off-premises, the: Name of the facility to be used; and Procedures for transporting food to the premises; The name, address, and telephone number of a responsible contact individual; and Any other information requested by the approving authority in order to review the food preparation and service. The person-in-charge shall ensure that when an unlicensed excluded organization plans to serve food to the public for up to 30 consecutive days, a written notice is provided to the Department that includes the: Dates on which the food will be prepared; Methods of storing and serving food; and Methods or procedures that will be followed to ensure food: Safety; and Security. In Carroll County, a religious organization that meets the definition of an excluded organization as set forth in Regulation .02B(28) of this chapter, and complies with COMAR 10.15.01.09A—D and .10A and 10.15.04.08, or a county-owned and county-operated park or facility that is hosting a public festival, may offer for sale directly to the public the following types of homemade style food, only if the food is produced at the kitchen of the excluded organization: Fruit butter made only from: Apples; Apricots; Grapes; Peaches; Plums; or Quince; Jam, preserve, or jelly, made only from: A fruit listed in §G(1) of this regulation; Oranges; Nectarines; Tangerines; Blackberries; Raspberries; Blueberries; Boysenberries; Cherries; Cranberries; Strawberries; or Red currants; Fruit pies made from a fruit listed in §G(1) and (2) of this regulation; and Honey. A cottage food business may offer for sale the homemade foods specified in §B of this regulation when the foods are: Made in a private home kitchen; and Offered or sold only in the State: Subject to the requirements of §C(6) and (7) of this regulation, at a retail food store; or Directly to a consumer: At a farmer’s market; At a bake sale; At a public event; By personal delivery; or By mail order. The Department shall allow the preparation and sale of the following foods in accordance with §A of this regulation: Non-potentially hazardous hot-filled canned acid fruit jellies, jams, preserves, and butters that are: Unadulterated; Packaged to maintain food safety and integrity; and Labeled in accordance with Regulation .12 of this chapter; Fruit butters made only from: Apples; Apricots; Grapes; Peaches; Plums; Prunes; Quince; or Another fruit or fruit mixture that will produce an acid canned food; Jam, preserve, or jelly made only from: A fruit listed in §B(2) of this regulation; Oranges; Nectarines; Tangerines; Blackberries; Raspberries; Blueberries; Boysenberries; Cherries; Cranberries; Strawberries; Red currants; or Another fruit or fruit mixture that will produce an acid canned food; Non-potentially hazardous baked goods; Foods manufactured on a farm by a licensed food processor in accordance with COMAR 10.15.04.19; Non-potentially hazardous candy; and All other non-potentially hazardous foods produced by a licensed entity. Cottage Food Business. The Department shall allow the owner of a cottage food business to sell only cottage food products processed and packaged in Maryland that are: Produced or packaged in a residential kitchen; Stored on the premises of the cottage food business; and Prepackaged with a label that contains the following information: The name and address of the cottage food business or the name, phone number, and identification number assigned to the cottage food business by the Department; The name of the cottage food product; The ingredients of the cottage food product in descending order of the amount of each ingredient by weight; The net weight or net volume of the cottage food product; Allergen information as specified by federal labeling requirements; Nutritional information as specified by federal labeling requirements, if any nutritional information claim is made; Printed in 10 point or larger type in a color that provides a clear contrast to the background of the label: “Made by a cottage food business that is not subject to Maryland’s food safety regulations.”; and For a cottage food product offered for sale at a retail food store, the phone number and email address of the cottage food business and the date the cottage food product was made. A cottage food business may request a unique identification number from the Department which can be used in lieu of the address of the cottage food business on the product label required under §C(1) of this regulation. The owner of a cottage food business shall comply with all applicable county and municipal laws and ordinances regulating the preparation, processing, storage, and sale of cottage food products. Upon receipt of a complaint or outbreak of illness the Department may: Investigate the conditions under which the product was produced and any complaint alleging that a cottage food business has violated this regulation; Send a representative of the Department, at a reasonable time, to enter and inspect the premises of a cottage food business to determine compliance with this regulation; and Collect samples of a cottage food product or its ingredients to determine if the cottage food product is misbranded or adulterated. The owner of a cottage food business may not: Refuse to grant access to a representative who requests to enter and inspect the premises of the cottage food business in response to a complaint; or Interfere with any inspection or collection of samples in response to a complaint or outbreak of illness. Before the owner of a cottage food business may sell a cottage food product to a retail food store, the owner shall submit to the Department for review: The label that will be affixed to the cottage food product in accordance with §C(1)(c) of this regulation; and Documentation of the owner’s successful completion of a food safety course in the past 3 years that is approved by the Department and the American National Standards Institute and includes, at a minimum, the following subjects: Basic food safety; Cleaning and sanitizing; Personal hygiene; Pest control and prevention; and Receiving, storing, preparing, and serving food. The owner of a cottage food business may not sell or offer for sale a cottage food product to a retail food store until notified by the Department, in writing, that the requirements stated in §C(6) of this regulation are satisfactorily met. The phone number required in §§C(1)(c)(i) and (viii) of this regulation shall enable contact with the cottage food business by the Department within 24 hours. The email address required in §C(1)(c)(i) of this regulation shall enable contact with the cottage food business by the Department within 48 hours. If the Department finds a person to be in violation of any provision of this regulation, the Department: Shall take action against a misbranded or adulterated food offered or sold under this regulation in accordance with Health-General Article, §§21-211, 21-253, and 21-254, Annotated Code of Maryland; and May determine that food produced in a private home kitchen by the person may not be offered for sale as a cottage food. The approving authority shall require a farmer to obtain a producer mobile farmer's market unit license as specified in COMAR 10.01.17 and 10.15.04 for the sale of a farm product at a farmer's market or at a public event that is not: A raw agricultural product as defined in Regulation .02B(61) of this chapter; or A pre-packaged non-potentially hazardous food. A local health department may: Not require a farmer to obtain a producer mobile farmer's market unit license for that local jurisdiction; and Require a farmer to obtain a seasonal farmer's market producer sampling license if the farmer prepares and offers samples of a farm product for human consumption at a farmer's market or at a public event in that local jurisdiction. The approving authority shall issue and renew licenses in accordance with Health-General Article, §§21-309 and 21-310, Annotated Code of Maryland, and this chapter. The approving authority may deny an application for a food service facility license in accordance with Health-General Article, §21-311, Annotated Code of Maryland, and this chapter. A person: Shall obtain a food service facility license before the person operates a food service facility; and May not operate a food service facility if the person does not have a current and valid license issued by the approving authority, except: As provided in: Health-General Article, §21-305, Annotated Code of Maryland; and Regulation .26A(2) of this chapter; or A caterer: As provided in §G of this regulation; or When from outside the State, that conforms to the provisions of this chapter or to substantially equivalent provisions as indicated by a report from the caterer's licensing agency to the approving authority indicating that the facility is licensed and inspected in the jurisdiction where the food service facility is located. The person-in-charge shall ensure that: Application for a food service facility license is submitted in accordance with Health-General Article, §§21-306 and 21-307, Annotated Code of Maryland; A valid license is displayed in a conspicuous place in the food service facility; and When catering services are offered, the food service facility license number and the identity of the issuer of the number are located: On advertising and business cards; In published print media; On flyers; In brochures; On vehicles used in connection with catering services; On contracts for catering services; In telephone directories; and In or on any other advertising and solicitations. The approving authority may not require a caterer licensed in Maryland to obtain a separate license for each catered event, including events across jurisdictional lines within the State, when the: Major food preparation for the event is completed at the caterer's food service facility, including: Thawing potentially hazardous food; Cooking potentially hazardous food, except at outdoor barbecues when the food will be immediately consumed or discarded; Cooling potentially hazardous food; or Preparing salads that contain potentially hazardous foods; and Event is at a location other than the caterer’s food service facility if the caterer and location comply with Regulations .01—.06, .08—.14, .15A(3)—(8), and .18I and L of this chapter. Except as provided in §I of this regulation, a license may not be transferred from one person to another person or from one food service facility to another. Upon the death of a licensee, the approving authority may transfer a food service facility license if: An application is filed in accordance with Health-General Article, §21-306, Annotated Code of Maryland; and Written evidence establishes that the applicant's relationship with the deceased was as a: Spouse of the deceased licensee; Blood relative to the first degree of consanguinity; or Current officer or surviving partner in the business operating the food service facility. A local health department: Shall issue a mobile reciprocity license: In accordance with Health-General Article, §21-304, Annotated Code of Maryland; To a mobile food service facility that: Holds a valid license from the county of origin; Is operating in the jurisdiction; and Is operating within 90 miles of its base of operations, which shall be located in Maryland. Shall provide copies of inspection or other supporting documentation for a mobile food service facility with a base of operations within the jurisdiction of the local health department to the jurisdiction in which the mobile food service facility is seeking a mobile reciprocity license; May inspect the mobile food service facility during operation in the jurisdiction after a mobile reciprocity license has been issued; May suspend a mobile reciprocity license for not maintaining a valid license from the county of origin until such time that the county of origin license is renewed; May issue a violation of this regulation as set forth in Regulation .35 of this chapter; and Shall notify all known Maryland jurisdictions which license the mobile food service facility if: Any fines are issued to a mobile reciprocity licensee; or Enforcement action is taken against a mobile reciprocity licensee under §J(3) of this regulation. A mobile reciprocity license: May not exceed $300; and Is valid for a period of 1 year. The person-in-charge shall permit a representative of the approving authority to: Enter a food service facility at a reasonable time for the purpose of making inspections to determine compliance with this chapter; and Examine the records of the facility that pertain to information regarding food and supplies purchased, received, or used. The person-in-charge shall inform the approving authority of, and keep confidential, a food ingredient or a recipe that the person-in-charge considers a trade secret, except as provided in §C of this regulation. The person-in-charge shall furnish information to the approving authority regarding a food ingredient or recipe that the person-in-charge considers a trade secret if: An immediate and substantial danger to public health exists involving the food ingredient or recipe; or The approving authority determines that the information about the food ingredient or recipe is necessary to conduct a foodborne disease investigation. The approving authority shall maintain the confidentiality of trade secret information in accordance with State Government Article, §10-617, and Health-General Article, §21-259, Annotated Code of Maryland. When an inspection of a food service facility is made, the approving authority shall: Document: The inspection results on an inspection report form provided by the Department; and On the report: Conditions found that violate the provisions of this chapter; and Critical item violations, noted separately from all other violations; Furnish one copy of the inspection report to the person-in-charge of the facility; and Make the completed inspection report form available for public disclosure in accordance with State Government Article, §10-611—10-628, Annotated Code of Maryland. The approving authority shall ensure that: The following types of inspections are conducted: A comprehensive inspection that contains: A monitoring inspection as set forth in §A(2) of this regulation; A HACCP compliance inspection as set forth in §A(3) of this regulation; and An inspection of the physical facility to ensure compliance with the applicable sections of this chapter, including those governing: Floors; Walls; Ceilings; Lighting; Ventilation; Hoods; Food equipment; Toxic substances and cleaning supplies storage and use; Cleaning, rinsing, and sanitizing; Mechanical warewashers; Insects, rodents, birds, or other animals; Trash disposal; Hand sinks; Bathroom fixtures; and Backflow and backsiphonage prevention; A monitoring inspection that contains: An inspection for compliance with critical items as: Defined in Regulation .02B(19) of this chapter; and Outlined in §C of this regulation; A menu review to determine whether the existing priority assessment is correct; and An evaluation of the physical facility to ensure that food is protected; and A HACCP compliance inspection that contains: An inspection for compliance with Regulation .34 of this chapter; A comparison of the HACCP plan on site to the current menu; An evaluation of the food preparation in progress to ensure that each CCP: Is properly identified; Is monitored according to the procedures contained in the HACCP plan; and Has a corrective action that is implemented according to procedures contained in the HACCP plan; Verification that the procedures used to monitor each CCP are accurate; and Action to: Enforce compliance with the HACCP plan; or Have the existing HACCP plan revised to comply with Regulation .33E and F of this chapter; The person-in-charge is in compliance with critical items when the person-in-charge: Receives food from approved sources; Protects food from adulteration; Ensures that an individual who works with food: Washes hands as necessary to protect food and food contact surfaces from contamination; and Is excluded if ill as set forth in Regulation .14A and B of this chapter; Cools potentially hazardous food: As set forth in Regulation .11A—C of this chapter; and In equipment that complies with Regulation .15 of this chapter; Maintains potentially hazardous food: Hot: At hot holding temperatures as set forth in Regulation .06B(7) of this chapter; and In equipment that complies with Regulation .15 of this chapter; or Cold: At refrigeration temperatures as set forth in Regulation .06B(7) of this chapter; and In equipment that complies with Regulation .15 of this chapter; Cooks and reheats potentially hazardous food: As set forth in Regulations .10 and .11D of this chapter; and In equipment that complies with Regulation .15 of this chapter; Provides an adequate supply of potable water for: Food preparation; Hand washing; Utensil washing; Toilet facilities; and Facility sanitation; and Properly discharges sewage as set forth in Regulation .18F and G of this chapter; A food service facility is inspected: As needed for the enforcement of this chapter; When a high priority food service facility: At a minimum frequency of three times per year, one at every 4-month interval; Except as provided in §D of this regulation, using: A comprehensive inspection; and Two monitoring inspections; and That operates fewer than 12 months in a year, using one comprehensive inspection: Per operating season if the operating season is less than 4 months; or During each 4 month interval if the operating season is 4 months or greater; When a moderate priority food service facility: At a minimum of two times per year, one every 6 months; Except as provided in §D of this regulation, using: A comprehensive inspection; and A monitoring inspection; and That operates fewer than 12 months a year, using a comprehensive inspection during each period of 6 months or less; When a low priority food service facility, using a comprehensive inspection at a minimum of once every 2 years except that a HACCP compliance inspection is not required; When a temporary food service facility, using a monitoring inspection as set forth in Regulation .30A(2) of this chapter during each licensure period; and When a seasonal farmer’s market producer sampling food service facility, using a monitoring inspection: A minimum of two times per year, once every 6-month interval; Except as provided in §D of this regulation; and That operates fewer than 12 months in a year: Per operating season if the operating season is less than 6 months; or During each 6-month interval if the operating season is 6 months or greater; and A food service facility is inspected as soon as possible when the food service facility has been associated with foodborne illness, using a: HACCP compliance inspection that focuses on the food implicated with illness; and Upon completion of the HACCP compliance inspection, either a: Comprehensive inspection; or Monitoring inspection. The person-in-charge shall correct: Critical item violations immediately; Other violations except as provided in §A(3) of this regulation within: 30 days of the inspection; or Another time period specified by the approving authority based on applicable State and local laws, regulations, and ordinances; and Other violations at a temporary food service facility within: 24 hours of the inspection; or Another time period specified by the approving authority based on applicable State and local laws, regulations, and ordinances. The approving authority may modify the specified time period for correcting a violation if the person-in-charge: Submits a written schedule of compliance within a time frame for correcting a violation that is acceptable to the approving authority; and There is no immediate or substantial danger to public health. The person-in-charge shall ensure that a food service facility: That prepares food and provides seating for patrons posts a diagram on the use of manual maneuvers to prevent asphyxiation due to choking, in accordance with Health-General Article, §21-326, Annotated Code of Maryland; and Displays prominently in the staff area of the food establishment a poster related to food allergy awareness that includes information regarding the risk of an allergic reaction, in accordance with Health-General Article, §21-330.2(a), Annotated Code of Maryland. The person-in-charge shall ensure that plans and specifications are submitted to and approved by the approving authority before a food establishment is: Constructed; Remodeled; or Materially altered. The person-in-charge shall ensure that the information submitted to the approving authority includes: A scale drawing of the proposed facility that identifies the layout and arrangement of work areas and the location of all equipment; A description of: Materials to be used for interior finishes; The layout and types of lighting to be used; The proposed ventilation system; and Methods and facilities for trash storage and disposal; A plumbing diagram, including specifications of the method of sewage disposal and the source of potable water; A complete list of specifications for the proposed food equipment; A menu or other written description of the foods to be prepared or served; General food handling information and procedures for: Receiving; Storage; Thawing; and Preparation; A list of foods that will be: Prepared in advance of service; or Distributed off premises; A description of the food systems that will be used, such as: Cook-hot hold-serve; Cook-cool-reheat-hot hold-serve; and Cook-cool-cold hold-serve; and Any other information that is required by the approving authority to ascertain compliance of the plans and specifications with all applicable State and local laws, regulations, and ordinances. The approving authority shall: Conduct a priority assessment of the facility based upon the information obtained in §B of this regulation; Classify each food service facility as a: High priority facility; Moderate priority facility; or Low priority facility; Designate as a high priority facility, a facility that: Is a health care facility; or Serves potentially hazardous food that is prepared: A day or more in advance of service; or Using food preparation methods that require the food to pass through the temperature range of 41°F to 135°F two or more times before service, such as cooking, cooling, and then reheating; Designate as a moderate priority facility, a facility that serves potentially hazardous food: That is prepared using methods that require the food to pass through the temperature range of 41°F to 135°F not more than one time before service, such as cooking, hot holding, and then serving; or That is cut, assembled, or packaged on the premises, such as meats; and Designate as a low priority facility, a facility that serves: Commercially packaged potentially hazardous foods directly to the consumer; Non-potentially hazardous food that is cut, assembled, or packaged on the premises, such as candy, popcorn, and baked goods; or Hand dipped ice cream. Except for a temporary food service facility, the person-in-charge shall ensure that a HACCP plan is submitted to the approving authority for each high or moderate priority facility as specified in §C of this regulation. The person-in-charge shall ensure that the HACCP plan includes the: Identification of each CCP; Critical limits for each CCP; Monitoring procedures at each CCP; Corrective action that will be taken if there is a loss of control at a CCP due to: Employee error; Equipment malfunction; Power failure; or Any other factor that causes loss of control at a CCP; Verification procedures that will ensure proper monitoring of each CCP, such as: Calibration of cooking and holding equipment and thermometers; and Review of records such as temperature logs; Written procedures for employee training in HACCP plan procedures; and A list of the food service equipment that will be used at each CCP. The person-in-charge shall construct the HACCP plan by: Listing, for each CCP, the: Menu items controlled by the CCP; Equipment used; and Monitoring, corrective action, and verification procedures; Incorporation of the requirements of §E of this regulation into a recipe or preparation instructions; or Another way that meets the requirements of §E of this regulation. The person-in-charge of a high or moderate priority food service facility shall ensure that: A HACCP plan is: In compliance with Regulation .33E and F of this chapter; Within the food preparation area during operation; Readily accessible to employees at all times; and Updated as follows: When a change in food processes or procedures change one or more CCP; and At least once every 5 years; An employee involved in food preparation is trained in the HACCP procedures; and Changes to the HACCP plan are submitted to the approving authority before implementation of the HACCP plan. The approving authority shall ensure that when a food service facility is found in violation of any provision of this chapter, the licensee is notified: Of the specific findings; Of a specific date by which the licensee shall correct the violations or deficiencies; and That, if the licensee fails to correct the violation by the date specified, the approving authority may suspend or revoke the license. When a person is violating any provision of this chapter, the approving authority may serve the person with a written order pursuant to Health-General Article, §21-318 or 21-261, Annotated Code of Maryland, directing the person to abate the violation within a specified time period. When an inspection indicates that an immediate and substantial danger to public health exists and requires emergency action at a facility operated by an excluded organization, the approving authority may seek injunctive relief as provided in Health-General Article, §§21-1214 and 21-1215, Annotated Code of Maryland. The approving authority shall ensure that an opportunity for a hearing is provided to a person served with an order, pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. In order to preserve a right to a hearing under any provision of this regulation, a person shall: Make a request for a hearing in writing; and Submit the request to the approving authority that issued the order or inspection report: Within 10 days of receipt of the order; Sooner if specified in the order; or Within 24 hours if: The violation requires immediate correction or correction within 24 hours; or The facility is a temporary food service facility. The approving authority shall suspend or revoke the license of a food service facility if the licensee fails or neglects to: Correct a violation within the specified time period; Comply with an approved written schedule of compliance; Correct a critical item immediately; or Correct a violation in a temporary food service facility within 24 hours. The approving authority shall ensure that an action to suspend or revoke a license: Complies with the provisions of: State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; and Health-General Article, §21-315, Annotated Code of Maryland; and The person against whom the action is contemplated is given an opportunity for a hearing in accordance with Health-General Article, §21-316, Annotated Code of Maryland. When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, the: Approving authority shall: Summarily suspend the license at a food service facility; Order the food service facility to cease operation immediately; and Promptly provide the licensee with: A written notice of suspension of the license; The reasons for the suspension; and An opportunity to be heard; and Person-in-charge shall immediately cease the operation of the food service facility. The person-in-charge shall ensure that a food service facility that has been required under the provisions of this regulation to cease operations does not resume operations until a reinspection by the approving authority shows that the condition or conditions responsible for the requirement to cease operations no longer exists. The approving authority shall ensure that appropriate steps are taken to ensure that the licensee ceases operation of the food service facility upon suspension or revocation of the license, including: Taking and keeping physical possession of the license until the license is reinstated; Posting a sign on the facility door stating that the license has been suspended or revoked by the approving authority; or Taking another measure within the law that will ensure that the facility does not operate. A person whose food service facility license has been suspended or revoked may apply for reinspection and reinstatement of the license by submitting to the approving authority a written request that details the actions taken by the person to correct each violation of a food statute or regulation that caused the suspension or revocation. The approving authority shall ensure that: When there is reasonable cause to suspect foodborne disease transmission from a food service facility employee: A morbidity history of the suspected employee is taken; An investigation is conducted; and The appropriate follow-up action is taken that may include: Immediate exclusion of the employee from all food handling positions within the facility; and Immediate closing of the food service facility until medical and epidemiological evidence shows that the likelihood of further foodborne disease transmission is low; and An investigation, a report, and the control of a foodborne disease outbreak is conducted in accordance with the provisions of COMAR 10.06.01. The approving authority shall: Sample and examine food as often as necessary for enforcement of this chapter; Sample food in accordance with Health-General Article, §§21-249 and 21-251, Annotated Code of Maryland; and Take action on a food in accordance with Health-General Article, §§21-211, 21-253, and 21-254, Annotated Code of Maryland, by: Issuing a detention order; Destroying the food; or Making the food unusable for consumption. A person who violates any of the provisions of this chapter or refuses, neglects, or fails to comply with the provisions and requirements of this chapter is subject to: Penalties, fines, and imprisonment as set forth in Health-General Article, §§21-1214 and 21-1215, Annotated Code of Maryland; and Penalties and fines as provided by local law, ordinance, or regulation in accordance with Health-General Article, §21-309.2(e)(3), Annotated Code of Maryland. In addition to the other requirements set forth in this chapter, the person in charge shall ensure that the food service facility meets all of the requirements applicable to food sources, storage, preparation, and service that are set forth at: 21 CFR, as amended; 9 CFR, as amended; and 21 U.S.C. §343, as amended. The owner or operator of a micro market may not be required to have a person-in-charge present during the hours of operation of the micro market if the micro market meets the requirements of this regulation. Food sold at a micro market shall: Be commercially prepackaged food or ready-to-eat food; Be prepackaged in tamper-evident packaging; and Contain all the following information on the packaging label: Nutrition information required by the federal Food, Drug, and Cosmetic Act; A freshness or expiration date; and Any other information required by Maryland law. Refrigerated or frozen food sold at a micro market shall be stored and displayed in a refrigerator, refrigerated cooler, or freezer that: Maintains an internal temperature of 41°F or lower; Has self-closing doors; Has doors that allow the food on display to be viewed without opening the door to the refrigerator, refrigerated cooler, or freezer; and Has an automated self-locking feature that prevents a consumer from accessing the food on the occurrence of any condition that results in the failure of the refrigerator, refrigerated cooler, or freezer to maintain the internal temperature required under Regulation .06 of this chapter. Signage and Notice. The owner or operator of a micro market shall post a sign that is clearly visible to the consumer near the micro market entryway or while using the electronic payment device that includes the following information: The name of the owner or operator of the micro market to whom complaints and comments regarding the micro market may be addressed; The business mailing address of the owner or operator; The business telephone number of the owner or operator; and The email address and website address of the owner or operator, if applicable. Security. The owner or operator of a micro market: May secure the products and premises of a micro market by the use of video surveillance that: Operates 24 hours per day, 7 days per week; Records consumers viewing, selecting, handling, and purchasing products from the micro market; and Provides sufficient resolution to identify consumers described in §E(1)(b) of this regulation; and Shall ensure that video surveillance recordings made under §E(1) of this regulation are: Maintained by the owner for 14 days after the date of the video recording; and Made available for inspection by the appropriate health or law enforcement agency on the request of the agency within 24 hours from the time the request is received by the owner or operator. Record Keeping. The owner or operator of a micro market shall ensure that: In the event of a failure of an automated self-locking unit, records are kept for: The repair or replacement of the failed unit in the form of receipts or a completed service order; and All products in the unit at the time of the failure and include: Product description; and Quantity of products discarded or destroyed; Service receipts for the repair or replacement of the failed unit and product destruction shall be kept for a minimum of 90 days; and All records are available for review upon request. Agriculture Article, §4-311; Health-General Article, §§18-102, 21-101, 21-102, 21-211, 21-202, 21-234, 21-301, 21-304, 21-308, 21-309.1, 21-309.2, 21-324.1, and 21-330.1; Annotated Code of Maryland Effective date: January 1, 1976 (2:28 Md. R. 1669) Regulations .01; .02K, N, X; .03A, B; .05B; .06D, G; .07A—C; .08B amended and .02Q-1 adopted effective December 19, 1983 (10:25 Md. R. 2268) Regulation .02X adopted effective September 21, 1979 (6:19 Md. R. 1518) Regulations .03B, .05B, .07E, and .09B, C amended effective September 21, 1979 (6:19 Md. R. 1518) Chapter revised as an emergency provision effective August 2, 1989 (16:17 Md. R. 1882); adopted permanently effective December 25, 1989 (16:25 Md. R. 2710) Regulation .01B amended effective February 15, 1993 (20:3 Md. R. 259) Regulation .01C adopted effective March 4, 1991 (18:4 Md. R. 447) Regulation .02 repealed and new Regulation .02 adopted effective March 4, 1991 (18:4 Md. R. 447) Regulation .02B amended effective February 15, 1993 (20:3 Md. R. 259); October 6, 1997 (24:20 Md. R. 1403); July 27, 1998 (25:15 Md. R. 1191) Regulation .03G amended effective March 4, 1991 (18:4 Md. R. 447); February 15, 1993 (20:3 Md. R. 259); October 6, 1997 (24:20 Md. R. 1403) Regulation .04B and F amended effective February 15, 1993 (20:3 Md. R. 259) Regulation .04C amended effective October 6, 1997 (24:20 Md. R. 1403) Regulation .06A amended effective March 4, 1991 (18:4 Md. R. 447) Regulation .09A, B, and D amended effective March 4, 1991 (18:4 Md. R. 447) Regulation .10 amended effective March 4, 1991 (18:4 Md. R. 447); February 15, 1993 (20:3 Md. R. 259); October 6, 1997 (24:20 Md. R. 1403) Regulation .11 repealed and new Regulation .11 adopted effective March 4, 1991 (18:4 Md. R. 447) Regulation .11B and C amended effective February 15, 1993 (20:3 Md. R. 259) Regulation .12 recodified to Regulation .25 effective March 4, 1991 Regulations .12—.24 adopted effective March 4, 1991 (18:4 Md. R. 447) Regulation .18A amended effective February 15, 1993 (20:3 Md. R. 259) Form DHMH 205 repealed effective March 4, 1991 (18:4 Md. R. 447) Regulations .01—.25 repealed and new Regulations .01—.39 adopted effective December 17, 2007 (34:25 Md. R. 2211) Regulation .02B amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .02B amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) Regulation .02B amended effective February 3, 2012 (39:1 Md. R. 17); March 4, 2013 (40:4 Md. R. 346); February 15, 2016 (43:3 Md. R. 272); December 31, 2018 (45:26 Md. R. 1245); October 5, 2020 (47:20 Md. R. 875); December 11, 2023 (50:24 M. R. 1042) Regulation .04 amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .04E amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .06 amended effective March 19, 2010 (37:4 Md. R. 341); October 5, 2020 (47:20 Md. R. 875) Regulation .06C amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) Regulation .07A amended effective January 6, 2014 (40:26 Md. R. 2163) Regulation .07B amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .08B amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .09 amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .09D amended effective October 5, 2020 (47:20 Md. R. 875) Regulation .10 amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .10A amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .11 amended effective October 5, 2020 (47:20 Md. R. 875) Regulation .11C amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .12A amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .14F amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .14I amended effective February 3, 2012 (39:1 Md. R. 17) Regulation .15 amended effective March 19, 2010 (37:4 Md. R. 341); October 5, 2020 (47:20 Md. R. 875) Regulation .15A amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) Regulation .16 amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .17G amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .18H, I amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .19A amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .20 amended effective March 4, 2013 (40:4 Md. R. 346) Regulation .21 amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .22B, I amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .23 amended effective February 3, 2012 (39:1 Md. R. 17) Regulation .23L amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .24B amended effective October 5, 2020 (47:20 Md. R. 875) Regulation .25 amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .25 amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) Regulation .25A, B amended effective October 5, 2020 (47:20 Md. R. 875) Regulation .25C amended effective December 31, 2018 (45:26 Md. R. 1245); October 5, 2020 (47:20 Md. R. 875) Regulation .26 amended effective March 19, 2010 (37:4 Md. R. 341); October 5, 2020 (47:20 Md. R. 875) Regulation .26G amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) Regulation .27 amended effective March 19, 2010 (37:4 Md. R. 341); February 3, 2012 (39:1 Md. R. 17); March 4, 2013 (40:4 Md. R. 346); October 5, 2020 (47:20 Md. R. 875); December 11. 2023 (50:24 Md. R. 1042) Regulation .27A amended effective December 27, 2021 (48:26 Md. R. 1111) Regulation .27C amended effective February 15, 2016 (43:3 Md. R. 272); December 27, 2021 (48:26 Md. R. 1111) Regulation .27C amended as an emergency provision effective November 27, 2024 (51:26 Md. R. 1185); amended permanently effective April 28, 2025 (52:8 Md. R. 358) Regulation .28 amended effective February 3, 2012 (39:1 Md. R. 17) Regulation .28C, E amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .28 amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) Regulation .28G, J amended effective October 5, 2020 (47:20 Md. R. 875) Regulation .28J, K adopted effective December 31, 2018 (45:26 Md. R. 1245) Regulation .30B amended effective October 5, 2020 (47:20 Md. R. 875) Regulation .30B, C amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .30C amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) Regulation .32, Choking Posters, renamed, Required Postings and amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .33A, C amended effective March 19, 2010 (37:4 Md. R. 341) Regulation .33C, D amended effective February 3, 2012 (39:1 Md. R. 17) Regulation .38 amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) Regulation .40 adopted effective October 5, 2020 (47:20 Md. R. 875) This chapter: Provides the minimum food safety and sanitation requirements for food processing plants, including warehouses and transfer stations, and the transportation of food; Is not intended to govern a meat processing plant that solely processes meat products under the regulation and inspection of the United States Department of Agriculture in accordance with the Code of Federal Regulations. In this chapter, the following terms have the meanings indicated. Terms Defined. Adulterated Food. “Adulterated food” has the meaning stated in Health-General Article, §21-207, Annotated Code of Maryland. “Adulterated food” includes food that is: Is diseased; Is contaminated; Is filthy; Is putrid; Has decomposed; Contains any poisonous or otherwise deleterious substance that, in the quantity present, reasonably would be expected to make it injurious to health; Contains any food additive or color additive, the particular use of which has not been found safe as provided under Health-General Article, §21-239, Annotated Code of Maryland; Was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have contaminated it with filth; Was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have caused it to be diseased, unwholesome, or injurious to health; Was packaged in a container composed of any poisonous or otherwise deleterious substance that reasonably would be expected to have caused the food to be injurious to health; or Is misbranded so that the food is unsafe for human consumption. “Allergen cross-contact” means the unintentional incorporation of a food allergen into a food that has not been identified as containing it. “Approving authority” means the agency designated in the laws of another state or country to license or permit a food processing plant. “Approved source” means a source of food or food ingredients accepted by the Department because the food or food ingredients from the source: Are not adulterated foods or misbranded as defined in §B(1) and (21) of this regulation; and Where required, are regulated by the approving authority. “Charity deer processing” means the processing of legally harvested whitetail deer into cuts of raw meat as only a service for a charitable organization that donates the meat to the needy for consumption. “Contamination” means the process or state that potentially renders a food unsafe for human consumption due to the adulteration of the food with: Pathogens; Chemicals; Allergens; Foreign objects; or Filth. “Corrective action” means the documented steps taken when a deviation occurs at a control point to: Address the cause of the deviation; Restore control; and Prevent the affected food from entering commerce. “Critical control point” means a step or procedure in a food process at which control can be applied, and is essential to: Prevent a food safety hazard; Eliminate a food safety hazard; or Reduce a hazard to an acceptable level. Critical Item. “Critical item” means a food safety requirement that if violated requires: Immediate correction; The cessation of some or all processing operations; or Plant closure. “Critical item” includes the following requirements: Food is obtained from an approved source; Food is protected from contamination and allergen cross-contact; Food processes provide safe food with proper control at critical control points; Food is protected by ensuring that all personnel wash hands thoroughly as often as necessary to prevent food contamination by hand contact; Personnel are restricted from food handling positions or the plant as indicated if they have an illness or infection that is transmissible through food as defined in COMAR 10.06.01.06E; Food is packaged and labeled for safety with allergens properly identified on the label; A sufficient volume of potable hot and cold water supply under pressure is available; and Sewage is discharged in compliance with applicable laws and regulations. “Department” means the Maryland Department of Health or the Department's designee. Farm. “Farm” means a place where agricultural commodities are grown, raised, or harvested for commercial purposes. “Farm” includes a place where, for commercial purposes: Crops are grown and harvested; Fruit, nuts, or other agricultural commodities are harvested from trees; or Animals are raised, fed, and managed for meat or other agricultural commodities. “Food” means: Articles used for food or drink for humans or other animals; Chewing gum; and Individual components of such articles. “Food allergen” means an ingredient that contains protein derived from one of the following foods or food groups: Milk; Egg; Fish; Crustacean shellfish; Tree nuts; Wheat; Peanuts; Soybeans; or Sesame. Food Processing Plant. “Food processing plant” means a place used for or in connection with commercial food: Manufacturing; Processing; Packing; Repacking; Storage; or Distribution. “Food processing plant” includes a: Crab meat picking plant; Food manufacturing plant; Cold food warehouse; Ambient food warehouse, except as specified in §B(14)(c) of this regulation; Shellfish plant or dealer; Bottled water plant; Meat processing plant or poultry processing plant that is not subject to regulation by the United States Department of Agriculture or by a meat inspection program or poultry inspection program administered by the Maryland Department of Agriculture; Cider plant; Charity deer processing plant; and Producer mobile farmer’s market unit. “Food processing plant” does not include a warehouse or distribution center that: Stores only sealed containers pre-packaged, ready-to-eat snack foods that do not require temperature control for safety; Stores only bottled beverages that do not require temperature control for safety; Stores only packaged ice; Stores only whole bean, ground or instant coffee, or leaf or instant teas; Stores only nondairy dehydrated whiteners, sugar, or sugar-free sweeteners; or Is a food transfer station where food is transferred between transportation vehicles or there is an area maintained for food that is stored for less than 24 hours. “Generally recognized as safe (GRAS)” means that a substance is: Not harmful to humans consuming the substance under the intended conditions of use; and In accordance with 21 CFR §170.30. “Hazard” means any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury “Hazard Analysis Critical Control Point (HACCP)” means a management system that addresses the safety of food that is temperature controlled for safety (TCS) at critical control points as specified by: COMAR 10.15.10 Procedures for the Safe Handling and Processing of Seafood; COMAR 10.15.12 Procedures for the Safe Handling and Processing of Juice; 21 CFR Part 123 Fish and Fishery Products; or The National Advisory Committee on the Microbiological Criteria for Food. “Indirect food additive” means a substance that is unintentionally incorporated into food due to processing, holding, or packaging. “Label” means a display of written or graphic matter on the container, other than the package liner, of a food. “Labeling” means any label or other written or graphic material that: Is on a: Food; Food container; or Food wrapping; or Accompanies a food. “Misbranded” has the meaning stated in Health-General Article, §21-210, Annotated Code of Maryland. “Person-in-charge” means: The licensee; or Another person responsible for the operation of the food processing plant. “Potable water” means a water supply that meets the requirements of the Safe Drinking Water Act, as administered by the EPA and COMAR 26.04.02.01B(33). “Poultry” means any domesticated bird. Preventive Controls. “Preventive controls” means a step or combination of steps that are taken to minimize, prevent, or eliminate: Identified food safety hazards; or Food safety hazards that are reasonably likely to occur. “Preventive controls” includes: Process controls; Allergen controls; Sanitation controls; and Other appropriate controls taken at critical control points or at other points as necessary to ensure food safety based on the outcome of a hazard analysis. “Preventive controls qualified individual (PCQI)” means an individual who has: Successfully completed training in the development and application of risk-based preventive controls; or The education, experience, and knowledge to develop and implement a food safety system. “Principal display panel” means the part of a label that is the most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. “Process” means a specific set of operations or procedures used to manufacture a food. “Process authority” means an individual having expert knowledge of specialized food processes acquired through : Training; and Experience. Producer Mobile Farmer’s Market Unit. “Producer mobile farmer’s market unit” means a unit designed to ensure that food is: Protected from contamination during transportation from farm to farmer’s market or public festival or event; and Kept at temperatures that support the safety and wholesomeness of the food. “Producer mobile farmer’s market unit” does not include a unit used to deliver: Prepackaged foods to fill an order of a customer; Raw agricultural products; or On-farm home processed foods that do not require temperature control for safety. “Qualified auditor” means a qualified individual with necessary technical expertise regarding hazards being controlled to evaluate food safety regulations and review a supplier’s written plan, for example, the Hazard Analysis and Critical Control Point (HACCP) plan or other food safety plan, and its implementation through: Education; Training; or Experience. “Qualified individual” means a person who is able to handle food safely as appropriate to the individual’s assigned duties, as determined by having the: Education; Training; or Experience. “Scheduled process means a method or set of procedures established by a process authority for processing a food, includes the critical factors that may impact the food’s safety or stability to achieve and maintain a food that will not permit the growth of microorganisms having public health significance. “Shelf life study” means a food evaluation using microbiological, physical, chemical, organoleptic, or other tests to determine the length of time a food may be stored before the food becomes unfit for sale or human consumption. “Shell eggs” means raw or treated eggs produced by poultry for human consumption. “Snack foods” means chips, pretzels, candy, and other novelty snacks. “Temperature control for safety (TCS)” means a food requires specific time and temperature control to limit pathogenic microorganism growth or toxin formation for safety. In this chapter, the following documents are incorporated by reference. Documents Incorporated. 9 CFR, as amended; 21 CFR, as amended; 21 U.S.C. §343, as amended; 21 U.S.C. §§451 — 471, as amended; and 21 U.S.C. §§601 — 695, as amended. The person-in-charge shall manufacture, process, pack/repack, label, store, or distribute food and design, operate, and maintain a food processing plant and the facilities and equipment associated with a food processing plant in compliance with this chapter and with COMAR 10.15.01, 10.15.02, 10.15.07, 10.15.10, and 10.15.12, as applicable. The person-in-charge shall ensure that: Individuals do not cause contamination of: Food; Food-contact surfaces; and Food-packaging material; Individuals are excluded from working with food, food-contact surfaces, and food-packaging materials: As provided in COMAR 10.06.01.06E; and When an individual has an: Illness transmissible through food; or Exposed and open sore or cut; Individuals working in direct contact with food, food-contact surfaces, and food-packaging material: Wear suitable, clean outerwear garments in a manner that protects the food, food-contact surfaces, and food-packaging material against contamination; Wear hair nets, beard covers, or other effective hair restraints; Keep fingernails clean and neatly trimmed; Prevent fingernail polish or artificial fingernails from coming into contact with food, food-contact surfaces, and food-packaging material; Remove all unsecured jewelry and other objects that may fall into food, equipment, or containers; Secure any jewelry that cannot be removed with material which can be maintained in an intact, clean, and sanitary condition; Wash hands and exposed arm areas thoroughly with soap and warm water: At a hand washing facility in compliance with regulation .12G of this chapter; Before starting work; After each absence from the workstation; and At any other time when hands may have become soiled or contaminated or as often as required to remove soil and contamination; and Apply sanitizer as necessary to protect against contamination with undesirable microorganisms; Individuals wearing gloves while working with food or food-contact surfaces shall: Use gloves that are intended for food contact; Maintain gloves in an intact, clean, and sanitary condition; Wash hands thoroughly before putting on gloves; Clean and sanitize reusable gloves using approved methods or equipment. Replace gloves: When the gloves are damaged or soiled; Between unrelated tasks; and After an interruption in working with food or food-contact surfaces; Individuals store personal items in a designated area other than where food is exposed or stored, or where equipment or utensils are washed; Individuals do not use tobacco, chew gum, eat food, drink beverages, or engage in any activity that might contaminate food in an area that is used for: Food processing; Equipment or utensil washing; Storage of: Food; Food-contact surfaces; or Food packaging; Individuals prevent allergen cross-contact and contamination with microorganisms, deleterious substances, or foreign matter of food, food-contact surfaces, and food-packaging materials; Education and training in personal hygiene, food handling, and plant sanitation is provided to personnel, food handlers, and supervisors in a language and form they understand as it relates to assigned duties such that: Each individual engaged in food handling or in the supervision of one or more individuals be qualified by: Education; Training; Experience; or A combination of education, training, and experience; Responsibility for education and training shall be clearly assigned to qualified supervisory personnel; and Records that document each individual’s training are maintained according to Regulation .06 of this chapter; and When specialized personnel training is required by COMAR 10.15.01, 10.15.02, 10.15.07, 10.15.10, or 10.15.12 or this chapter, or 21 CFR Part 112, Subpart M, the specialized training is obtained as required. The person-in-charge shall ensure that all required records: Be kept as original records, true copies, or electronic records; Identify the name and location of the food processing plant; Contain the time and date the activity was performed and documented; Include the signature or initials of the individual performing and documenting the activity; Contain actual values and observations obtained during monitoring and verification activities; Be accurate, indelible, and legible; Be created concurrently with performance of the activity documented; Be as detailed as necessary to provide a history of work performed; Identify the product and lot code if applicable; Are original or accurate reproductions of the original and are retained at the plant or facility for at least 2 years after the date they were prepared; and Are made available to an authorized representative of the Department for official review and reproduction upon oral or written request. The person-in-charge shall ensure that: All food and food ingredients processed in a food processing plant: Are from an approved source; Are GRAS; If applicable, conform to a standard of identity, as defined in 21 CFR Part 130; Comply with FDA regulations for poisonous or deleterious substances; and Are identified and held in a manner that prevents allergen cross-contact if the food and food ingredients are an allergen or contain an allergen; When ice is used in contact with food, it shall be: Made from potable water; and Manufactured and stored in accordance with this chapter; Compressed air or other gasses mechanically introduced into food do not contaminate the food with unlawful indirect food additives; Raw materials and other ingredients: Are inspected at receipt to ensure that they are acceptable for use; and Are washed or cleaned as necessary to remove soil or other contamination; Food is processed and stored under conditions and control procedures that prevent and protect from: Contamination; and Allergen cross-contact; The potential for contamination and allergen cross-contact is reduced by: Food safety controls; Operating practices; and Separation of operations by: Location; Time; or Effective design; Food is processed and stored at temperatures that: Minimize the potential for the growth of microorganisms; and Prevent adulteration; The thermal processing of food eliminates or reduces the number of pathogens in the food so that the food is safe for human consumption; The cooling of foods is conducted using methods that: Minimize the potential for the growth of microorganisms; and Prevent adulteration; Foods that require temperature control for safety are maintained at the temperature: 38°F or less for foods with a non-proteolytic Clostridium botulinum potential hazard; 40°F or less; 45°F or less for molluscan shellfish or shell eggs; 135°F or higher; or As otherwise approved by the Department; Food that relies principally on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level; Food that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below; Adequate measures are taken to protect against the inclusion of metal or other extraneous material in food; Frozen food remains frozen when stored or removed from refrigeration in order to be segregated, organized, or moved; Frozen foods are thawed in a manner that prevents contamination; Any food, raw material, or ingredient that is adulterated is not offered to human beings and is: Rejected upon receipt; Treated or processed to eliminate the contamination; Destroyed in a manner that protects against the contamination and allergen cross-contact of other food; Stored only in a designated area that is: Separated from all other food and food process operations; and Conspicuously marked with the intended disposition; Reconditioned using a method that is safe and effective; Reexamined following reconditioning and subsequently found not to be adulterated; Not mixed with another lot of food that is not adulterated; and If detained by the Department: Reconditioned; or Destroyed in a manner approved by the Department; A facility that only stores unexposed packaged foods that require time and temperature control to significantly minimize or prevent pathogens: Establishes and implements temperature controls that significantly minimize or prevent the growth of, or toxin production by, pathogens; Monitors the temperature controls with adequate frequency; Takes appropriate corrective actions if there is a loss of temperature control that may impact the safety of the food; Establishes and maintains affirmative or exception records that document implementation of temperature controls, calibration, or accuracy checks of temperature monitoring and recording devices, and corrective actions; Reviews records of monitoring and corrective actions taken to correct a problem with the control of temperature within: 7 working days after the records are created; or A reasonable time frame; and Reviews records of calibration or accuracy checks within a reasonable time frame after the records are created; Written standard operating procedures are: Available to employees in a format they understand; Implemented; and Reflective of current manufacturing procedures; When the Department requires a scheduled process, the scheduled process is: Established by a process authority; Used to manufacture the target food; Not changed without approval of the process authority; Documented by: Production records; and Process deviation records; and Verified by: Production records review; Equipment calibration; or Laboratory testing; Records that document compliance with this regulation are maintained in accordance with Regulation .06 of this chapter; Human food by-products for use or distribution as animal food without additional manufacturing or processing are: Accurately identified when stored; Stored under conditions that protect against contamination; and Labeled or accompanied by a label identifying the by-product by the common or usual name when distributed; Finished product testing for chemicals, microbes, or extraneous materials is conducted when necessary to identify failures to protect ready to eat food from contamination or allergen cross-contact; and Environmental testing for chemicals or microbes is conducted when necessary to identify failures to protect ready to eat food from contamination or allergen cross-contact. The person-in-charge: Is exempt from this regulation if: They meet the definition of a qualified facility in 21 CFR §117.3; or They meet the qualifications defined in: 21 CFR §§117.5—117.8; 21 CFR §117.201; 21 CFR §§117.251—117.287; and 21 CFR §117.315(a)(2); Shall ensure that a food safety plan: Is prepared, implemented, and managed by one or more individuals qualified in preventative controls; Is signed and dated by the owner, operator, or agent in charge: Upon initial completion; When any modification takes place; and At least once every 3 years; Includes a written hazard analysis that identifies all known and reasonably likely to occur biological, chemical, and physical hazards associated with each type of food manufactured in the plant; Includes written procedures for: Preventive controls; Process controls with parameters and values; Allergen controls; Sanitation controls; Other controls necessary as identified in the hazard analysis; Monitoring and record keeping for each preventive control identified in the hazard analysis that include an adequate frequency to control the hazard; Corrective actions that: Identify and correct the problem; Reduce the likelihood the problem will recur; Evaluate all affected food for safety; and Prevent all affected food from entering commerce; Verification activities that ensure that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards; Validation for process controls; A supply chain program that complies with 21 CFR §§117.405—117.475 if the receiving facility has identified a hazard requiring a supply-chain-applied control; and A recall plan for a food with a hazard requiring a preventive control, that includes: Maintaining accurate records to identify the initial distribution of the food; Direct notification of the consignees of the food being recalled, including how to return or dispose of the affected food; Public notification about any hazard presented by the food when appropriate to protect public health; and Effectiveness checks to account for all products affected; Is implemented to prevent, eliminate, or reduce to an acceptable level, all identified hazards; Includes records that document implementation of: The food safety plan monitoring; Corrective actions; and Supply chain, verification, validation, and applicable training for the preventive controls qualified individual and the qualified auditor; Includes that records of monitoring and corrective actions are reviewed by a preventive controls qualified individual within 7 working days after the records are created, or within a reasonable time frame; and Includes that records of verification activities are reviewed within a reasonable time by a preventive controls qualified individual; and Shall ensure that a processing plant complies with the 21 CFR §§117.136—117.137 and 117.335 if results of the hazard analysis determine the facility is not required to implement preventive controls for a food item. The person-in-charge shall ensure that: The food processing plant and grounds around a food processing plant are: Maintained free of attractants, breeding places, or harborage for pests and insects, including: Unused equipment; Debris; Litter; Waste; or High weeds or grass; and Adequately drained to promote sanitation and prevent breeding places for pests and insects; The design and construction of the plant facilitates maintenance and sanitary operations for food processing and: Is suitable in size; Affords protection against the weather; and Minimizes the potential for contamination and allergen cross-contact by providing: Adequate space for the placement of: Equipment; Utensils; and Materials storage; and Effective designing the flow of food through the plant; Except as provided for in Regulation .15 of this chapter, a room or area in which food is processed or stored or in which utensils, equipment, or food-packaging materials are cleaned, sanitized, or stored: Is separated from other rooms or areas in the plant to preclude allergen cross-contact and contamination by: A distance that precludes allergen cross-contact and contamination; or Tight fitting: Walls; Ceilings; and Self-closing doors; Is, if not refrigerated, mechanically ventilated using exhaust and supply fans to ensure: Filtered air is supplied to provide a positive air pressure in the room; Condensation and grease do not accumulate on room surfaces and equipment; and Removal of excessive: Grease vapors; Steam; Heat; and Odors; Has a floor, walls, and ceiling that are: Smooth; Washable; Easily cleanable; and Impervious to water; Has only the exposed overhead pipes, ducts, conduits, evaporators, and other structures that are needed for proper processing, which are installed so that food is protected against leakage; Has floor-wall junctures that are: Coved; and Impervious to water; Has aisles or working spaces between equipment and walls that: Are unobstructed; Of adequate width to permit employees to perform their duties; and Protect against the contamination of food, food-contact surfaces, or food-packaging materials by clothing or personal contact; Provides adequate lighting in all areas that: Uses shatter-resistant light bulbs, fixtures, skylights, or other light sources if suspended over exposed food, food-contact surfaces, or food-packaging materials in any step of preparation; or Otherwise protects against food contamination in case of glass breakage; and Has well-maintained, sealed walls, floors, and ceilings to prevent entry or harborage areas for pests; Except as provided for in Regulation .15 of this chapter, an area is designated for employees to eat, drink, and securely store personal items which is separate from areas designated for the cleaning, sanitation, or storage of: Utensils; Equipment; or Food-packaging materials; The food processing plant is completely separated by solid, impervious floors, walls, and ceilings with no connecting openings from areas used as living quarters; and Plans provided for review to the Department of the plant, facilities, and grounds design and construction that are not provided for in this regulation: Provide for adequate food safety, food protection, and sanitation; and Are equivalent to regulatory and industry standards. The person-in-charge shall ensure that: Except as provided in §§B and M of this regulation, equipment and utensils meet one or more of the following sanitation design standards: National Sanitation Foundation (NSF); The ETL SEMKO division of Intertek Group PLC (Intertek ETL SEMKO); Canadian Standards Association (CSA); Underwriters Laboratories (UL); Bakery Industry Sanitation Standards Committee; National Automatic Merchandising Association; International Association of Food Protection; American Society of Mechanical Engineers; U.S. Department of Agriculture; or Another applicable published standard acceptable to the Department; When design standards conflict with State laws, codes, or regulations, the State laws, codes, or regulations are followed; Food processing equipment and utensils are: Designed and constructed to allow for adequate cleaning and sanitizing; Installed in a way to facilitate cleaning, sanitizing, and maintenance of the equipment and the surrounding areas, including equipment that does not come in contact with food; Designed and constructed to prevent contamination and allergen cross-contact; and Maintained in: Proper working condition; and A manner that protects against contamination and allergen cross-contact; Each freezer and cold storage unit used to store and transport food capable of supporting growth of microorganisms: Maintains temperatures that ensure food safety and protect against spoilage; Is fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device that is: Calibrated to be accurate to within plus or minus 2°F; and Placed in a conspicuous location to show the temperature accurately within the unit; All food-contact surfaces are designed, constructed, and maintained to be: Smooth; Easily cleanable; Durable; Non-absorbent; Constructed of food grade material where applicable; Corrosion resistant; Made of nontoxic material that does not impart toxic or deleterious matter to the food; Inert to food and do not migrate into or adulterate food; and Smoothly bonded at the seams and maintained to minimize accumulation of: Food particles; Dirt; and Organic matter; Food-packaging material: Is food grade; Is safe; Is able to maintain food safety and integrity; Is appropriate for the food item and the intended use; Is not reused if intended for single-service; Meets the labeling requirements in Regulation .13B(2) of this chapter; Does not migrate to or have the potential to be absorbed by food; and Complies with the requirements of the U.S. Food and Drug Administration in 21 CFR Parts 174—178 for indirect food additives; Instruments and controls required for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food are accurate and adequate in number for their designated uses; Thermometers used to monitor required temperatures are calibrated or checked for accuracy annually using an approved method; Compressed air or other gasses mechanically used to clean food-contact surfaces or equipment are treated in such a way that food is not contaminated with unlawful indirect food additives; Non-food-contact equipment is: Smooth; Easily cleanable; Durable; and Non-absorbent; The food storage area of a transportation vehicle is maintained in: Good repair; Working condition; and A manner that protects against contamination of food; Containers, equipment, and vehicles used to convey or hold human food by-products for use as animal food are designed and constructed of appropriate material to protect against contamination; and Equipment submitted to the approving authority for review that meets the provisions of §§C—E of this regulation but fails to comply with §A of this regulation is: Not harmful to public health; and Consistent with industry standards and practice. The person-in-charge shall ensure that: All food processing, food storage, and food-packaging storage areas are maintained in a clean and sanitary manner; Equipment is used and maintained to avoid contamination and allergen cross-contact of food; Food-packaging material is stored to be protected from contamination; Overall sanitation of the plant is under the supervision of one or more qualified individuals; The equipment and facilities needed for cleaning and sanitizing food-contact surfaces are provided and maintained in a sanitary condition; Cleaning and sanitizing of plant facilities, equipment, and utensils are conducted in a manner that protects against allergen cross-contact and against contamination of: Food; Food-contact surfaces; and Food-packaging materials; All food-contact surfaces are cleaned and sanitized as frequently as necessary to protect against allergen cross-contact and against contamination of food; Before use, food-contact surfaces used for processing or holding low-moisture food are: Clean; Dry; and Sanitary; Food-contact surfaces are cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated; When equipment and utensils are washed, rinsed, and sanitized using a three-compartment sink: Each sink compartment is sized to allow sufficient immersion of the equipment or utensils; and The washed, rinsed, and sanitized items are dry before stacking or nesting; Non-food-contact surfaces of equipment used in the operation of a food plant are cleaned as frequently as necessary to be maintained in a sanitary condition; Cleaned equipment and utensils are stored to prevent contamination of the equipment and utensils; Toxic chemicals, cleaning compounds, sanitizing agents, and pesticide chemicals used in the facility are: Safe and adequate under the conditions of use; Used in accordance with the manufacturer’s instructions and applicable State laws and regulations; and Identified and stored in a manner that protects against contaminating: Food; Food-contact surfaces; or Food-packaging materials; All processing and storage areas are maintained free of pests; Effective measures are taken to: Monitor for and exclude pests from processing and storage areas; and Protect against the contamination of food by pests; The food storage area of a transportation vehicle is: Maintained in a clean and sanitary condition; and Inspected as often as necessary to maintain it in a clean and sanitary condition; Containers, equipment, and vehicles used to convey or hold human food by-products for use as animal food before distribution are: Cleaned as necessary; Examined prior to use to protect against contamination from the container or vehicle; and Maintained to protect against contamination; and If ready-to-eat foods are processed, environmental testing is conducted when necessary to demonstrate effectiveness of sanitation operations. The person-in-charge shall ensure that: The water supply is adequate for the operations intended and is: From an approved potable source; At an adequate temperature; Under adequate pressure; and Protected against backflow; All plumbing is of adequate size and is designed, installed, and maintained to: Carry adequate quantities of water to required locations throughout the plant; Convey sewage and liquid waste from the plant; Prevent contamination of: Food; Water supplies; Equipment; Utensils; and Food-packaging materials; Ensure sanitary conditions; Prevent backflow from, or cross-connection between, piping systems that carry wastewater and potable water; and Be in compliance with State and local codes; Adequate floor drainage is provided in all areas where: Floors are subject to water accumulation during cleaning; or Normal operations release or discharge water or other liquid waste on the floor; Floors are sloped to floor drains to prevent water accumulation and ponding; Sewage and wastewater is discharged: In compliance with applicable laws and regulations; Into a sewage disposal system that meets all applicable State and local codes; or Through other acceptable means approved by the Department; Toilet facilities: Are readily accessible and adequate in number for employee use; Are kept clean and are not a potential source of contamination of: Food; Food-contact surfaces; and Food-packaging materials; and Are provided with: Signage that instructs individuals to wash their hands before returning to work; Mechanical air exhaust and intake of an equal amount of makeup air at the rate of 2 cubic feet per minute of air for each square foot of floor area or a screened window that allows the adequate exchange of outside air; Floors, walls, and a ceiling that are: Smooth; Washable; Easily cleanable; and Impervious to water; Floor-wall junctures that are sealed to be impervious to water; Adequate lighting; and Hand washing facilities as specified in §G of this regulation; Hand washing facilities: Are provided that are adequate in number and conveniently located in areas where food is processed or equipment or utensils are washed and sanitized; and Are supplied with: Soap; Warm water of sufficient volume, under pressure for effective hand washing; Paper towels or warm air hand drying device; A conveniently located trash receptacle; and Hand sanitizer, if necessary to protect against contamination; and Solid waste: Is handled and disposed of using waste containers that are: Adequate in number and size to maintain sanitary conditions; Conveniently located where waste is generated; Easily cleanable; Leak proof; and Emptied and cleaned at a frequency that maintains sanitary conditions; and Is handled, stored, and disposed of in a manner that: Minimizes the development of odors; Minimizes the potential for becoming an attractant or harborage for pests; Meets all applicable State and local codes; and Protects against contamination of: Food; Food-contact surfaces; Food-packaging materials; Water supplies; and Plant and grounds. In accordance with Health-General Article, §21-212, Annotated Code of Maryland, a federal rule that exempts a food from label requirements is effective automatically in the State. The person-in-charge shall ensure that: Except as provided in §A of this regulation, food labeling meets the requirements in 21 CFR Part 101; Except as provided in §A of this regulation, the following information is provided on a label of food in packaged form: Common or usual name of the food; Statement of ingredients that gives the common or usual names of the ingredients in descending order of prominence with sub-ingredients listed; Name and address of the manufacturer or distributor with: The full street address including the zip code of the manufacturer or distributor if the address is not listed on a website, current city directory, or telephone directory; or A minimum of the town and zip code if the manufacturer or distributor is listed on a website, current city directory, or telephone directory; Net quantity in terms of: Weight in U.S. Customary units and equivalent metric units; Fluid measure in U.S. Customary units and equivalent metric units; Numerical count; or Combination of numerical count and weight; If a food coloring has been added, the food coloring in the statement of ingredients; If a chemical preservative has been added, a label declaration stating: The common or usual name of the ingredient; and A separate description of its function such as “preservative” or “mold inhibitor”; Major food allergens in accordance with 21 U.S.C. §343(w); For a food that requires refrigeration for safety, the words “keep refrigerated” or equivalent; For a food that requires refrigeration for safety after the food’s packaging is opened, the words “refrigerate after opening” or equivalent; For a food that is frozen for safety or quality, the words “keep frozen” or equivalent; A “use by date” if the package contains a food whose safety is assured only until the date specified on the label; For a food that is frozen during processing or after processing and then thawed before being offered for human consumption, the words “previously frozen, should not refreeze”; and The exact words “WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.” for a juice product that has not been processed in accordance with COMAR 10.15.12; A food label and the labeling information in §B(1) of this regulation are: Durable; Conspicuous; Legible; Able to remain on a container for the shelf life of the food; and Placed on the food container by: Imprinting; Embossing; Lithography; Ink jetting; or Another method set forth in 21 CFR Parts 100 and 101 or in conformance with §B(2) of this regulation; The information required in §B(2) of this regulation is located on the principal display panel; If the food is not manufactured by the business whose name appears on the label, the business name is qualified by a phrase that reveals the connection the business has with the food, such as “Manufactured for” or “Distributed by”; If the address given on the label is not the place where the food was actually manufactured, packaged, or distributed, it is the address of the principal place of business of the manufacturer or distributor given on the label; A food’s labeling or packaging is not false or misleading in any way; and A food that has been frozen or thermally processed is not labeled “fresh”. The person-in-charge may forego: Declaring on the label the common or usual name of each ingredient for incidental additives that: Have no technical or functional effect in the food; and Are not required by a federal rule to be declared; and Complying with the requirements in §B(2)(a)—(f) and (j) of this regulation for a shipment of food that, in accordance with the practice of trade, is processed, labeled, or repacked in substantial quantity at an establishment other than where originally processed or packed if: The person who introduced the shipment of food into interstate commerce is the operator of the establishment where the food is to be processed, labeled, or repacked; or The shipment or delivery to the establishment is made under a written agreement as set forth in 21 CFR §101.100(d). The person-in-charge shall ensure that plans and specifications are submitted to the Department: Before: A food processing plant is: Constructed; Remodeled; or Materially altered; An existing building or structure is converted or remodeled for use as a food processing plant; A food or process is added or significantly modified; or A new scheduled process or shelf life study is used; and That include the following information, as applicable: A scale drawing in horizontal view that identifies the: Layout and arrangement of work areas; Location of food equipment including exhaust ventilation hoods; and Location of plumbing and plumbing fixtures such as water lines, sewer lines, hand sinks, toilets, utility sinks, utensil washing sinks, floor drains, floor sinks, and hose stations; Specifications for the: Construction materials for the building and interior finishes; Disposal of sewage; Provision of potable water; Exclusion and control of pests; Ventilation of the plant and individual areas within the plant; Methods and facilities for waste storage and disposal; and Lighting; A complete list of specifications for the proposed equipment; A written description of the foods to be processed, stored, or distributed; Written standard operating procedures for: Processing foods named in §A(2)(d) of this regulation; Employee health and personal hygiene; and Plant sanitation; When required by Regulation .02, .07, .10, or .12 of this chapter, a HACCP plan; When required by the Department, a scheduled process or shelf life study, performed by a process authority; When required by the Department, a laboratory analysis, performed by a laboratory with a current accreditation to the ISO/IEC 17025; A hazard analysis and food safety plan as required by Regulation .08B and C of this chapter; and Any other information that may be required by the Department to ascertain compliance of the plans and specifications with all applicable federal, State and local laws, regulations, and ordinances. The person-in-charge may not construct a new food processing plant, remodel an existing food processing plant, or manufacture a food using a new or modified process before receiving written approval of the plans and specifications from the Department. The Department shall: Review the plans and specifications to ensure compliance with the applicable regulations; Inform in writing the individual who submitted the plans and specifications: Of additional information that may be required; and Following the review, whether the plans and specifications are approved or denied; and If the plans are denied, provide the individual in writing who submitted the plans and specifications with information on how to appeal the decision, as set forth in State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. The person-in-charge shall ensure that before a new or remodeled food processing plant is operated: The Department schedules and completes an inspection; The Department issues written approval for the use of the new or remodeled plant; and For a new plant, a food processing license is obtained. The Department shall: Review the plans and specifications to ensure compliance with the applicable regulations; Conduct a priority assessment of the facility based on the information obtained pursuant to §A(2)(d) and (e) of this regulation; and Classify a food processing plant as a: High priority facility, if the food processing plant manufactures food: Using specialized processes that require a scheduled process or a HACCP Plan; Using ingredients that require temperature control for safety; or That is temperature controlled for safety; Moderate priority facility, if the food processing plant: Manufactures food using ingredients that do not require temperature control for safety; Manufactures food that is not temperature controlled for safety; or Is a food warehouse that stores and distributes food that requires temperature control for safety; or Low priority facility, if the food processing plant is a food warehouse that stores food or ingredients that do not require temperature control for safety. The Department may allow the use of equipment that meets the requirements of Regulation .10C—E of this chapter but fails to comply with Regulation .10A of this chapter if a review indicates the equipment and its use are: Not harmful to public health; and Consistent with industry standards and practices. The Department may accept plant, facilities, and grounds design and construction other than those that are provided for in Regulation .09 of this chapter based on a review that shows the alternative plant, facilities, and grounds design: Provides for adequate food safety, food protection, and sanitation; and Is equivalent to regulatory and industry standards. The Department may issue a food processing plant license to an individual who owns, leases, rents, or resides on a farm to process food in a home or domestic kitchen, located on the individual’s farm, as set forth in this regulation. While operating with a license issued in accordance with §A of this regulation, the person-in-charge shall: Comply with this chapter except for: Regulation .09C(2)(a), D, and E; and Regulation .12D, F(3), and G(1); Limit processed food production to: An amount of food that can safely be produced in the domestic kitchen as evidenced by: Sanitation; Process; and Cross-contamination control; and $50,000 or less of sales other than foods processed under §§E and F of this regulation; Process commercially only during times when the kitchen is not being used for domestic purposes; Clean and sanitize all food-contact surfaces, equipment, and utensils, immediately before and after processing commercially; While processing commercially: Use only building areas, equipment, and utensils that the Department has reviewed or inspected and approved; and Remove all animals and individuals not involved in food processing from the kitchen; and Store ingredients for commercial manufacturing and finished manufactured food in a separate area from foods used domestically. Except as provided in §§E and F of this regulation, an individual licensed in accordance with this regulation may manufacture and process only: Baked cakes, muffins, or cookies with a water activity of .85 or less; Fruit pies with an equilibrated pH of 4.6 or less; Canned acid foods with an equilibrated pH of 4.6 or less; Herbs in vinegar with an equilibrated pH of 4.6 or less; Honey and herb mixtures; Dried fruits and vegetables; and Acidified foods. An individual licensed in accordance with this regulation may not process: Low-acid canned foods; Cured or fermented foods; Except as provided in §E(6) of this regulation, seafood; Apple cider or other juices; Grade A milk product or manufactured grade milk product as defined in Health-General Article, §21-401, Annotated Code of Maryland; and A frozen dessert as defined in Health-General Article, §21-801(b), Annotated Code of Maryland. An individual licensed in accordance with this regulation may: Weigh, label, and sell raw meat and poultry that is under the jurisdiction of the United States Department of Agriculture; Distribute raw meat or poultry that is under the jurisdiction of the United States Department of Agriculture; Weigh, package, label, and sell raw meat and poultry that is inspected by the Maryland Department of Agriculture in accordance with Regulation .20 of this chapter; Distribute raw meat or poultry that is inspected by the Maryland Department of Agriculture in accordance with Regulation .20 of this chapter; Process only animals that were: Commercially raised, fed, or managed on the farm; and Slaughtered and processed in accordance with Regulation .17 of this chapter; While operating a fish farm, clean, weigh, package, label, and sell, or distribute, raw finfish from the farm that are not associated with histamine intoxication; and Use shared equipment and utensils for both domestic and commercial uses provided that the equipment and utensils are: Designed and constructed as set forth in Regulation .10 of this chapter; and Cleaned and sanitized as set forth in Regulation .11 of this chapter. An individual licensed in accordance with this regulation may weigh, label, store, and distribute cheese that: Is made on a licensed out-of-State dairy facility using only the raw milk produced by the herd on the dairy farm licensed by the Department; and Meets the definition and standards of a hard cheese, as set forth in section 21 CFR §133.150. When a farm ceases to be a farm, a food processing license issued in accordance with this regulation becomes void. In the absence of a license issued in accordance with COMAR 10.15.03, a license issued in accordance with this regulation shall provide for the sale on the farm of food processed on the farm by the licensee. Except as provided in Regulation .17 of this chapter, a person may not process food for human consumption on a farm without the license required in Regulation .18A of this chapter. The Department may issue a food processing plant license to operate a producer mobile farmer’s market unit to transport for sale at a farmer’s market, public festival, or public event, TCS food products: Produced or stored on the farm by the licensee under an on-farm home processing plant license; Produced or stored on the farm by the licensee, as authorized by the Department in regulation; or That have been inspected, licensed, or certified for food safety by the Maryland Department of Agriculture. The person-in-charge shall ensure that the producer mobile farmer’s market unit: Complies with Regulations .07G, N, and O and .10D, H, and K of this chapter; and Displays the license on the unit during operation. A local health department shall: Enforce §B of this regulation; Levy fines as established in local law, ordinance, or regulation; Notify the Department of any violations occurring in the county; and Accept a valid producer mobile farmer’s market unit license to sell products authorized for sale under the license without requiring separate licenses or permits. A person that slaughters animals and processes meat shall ensure that: Animal slaughtering, meat processing, poultry processing, meat sales, and poultry sales are regulated and inspected in conformance with the applicable: Federal laws; Federal regulations; State laws; State regulations; Local laws; and Local regulations; Cattle, sheep, swine, goats, horses, mules, and other equine are slaughtered and processed in accordance with: The Federal Meat Inspection Act, 21 U.S.C. §§601—695; and Applicable federal, State, and local laws and regulations; Poultry are slaughtered and processed in accordance with: The Poultry Products Inspection Act, 21 U.S.C. §§451—471; and Applicable federal, State, and local regulations; When slaughtered and processed for food for the public, domesticated animals, including poultry and rabbits that are not required by federal law or regulation to be inspected by the United States Department of Agriculture, are: Inspected by the: United States Department of Agriculture under a voluntary inspection program; or Maryland Department of Agriculture under a voluntary inspection program; and Processed into human food while being regulated by: The United States Department of Agriculture under a voluntary inspection program; or A meat inspection program or poultry inspection program administered by the Maryland Department of Agriculture; and When processing deer meat for charitable donation: Any processed deer is legally harvested; Gutting and skinning of the deer and butchering operations shall be separated by: Time; or Distance; Processing other animal species is separated by: Time; or Distance; Hanging meat carcasses are stored at an internal temperature of 41°F or less; Deer is processed for distribution only as fresh or frozen: Raw whole cuts; or Raw, ground 100 percent venison; Organ meat is not donated; and A label containing cooking instructions is included. In order to operate a food processing plant, a person shall obtain a food processing license pursuant to the provisions of: Health-General Article, §§21-211 and 21-305, Annotated Code of Maryland; and This chapter. The Department shall specify on the food processing license what foods or food types the licensee is authorized to process. The Department shall deny an application for a license if the applicant: Does not meet the requirements of: Health-General Article, §21-211, or Title 21, Subtitle 3, Annotated Code of Maryland; or A regulation promulgated under Health-General Article, §21-211, or Title 21, Subtitle 3, Annotated Code of Maryland; or Fraudulently or deceptively attempts to obtain a license. The Department may suspend or revoke a license if the licensee: Violates or fails to meet the requirements of §C of this regulation; or Fraudulently or deceptively obtains a license. The Department may deny an application for a food processing plant license and may suspend or revoke a license pursuant to the provisions of: Health-General Article, §§21-211, 21-311, and 21-314—21-317, Annotated Code of Maryland; and State Government Article, §10-226, Annotated Code of Maryland. The person-in-charge shall ensure that: Food is not processed without the license required by Health-General Article, §21-305, Annotated Code of Maryland; The required food processing license is conspicuously posted in the plant; and The processing operations in the plant are limited to the food type or types specified on the license pursuant to §B of this regulation. Except as provided in §H of this regulation, a license may not be transferred from one person to another person or from one food processing plant to another. On the death of a licensee, the approving authority may transfer a food processing plant license if: An application is filed in accordance with Health-General Article, §21-306, Annotated Code of Maryland; and Written evidence establishes that the applicant’s relationship with the deceased was as a: Spouse of the deceased licensee; Blood relative to the first degree of consanguinity; or Current officer or surviving partner in the business operating the food processing plant. The person-in-charge shall permit a representative of the Department to: Enter a food processing plant at a reasonable time for the purpose of making inspections to determine compliance with this chapter; and Examine the records of the facility that pertain to information regarding food and supplies: Purchased; Received; Manufactured; Sold; or Distributed. The person-in-charge shall inform the Department of a food ingredient or a recipe that the person-in-charge considers a trade secret, except as provided in §C of this regulation. The person-in-charge shall provide information to the Department regarding a food ingredient or recipe that the person-in-charge considers a trade secret if: An immediate and substantial danger to public health exists involving the food ingredient or recipe; or The Department determines that the information about the food ingredient or recipe is necessary to conduct a foodborne disease investigation. The person-in-charge shall ensure that: Compliance with this chapter is continuous; Violations are corrected within the time for correction given by the Department; When a violation of a critical item exists: The violation is corrected immediately; Food processing affected by the critical item violation ceases; or The food processing plant is closed immediately; and For a food processing plant that operates seasonally or intermittently, inspection and regulation by the Department is facilitated by notifying the Department of: The dates and times of operation; or Information necessary to ensure that the Department has the opportunity to inspect the food processing plant during plant operation. The Department shall maintain the confidentiality of trade secret information in accordance with General Provisions Article, §4-335, and Health-General Article, §21-259, Annotated Code of Maryland. When an inspection of a food processing plant is made, the Department shall: Complete an inspection report that identifies the: Conditions found that violate the provisions of this chapter; and Critical item violations, noted separately from all other violations; Provide a copy of the inspection report to the person-in-charge of the plant; and Make the completed inspection report form available for public disclosure in accordance with General Provisions Article, §§4-101—4-104, 4-201—4-206, 4-301—4-362, and 4-501—4-503, Annotated Code of Maryland. The Department shall ensure that a food processing plant is inspected: As determined by the Department or by statute for the enforcement of this chapter; At a minimum of the frequency required by COMAR 10.15.07.01 for any shellfish: Shucker-packer; or Repacker; At a minimum of two times per year for any shellfish: Shipper; or Reshipper; At another frequency for shellfish required by COMAR 10.15.07.01; or When a: High priority plant, at a minimum of once per 12 months; Moderate priority plant, at a minimum of once per 24 months; and Low priority plant, at a minimum of once every 36 months. The approving authority shall ensure that when a food processing plant is found in violation of any provision of this chapter, the licensee is notified: Of the specific: Findings; and Date by which the licensee shall correct the violations or deficiencies; and That, if the licensee fails to correct the violation by the date specified, the approving authority may suspend or revoke the license. When a person is violating any provision of this chapter, the approving authority may serve the person with a written order pursuant to Health-General Article, §21-261 or 21-318, Annotated Code of Maryland, directing the person to abate the violation within a specified time period. The approving authority shall ensure that an opportunity for a hearing is provided to a person served with an order, pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. In order to preserve a right to a hearing under any provision of this regulation, a person shall: Make a request for a hearing in writing; and Submit the request to the approving authority that issued the order or inspection report: Within 10 days of receipt of the order; Sooner if specified in the order; or Within 24 hours if the violation requires immediate correction or correction within 24 hours. The approving authority shall suspend or revoke the license of a food processing plant if the licensee fails or neglects to: Correct a: Violation within the specified time period; or Violation of a critical item immediately; or Comply with an approved written schedule of compliance. The approving authority shall ensure that: An action to suspend or revoke a license, complies with the provisions of: State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; and Health-General Article, §21-315, Annotated Code of Maryland; and The person against whom the action is contemplated is given an opportunity for a hearing in accordance with Health-General Article, §21-316, Annotated Code of Maryland. When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to State Government Article, §10- 226(c)(2), Annotated Code of Maryland, the: Approving authority shall: Summarily suspend the license at the food processing plant; Order the food processing plant to cease operation immediately; and Promptly provide the licensee with: A written notice of suspension of the license; The reasons for the suspension; and Instructions on requesting an administrative hearing if desired; and Person-in-charge shall immediately cease the operation of the food processing plant. The person-in-charge shall ensure that a food processing plant that has been required under the provisions of this regulation to cease operations does not resume operations until a reinspection by the approving authority shows that the condition or conditions responsible for the requirement to cease operations no longer exist. The approving authority shall confirm that appropriate steps are taken to ensure that the licensee ceases operation of the food processing plant on suspension or revocation of the license, including: Taking and keeping physical possession of the license until the license is reinstated; and Posting a sign on the facility door stating that the license has been suspended or revoked by the approving authority. A person whose food processing plant license has been suspended or revoked may apply for reinspection and reinstatement of the license by submitting to the approving authority a written request that details the actions taken by the person to correct each violation of a food statute or regulation that caused the suspension or revocation. The approving authority shall ensure that: When there is reasonable cause to suspect foodborne disease transmission or an outbreak from a food processed or distributed by a food processing plant, an inspection of the plant is conducted to: Identify: Potential points of food contamination in the facility; Whether employee illness may have contributed; and Whether a contaminated ingredient was used to process a food; and Determine if affected food has been distributed into commerce; and The appropriate follow-up action is taken, which may include immediate: Closing of the food processing plant, or a portion of the plant that is used to process the implicated product; or Exclusion of a suspect employee from all food handling positions within the plant until medical and epidemiological evidence shows that the likelihood of further foodborne disease transmission is low in accordance with COMAR 10.06.01. The person-in-charge shall ensure that: Records are maintained that allow for traceability of food or food ingredients received by the food processing plant that include the: Date received; and Previous source’s: Name; Address; and Contact information; Records are maintained that allow for traceability of food and food ingredients that identify the initial distribution of the food that include: The date the food was released; A lot code number or other identifier, if available; The type of food released, including brand name and specific variety; and For the transporter of the food and the intended immediate recipient, the: Name; Address; and Contact information; All records maintained that allow for traceability are made available to the Department for review and copying upon request; and The collection of food and environmental samples by the Department is allowed in accordance with Health-General Article, §§21-249 and 21-251, Annotated Code of Maryland. The Department shall: Collect food and environmental samples as often as necessary for enforcement of this chapter; Sample food in accordance with Health-General Article, §§21-249 and 21-251, Annotated Code of Maryland; and Take action on a food where indicated in accordance with Health-General Article, §§21-211, 21-253, and 21-254, Annotated Code of Maryland, by: Issuing a detention order; Seeking voluntary destruction; or Filing a petition for an order of forfeiture for destruction. Agriculture Article, §4-311; Health-General Article, §§18-102, 21-101, 21-102, 21-211, 21-234,21-301, 21-304, 21-308, 21-309.1, 21-309.2, and 21-336; Annotated Code of Maryland Effective date: November 18, 1960 Amended effective January 1, 1964; June 8, 1965; July 1, 1966; April 1, 1967; December 1, 1970 Regulation .29 adopted effective September 21, 1979 (6:19 Md. R. 1519) Regulation .29 amended effective December 14, 1979 (6:25 Md. R. 1980) Chapter revised as an emergency provision effective August 2, 1989 (16:17 Md. R. 1882); adopted permanently effective December 25, 1989 (16:25 Md. R. 2711) Regulation .01B amended effective September 28, 1992 (19:19 Md. R. 1708) Regulation .02B amended effective September 28, 1992 (19:19 Md. R. 1708); April 3, 2000 (27:6 Md. R. 641) Regulation .31 amended effective September 28, 1992 (19:19 Md. R. 1708) Regulation .33A amended effective March 4, 1991 (18:4 Md. R. 447); September 28, 1992 (19:19 Md. R. 1708); October 6, 1997 (24:20 Md. R. 1404) Regulations .01 — .37 repealed and new Regulations .01 — .20 adopted effective November 22, 2004 (31:23 Md. R. 1652) Regulation .02B amended effective May 4, 2009 (36:9 Md. R. 651) Regulation .03B amended effective May 4, 2009 (36:9 Md. R. 651) Regulation .08A amended effective May 4, 2009 (36:9 Md. R. 651) Regulation .09B amended effective May 4, 2009 (36:9 Md. R. 651) Regulation .10D amended effective May 4, 2009 (36:9 Md. R. 651) Regulation .17A amended effective May 4, 2009 (36:9 Md. R. 651) Regulation .19C, D amended effective May 4, 2009 (36:9 Md. R. 651) Regulation .19G adopted effective May 4, 2009 (36:9 Md. R. 651) Regulation .21 adopted effective May 4, 2009 (36:9 Md. R. 651) Chapter revised as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); revised permanently effective January 24, 2011 (38:2 Md. R. 83) Regulation .02B amended effective March 5, 2012 (39:4 Md. R. 337); January 6, 2014 (40:26 Md. R. 2163); February 15, 2016 (43:3 Md. R. 272) Regulation .03B amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .04 amended effective March 5, 2012 (39:4 Md. R. 337) Regulation .05 amended effective March 5, 2012 (39:4 Md. R. 337) Regulation .07B amended effective March 5, 2012 (39:4 Md. R. 337) Regulation .08A amended effective March 5, 2012 (39:4 Md. R. 337) Regulation .09D amended effective March 5, 2012 (39:4 Md. R. 337); February 15, 2016 (43:3 Md. R. 272) Regulation .13A amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .14 amended effective March 5, 2012 (39:4 Md. R. 337) Regulation .14B amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .15A, D amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .16A amended effective March 5, 2012 (39:4 Md. R. 337); February 15, 2016 (43:3 Md. R. 272) Regulation .17A amended effective March 5, 2012 (39:4 Md. R. 337) Regulation .17D, E adopted effective March 5, 2012 (39:4 Md. R. 337) Regulation .17E amended effective January 6, 2014 (40:26 Md. R. 2163) Regulation .18 amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .19A amended effective March 5, 2012 (39:4 Md. R. 337) Regulation .20C, D amended effective March 5, 2012 (39:4 Md. R. 337); January 6, 2014 (40:26 Md. R. 2163) Regulation .20E adopted effective January 6, 2014 (40:26 Md. R. 2163) Regulation .20E adopted effective March 5, 2012 (39:4 Md. R. 337) Regulation .22 repealed effective March 5, 2012 (39:4 Md. R. 337) Regulation .23G amended effective January 6, 2014 (40:26 Md. R. 2163) Regulation .28C amended effective February 15, 2016 (43:3 Md. R. 272) Chapter revised effective August 5, 2024 (51:15 Md. R. 708) Regulation 15A, B, F amended effective January 5, 2026 (52:26 Md. R. 1309) Regulation .16A, C amended effective January 5, 2026 (52:26 Md. R. 1309) The Grade “A” Pasteurized Milk Ordinance, 2015 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), Item 10p., Item 11p., Appendix H, Appendix I, and Appendix N only, is incorporated by reference. Ice cream and frozen custard are the foods prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110, Ice Cream and Frozen Custard. Ice milk is the food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120, Ice Milk. Ice milk shall be offered for sale, sold, or served only in properly labeled factory-filled containers, if the ice milk or any of its ingredients contain added color or any ingredients added for the purpose of imparting a characterizing flavor, except that ice milk may be served and sold at retail from a dispensing freezer. When ice milk is sold at retail, direct from a frozen dessert dispensing freezer, a sign shall be prominently and conspicuously displayed, where it can be clearly read by customers under normal conditions of purchase, stating “Ice Milk Sold Here”. The letters on the sign shall be bold-face capitals at least 3 inches high and in contrasting color to the background. When ice milk is sold at retail, only in properly labeled factory-filled containers, this sign is not required. Mellorine is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.130, Mellorine. Mellorine shall be sold, held, offered for sale only in factory-filled containers. Sherbet is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.140, Sherbet. Water ices are the foods each of which is prepared from the ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21, Food and Drugs, Part 135.160, Water Ices. Description. Goat milk ice cream is the food prepared from the same ingredients and in the same manner, including the requirements for label statements of optional ingredients, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110, Ice Cream and Frozen Custard, except that all milkfat and nonfat milk solids shall be derived from goat milk. Nomenclature. The name of the food is “goat milk ice cream”. Label Declaration. On the label, in the name of the food, the letters in the words, “goat milk” shall be the same size, type, and color, and on the same contrasting background as the letters in the words “ice cream”. Description. Goat milk ice milk is the food prepared from the same ingredients and in the same manner, including the requirements for label statements of optional ingredients, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120, Ice Milk, except that all milkfat and nonfat milk solids shall be derived from goat milk. Nomenclature. The name of the food is “goat milk ice milk”. Label Declaration. On the label, in the name of the food, the letters in the words, “goat milk” shall be the same size, type, and color, and on the same contrasting background as the letters in the words, “ice milk”. Description. Frozen yogurt is the food prepared by freezing while stirring a pasteurized mix consisting of the same ingredients permitted for ice cream in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110. These ingredients are cultured after pasteurization by one or more strains of Lactobacillus bulgarius and streptococcus thermophilus, provided, however, fruits, nuts or other flavoring materials may be added before or after the mix is pasteurized and cultured. Bacteria and coliform requirements for frozen yogurt shall apply to the mix before culturing. Coliform requirements for frozen yogurt shall apply to the mix after culturing. Frozen yogurt, exclusive of any flavoring, shall contain not less than 3.25 percent milkfat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than the result of bacterial activity, shall be applied to the product after culturing. No heat or bacteriostatic treatment (other than refrigeration), which results in the total destruction of the microorganisms, may be applied to the product after culturing. The finished yogurt shall weigh not less than 5 pounds per gallon. Nomenclature. The name of the food is “frozen yogurt”. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. Lowfat frozen yogurt is the food prepared from the same ingredients and in the same manner prescribed in Regulation .08 of this chapter. Lowfat frozen yogurt, exclusive of any flavorings, shall contain not less than .5 percent or more than 2.0 percent milkfat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than .5 percent expressed as lactic acid. Nomenclature. The name of the food is “lowfat frozen yogurt”. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. Nonfat frozen yogurt is the food prepared from the same ingredients and in the same manner prescribed in Regulation .08 of this chapter. Nonfat frozen yogurt, exclusive of any flavorings, shall contain less than .5 percent milkfat. Nomenclature. The name of the food is “nonfat frozen yogurt”. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. Quiescently frozen confection means the frozen product made from sweetening agents, harmless natural or artificial flavoring, and water, and it may contain milk solids, harmless coloring, organic acids, and any safe and suitable functional ingredient approved by the Secretary. The finished product shall contain not less than 17 percent by weight of total food solids. In the manufacture of this product, freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). In the production of this quiescently frozen confection, no processing or mixing before quiescent freezing may be used that develops in the finished confection mix any physical expansion in excess of 10 percent. This confection shall be manufactured in the form of servings, individually packaged, bagged, or otherwise wrapped, properly labeled, and purveyed to the consumer in its original factory-filled package. The individually wrapped confection need not be labeled if it is contained in a multiple package which is properly labeled and purveyed unopened to the consumer. Nomenclature. The name of the food is “quiescently frozen confection”. Labeling. In addition to all other required information, the label shall comply with the applicable regulations promulgated under the Code of Federal Regulations, Title 21 Food and Drugs. Description. Quiescently frozen dairy confection means the frozen product made from milk products, sweetening agents, harmless natural or artificial flavoring, and water, and it may contain harmless coloring, and any safe and suitable functional ingredient approved by the Secretary. The finished product contains not less than 33 percent by weight of total food solids. In the manufacture of this product, freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). In the production of this quiescently frozen dairy confection, no processing or mixing before quiescent freezing may be used that develops in the finished confection mix any physical expansion in excess of 10 percent. This confection shall be manufactured in the form of servings, individually packaged, bagged, or otherwise wrapped, properly labeled, and purveyed to the consumer in its original factory-filled package. The individually wrapped confection need not be labeled if it is contained in a multiple package which is properly labeled and purveyed unopened to the consumer. Nomenclature. The name of the food is “quiescently frozen dairy confection”. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. Frozen dietary dairy dessert means a frozen dessert prepared for persons who wish to restrict their intake of ordinary sweetening ingredients. It is produced by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Regulation .01-1 of this chapter. The minimum fat content shall be 3 percent, it shall contain no sugars other than those naturally present in the milk solids or flavoring agents which have been added to it, and it may contain edible carbohydrates other than sugars. The edible carbohydrates must be approved by the Department. The product may not be sold in any manner other than in sealed or unbroken packages or containers. Nomenclature. The name of the food is “frozen dietary dairy dessert”. Labeling. Immediately preceding or following the name of the product, there shall be a statement as follows: “Contains ___% milkfat”. The blank is to be filled in with the percentage of milkfat in the product. The label of frozen dietary dairy dessert shall contain the statement: “Diabetics: This product may be useful in your diet on the advice of a physician. This food is not a reduced calorie food.” In addition to all other required information, the label shall comply with the applicable regulations promulgated under the Code of Federal Regulations, Title 21 Food and Drugs. Description. Dietary frozen dessert or lowfat frozen dairy dessert is the food prepared by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Regulation .01-1 of this chapter. The finished product contains less than 2 percent by weight of ether extractable fat: its content of total milk solids is not less than 7 percent by weight. The product weighs no less than 4.5 pounds per gallon and the quantity of food solids per gallon is not less than 1.1 pounds or more than 1.9 pounds, exclusive of any microcrystalline cellulose used as an ingredient. One or more vitamins or minerals, or both, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.9 may be added to the product. If vitamins or minerals, or both, are added, each 4-fluid-ounce serving of finished product shall provide not less than 8 percent or more than 20 percent of the U. S. Recommended Daily Allowance of these vitamins or minerals, or both. Dietary frozen dessert or lowfat frozen dairy dessert may be sold in properly labeled factory-filled containers, except it may be sold directly from a dispensing freezer at the time of a direct request from a customer. When sold directly from a dispensing freezer, each container shall be labeled with the name of the product and with the name of the product and with nutritional and ingredient information as prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Nomenclature. The name of the food is “dietary frozen dessert” or “lowfat frozen dairy dessert”. Labeling. If vitamins or minerals, or both, are added, the name of the food on the principal display panel and each alternate principal display panel shall be immediately preceded or followed by the word “fortified” in the same style and at least one-half the size of the type used for the name “dietary frozen dessert” or “lowfat frozen dairy dessert” and on the same contrasting background. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. Non-fruit sherbet is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.140 Sherbet, except that the food may not contain any fruit or fruit juice. Nomenclature. The name of the food is “Non-fruit ___ Sherbet”. The blank is to be filled in by the characterizing flavor used. Labeling. The label shall contain the following statement: “Imitation ___ Sherbet”, the blank to be filled in by the characterizing flavor used. The letters in the word “imitation” shall be the same size, type, and color and on the same contrasting background as the name of the characterizing flavor and the word, sherbet. The statement in §C(1), of this regulation, shall be followed immediately by the words, “contains no fruit or fruit juice” in letters at least half the size of the words used in the statement. When a sign is used at the point of purchase to advertise the product, it shall contain the same information prescribed in §C(1) and (2), of this regulation. Description. Non-fruit water ice is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.160 Water Ices, except that the food may not contain any fruit or fruit juice. The finished non-fruit water ice weighs not less than 6 pounds per gallon. Nomenclature. The name of the food is “Non-fruit ___ Water Ice”. The blank is to be filled in by the characterizing flavor used. Labeling. The label shall contain the following statement: “Imitation ___ Ice”. The blank is to be filled in by the characterizing flavor used. The letters in the word imitation shall be the same size, type, and color and on the same contrasting background as the name of the characterizing flavor and the word, ice. The statement in §C(1), of this regulation, shall be followed immediately by the words, “contains no fruit or fruit juice”, in letters at least half the size of the words used in the statement. When a sign is used at the point of purchase to advertise the product, it shall contain the same information prescribed in §C(1) and (2), of this regulation. Description. “Manufactured desserts mix”, whipped cream confection, bisque tortoni, means a frozen dessert made with milk products, sweetening agents, flavoring agents, with or without harmless coloring or any other safe and suitable ingredients approved by the Secretary. It contains not less than 18 percent by weight of milkfat, and not more than 12 percent of milk solids not fat, and may be packaged with harmless gas causing it to fluff upon ejection from the package or container. Labeling. In addition to all other required information, the label shall comply with the provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. “Freezer-made milk shake” means a pure, clean, wholesome semi-viscous drink prepared by stirring while freezing in a dispensing freezer a pasteurized mix consisting of the ingredients prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120 Ice Milk, except that: It shall contain not less than 3-1/4 percent and not more than 6 percent milkfat. Its contents of milk solids not fat shall be not less than 10 percent. Freezer-made milk shake may only be sold or served from a dispensing freezer and may not be sold hard-frozen. Other freezer-made shakes including jumbo shake, thick shake, T.V. shake, or any coined or trade name containing the word, “shake”, shall meet the requirements of §A, of this regulation, except that the minimum percent of milk fat may be less than 3-1/4 percent. “Shakes” not meeting the requirements for “milk shakes” may not be advertised, sold, or served as milk shakes. When any freezer-made milk shake or other freezer-made shake purports to be or is represented for any special dietary use by man, it shall be sold only in a container labeled in accordance with all applicable provisions of the Code of Federal Regulations, Title 21 Food and Drugs. Description. Parevine is the food which is prepared by freezing while stirring, a pasteurized mix composed of one or more edible vegetable oils or fats, protein and carbohydrate food ingredients from other than milk or meat sources, nutritive sweeteners other than lactose, characterizing ingredients except any containing meat or milk, and any other safe and suitable ingredient which is not milk or meat or a product or derivative of milk or meat. This product may not contain any milk, milk product, meat, or meat products or any of their derivatives of any kind. Its fat content shall be not less than 10 percent, except that when bulky optional characterizing ingredients are used, the fat content may be reduced, as a result of the addition of these ingredients, but may not be less than 8 percent. Its content of food solids shall be not less than 1.3 pounds per gallon of finished product. Parevine shall be sold, held, offered for sale by any manufacturer, wholesaler, retailer, or any other seller only in factory-filled containers. Parevine may be served for consumption on the premises provided that the individual service is taken from a properly labeled factory-filled container. When parevine is served for consumption on the premises, a sign shall be conspicuously displayed on the sale premises or vehicle where it can be clearly read by customers under normal conditions of purchase, stating “PAREVINE SOLD HERE”. Letters on the sign shall be bold face capitals at least 3 inches high and in contrasting color to the background. The sign need not be displayed if each customer is provided with a menu which there is stated “PAREVINE SERVED HERE” in bold face capitals as large as those in listing most food items. Nomenclature. The name of the food is “parevine”. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. “Lowfat parevine” means food which meets all of the requirements of Regulation .19, of this chapter, relating to parevine except its fat content shall be not more than 6.0 percent. The sign required by Regulation .19A(4), of this chapter, shall read “LOWFAT PAREVINE SOLD HERE”. Nomenclature. The name of the food is “lowfat parevine”. Labeling. The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutrition information as required by Title 21, Part 101.9. Description. “Lo-mel” means a pure, clean, wholesome semi-viscous drink prepared by stirring while freezing in a dispensing freezer a pasteurized mixture of edible fats or oils other than milkfat, milk solids not fat, water, optional sweetening ingredients as approved by the Secretary, with or without egg or egg products, with or without harmless flavoring, with or without harmless coloring, and with or without stabilizer or emulsifier as approved by the Secretary. It shall contain not more than 6 percent edible fats or oils. It shall contain not less than 10 percent milk solids not fat. It may contain any other safe and suitable ingredients approved by the Secretary. It shall contain not more than 1/2 percent by weight of stabilizer and not more than one-fifth of one percent of emulsifier. Lo-mel may only be served or sold directly from a dispensing freezer and may not be sold hard frozen. When Lo-mel is sold from a dispensing freezer a sign shall be displayed which shall read “Lo-mel Served Here”, in letters at least 3 inches high and shall include a list of all ingredients in a manner prescribed by the Secretary, provided, however, that the name of the edible fats or oils other than milk fat used must be specified. The letters of the sign are to be of sufficient size to be read by consumers under normal conditions of purchase. The list of ingredients need not be included on the sign if the list of ingredients is printed on the side of the container in which the product is served to the customer. Nomenclature. The name of the food is “lo-mel”. Labeling. When any lo-mel purports to be or is represented for any special dietary use by man, it shall be sold only in a container labeled in accordance with all applicable provisions of the Code of Federal Regulations, Title 21 Food and Drugs. Description. “Lactose reduced ice cream” means the product resulting from the treatment of ice cream, as defined in Regulation .01-1 of this chapter, by the addition of a safe and suitable enzyme, or enzymes, so that the lactose remaining is 30 percent or less than lactose in ice cream. Nomenclature. The name of the food is “lactose reduced ice cream”. Labeling. The package label shall include in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutritional information as required Part 101.4 and contain nutritional information as required by Title 21, Part 101.9. Whenever the name of the food appears on the container, the words “Lactose Reduced” shall be in the same type, style, and size and in the same color and contrasting background as the words “Ice Cream”. Description. “Lactose reduced ice milk” means the product resulting from the treatment of ice milk, as defined in Regulation .02, of this chapter, by the addition of a safe and suitable enzyme, or enzymes, so that the lactose remaining is 30 percent or less than lactose in ice milk. Nomenclature. The name of the food is “lactose reduced ice milk”. Labeling. The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutritional information as required by Title 21, Part 101.9. Whenever the name of the food appears on the container, the words “Lactose Reduced” shall be in the same type, style and size and in the same color and contrasting background as the words “Ice Milk”. Description. “Frozen pudding” means the product made from a pasteurized mix, intended to be eaten in the frozen state. The mix may be composed of milk and milk products, modified or unmodified food starch, sweetening agents, harmless natural or artificial flavoring, or both, harmless natural or artificial color, or both, or any other safe or suitable functional ingredient. The finished product shall contain less than 25 percent total food solids. The weight of the finished product shall not be less than 4.5 pounds per gallon. If not frozen promptly after pasteurization, the finished product shall be cooled to 45°F or lower and maintained under conditions to assure suitability for consumption. Nomenclature. The name of the food is “frozen pudding”. Labeling. The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4. In Regulations .21 — .34 of this chapter the following terms have the meanings indicated. Terms Defined. “Adulterated”. Frozen desserts or frozen desserts mix shall be deemed to be adulterated if: It bears or contains any poisonous or deleterious substance in a quantity which may render it injurious to health; It bears or contains any added poisonous or deleterious substances for which a safe tolerance has not been established by State or federal regulations, or in excess of the tolerance if one has been established; It consists, in whole or in part, of any substance unfit for human consumption; It has been produced, processed, prepared, packed, dispensed, or held under insanitary conditions; Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or Any substance has been added, mixed, or packed within the mix to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is. “CFR” means the Code of Federal Regulations of the United States Government. “C-I-P” means a procedure by which equipment, pipelines and other facilities are cleaned-in-place in accordance with 3-A Accepted Practices for Permanently Installed Sanitary Product-Pipelines and Cleaning Systems. “Dispensing freezer” means that type of equipment that freezes reconstituted powdered frozen dessert ingredients or frozen desserts mix into a semi-soft condition for serving to a customer. “Food service facility” means restaurants, coffee shops, cafeterias, short order cafes, luncheonettes, taverns, sandwich stands, sofa fountains, retail markets, and food operations in industries, institutions, hospitals, clubs, schools, camps, churches, catering kitchens, commissaries, or similar places in which food or drink is prepared for sale or for service on the premises or elsewhere, or any other operation where food is served or provided for the public with or without charge. “Frozen desserts” means any of the products enumerated in the law, Health-General Article, Title 21, Subtitle 8, and as provided in Regulations .01-1 — .20-3 of this chapter. “Frozen desserts distributor” means any person who offers for sale or sells prepackaged frozen desserts. “Frozen desserts mix” or “mix” means any frozen dessert in a liquid form, prepared by a frozen desserts plant and intended for freezing before consumption. “Frozen desserts plant” means any place or premise where frozen desserts or frozen dessert mixes are manufactured, pasteurized, frozen, and packaged. “Milk products” include milk, cream, and all other products listed under optional dairy ingredients as provided in Regulation .01-1 of this chapter. “Misbranded”. Frozen desserts and frozen desserts mix are misbranded when: Their containers bear or accompany any false or misleading written, printed, or graphic matter; Frozen desserts do not conform to their definitions as contained in these regulations; and Products are not labeled in accordance with Regulation .24 of this chapter. “National Sanitation Foundation” means the National Sanitation Foundation, NSF Building, P.O. Box 1468, Ann Arbor, Michigan 48106. “Pasteurization”. The terms “pasteurization”, “pasteurized”, and similar terms mean the process of heating, in approved and properly operated equipment, every particle of mix containing milk and milk products to one of the following minimum temperatures and holding at this temperature continuously for the specified time as indicated below: 155°F and holding at that temperature for at least 30 minutes; 175°F and holding at that temperature for at least 25 seconds; 180°F and holding at that temperature for at least 15 seconds; 194°F and holding at that temperature for at least 0.5 second. Nothing contained in this section shall be construed as barring any other method or process, as may be demonstrated to be equally efficient and which is approved by the Secretary. “Person” means any individual, partnership, firm, corporation, or association. “Powdered frozen dessert ingredients” means any dry mixture of pasteurized dry milk products, including whey, reduced mineral whey, whey protein concentrate, reduced lactose whey, or optional casseinates, which is intended for reconstitution, freezing, and retail sale by a food service facility. “Retail frozen desserts manufacturer” means a person who manufactures frozen desserts from commercially supplied pasteurized mix derived from raw milk supplies having acceptable United States Public Health Service (U.S.P.H.S.) ratings, for retail sale directly to the consumer on the premises where manufactured. “Sanitization” means the application of any effective method or substance to a clean surface for the destruction of pathogens, and of other organisms as far as is practicable. This treatment may not adversely affect the equipment, frozen desserts, or the health of consumers, and shall be acceptable to the Secretary. “Secretary” means the Secretary of Health or his designee. "3-A Standards" means the standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committee representing the International Association of Milk, Food and Environmental Sanitarians, the U.S. Public Health Service, and the Dairy Industry Committee, as published by the Journal of Food Protection, P.O. Box 701, Ames, Iowa 50010. “Wholesale frozen desserts manufacturer” means a person who manufactures, pasteurizes, packages, or freezes any frozen desserts mix for distribution or sale other than for retail sale directly to the consumer on the premises where manufactured. All milk products used in frozen desserts shall be derived from Grade “A” milk or milk products as defined in COMAR 10.15.06.02 or manufactured grade milk or milk products as defined in COMAR 10.15.09.02. A person may not manufacture, freeze, sell, offer or expose for sale, or have in his possession with the intent to sell any milk product, frozen dessert ingredients, frozen dessert mix which is adulterated or misbranded or which does not conform to the product definition or of any regulation made and promulgated under these regulations. Any adulterated or misbranded milk product, frozen dessert ingredients, frozen dessert, or frozen dessert mix may be detained by the Secretary and disposed of in accordance with Health-General Article, §§21-253 and 21-254, Annotated Code of Maryland. All labeling shall comply with the regulations promulgated under the Fair Packaging and Labeling Act and the Federal Food, Drug and Cosmetic Act, as contained in the Code of Federal Regulations, Title 21 Food and Drugs, and in addition shall contain: The name of the product, and shall conform with product standards of identity as provided in Regulations .01-1 — .20 of this chapter. A statement of net contents or net volume. One of the following: The name of the manufacturer and the address of his plant; The Federal Information Processing System (FIPS) Number assigned by State agency followed by the general office address; or In case of private labels, the Federal Information Processing System (FIPS) Number and the name and address of the distributor, preceded or followed by “Distributed by” or “Distributor”. The “date of pasteurization” in case of frozen dessert mixes. When frozen desserts are dispensed from factory-filled containers, each container shall bear an identity as described above so that it can be read after the lid or cover has been removed and discarded. Required labeling information shall be in letters of an acceptable size, kind, and color satisfactory to the Secretary and may not bear or accompany any false or misleading written, printed, or graphic matter. All milk and milk products used as ingredients in frozen desserts and frozen desserts mix shall be produced, processed, and pasteurized to conform with the following chemical, bacteriological, and temperature standards: A process or manipulation, other than pasteurization processing methods, and appropriate refrigeration, may not be applied to milk and milk products for the purpose of removing or deactivating microorganisms. Bacterial counts, coliform determinations, cooling temperatures, phosphatase test and other laboratory and screening tests shall conform to the procedures in the latest edition of Standard Methods for the Examination of Dairy Products of the American Public Health Association and the latest edition of the Official Method of Analysis of the Association of Official Analytical Chemists. Examinations and tests shall include any other chemical, bacteriological, or physical determinations as the Secretary deems necessary for the detection of adulteration. Sterile frozen desserts mix in hermetically sealed containers shall meet all applicable requirements. Bacterial, coliform, and cooling standards do not apply to mix in hermetically sealed containers. When samples are obtained from bulk containers of frozen desserts or frozen desserts mix, only a cleaned and sanitized dipper shall be used to obtain a sample from a portion of the bulk amount not previously contacted by a dipper. Frozen dessert mix samples for determining the wholesale frozen dessert manufacturer’s compliance with bacteriological and temperature standards shall be collected while in the possession of the wholesale frozen dessert manufacturer before final delivery. Frozen dessert mix samples for chemical and physical analysis may be taken at any time. The wholesale frozen desserts manufacturer shall be held responsible only for those samples taken from unopened containers. Samples of hard frozen desserts, in unopened factory-filled containers, may be collected any time before sale for determining the wholesale frozen dessert manufacturer's or retail frozen dessert manufacturer's compliance with chemical and physical standards. Mix once drawn from a dispensing freezer shall not be re-used. Floors — Construction. The floors of all rooms shall be kept in good repair subject to the following provisions: Rooms used for storing milk products or frozen desserts ingredients need not be provided with floor drains when the floors are sloped to drain to one or more exits; Rooms used for the hardening and storage of frozen desserts are not required to have floor drains or sloped floors; Storage rooms for storing dry ingredients, dry milk products, or packaging materials need not be provided with drains, and the floors may be constructed of tightly joined wood; and Construction of establishments which freeze and sell only at retail on the premises, shall require that the portion of the room in which the freezer is installed and the room in which containers or utensils are washed have solid impervious floors of an approved washable material; The floors of all rooms except as provided in §A(1)(a) — (c) of this regulation shall be: Constructed of concrete or other equally impervious and easily cleaned material; Smooth; Properly sloped; and Provided with trapped drains. Walls and Ceilings — Construction. Walls and ceilings of rooms in which milk products, frozen desserts ingredients, and frozen desserts are handled, processed, packaged, or stored, or in which product-contact containers, utensils, and equipment are washed, shall have a surface that is: Smooth; Washable; Light colored; and In good repair. Doors and Windows. Effective means shall be provided to prevent the access of flies and rodents. Air screens and flaps may be used where they effectively prevent the entrance of insects. Openings to the outside shall have solid doors or glazed windows which shall be closed during dusty weather. Outside doors shall be self-closing where practicable. Lighting and Ventilation. Rooms in which milk products, frozen desserts ingredients, or frozen desserts are handled, processed, stored, and packaged, or in which product-contact containers, utensils, and equipment are washed shall be well lit and well ventilated. Separate Rooms. There shall be separate rooms for the following: Pasteurizing, processing, cooling, freezing, and packaging; Freezer-storage; Cleaning of milk cans and containers; and Boiler rooms. Receiving Rooms. A plant receiving milk products or mix in bulk transport tanks shall provide a receiving room for receiving, cleaning, and sanitizing transport tanks. Unless all milk products and mix are received in bulk transport tanks, a receiving room separate from the rooms listed in §E(1) of this regulation, is required. Rooms in which milk products, frozen dessert ingredients, or frozen desserts are handled, processed, stored, or packaged, or in which product-contact containers, utensils, and equipment are washed or stored, may not open directly into any room for domestic purposes. Sanitary Piping. Sanitary piping, fittings, and connections which are exposed to milk products, frozen dessert ingredients, and frozen desserts mix, or from which liquids may drip, drain, or be drawn into the product, shall be constructed of material that is: Smooth; Impervious; Corrosion-resistant; Nontoxic; and Easily cleanable. Piping shall be kept in good repair. Pasteurized milk products, frozen dessert ingredients, and frozen desserts mix shall be conducted from one piece of equipment to another only through sanitary piping as described in Items 10p. and 11p. in the Grade “A” Pasteurized Milk Ordinance. Toilet-Sewage Disposal Facilities. A frozen desserts plant shall provide toilet facilities. Toilet rooms may not open directly into any room in which milk products, frozen dessert ingredients, or frozen desserts are processed or packaged. Toilet rooms shall: Be completely enclosed; and Have tight-fitting, self-closing doors. Dressing rooms, toilet rooms, and fixtures shall be kept in a clean condition, in good repair, and shall be well ventilated and well lit. Sewage and other liquid wastes shall be disposed of as approved by the Secretary. Water Supply. Water for frozen desserts plant purposes shall be: Obtained from a properly located, protected, and operated supply; Easily accessible; Adequate; Of a safe sanitary quality; and Approved by the Secretary. Both hot and cold water shall be available in sufficient quantity for all plant operations and facilities. Handwashing Facilities. Convenient handwashing facilities shall be provided, including: Hot and cold or warm running water; Soap; and Individual sanitary towels or other approved hand-drying devices. Handwashing facilities shall be kept in a clean condition and in good repair. Plant Cleanliness. Rooms in which milk products, frozen dessert ingredients, and frozen desserts are handled, processed, stored, or packaged or in which containers, utensils, or equipment are washed or stored, shall be kept clean, neat, and free of evidence of insects and rodents. Only properly applied pesticides, approved by the State and federal agencies for pesticide control, shall be used. Only equipment directly related to processing and packaging operations, or to handling of containers, utensils, and equipment shall be permitted in the pasteurizing, processing, cooling, packaging, and bulk milk storage rooms. Construction and Repair of Containers and Equipment. Multiuse containers and equipment with which milk products, frozen dessert ingredients, and frozen desserts come into contact shall be: Of smooth, impervious, corrosion-resistant, nontoxic material; Constructed and installed for ease of cleaning; and Kept in good repair. Single-service Containers. Single-service containers, closures, gaskets, and other articles with which milk products, frozen dessert ingredients, or frozen desserts come into contact shall: Be nontoxic; and Have been manufactured, packaged, transported, and handled in a sanitary manner. Articles intended for single-service use may not be reused. Equipment pertaining to materials, design, and finish shall comply with applicable 3-A Sanitary Standards. Cleaning and Sanitizing of Containers and Equipment. The product-contact surface of all multiuse containers, utensils, and equipment used in the transportation, processing, handling, freezing, packaging, and storage of milk products, frozen dessert ingredients and frozen desserts mix shall be effectively cleaned and sanitized before each use. Storage of Cleaned Multiuse Containers and Equipment. After cleaning, multiuse milk products, frozen dessert ingredients, and frozen dessert containers, utensils, and equipment shall be: Transported and stored to assure complete drainage; and Protected from contamination before use. Storage of Single-Service Containers, Utensils and Materials. Single-service parchment papers, containers, gaskets, and other single-service articles for use in contact with milk products, frozen dessert ingredients, or frozen desserts shall be: Purchased and stored in sanitary wrappings or cartons; Kept in a clean dry place until used; and Handled in a sanitary manner. Protection from Contamination. Frozen desserts plant operations, equipment, and facilities shall be located and conducted to prevent any contamination of: Milk products; Frozen dessert ingredients; Frozen desserts; Equipment; Containers; and Utensils. Unless the equipment has first been properly washed and subjected to a satisfactory bactericidal treatment, pasteurized mix or frozen desserts may not be permitted to come in contact with equipment or containers with which unpasteurized mix, frozen desserts, milk, or milk products have been in contact. In a frozen desserts plant, processing and handling shall be performed to preclude the contamination of the products. Pasteurization. Frozen desserts shall be made from pasteurized mixes. After formulation of the entire mix except for flavoring, ingredients shall be pasteurized as provided in Regulation .21B(13) of this chapter. The design and operation of all pasteurization equipment and all appurtenances to it shall comply with the applicable specifications and operational procedures as outlined in Appendices H and I of the Grade “A” Pasteurized Milk Ordinance. Cooling of Milk Products and Frozen Desserts Mix. Raw milk products shall be maintained at 45°F or less until processed. Pasteurized milk products and frozen desserts mix shall be cooled immediately, in approved equipment, to a temperature of 45°F or less. Pasteurized milk and frozen desserts mix shall be stored at a temperature of 45°F or less and maintained at that temperature until further processed. A room or tank in which products or frozen desserts mix are stored shall be equipped with an accurate thermometer. A mix which is not frozen at the plant at which it is pasteurized shall be: Transported to the place of manufacturing or freezing in sealed containers; Handled in a sanitary manner; and Stored at a temperature of 45°F or less until frozen. Except for sampling, dipping from containers of pasteurized mix is prohibited. Container Packaging, Closure, Sealing, and Storage. Closing or sealing of frozen desserts containers shall be done in a sanitary manner. The closing or sealing of individual containers of frozen desserts shall be done by methods which preclude product contamination. Frozen desserts shall be stored in a sanitary manner. Personnel Cleanliness. Hand Washing. Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination. An employee may not resume work after visiting the toilet room without thoroughly washing the employee’s hands. Garments and Hair Coverings. An individual engaged in processing, pasteurization, handling, storage, transportation, or packaging of milk products, frozen dessert ingredients or frozen desserts, containers, utensils, or equipment shall wear clean outer garments and a head covering. An employee with long hair shall wear hair restraints. The use of tobacco by any person while engaged in the processing of milk products, frozen desserts ingredients, or frozen desserts is prohibited. Packaging, Overflow, and Spillage. Packaging. The filling of frozen desserts containers shall be done only by approved mechanical equipment or by methods which preclude contamination. Frozen desserts shall be packaged in containers which protect the contents from contamination. Frozen desserts or frozen desserts mix: May be transported in sealed containers in a sanitary manner from one plant to another for further processing or packaging; and Shall be stored in a sanitary manner. Milk products, frozen desserts, or their ingredients which have been spilled, overflowed, or leaked shall be discarded and may not be sold for human consumption. Vehicles. Vehicles used for transportation of frozen desserts mix shall be constructed and operated so that the frozen desserts mix is: Maintained at 45°F or less; and Protected from; Sun; Freezing; and Contamination. Vehicles used for transportation of frozen desserts mix shall be kept clean. Substances capable of contaminating mix or frozen desserts or their ingredients may not be transported with frozen desserts mixes in a manner which permits contamination. Vehicles transporting frozen desserts or mix to wholesale or retail outlets shall have the name and address of the distributor prominently displayed on them. Transferring and Dispensing Frozen Desserts. Except for in a sanitary room or enclosure under approved conditions a person may not: Transfer frozen desserts from one container to another; or Package frozen desserts: On the street; or In any open vehicle. The direct sale of frozen desserts in packages, cones, or servings to the consumer may take place at roadside stands or concessions where the sanitary conditions are approved by the Secretary. Surroundings. Frozen desserts plant surroundings shall be kept clean, neat, and free from conditions which might attract or harbor flies or other insects and rodents, or which otherwise constitute a nuisance. Roads, driveways, yards, and parking areas adjacent to the plant shall be: Paved or otherwise treated to prevent dust; and Smooth and well drained to prevent accumulation of stagnant liquid. Upon application for a frozen desserts license, every plant shall be inspected to determine compliance with these regulations. Following the issuance of a license, every plant shall be inspected at least once every 3 months. If violations are found, notice shall be given as provided in the Frozen Desserts Law, Health-General Article, §21-813, Annotated Code of Maryland. Every licensee shall permit access to all parts of the establishment, and shall furnish the Secretary upon his request, for official use only: A true statement of actual quantities of milk products, mix, or frozen desserts used or produced; Sources of milk products, ingredients, or mix; Inspection and tests; Past records; and Pertinent information as to persons employed. Before engaging in the business of manufacturing any frozen desserts mix or frozen dessert regardless of the name under which the product is sold, every person shall first obtain a license from the Maryland Department of Health, Office of Environmental Programs, Division of Milk Control. Only a person who complies with the requirements of this regulation is entitled to receive and retain a license. Suspension — Revocation of License. A license may be suspended or revoked by the Secretary as follows: Upon the violation by the holder of any of the provisions of this law and regulations; Immediately when an imminent health hazard is found to exist; or For interference with the Secretary in the performance of his duties. Frequency of Sampling. Pursuant to Health-General Article, §21-804, Annotated Code of Maryland, during any consecutive 6-month period at least two samples of frozen desserts mix and frozen desserts shall be taken from each wholesale frozen dessert manufacturer. Samples of milk and milk products used as ingredients in frozen desserts shall be taken periodically. Enforcement. In accordance with Health-General Article, §21-813, Annotated Code of Maryland, the licensee shall be notified of violations. Whenever two of the last four consecutive samples of different batches of the same flavor of the same product, taken on separate days, exceed bacteria count, coliform determinations, or temperature standards as provided in Regulation .25 of this chapter, the licensee shall be notified of the results by mail and ordered to appear before the Secretary to review possible causes. At the same time, the licensee shall be warned that should the results of the next sample, collected within 14 days of the meeting, violate the standards by three of the last five bacteria counts, coliform determinations, or cooling temperatures, his license may be suspended. The suspension shall remain in effect so long as two of the last four consecutive samples exceed the limit of the standards. Failure to appear, without due notification, shall be cause for immediate suspension. Upon repeated violations, the Secretary may revoke a license following reasonable notice to the licensee and an opportunity for a hearing. This section is not intended to preclude the institution of court action. The Secretary may forego suspension of the license provided the product or products in violation are not sold, offered for sale, or given away. Whenever a phosphatase test is positive the cause shall be determined. When the cause is improper pasteurization, it shall be corrected and any product involved may not be sold, offered for sale, or given away. Reinstatement of License. In accordance with Health-General Article, §21-814, Annotated Code of Maryland, any license holder whose license has been suspended may make written application at any time for the reinstatement of his license. When the license suspension has been due to a violation of any of the bacteria, coliform, or cooling temperature standards, the Secretary, within 1 week after the receipt of a written application for reinstatement of license, shall issue a temporary license by letter, after determining by an inspection of the facilities and operation methods that the conditions responsible for the violation have been corrected. Samples shall then be taken at the rate of not more than two per week on separate days within a 3-week period, and the Secretary shall reinstate the license upon compliance with the appropriate standard as determined in accordance with §B of this regulation. Whenever the license suspension has been due to a violation of a requirement other than the bacteriological, coliform, or cooling temperature standards, the application shall contain a written statement of the effect that the violation has been corrected. Within 1 week of the receipt of the application, the Secretary shall make an inspection of the applicant's establishment and as many additional inspections thereafter as are deemed necessary to determine that the applicant's establishment is complying with the requirements. When the findings justify, the license shall be reinstated. Only frozen desserts and frozen desserts mix manufactured by a licensed wholesale frozen desserts manufacturer or retail frozen desserts manufacturer shall be sold to the final consumer, or to restaurants, soda fountains, grocery stores, or similar establishments. Properly prepared plans for all frozen desserts plants regulated under these regulations, which are hereafter constructed, reconstructed, or extensively altered, shall be submitted to the Secretary for written approval before work is begun. A person affected with any disease in a communicable form, or who is a carrier of a communicable disease, may not work at any frozen desserts plant in any capacity which brings him in contact with the production, handling, storage, or transportation of milk, milk products, other frozen dessert ingredients, frozen desserts, or frozen desserts mix containers, equipment, and utensils. A plant operator may not employ in this capacity any infected person, or any person suspected of having any disease in a communicable form, or of being a carrier of a communicable disease. Any permit holder, in whose frozen desserts plant any communicable disease occurs, or who suspects that any employee has contracted any disease in any form, or has become a carrier of a disease, shall notify the Secretary immediately. When reasonable cause exists to suspect the possibility of transmission of infection from any person concerned with the handling of milk, milk products, other than frozen dessert ingredients, frozen desserts, or frozen desserts mix, the Secretary is authorized to require any or all of the following measures: The immediate exclusion of that person from product handling; The immediate exclusion of the products concerned from distribution and use; and Adequate medical and bacteriological examination of the person, of his associates, and of his and their body discharges. When a dispensing freezer is used in a food service facility, it shall be exempt from the provisions of Regulations .22 — .24, .26 — .33, and .35 of this chapter. The operation and maintenance of this equipment shall comply with the provisions of COMAR 10.15.03. Retail frozen dessert manufacturers shall be exempt from the provisions of Regulations .22—.24, .26—.27 and .31—.33 under this chapter. The sanitation requirements and operation and maintenance of equipment of retail frozen dessert manufacturers shall comply with the provisions of COMAR 10.15.03. Retail frozen dessert manufacturers shall manufacture frozen desserts from Grade “A” milk or milk products as defined in COMAR 10.15.06.02 or manufactured grade milk or milk products as defined in COMAR 10.15.09.02. Health-General Article, §21-804, Annotated Code of Maryland Effective date: November 15, 1973 Regulations .25A, .26U, and .27A amended effective August 25, 1978 (5:17 Md. R. 1330) Chapter revised effective June 12, 1981 (8:12 Md. R. 1062) Regulations .02C, .14, .21B, .25G, H, I, .29A, and .30 amended effective January 12, 1987 (14:1 Md. R. 31) Regulations .10-1, .20-1, .20-2, and .20-3 adopted effective January 12, 1987 (14:1 Md. R. 31) Regulation .21B amended effective January 2, 1994 (20:26 Md. R. 2027) Regulation .22 amended as an emergency provision effective June 27, 2012 (39:15 Md. R. 962); amended permanently effective October 1, 2012 (39:19 Md. R. 1236) Regulation .25A amended effective January 2, 1994 (20:26 Md. R. 2027) Regulation .35 repealed and new regulation .35 adopted effective January 12, 1987 (14:1 Md. R. 31) Regulation .35 amended as an emergency provision effective June 27, 2012 (39:15 Md. R. 962); amended permanently effective October 1, 2012 (39:19 Md. R. 1236) Chapter revised effective February 27, 2017 (44:4 Md. R. 254) This chapter: Governs permits for the sale of Grade “A” milk and milk products, as set forth in Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland; Requires a permit for the sale of Grade “A” milk and milk products; Regulates the inspection of Grade “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products; and Sets forth: Standards for Grade “A” milk and milk products; The enforcement process for the examination, labeling, pasteurization, aseptic processing, retort processing, packaging, and distribution and sale of Grade “A” milk and milk products; Penalties pursuant Health-General Article, §§21-211, 21-252— 21-256, 21-418, 21-419, 21-428, 21-1202, and 21-1203, Annotated Code of Maryland; and Requirements for Grade “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products. In this chapter, the following terms have the meanings indicated. Terms Defined. “Bobtailer” means a person who operates or controls a Grade “A” milk route, and distributes Grade “A” pasteurized milk products that the person buys from a Grade “A” distributor or milk processor. “Bulk milk hauler/sampler” means a person who: Collects official samples; Transports raw milk from a farm or raw milk products to or from a milk plant, receiving station, or transfer station; Possesses a permit from any state to sample raw milk or raw milk products; and Possesses a Maryland Bulk Milk Hauler license if they are sampling milk or raw milk products in Maryland. “Certified industry dairy farm inspector” means an individual who is certified by the Secretary under Health-General Article, §21-414, Annotated Code of Maryland, to carry out the inspections of dairy farms. “Dairy farm” means a place where at least one cow, goat, or other hoofed mammal is kept, and from which the milk is sold or offered for sale. “Department” means the Maryland Department of Health or the Department's designee. “Extensive alteration” means the adding or tearing down of walls, plumbing, or other structural components of a dairy farm or milk plant. “Grade “A” distribution station” means a place or vehicle where, for redistribution and sale, Grade “A” pasteurized milk products routinely are received, stored, or transferred. “Grade “A” fluid milk” means pasteurized homogenized or pasteurized non-homogenized Grade “A” milk, cream, or half and half that has been processed to produce whole milk, low fat milk, or nonfat milk. “Grade “A” milk or milk products” means the milk of a cow, goat, or other hoofed mammal that is produced, processed, pasteurized, bottled, packaged, or prepared in accordance with the Grade “A” Pasteurized Milk Ordinance. “Impound” means to detain and hold milk or milk products under the authority of the Secretary, as provided under Health-General Article, §21-428, Annotated Code of Maryland. “Improper handling” means Grade “A” milk or a milk product intended for human consumption that: Has been adulterated; Has been misbranded; Has not been kept at the required temperature; Is injurious to health if consumed; or Is otherwise unsafe. “Industry plant sampler” means a person employed at a milk plant, a receiving station, or a transfer station who is responsible for the collection of official samples for regulatory purposes at the milk plant, receiving station, or transfer station. “Milk” means the milk of a cow, goat, or other hoofed mammal that is produced, processed, pasteurized, bottled, packaged, or prepared in accordance with the Grade “A” Pasteurized Milk Ordinance. “Milk facility” means a: Milk plant; Grade “A” distribution station; Receiving station; Transfer station; Milk processor; or Milk tank truck cleaning facility. “Milk marketing agency” means a person who negotiates the price of milk to be offered for sale and supplies milk. Milk Plant. “Milk plant” means a place where, for distribution, milk products are: Processed; Pasteurized; Bottled or packaged; or Prepared. “Milk plant” does not include a place where milk products are sold at retail only. “Milk processor” means a person who owns, operates, or controls a milk plant. “Milk producer” means a person who: Operates a dairy farm; and Provides, sells, or offers milk for sale to a: Milk plant; Receiving station; or Transfer station. “Milk tank truck” means a truck and its equipment that are used to transport milk or milk products. “Milk tank truck cleaning facility” means a place, premises, or establishment, separate from a milk plant, receiving station, or transfer station, where a milk tank truck is cleaned and sanitized. “Milk transportation company” means a person who is responsible for a milk tank truck. “Official laboratory” means a biological, chemical, or physical laboratory that is operated by the Department. “Officially designated laboratory” means a commercial laboratory authorized to conduct testing of milk and milk products on behalf of the Department or a milk industry laboratory officially designated by the Department for the examination, pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, of: Producer samples of Grade “A” raw milk for pasteurization; or Commingled milk tank truck samples of Grade “A” raw milk. “On-farm processor” means a licensed milk plant that is located on the same premises as a licensed milk producer. Pasteurization. “Pasteurization” has the meaning stated in 21 CFR §131.3. “Pasteurization” includes any other process found equivalent to pasteurization for milk and milk products as stated in 21 U.S.C. §343(h) “Permit” means an official document issued by the Secretary in accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, that authorizes the holder of the permit to do an act that is within the scope of the permit. “Permittee” means a person who holds a permit. Person. “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. “Person” includes: An operator of a facility that is owned by a State or local unit of government; or A State or local unit of government if the State or local unit of government is the operator of the facility. “Raw milk” means unpasteurized milk. “Receiving station” means a place where, for delivery to a milk plant, raw milk is collected, cooled, and stored. “Sale” or “sell” means a transaction that involves the: Transfer, dispensing, or serving of milk and milk products with or without charge; or Right to acquire milk and milk products: Through barter or contractual arrangement; or In exchange for any other form of compensation including, but not limited to, an agistment agreement, which is the sale of shares or interest in a cow, goat, or other lactating hoofed mammal, or herd of cows, goats, or other lactating hoofed mammals. “Sanitization” means the application of an effective method or substance to clean surfaces to destroy pathogens and other microorganisms. “Seasonal milk producer” means a milk producer that holds a permit to produce milk seasonally and stops producing milk for 30 days or more and then starts producing milk again within 12 months year after year. “Secretary” means the Secretary of Health or the Secretary's designee. “Sell-by date” means the end of the sell-by period. “Transfer station” means a place where milk is transferred directly from a milk tank truck to another milk tank truck for delivery to a milk plant. “Ultra-pasteurization” means the process of heating milk or milk product in properly designed and operated equipment to a minimum of 280°F for at minimum two seconds, either before or after packaging, so as to produce a milk or milk product which has an extended shelf-life under refrigerated conditions. In this chapter the following documents are incorporated by reference: Grade “A” Pasteurized Milk Ordinance, 20239evision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration); Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f, as amended; Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended; FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252, as amended; and; 21 CFR §§130—131, as amended. The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth at and in compliance with the standards, requirements, and procedures specified at: Health-General Article, Title 21, Annotated Code of Maryland; Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f; Nutrition Labeling and Education Act of 1990 (Public Law 101-535); Grade “A” Pasteurized Milk Ordinance; and FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252. A person engaged in an occupation involving Grade “A” milk shall conduct all Grade “A” milk activities as set forth at and in compliance with the standards, requirements, and procedures specified at: Health-General Article, Title 21, Annotated Code of Maryland; Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f; Nutrition Labeling and Education Act of 1990 (Public Law 101-535); and Grade “A” Pasteurized Milk Ordinance. A permittee shall ensure that all raw milk for pasteurization and all pasteurized milk and milk products conform to the standards, requirements, and procedures established by the: Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f; Nutrition Labeling and Education Act of 1990 (Public Law 101-535); Health-General Article, §§21-422 and 21-434, Annotated Code of Maryland; and Grade “A” Pasteurized Milk Ordinance. A bulk milk hauler/sampler shall ensure that: Bulk raw milk is delivered or received by the processor or receiving station within 12 hours of pickup route completion; Bulk raw milk is picked up from every dairy farm at least once every 72 hours; and; The temperature of the bulk raw milk does not exceed 45F. The person in charge of an official laboratory or officially designated laboratory shall ensure that: The laboratory is operated according to the requirements established by the Grade “A” Pasteurized Milk Ordinance; and All raw milk for pasteurization, all pasteurized milk and milk products, and all dairy product containers and lids are tested according to the requirements established by the Grade “A” Pasteurized Milk Ordinance. Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, to the Department before that person may: Be a: Bobtailer; Bulk milk hauler/sampler; Certified industry dairy farm inspector; Milk processor; Milk producer; or Seasonal milk producer; or Operate a: Grade “A” distribution station; Milk tank truck cleaning facility; Milk transportation company; Receiving station; or Transfer station. Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, for a milk tank truck. Under Health-General Article, §21-410(c), Annotated Code of Maryland, a permit is not required for: A milk producer who is outside the departmental inspection area if the raw milk from that milk producer is processed by a milk processor who holds a permit issued under this chapter; A bulk milk hauler/sampler who receives raw milk from outside the departmental inspection area; A grocery store, restaurant, soda fountain, or similar establishment where milk products are served or sold at retail if: The establishment complies with all applicable provisions of Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, and all applicable rules or regulations; and The milk product is received from a permittee; or An individual who only transports milk in a sealed tanker to a milk plant, receiving station, or transfer station and not producers’ samples. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall inspect: A milk tank truck; A milk producer; A seasonal milk producer; A transfer station; A milk tank truck cleaning facility; A milk plant; and A receiving station. The Secretary shall inspect a seasonal milk producer before the first shipment of milk and at least every 6 months until production of milk for sale has ceased. The Secretary shall inspect a Grade “A” distribution station at least once every 6 months. The Secretary shall inspect a bobtailer at least once every 12 months. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall evaluate: The ability of the certified industry dairy farm inspector to perform dairy farm inspections and raw milk sampling; The pick-up and sampling procedures that a bulk milk hauler/sampler performs; and The sampling procedures of the industry plant sampler. The Secretary shall inspect and evaluate a bulk milk hauler/sampler as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B. The Secretary shall inspect a milk tank truck as set forth in the Grade “A” Pasteurized Milk Ordinance and Appendix B. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix N, the Secretary shall evaluate: Laboratories performing Grade “A” milk product testing for official use; Laboratories performing drug residue testing; and Laboratory analysts performing testing as required by the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix N. Under Health-General Article, §21-428, Annotated Code of Maryland, and to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall impound Grade A milk or milk products intended for human consumption due to improper handling. After impounding the Grade A milk or milk product, the Secretary may issue an order to: Dispose of the milk or milk product; Make the milk or milk product unusable for consumption; or Under Health-General Article, §21-428, Annotated Code of Maryland, impose a civil monetary penalty, as set forth in §C of this regulation. The Secretary shall determine the amount of the civil monetary penalty by multiplying the current milk price, as announced by the Federal Milk Market Administrator, on the date of the impounding by the volume of the milk listed on the shipping documents. A person subject to an impoundment order may seek legal recourse as set forth at Health-General Article, §21-428, Annotated Code of Maryland, by: Appealing a civil penalty; or Bringing an action for damages. A permittee shall ensure that milk product labels conform to the standards and requirements established by the: Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §§341—350f; Nutrition Labeling and Education Act of 1990 (Public Law 101-535); Grade “A” Pasteurized Milk Ordinance; and Health-General Article, §§21-422, 21-424, and 21-425, Annotated Code of Maryland. Unless approved by the Department as described in §B of this regulation, a person may not sell, deliver, or offer Grade “A” milk or milk products that are cooled to, packaged, and stored at 45°F or less for sale after 18 days from the date of processing. In order to sell, deliver, or offer Grade “A” milk or milk products that are cooled to, packaged, and stored at 45°F or less for sale after 18 days from the date of processing, an applicant shall: Submit to the Department: A written request; and A shelf life study to show that the product meets standards set forth in this chapter; and Be approved by the Department. A permittee shall conspicuously and legibly mark the cap or non-glass container of Grade “A” fluid milk with the words “Sell by”, followed by the designation of the month and the day of the month after which the product may not be sold, delivered, or offered for sale. Milk products exempt from dating requirements are: Cultured milk products and eggnog; Milk and dairy products as defined by 21 CFR §§130—131, which have been subjected to aseptic processing and packaging; and Milk and dairy products as defined in 21 CFR §131.3(c), which have been subjected to ultra-pasteurization. Except as provided in §B of this regulation, a person may not offer Grade “A” fluid milk for sale beyond the sell-by date. The following establishments may use or serve Grade “A” fluid milk up to 4 days beyond the sell-by date: Food service facilities; Hospitals; Schools; Institutions; and Places where milk is consumed on the premises. An establishment listed in §B of this regulation shall ensure that Grade “A” fluid milk is used by the establishment not later than 4 days beyond the sell-by date. Under Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell raw milk for human consumption. A permitted milk producer may sell raw milk from the milk producer’s dairy farm only to a permitted: Receiving station; Transfer station; Milk plant; or Milk marketing agency. Pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, for construction, reconstruction, or extensive alteration of a dairy farm, a person shall submit to the Department: A plan and specifications before: Constructing or reconstructing a milk house, milking barn, milking stable, or milking parlor; Converting or remodeling an existing building or structure for use as a milk house, milking barn, milking stable, or milking parlor; or Adding, modifying, or replacing: A bulk milk tank; A milking system; Any part of a milking system; A washing system; Any part of a washing system; or A cooling system, including a plate cooler or bulk tank cooling system; and A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work; Contact information for the dairy farm, including: The full name, title, and telephone number of each applicant; The name of the dairy farm; The mailing address; The location; and Directions to the site; A site drawing showing the location of the milk house, milking barn, milking stable, milking parlor, and each animal housing area, with approximate distances in feet, to: Manure pits; Cow yards; Silos; Wells or other approved water systems; Septic systems; Frost free style watering hydrants; Ditches; and Streams; A detailed drawing of the interior of the milk house, milking barn, milking stable, milking parlor, and each animal housing area indicating dimensions and showing the location of: Equipment; Pre-coolers; Floor drains; Lighting; Hose bibs; Watering troughs; Frost free style watering hydrants; Washing systems; Chemical dispensers; Compressors; Back flow prevention devices; and Toilets; For pipeline and milking system installations: The make, model number, quantity, and specifications of milking equipment including pipeline and milking units; The make and model number of pumps used in the milking system, including specifications such as horsepower and cubic feet per minute; A drawing of the parlor or barn showing the location of: Milking equipment; Pipeline, including size and length of the piping; Wash line, including size and length of the wash line; Receiver, if applicable; Pre-cooler, if applicable; Any other milk equipment; and The milk house, bulk tank, and animal housing area in relation to the milking parlor or milking barn; A description and diagram of the location of the back flow protection methods or devices that will be installed to protect the potable water supply on all plate coolers, chemical pumps, water lines, and other fixtures; The type, such as gas or electric, and capacity of the hot water heating system; and Information and specifications for booster or supplemental heating systems, if utilized; For bulk tank/milk cooling systems installation: A drawing of the milk house with bulk tank location, floor drain locations, and clearance dimensions on both sides, in front, and above the manhole of the bulk tank; Specific floor, wall, and ceiling finishes, if part of a new installation; Bulk tank specifications, including make, model number, and capacity; Cooling system specifications, including make, model number, and capacity; and Pre-cooler type and British thermal units capability, if applicable. A milk producer shall ensure that: Construction of all equipment, milking barns, stables, parlors, milk houses, and each animal housing area complies with the requirements of the Grade “A” Pasteurized Milk Ordinance and Regulation .13 of this chapter, as applicable; Water used at a dairy farm shall: Be obtained from a water supply system that complies with: Environment Article, Title 9, Annotated Code of Maryland; COMAR 26.04.04; and The Grade “A” Pasteurized Milk Ordinance; Be installed in a manner that prevents backflow or back-siphoning; Be separate from a non-potable water supply system so that non-potable water cannot be drawn or discharged into the potable water supply system; Provide hot and cold running water in areas where milk processing equipment is washed; and Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system; Hand sinks shall have: Either: Hot and cold running water under pressure; or Warm running water; A supply of hand-cleaning soap or detergent; and A sanitary means of drying hands, such as individual towels or a hand-drying device; A sewage system is constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance; Toilet facilities, if any, are constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance; Plumbing is sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and Electrical systems comply with State and local electrical laws, ordinances, and regulations, and the Grade “A” Pasteurized Milk Ordinance. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department: Plans and specifications before: Constructing, reconstructing, or extensively altering a milk facility; Converting or remodeling an existing building or structure for use as a milk facility; Adding, replacing, relocating, or modifying a milk facility process; or Adding, modifying, or replacing a clean-in-place (CIP) or other washing system or any part of a clean-in-place or other washing system; Plans and drawings bearing the name of a professional engineer or a representative of the company performing the work. Contact information for the facility, including: The full name, title, and telephone number of each applicant; The name of the plant; The mailing address; The location; and Directions to the site; A narrative describing the scope and purpose of the project, including a projected time line from start to completion; An estimate of finished product output per day; Sample product labels for each product; A list of: All products to be produced; Raw cream and skim, condensed, or any other milk or milk products to be sold; and Single service container sources; A scale drawing showing the layout and arrangement of areas within and around the milk facility, including areas for: Processing; Chemical storage; Dry storage; Ingredient and product storage; Receiving; Load out; Laboratories; Offices; Restroom facilities; Lockers or a facility for the storage of personal items; and Employees to eat and drink beverages; A scale drawing showing the location of all equipment, including: Pasteurizers and sterile systems; Milk processing equipment; Fillers; Raw and pasteurized tanks and silos; Clean-in-place (CIP) systems; Glycol water tanks; Recirculating cooling water tanks; Boilers; Boiler makeup tanks; Culinary steam systems; and Blow mold systems; A scale drawing showing the location of plumbing and plumbing fixtures, including: Water lines; Sewer lines; Hand sinks; Toilets; Utility sinks; Utensil washing sinks; Floor drains; Floor sinks; Hose stations; and All back flow prevention devices; A legend for each drawing; Specifications for: Ventilation including, but not limited to, the type and location of: An air filter; An air pump; and A compressor; Construction materials for the building and interior finishes; and Pasteurizer plate coolers, if separate from the pasteurization system; A list and description of all boiler, glycol, and recirculating water additives and water treatment; A description of the: Type of disposal for wastewater and sewage; Source and system for the facility’s potable water supply; Lighting fixtures and placement; and Recirculating cooling system; Specification sheets, including manufacturer and model number of all milk facility equipment; A document that lists the flow for all products through the plant, grouped in categories, identifying each functional piece of equipment and each process used in processing and packaging, including: Reclamation systems; Standardization procedures or formulation procedures, or both; Vitamin addition protocol; and Draining of product lines; Plans, specifications, drawings, and flow diagrams for each high temperature short time (HTST) and higher heat short time (HHST) system, showing each functional component; Clean-in-place (CIP) flow diagrams from the makeup tanks through all equipment; Information and drawings on how separation from product lines will be accomplished, if applicable; Written step-by-step standard operating procedures for: Receiving, processing, storing, and packaging of each project; Drug residue testing; Cleaning and sanitization for all equipment; Cleaning and sanitization for the facility; Product trace back, inclusive of production or make sheet; and Product recall; A pest control program; and Employee training and personal hygiene practices. Water used at a milk facility shall: Be obtained from a potable water supply system that complies with: Environment Article, Title 9, Annotated Code of Maryland; COMAR 26.04.04; and The Grade “A” Pasteurized Milk Ordinance; Be installed in a manner that prevents backflow or back-siphoning; and Be separate from a non-potable water supply system so that non-potable water cannot be drawn or discharged into the potable water supply system; Provide hot and cold running water in areas where milk processing equipment is washed; and Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system. Hand sinks shall have: Either: Hot and cold running water under pressure; or Warm running water; A supply of hand-cleaning soap or detergent; and A sanitary means of drying hands, such as individual towels or a hand-drying device. A sewage system shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance. Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations. Toilet facilities shall: Be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance; For a milk plant that is not an on-farm processor, be available within the physical plant for use by employees; and For a milk plant that is an on-farm processor, if not located within the physical plant building: Be located within 500 feet of the physical plant building; Be accessible at all times that the plant is in operation; Have documented and implemented measures for re-entry into the plant to protect against facility and product contamination; and Have documentation from the local approval authority that an on-site sewage disposal system, if present, is adequate for the total number of users and meets all other requirements of COMAR 26.04.02. Electrical systems at the facility shall: Comply with State and local electrical laws, ordinances, and regulations; Provide adequate lighting sources that furnish at least 40 foot-candles of light in all working areas in all rooms where: Milk or milk products are handled, processed, packaged, or stored; or Containers, utensils, and equipment are washed; and Provide adequate lighting sources that furnish at least 20 foot-candles of light in dry storage and cold storage rooms. An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department. An applicant for a permit shall submit a plan to the Department that includes the requirements set forth in Regulations .13—.16 of this chapter. The Department shall: Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .13—.16 of this chapter; and Inform the applicant: That the plan has been received; If additional information is required to complete the plant review; Whether the plan is approved or denied; and Of the appeal process if the plan is denied. The Department shall maintain confidentiality of records submitted by a person in accordance with General Provisions Article, §4-335, Annotated Code of Maryland. When a permittee is found in violation of this chapter and the Grade “A” Pasteurized Milk Ordinance, the Secretary may suspend or revoke a permit as set forth in this regulation and Health-General Article, §21-211, 21-418, or 21-419, Annotated Code of Maryland or the Grade “A” Pasteurized Milk Ordinance. Except as otherwise provided in this regulation, before suspending a permit, the Secretary shall give to the permittee notice of intent to suspend as provided by Health-General Article, §21-418, Annotated Code of Maryland. The Department may suspend a permit if the permittee fails or neglects to correct a violation within the specified time period. If a permit has been suspended more than once, the Secretary may revoke the permit. The Department shall ensure that an opportunity for a hearing is provided to a person whose permit has been suspended or revoked. When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to Health-General Article, §21-418(c) and State Government Article, §10-226(c)(2), Annotated Code of Maryland, the: Department shall: Summarily suspend the permit; Order the permittee to cease operation immediately; and Promptly provide the permittee with: A written notice of the suspension of the permit; The reasons for the suspension; and An opportunity to be heard; and Permittee shall immediately cease operation upon the receipt of the summary suspension order. In accordance with the Administrative Procedures Act and Health-General Article, §21-419, Annotated Code of Maryland, the Department shall ensure that an opportunity for a hearing is provided to a permittee whose plan review or permit has been: Denied; Suspended; or Revoked. Health-General Article, §§2-104, 2-105, 21-207, 21-208, 21-210, 21-211, 21-406, and 21-428, Annotated Code of Maryland Effective date: July 1, 1972 Regulations .01 and .03A amended effective February 2, 1977 (4:3 Md. R. 145) Regulation .01AA, FF adopted effective August 25, 1978 (5:17 Md. R. 1330) Regulation .01-1 adopted effective February 12, 2007 (34:3 Md. R. 299) Regulation .01-2 adopted effective February 12, 2007 (34:3 Md. R. 299) Regulation .03A amended effective October 20, 1997 (24:21 Md. R. 1449) Regulation .03C amended effective August 25, 1978 (5:17 Md. R. 1330) Regulation .03D, E effective September 6, 1974 Regulation .03F adopted effective January 11, 1980 (7:1 Md. R. 44) Regulation .03F repealed effective October 20, 1997 (24:21 Md. R. 1449) Regulation .06 amended as an emergency provision effective April 6, 2006 (33:9 Md. R. 795); amended permanently effective August 28, 2006 (33:17 Md. R. 1436) Regulation .06C amended effective September 5, 1988 (15:18 Md. R. 2148); September 13, 1993 (20:18 Md. R. 1430) Regulation .08B amended effective August 24, 1979 (6:17 Md. R. 1394) Regulations .01—.11 repealed and new Regulations .01—.19 adopted effective March 19, 2010 (37:4 Md. R. 341) Regulation .03A amended effective March 7, 2011 (38:5 Md. R. 317) Regulation .03A amended effective October 15, 2012 (39:20 Md. R. 1306) Chapter revised effective February 27, 2017 (44:4 Md. R. 254) Regulation .02B amended effective May 18, 2020 (47:10 Md. R. 517); August 5, 2024 (51:15 Md. R. 708) Regulation .03 amended effective August 5, 2024 (51:15 Md. R. 708) Regulation .03A amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .03B amended effective February 16, 2026 (53:3 Md. R. 122) Regulation .05B amended effective August 5, 2024 (51:15 Md. R. 708) Regulation .10D amended effective August 5, 2024 (51:15 Md. R. 708) Regulation .11 amended effective August 5, 2024 (51:15 Md. R. 708) Regulation .16E adopted effective May 18, 2020 (47:10 Md. R. 517) Regulation .16F amended effective May 18, 2020 (47:10 Md. R. 517) In this chapter, the following documents are incorporated by reference: National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish 2023 Revision (US Food and Drug Administration), Section I. Purpose & Definitions and Section II. Model Ordinance except for Chapter IV, Shellstock Growing Areas; and American Public Health Association, Recommended Procedures for the Examination of Sea Water and Shellfish, 4th Edition, 1970. In this chapter, the following terms have the meanings indicated. Terms Defined. “Dealer” means a person who is issued a certificate by the Department for the activities of shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor. “Department” means the Maryland Department of Health or the Department's designee. “Mechanical refrigeration” means the removal of heat by using a refrigerant subjected to cycles of refrigerating thermodynamics and employing a mechanical compressor. Person-in-Charge. “Person-in charge” means the licensee or other person responsible for the operation of the shellfish plant. “Person-in-charge” includes the dealer as used in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, Model Ordinance. Shellfish Aquaculture Harvester Permittee. “Shellfish aquaculture harvester permittee” means a person who is issued a permit by the Department of Natural Resources in accordance with COMAR 08.02.23.04 to harvest shellfish from a submerged land lease or water column lease. “Shellfish aquaculture harvester permittee” includes a person registered to harvest shellfish from the lease cited on a shellfish harvester aquaculture permit. “Temperature control” means the management of the temperature of shellstock by means of ice, mechanical refrigeration, or other approved means necessary to lower and maintain the temperature of the shellstock to 50°F (10°C) or below. The person-in-charge shall ensure that shellfish are processed and the facilities and equipment of a shellfish plant are designed, operated, and maintained in compliance with: This chapter; COMAR 10.15.04 and 10.15.10; and The National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, Model Ordinance. If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 or 10.15.10 regarding shellfish plants or the processing of shellfish, this chapter takes precedence. Except for a licensed harvester delivering the harvester's catch to a certified dealer on the day of harvest, a person may not offer shellfish for sale in-State or interstate unless the person is licensed and certified in accordance with this chapter. In order to operate a shellfish plant, a person shall obtain a food processing plant license pursuant to the provisions of: Health-General Article, §21-305, Annotated Code of Maryland; COMAR 10.15.04; and This chapter. The person-in-charge shall ensure that: Shellfish are not purchased, sold, or processed without the: License required by the Health-General Article, §21-305, Annotated Code of Maryland; and Certification required by this chapter; and The required food processing plant license and certification are conspicuously posted in the plant. In order to purchase or ship shellfish products in in-State or interstate commerce, a person shall obtain certification pursuant to this chapter. The Department shall specify on the license and certification issued to a person operating a shellfish plant that the person is approved to operate as a: Shucker-packer (SP); Repacker (RP); Shellstock shipper (SS); Reshipper (RS); or Depuration processor (DP). The person-in-charge shall ensure that the operations in the plant are limited to the type of shellfish operation specified on the license and certification pursuant to §E of this regulation. The person-in-charge: Shall ensure that shellfish are harvested, handled, and processed to meet the bacteriological standards in this regulation; and May not distribute shellfish that do not meet the standards in this regulation. To establish whether compliance is met with the bacteriological standards for shellfish in §C of this regulation, a person shall utilize the isolation, identification, and enumeration in the American Public Health Association Recommended Procedures for the Examination of Sea Water and Shellfish, or other methods approved by the Secretary based on the ability of the methods to provide accurate and repeatable results. The bacteriological standards for shellfish are the following: Standard plate count (SPC) may not exceed 500,000 colony-forming units per gram of shellfish; Except when shellfish are further analyzed for Escherichia coli (E. coli), fecal coliform may not exceed 230 most probable number (MPN) per 100 grams of shellfish; and When shellfish exceed 230 MPN fecal coliform per hundred grams and are further analyzed for E. coli, E. coli may not exceed 330 MPN per 100 grams of shellfish. The Department shall construe numbers of bacteria in excess of the standards set forth in §C of this regulation as rendering the product adulterated, pursuant to Health-General Article, §21-207, Annotated Code of Maryland, and unfit for human consumption. A dealer and a shellfish aquaculture harvester permittee shall implement control measures as set forth in §B of this regulation to reduce the occurrence of Vibrio parahaemolyticus illness. Control Measures. From June 1 through September 30, a shellfish aquaculture harvester permittee shall: Protect harvested oysters from direct sun by providing shade over the area where the harvested oysters are stored; Maintain air flow to the area where the harvested oysters are stored; Designate a single site for landing the harvested oysters; Document the harvest start time, which is the time the first oysters are removed from the water, on a harvest trip record or harvest tag; and Provide the harvest time record as set forth in §B(1)(d) of this regulation to a dealer on delivery. From June 1 through June 30, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 11:30 a.m. on the day of harvest. From July 1 through August 31, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 10:30 a.m. on the day of harvest. From September 1 through September 30, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 12:30 p.m. on the day of harvest. From June 1 through September 30, a dealer may not: Receive oysters harvested from Maryland waters: After the harvest delivery times set forth in §B(2)—(4) of this regulation; and Without a harvest time record as set forth in §B(1)(d) of this regulation; or Sell or ship oysters that have not reached an internal temperature of 50°F (10°C) or below. From June 1 through September 30, a dealer shall: Place oysters under temperature control immediately upon delivery from the shellfish aquaculture harvester permittee: and Implement a HACCP plan as defined in COMAR 10.15.04 that recognizes pathogen growth of naturally occurring Vibrio bacteria present from June through September 30 as a significant hazard and includes: Control measures necessary to ensure, document, and verify that the internal temperature of oysters has reached 50°F (10°C) or below within 10 hours or less after being placed under temperature control; and Corrective action to ensure that oysters that are not cooled to an internal temperature of 50°F (10°C) within 10 hours are not directed to the raw shellfish market. To comply with §B(6) of this regulation, a dealer shall ensure that a temperature control mechanism for cooling and storing of oysters: Maintains a temperature of 45°F; and Cools oysters to an internal temperature of 50°F (10°C) in 10 hours or less. A shellfish aquaculture harvester permittee who is a dealer shall comply with the requirements set forth in §B(1)—(7) of this regulation. The Department may except a shellfish aquaculture harvester permittee who is a dealer from the harvest delivery times set forth in §B(2)—(4) and the receiving time set forth in §B(5)(a)(i) of this regulation if the permittee/dealer: Places harvested oysters under temperature control within 5 hours of harvest start time, which is the time the first oysters are removed from the water; and Implements an HACCP plan as defined in COMAR 10.15.04 that includes the control measures necessary to ensure, document, and verify that the harvested oysters are placed under temperature control within 5 hours of harvest start time. Health-General Article, §§18-102, 21-211, 21-234, 21-235, 21-304, 21-305, 21-321, and 21-346—21-350, Annotated Code of Maryland Effective date: September 1, 1967 Amended effective December 1, 1970 Regulations .01—.12 amended effective May 26, 1976 (3:11 Md. R. 592) Regulations .02—.06 amended as an emergency provision effective August 20, 1985 (12:19 Md. R. 1843); emergency status expired December 18, 1985 Regulations .02—.06 amended effective March 10, 1986 (13:5 Md. R. 543) Regulation .03C amended as an emergency provision effective June 1, 1978 (5:12 Md. R. 964); adopted permanently effective September 22, 1978 (5:19 Md. R. 1445) Regulations .01—.12 repealed and new regulations .01—.06 adopted effective November 6, 2006 (33:22 Md. R. 1733) Regulation .01A amended effective November 17, 2008 (35:23 Md. R. 2013); October 16, 2009 (36:20 Md. R. 1528); November 14, 2011 (38:23 Md. R. 1421); January 6, 2014 (40:26 Md. R. 2164); October 12, 2015 (42:20 Md. R. 1265); January 2, 2017 (43:26 Md. R. 1445); August 26, 2019 (46:17 Md. R. 726); July 24, 2023 (50:14 Md. R. 593); February 2, 2026 (53:2 Md. R. 61) Regulation .02B amended as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); amended permanently effective August 22, 2011 (38:17 Md. R. 1012) Regulation .02B amended as an emergency provision effective June 1, 2013 (40:13 Md. R. 1072); amended permanently effective September 30, 2013 (40:19 Md. R. 1547) Regulation .04 amended effective November 17, 2008 (35:23 Md. R. 2013) Regulation .04D amended effective October 16, 2009 (36:20 Md. R. 1528) Regulation .04E amended as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); amended permanently effective August 22, 2011 (38:17 Md. R. 1012) Regulation .06 adopted as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); adopted permanently effective August 22, 2011 (38:17 Md. R. 1012) Regulation .06B amended as an emergency provision effective June 1, 2013 (40:13 Md. R. 1072); amended permanently effective September 30, 2013 (40:19 Md. R. 1547) This chapter: Establishes a farmstead cheese program; and Sets forth the regulation and enforcement process for: The plan review process for facilities and equipment; The permitting process for the manufacture of cheese made from raw milk; Farmstead cheese: Production; Labeling; Record keeping; Inspections; Packaging; Distribution; Sale; Sampling; Testing; and Assessment of the penalties pursuant to Health-General Article, §§21-211, 21-252— 21-256, 21-418, 21-419, 21-428, 21-1202, 21-1203, and 21-1215, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Aging of cheese” means the storing and maturing of cheese under controlled conditions of temperature and humidity. “Aging period” means the aging of raw milk cheese for at least 60 calendar days at a temperature of not less than 35°F. “Aging room” means the area where the aging of cheese takes place. “Dairy farm” means a place or premises: Where one or more lactating animals, including cows, goats, sheep, water buffaloes, or other hooved mammals, are kept for milking purposes; and From which the milk is sold or offered for sale. “Department” means the Maryland Department of Health. “Departmental inspection area” means the area in which the Department routinely makes inspections under Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland. “Drug residue” means a substance that prevents the growth of bacteria in milk products. “Farmstead cheese” means a cheese made on a dairy farm: Using only the raw milk produced by the herd or flock on the dairy farm; and That meets the definitions and standards of a hard cheese, as set forth in 21 CFR Part 133. “Industry plant sampler” means: An individual responsible for the collection of official samples for regulatory purposes at a plant as outlined in the Grade “A” Pasteurized Milk Ordinance, Appendix N; and An employee of the plant who is evaluated a least once every 2-year period by a sampling surveillance officer or a properly delegated sampling surveillance official. “Milk” means the milk of a cow, goat, or other hooved mammals. “Official laboratory” means a laboratory that is a biological, chemical, or physical laboratory, which is under the direct supervision of the Department. “Officially designated laboratory” means a laboratory that is a: Commercial laboratory authorized to do official work by the Department; or Milk industry laboratory officially designated by the Department for the examination of producer samples of raw milk for drug residue. “Plant” means any place, premise, or establishment where milk or milk products are collected, handled, processed, stored, packaged or otherwise prepared for distribution as a farmstead cheese. “Raw milk” means unpasteurized milk. “Sanitation inspection” means an evaluation of the milk plant and associated processes in accordance with this chapter. “Sanitization” means: The application of any effective method or substance to properly clean surfaces for the destruction of pathogens and other microorganisms, as far as is practicable; and A treatment that: Does not adversely affect the equipment, the milk, milk product, or the health of consumers; and Is acceptable to the Department. In this chapter, the following documents are incorporated by reference: 21 CFR Part 101, as amended; 21 CFR Part 110, as amended; 21 CFR Part 133, as amended; Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended; United States Food and Drug Administration Food Compliance Program, “Domestic and Imported Cheese and Cheese Products”, November 19, 1998. 21 USC §§401—423, as amended; Food and Drug Administration Compliance Program Guidance Manual, Program 7303.803 (November 9, 2008); and Grade “A” Pasteurized Milk Ordinance, 2017 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), Section 8, Appendix D, Appendix G Section I, Appendix H Section II, and Appendix N only. The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth and in compliance with the standards, requirements, and procedures specified in: Health-General Article, Title 21, Annotated Code of Maryland; Federal Food, Drug and Cosmetic Act, 21 USC §§341—350; and Nutrition Labeling and Education Act of 1990 (Public Law 101-535). An individual engaged in an occupation involving farmstead cheese production shall conduct all farmstead cheese production activities as set forth at and in compliance with the standards, requirements, and procedures specified in: Health-General Article, Title 21, Annotated Code of Maryland; Federal Food, Drug and Cosmetic Act, 21 USC §§341—350; and Nutrition Labeling and Education Act of 1990 (Public Law 101-535). Pursuant to Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, to the Department before the person may be a: Milk producer; or Milk Processor — Farmstead Cheese Producer. The Department may grant or deny a permit based on the criteria, as set forth in this chapter. To qualify for a permit, an applicant shall: Provide the Department with the plans and specifications set forth in Regulations .14, .15, and .16 of this chapter; Submit an application to the Department on the forms that the Department provides; and Pay the Department’s required permit fee, as specified in COMAR 10.01.17. A permit: Expires 1 year from the date of issuance; May be renewed by a producer for a 1-year period upon the payment of the required fee, as specified in COMAR 10.01.17; and May not be transferred from one person to another person or from one farmstead cheese facility to another. Subject to the availability of sufficient inspection and testing staff, equipment, and other resources, the Department shall issue a permit entitled Milk Processor—Farmstead Cheese Producer: To an applicant in accordance with Health-General Article, §§21-415 and 21-416.1, Annotated Code of Maryland; and For the purpose of performing the specific process or processes to the specific milk or milk products as indicated on the plan review and permit applications. A farmstead cheese processor shall meet the standards set forth in this chapter. The Department shall conduct sanitation inspections of a plant within the Departmental Inspection Area and any other area designated by the Department: At the start-up of farmstead cheese processing; Once every 6 months; and In response to a complaint received by the Department or a local health department. Once a year a water supply survey shall be conducted to ensure that the requirements in Regulation .14 and .15 of this chapter are met. Reinspections. If an inspection discloses the existence of a critical or repeat violation of a requirement set forth in this chapter, the Department shall reinspect within 30 days to determine compliance with the requirements of this chapter. If the Department finds on the second inspection a violation of the same requirement of this chapter, the Department shall issue a notice of intent to suspend the permit or a compliance schedule. If the Department finds a violation of the same requirement as specified on the notice of intent to suspend the permit or the compliance schedule as specified in the notice, the Department shall: Suspend the permit in accordance with Regulation .20 of this chapter and Health-General Article, §§21-418 and 21-419, Annotated Code of Maryland; or Initiate appropriate court action. Inspection Reports. The Department shall give one copy of the inspection report to the permit holder or other responsible person or post the inspection report in a conspicuous place on an inside wall of the establishment immediately after the conclusion of the inspection. The permit holder: May not deface the inspection report; and Shall make the inspection report available to the Department upon request. A plant shall meet the sanitation inspection standards set forth in this regulation: Floor — Construction. The floor of each room in which product containers, utensils, equipment, milk, or cheese products are handled, processed, packaged, stored, or washed shall be: Constructed of concrete or other equally impervious and easily cleanable material; and Smooth, properly sloped, provided with trapped drains, and kept in good repair. Floor drains are not required in cold storage rooms used for storing milk and cheese products when the floor is sloped to drain to one or more exits. A storage room for storing dry ingredients, packaged dry ingredients, and packaging materials may have: Floor drains; and Floors constructed of tightly joined wood. Wall and Ceiling — Construction. The wall and ceiling of each room in which milk or cheese products is handled, processed, packaged, or stored shall: Have a smooth, washable, light colored surface; and Be in good repair. Door and Window. The plant shall provide effective means to prevent access by insects and rodents. An opening to the outside shall: Have solid doors or glazed windows; and Be closed during weather conditions that may result in particulate matter entering the facility. Lighting and Ventilation. Each room shall be well lit and well ventilated where: Milk and cheese products are: Handled; Processed; Packaged; or Stored; or Milk containers, utensils, and equipment are washed. Separate Room. There shall be a separate room for: Receiving farmstead cheese; Processing farmstead cheese; Cooling farmstead cheese; Aging farmstead cheese; Packaging farmstead cheese; and Cleaning raw milk cans and containers brought in from the farm. A room may not open directly into a stable or room used for a domestic purpose where: Milk or a farmstead cheese product is: Received; Handled; Processed; Stored; or Packaged; or Containers, utensils, or equipment are washed or stored. A room shall be of sufficient size for their intended purposes. Each designated area or room shall be provided for receiving, handling, and storage of a returned packaged or farmstead cheese not suitable for sale. Toilet Sewage Disposal Facility. Each toilet facility shall conform to the regulations of the local health department. Each toilet facility may not open directly into a room where milk or cheese products are processed. Each toilet facility shall be completely enclosed and have a tight fitting, self-closing door. Each dressing room, toilet room, and fixture shall be: Kept in a clean condition; Kept in good repair; Well ventilated; and Well lit. Sewage and other liquid waste shall be disposed of in a sanitary manner. Water Supply. Water for plant purposes shall be: From a supply properly located, protected, and operated; Easily accessible; Adequate; and Of a safe, sanitary quality. Handwashing Facility. A hand washing facility shall: Provide: Either: Hot and cold running water; or Warm running water; Soap; and Individual sanitary towels. Be kept in a clean condition and in good repair. Plant Cleanliness. A room shall be kept clean, neat, and free of evidence of insects and rodents where: Milk and a farmstead cheese product is: Handled; Processed; or Stored; or Containers, utensils, or equipment are washed or stored. Only equipment directly related to processing operations or the handling of containers, utensils, and equipment shall be permitted in a room where: Receiving; Processing; Cooling; Aging; Packaging; Bulk milk is stored; or A cheese product is stored. Sanitary Piping. The material of a sanitary piping fitting and connection exposed to milk, cheese products, or liquids drawn into milk and cheese products shall be: Smooth; Impervious; Corrosion resistant; Nontoxic; Easy cleanable; and An approved surface for food product contact. All piping shall be in good repair. Construction and Repair of Containers and Equipment. A multiuse container and equipment that milk and a farmstead cheese product comes into contact with shall be: Constructed of smooth, impervious, corrosion resistant, and nontoxic material; Constructed for ease of cleaning; and Maintained in good repair. A single service container, closure, gasket, and other article that milk and a farmstead cheese product come in contact with shall be: Nontoxic; and Manufactured, packaged, transported, and handled in a sanitary manner. Articles intended for single service use may not be reused. Clean and Sanitation of Containers and Equipment. The contact surface of a multiuse container, utensil, and equipment used in the farmstead cheese process from receiving through packaging shall, before each use, be effectively cleaned and sanitized. Sanitization: May not adversely affect the equipment, the milk or milk product, or the health of consumers; and Shall be acceptable to the Department. A cloth used for cheese making shall be cleaned and sanitized at intervals, and in accordance with the Department. Storage of Cleaned Containers and Equipment. After cleaning, a multiuse milk or farmstead cheese product container, utensil, and equipment shall be: Transported and stored to assure complete drainage; and Protected from contamination before use. Storage of Single Service Containers, Utensils, and Materials. A wrap, liner, bag, container, gasket, and other single service article in contact with milk and a farmstead cheese product shall be: Purchased and stored in a sanitary tube, wrapping, or carton; Kept in a clean, dry place until used; and Handled in a sanitary manner. Protection from Contamination. The facility, plant operation, and equipment shall be located and used in a manner to prevent contamination of a milk and farmstead cheese product, ingredient, container, utensil, and equipment. A milk or a farmstead cheese product ingredient shall be discarded if: Spilt; Overflowing; Leaking; or Dropped or has fallen onto an unsanitized contact surface or nonproduct contact surface. The processing or handling of a product other than milk or a farmstead cheese product in the plant, shall be performed to preclude the contamination of such milk and farmstead cheese products. The storage, handling, and use of a poisonous or toxic material shall be performed to preclude the contamination of: A milk and a farmstead cheese product; An ingredient of milk and a farmstead cheese product; or The product contact surface of a container, utensil, and equipment. Cross Contamination. During processing, a pipeline and equipment used to contain or conduct milk and a farmstead cheese product shall be effectively separated from each tank or circuit containing cleaning or sanitizing solutions. Separation shall be accomplished by: Physically disconnecting a connection point between each tank or circuit containing a cleaning or sanitizing solution from a pipeline and equipment used to contain or conduct a milk or farmstead cheese product; or A method approved by the Department. The farmstead cheese processor shall provide a means to prevent contamination of milk and a farmstead cheese product, container, utensil, and equipment from dripping, spillage, and splash from an overhead piping, platform, or mezzanine. A product that may create a public health hazard may not be handled in the plant. Permission to handle a product other than farmstead cheese or to conduct an operation in equipment or a room, other than those designated, shall be provisional and subject to revocation if found objectionable. Raw Milk Cooling and Farmstead Cheese Processing. Raw milk shall be maintained at 7ºC (45ºF) or less until processed. Farmstead cheese shall meet the definition of a hard cheese as found in 21 CFR 133.150 which states hard cheese: Contains not more than 39 percent of moisture; and Solids contain not less than 50 percent of milk fat, as determined by the methods prescribed in 21 CFR 133.5(a), (b), and (d). Farmstead cheese shall be cured at a temperature of not less than 35°F for not less than 60 days. Personnel Sanitation. An individual shall wash their hands thoroughly before commencing a plant function and as often as may be required to remove soil and contamination. An employee may not resume work after visiting the toilet room without thoroughly washing their hands. An individual shall wear clean outer garments while engaged in the: Handling of raw milk and ingredients; Processing of a farmstead cheese product; Storage of a farmstead cheese product; Transportation of a farmstead cheese product; Packaging of a farmstead cheese product; and Handling of a container, utensil, and equipment. An individual, while engaged in the processing of milk or a farmstead cheese product, shall: Wear an adequate hair covering; Abstain from tobacco use; Wear clean and sanitized footwear; Maintain trim and clean fingernails and not wear false fingernails; and Abstain from any activity that may contaminate food. The farmstead cheese processor shall ensure that education and training is provided to an employee in: Food processing and handling; Personal hygiene; and Plant sanitation. Vehicles. A vehicle used for the transportation of raw milk and a farmstead cheese product shall be constructed and operated so that the milk and the farmstead cheese product is maintained at 7ºC (45ºF) or less and is protected from contamination. A vehicle used to transport milk and a farmstead cheese product may not be used to transport or contain a substance that may be toxic or harmful to humans. Surroundings. Plant surroundings shall be kept neat, clean, and free from conditions which: Attract or harbor flies, other insects, or rodents; or Otherwise constitute a nuisance. Raw Milk Sampling and Testing Standards. The farmstead cheese processor is responsible for the collection and cost associated with the sampling and testing of raw milk used for the manufacture of farmstead cheese; Sampling shall be conducted by an industry plant sampler; The raw milk used for the manufacture of farmstead cheese shall be tested monthly for: Bacteria; Drug residue; Temperature; Odor; and Appearance. Raw Milk Quality Standards. A standard plate count of raw milk for farmstead cheese may not exceed 500,000 per milliliter; Raw milk shall meet the following drug residue standards: Raw milk for farmstead cheese shall be negative for drug residue. Before processing, the industry plant sampler shall collect a representative sample of raw milk used in the manufacture of farmstead cheese; and An official laboratory or officially designated laboratory shall conduct drug residue testing for the presence of drug residue in accordance with the Grade “A” Pasteurized Milk Ordinance, Appendix N. Raw milk shall meet the following temperature standards: Raw milk for farmstead cheese shall be cooled to 7°C (45°F) or less within two hours after initial milking; The blend temperature after the first and subsequent milkings may not exceed 10°C (50°F). Raw milk for farmstead cheese shall be cooled to and maintained at a temperature not to exceed 7°C (45°F). The appearance and odor of raw milk used for farmstead cheese shall be free from: Objectionable feed; Off odors; and Abnormalities. In accordance with the Department, an official laboratory or officially designated laboratory shall test a composite milk sample and shall rate it “acceptable for use” if there is no actionable residue for: Radionuclides; Pesticides; and Herbicides. Added water shall be tested on an individual producer’s milk in accordance with the Department’s official laboratory or officially designated laboratory and rated “acceptable for use” if the test result is -0.540°H or less. Farmstead Cheese Finished Product Sampling. The farmstead cheese processor is responsible for the collection and cost associated with the sampling and testing of a finished farmstead cheese product; Sampling shall be conducted by an industry plant sampler; The initial three finished products of each farmstead cheese shall be tested for: Salmonella; Escherichia coli (E. coli); Listeria monocytogenes; Staphylococcus aureus; Enterohemorrhagic E. coli (0157:H7); and Percent moisture. The finished product of each farmstead cheese shall be tested annually and is in accordance with §C(3) of this regulation. Farmstead Cheese Finished Product Quality Standards. The farmstead cheese finished product: Shall test negative for Salmonella, Enterohemorrhagic E. coli (0157:H7), and Listeria monocytogenes; Shall test less than 10 cfu/gram for E. coli and Staphylococcus aureus; and May not be greater than 39 percent moisture. Farmstead Cheese Processing Standards. The farmstead cheese: Finished product shall be aged at least 60 calendar days before offering for sale; Shall be aged or cured at a temperature of not less than 35°F; and Finished product may not contain more than 39 percent moisture at the end of the aging period. The farmstead cheese processor shall ensure that the result of all tested farmstead cheese finished products are submitted and approved by the Department before further processing or sale of the farmstead cheese. The Department may request that the farmstead cheese processor have the farmstead cheese finished product tested, as needed, as set forth in the United States Food and Drug Administration Food Compliance Program, “Domestic and Imported Cheese and Cheese Products,” to ensure compliance with this regulation. Water Samples. Samples for bacteriological testing of the plant water supply and, if applicable, any other water used for cooling and processing shall be collected: Upon the initial approval of the physical structure; Every 6 months thereafter; and When any repair or alteration to the water supply system has been made. Plant water for testing shall be obtained from a potable water supply system that complies with Regulation .15A of this chapter. Samples shall be taken by the Department and examined by an official laboratory. Record Keeping Required. Current written step by step standard operating procedures are required for: Product trace back; Product recalls; Drug residue testing; Cleaning of the equipment and facility; Sanitizing equipment and product contact surfaces; Receiving, processing, aging, storage, and packaging of each type of farmstead cheese produced; Pest control and preventative maintenance; and Employee training including personal hygiene practices; Processing records shall include the: Product being manufactured; Drug residue testing as set forth in the Grade “A” Pasteurized Milk Ordinance, Appendix N; Date and result of the raw milk testing; Date and result of the finished farmstead cheese product tested; The pH of each batch after inoculation at 5 hours, 24 hours, and the end of aging; and Raw ingredient: Origin; Storage; Transportation; and Other information required by the Department; and Temperature, as set forth in Regulation .07 of this chapter. For each batch of farmstead cheese produced, a make record shall be maintained and include: The name of the product being produced; The temperature of the milk being used; A unique identifier assigned at the start of the production of that batch of cheese shall be: Used to track each batch of cheese through the production process; and Included on the product label; The amount of product being produced; The name and amount of each ingredient added; The cook temperature; The pH of the product after inoculation at 5 hours, 24 hours, and the end of aging; and The production date for the product which is the date the batch entered the aging room to start the aging process; and Each record shall be available to the Department for review during each inspection. Raw Milk Enforcement. When two of the last four consecutive bacterial count or cooling temperatures, taken on separate days, exceed the limit for raw milk, as set forth in this chapter, the Department shall: Send to the permit holder a written notice of intent to suspend the permit which shall remain in effect as long as two of the last four consecutive samples exceed the limit of the standard; and Take an additional sample within 21 days of the written notice of intent to suspend, but not before 3 days have elapsed. When the standard set forth in Regulation .08 of this chapter is violated three of the last five consecutive bacterial counts or cooling temperature tests the Department shall immediately suspend the permit in accordance with this section, Regulation .20 of this chapter, and Health-General Article, §21-418, Annotated Code of Maryland. The Department shall conduct an investigation and take enforcement action in accordance with the Grade “A” Pasteurized Milk Ordinance, Appendix N, when a drug test is positive. When an odor and appearance evaluation results in rejection of milk: The Department shall conduct an investigation to determine the reason for the rejection; and A person may not offer the rejected milk for sale. When a pesticide, herbicide, or radionuclide residue test is positive: The Department shall conduct an investigation to determine the cause and the cause shall be corrected; An additional sample shall be taken and tested for the pesticide, herbicide, or radionuclide, and no milk shall be used for processing or offered for sale until it is shown by a subsequent sample to be free of the positive residue; and The Department may suspend a permit based on the presence of pesticide, herbicide, or radionuclide residue. Farmstead Cheese Finished Product Enforcement. When the pathogen testing result exceeds the limits set forth in Regulation .08 of this chapter, the cheese in violation may not be offered for sale, and the: Department shall conduct an investigation to determine the cause; and Cause shall be corrected prior to resumption of processing. A person may not offer for sale a farmstead cheese product if the processing requirement is in violation of this chapter at the end of the aging period: Days of aging; Temperature during aging; or Percent moisture. Cheese may be detained and further pathogen testing may be required to show compliance. Reinstatement of Permits. To reinstate a permit that is suspended for either a bacteria count or cooling violation the permit holder shall: Submit a written application for the reinstatement of the permit; Successfully complete a Department inspection of the facility within 1 week of a reinstatement request to ensure that the condition responsible for the violation is corrected; Accept a temporary permit if it has determined that the facility is in compliance; and Complete an accelerated sampling program at the rate of no more than two samples per week on separate days within a 3-week period to confirm that the violation has been corrected. The Department shall fully reinstate the permit upon compliance with the appropriate bacteria and temperature standard as determined in accordance with Regulation .08 of this chapter. To reinstate a suspended permit for violations other than bacteriological, drug residue test, or cooling temperature standards, the permit holder shall: Notify the Department that the violation has been corrected; and Successfully complete a Department inspection of the facility within 1 week of a reinstatement request to ensure that the condition responsible for the violation is corrected. When a permit suspension has been due to a positive drug residue, the permit shall be reinstated in accordance with the provisions of the Grade “A” Pasteurized Milk Ordinance, Appendix N, incorporated by reference in Regulation .03 of this chapter. Pursuant to Health-General Article, §21-428, Annotated Code of Maryland, the Department shall impound milk or a milk product intended for human consumption due to improper handling. The Department may: Issue an order to make the milk or milk product unusable for consumption before disposing of the milk or milk product; and Impose a civil monetary penalty, as set forth in §C of this regulation. The Department shall determine the amount of the civil monetary penalty by multiplying the volume of the milk listed on the shipping documents by the current milk price of the applicable market, as set by the Federal Milk Market Administrator on the date of the impounding. A person subject to an impoundment order may seek legal recourse, as set forth in Health-General Article §21-428, Annotated Code of Maryland, by: Appealing a civil penalty; or Bringing an action for damages. A farmstead cheese processor shall: Ensure all labels for a farmstead cheese product conform to the standards and requirements established by: The Federal Food, Drug, and Cosmetic Act, 21 USC, §§341—350f; The Nutrition Labeling and Education Act of 1990 (Public Law 101-535); 21 CFR Parts 101 and 133; and Health-General Article, §21-424, Annotated Code of Maryland; and Conspicuously mark each package containing farmstead cheese with the: Name of the product; Name of the manufacturer that made the farmstead cheese; Address of the manufacturer if: Listed in the local phone book, the address may consist of the city and state; or Not listed in the local phone book, the street address shall be included; Plant license number; Each ingredient in order of predominance; Net weight of the product in English and metric units; Batch identification of the product; Required nutritional information; Statement: “Cured or aged for 60 days at a temperature not less than 35° F;” or A variation of this phrase that conveys the fact that the product has been aged at least 60 days; and Statement that the milk was not pasteurized, using terms such as “raw milk” or “not pasteurized.” Pursuant to Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell raw milk for human consumption. All raw milk for farmstead cheese shall meet the Animal Health requirements as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 8, incorporated by reference in Regulation .03 of this chapter. Pursuant to Health-General Article, §§21-410, 21-411, and 21-413 for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department: A plan and specification before: A plant is constructed, reconstructed, or extensively altered; An existing building or structure is converted or remodeled for use as a plant; A plant process is added, replaced, relocated, or modified; or A clean-in-place (CIP), other washing system, or part of a CIP is added, modified, or replaced; A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work; Contact information for the facility, including: The full name, title, and telephone number of each applicant; The name of the plant; The mailing address; The location; and Directions to the site; A narrative describing the scope and purpose of the project, including a projected timeline from start to completion; An estimate of the finished product output per day; A sample product label for each product; A list of the: Type of raw milk cheese to be processed and sold; Each raw ingredient and the ingredient source; and Single service container source; A scale drawing showing the layout and arrangement of an area within and around the plant, including the: Processing area; Chemical storage; Dry storage; Ingredient and product storage; Receiving area; Load out area; Laboratory space; Office; Restroom facility; Locker or similar storage facility for the storage of personal items; and Separate area for employees to eat and drink beverages; A scale drawing showing the location of all equipment, including the: Milk processing equipment; Milk tank and silo; CIP system; Glycol water tank; Recirculating cooling water tank; Boiler; and Boiler makeup tank; A scale drawing showing the location of plumbing and each plumbing fixture, including the: Water line; Sewer line; Hand sink; Toilet; Utility sink; Utensil washing sink; Floor drain; Floor sink; Hose station; and Back flow prevention device; A legend for each drawing; Specifications for: Ventilation, including, but not limited to, the type and location of: An air filter; An air pump; and A compressor; and Construction material for the building and interior finish; A list and description of boiler, glycol, and recirculating water additive and water treatment; A description of the: Type of disposal for wastewater and sewage; Source and system for the facility’s potable water supply; Lighting fixture and placement; and Recirculating cooling system; Each specification sheet, including manufacturer and model number of the plant equipment; A document that lists the flow for a products through the plant identifying each functional piece of equipment and each process used in processing and packaging; A CIP flow diagram from the makeup tanks through all equipment; Information and drawings on how separation from product lines will be accomplished, if applicable; Written step by step standard operating procedures for: Receiving, processing, aging, storing, and packaging of each type of farmstead cheese product; Drug residue testing; Cleaning and sanitization for all equipment; Cleaning and sanitization for the facility; Product trace back, inclusive of production/make sheet; and Product recall; Pest and mite control program; A specification and standard operating procedure for how wood shelving used in the aging of cheese will be: Designed; Installed; Used; Cleaned; Sanitized; Maintained; and Inspected by the farmstead cheese processor; and Employee training and personal hygiene practices. Water used at a farmstead cheese facility shall: Be obtained from a potable water supply system that complies with: Environment Article, Title 9, Annotated Code of Maryland; COMAR 26.04.04; and The Grade “A” Pasteurized Milk Ordinance, Appendix D, incorporated by reference in Regulation .03 of this chapter; Be installed in a manner that prevents backflow or back siphoning; Be separate from a nonpotable water supply system so that nonpotable water can be drawn or discharged into the potable water supply system; Provide hot and cold running water in an area where milk processing equipment is washed; and Have sufficient water capacity, pressure, and hot water generation and distribution to meet peak demands throughout the washing system; Hand sinks shall have: Either: Hot and cold running water; or Warm running water; A supply of hand cleaning soap or detergent; and A sanitary means of drying hands, such as individual towels or a hand drying device; A sewage system shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations; Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and Electrical systems at the facility shall: Comply with State and local electrical laws, ordinances, and regulations; Provide adequate lighting sources that furnish at least 30 foot candles of light in all working areas and rooms where: Milk or a milk product is handled, processed, packaged, or stored; or A container, utensil, and equipment are washed; and Provide adequate lighting sources that furnish at least five foot candles of light in dry storage and cold storage rooms. An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department. An applicant for a permit shall submit a plan to the Department that includes the requirements set forth in Regulations .14 and .15 of this chapter. The Department shall: Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .14 and .15 of this chapter; and Inform the applicant: That the plan has been received; If additional information is required to complete the plan review; Whether the plan is approved or denied; and Of the appeal process, if the plan is denied. No individual affected with any disease capable of being transmitted to others through the contamination of food shall work at a plant in any capacity which brings them into direct contact with: Raw milk, a farmstead cheese product, and a food ingredient; or Associated raw milk and a food product contact surface. In accordance with Health-General Article, §§18-102, 21-253, 21-254, and 21-435, Annotated Code of Maryland, when an individual working at a plant has a communicable disease or is a carrier of a communicable disease the Department: Shall immediately exclude the: Individual from handling milk, milk products, milk containers, and milk equipment; and Milk supply that is handled by the infected individual from distribution and use; and May require medical and biological examination of the individual and the individual’s bodily discharges. The Department shall maintain confidentiality of records submitted by a person in accordance with §4-335 of the General Provisions Article, Annotated Code of Maryland. When a farmstead cheese processor is found in violation of this chapter, the Department may suspend or revoke a permit as set forth in this regulation and Health-General Article, §§21-211, 21-418, or 21-419, Annotated Code of Maryland. Except as otherwise provided in this regulation, before suspending a permit, the Department shall give to the farmstead cheese processor notice of intent to suspend as provided by Health-General Article, §21-418, Annotated Code of Maryland. The Department may suspend a permit if the farmstead cheese processor fails or neglects to correct a violation within the specified time period. If a permit has been suspended more than once, the Department may revoke the permit. When an immediate and substantial danger is found to exist to public health, safety, or welfare that requires emergency action, pursuant to Health-General Article, §21-418(c) and State Government Article, §10-226(c)(2), Annotated Code of Maryland, the: Department shall: Summarily suspend the permit; Order the farmstead cheese processor to cease operation immediately; and Promptly provide the farmstead cheese processor with: A written notice of the suspension of the permit; The reasons for the suspension; and An opportunity to be heard; and The farmstead cheese processor shall immediately cease operation upon the receipt of the summary suspension order. In accordance with the Administrative Procedures Act and Health-General Article, §21-419 the Department shall ensure that an opportunity for a hearing is provided to a farmstead cheese processor whose plan review or permit has been: Denied; Suspended; or Revoked. Health-General Article, §§21-211, 21-234, 21-406, 21-416.1, 21-417, 21-418, 21-419,21-428, 21-434, 21-252—21-256, 21-1202, 21-1203, and 21-1215, Annotated Code of Maryland Effective date: May 4, 2009 (36:9 Md. R. 651) Regulation .01A amended effective December 28, 2009 (36:25 Md. R. 1954) Regulation .04 amended effective December 28, 2009 (36:25 Md. R. 1954) Chapter revised effective March 28, 2016 (43:6 Md. R. 407) Regulation .02B amended effective February 27, 2017 (44:4 Md. R. 254) Regulation .03H amended effective February 27, 2017 (44:4 Md. R. 254); May 18, 2020 (47:10 Md. R. 517) In accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, this chapter: Governs permits for the sale of milk for manufacturing processes; Describes the requirement for a permit for the sale of milk for manufacturing purposes; and Regulates the inspection of manufactured grade dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products. This chapter also sets forth: Standards for milk manufacturing; The plan review process for manufactured grade dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products; The enforcement process for the examination, labeling, pasteurization, aseptic processing, retort processing, packaging, and distribution and sale of manufactured grade milk and milk products; Penalties pursuant to Health-General Article, §§21-211, 21-252—21-256, 21-418, 21-419, 21-428, 21-1202, and 21-1203, Annotated Code of Maryland; and Requirements for dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products. In this chapter, the following terms have the meanings indicated. Terms Defined. “3-A Sanitary Standards” means the standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committee representing the: American Dairy Products Institute; International Dairy Foods Association; Food Processing Suppliers Association; and International Association for Food Protection. “Agistment agreement” means the sale of shares or interest in a: Cow, goat, or other lactating hooved mammal; or Herd of cows, goats, or other lactating hooved mammals. “Approved” means meeting the criteria set forth in this chapter. “Aseptic processing and packaging” means the filling of a commercially sterilized cooled product into pre-sterilized containers, followed by aseptic hermetical sealing, with a pre-sterilized closure, in an atmosphere free of microorganisms. “Bobtailer” means a person who operates or controls a manufactured milk product route and distributes a manufactured milk product that the person buys from a distributer or manufactured milk processor. “Bulk milk hauler/sampler” means an individual who: Collects official samples; Transports raw milk from a farm, or raw milk products to or from a: Milk plant; Receiving station; or Transfer station; Possesses a permit from any state to sample milk or raw milk products; and If they are sampling raw milk in the State, possesses a Maryland Bulk Milk Hauler license. “Butter” means the food product that is made exclusively from milk or cream, or both, with or without salt, and with or without additional coloring matter, and that contains not less than 80 percent by weight of milk fat. “Certified industry dairy farm inspector” means a person who is certified by the Secretary under Health-General Article, §21-414, Annotated Code of Maryland, to perform as specified in that section. “Cheese” means the fresh or matured product that: Is obtained by draining after coagulation of milk, cream, skimmed or partly skimmed milk, or a combination of some or all of these products; and Meets the standards of identity in 21 CFR Part 133. “Commercial sterility” means the condition achieved by a treatment that renders equipment, containers, and food free of viable microorganisms that are capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution. “Dairy farm” means a place where at least one cow, goat, or other hooved mammal is kept, and from which the milk from these animals is sold or offered for sale. “Dairy plant sampler” mean a person responsible for the collection of official samples for regulatory purposes outlined in Section 6 of the Pasteurized Milk Ordinance. “Department” means the Maryland Department of Health or its designee. “Departmental inspection area” means the area in which the Department routinely makes inspections, which consists of that area within the boundaries of Maryland and any other area as may be designated by the Secretary. “Distribution station” means a place or vehicle where, for redistribution and resale, a manufactured grade milk product routinely is received, stored, or transferred. “Distributor” means a person who offers for sale a manufactured grade milk product. “Heat treated cream” means milk that has been heated during separation to temperatures greater than 52ºC (125ºF) but less than 75ºC (166ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping cream for bulk shipments. “Heat treated milk” means milk that has been heated one time during separation to temperatures greater than 52ºC (125ºF) but less than 72ºC (161ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping heat treated nonfat skim milk, reduced fat milk, or lowfat milk for bulk shipments. “Industry plant sampler” means a person employed at a milk plant, a receiving station, or a transfer station who is responsible for the collection of official samples for regulatory purposes at the milk plant, receiving station, or transfer station. “Instant nonfat dry milk” means nonfat dry milk that has been produced in such a manner as to substantially improve its dispersing and reconstitution characteristics over that produced by the conventional processes. “Manufactured grade milk” means the milk of a cow, goat, or other hooved mammal that is produced, processed, pasteurized, packaged, or prepared for human consumption in accordance with the standards set forth in this chapter. “Manufactured grade milk product” means: Butter; Cheese, natural or processed; Condensed skim milk, plain or sweetened; Condensed whole milk; Cream; Dry buttermilk; Dry whey; Dry whole milk; Evaporated milk, whole or skim; Nonfat dry milk; Quark; or Any other product made with manufactured grade milk that is regulated by the Department. “Milk” means the lacteal secretion of a cow, goat, or other hooved mammal, practically free from colostrum, obtained by the complete milking of one or more healthy hooved mammals. “Milk facility” means a: Distribution station; Milk plant; Milk processor; Milk tank truck cleaning facility; Receiving station; or Transfer station. “Milk hauler” means an individual who is in charge of a milk tank truck while it is receiving, transporting, or delivering milk or a milk product. “Milk marketing agency” means a person who negotiates the price of milk to be offered for sale and supplies milk. Milk Plant. “Milk plant” means a place where milk products are: Received and stored; Processed; Pasteurized; Packaged; or Prepared for distribution. “Milk plant” does not include a place where milk products are sold at retail only. “Milk processor” means a person who owns, operates, or controls a milk plant. “Milk producer” means a person who: Operates a dairy farm; and Provides, sells, or offers milk for sale to a: Milk plant; Receiving station; or Transfer station. “Milk product” means butter, cream, natural or processed cheese, dry milk or whey product, whole or skim evaporated milk, condensed whole milk, and plain or sweetened condensed skim milk, all of which are defined or described in this chapter, or at 21 CFR 131, 133, and 184, and any other product that may be developed and made from manufactured grade milk. “Milk tank truck” means a truck and its equipment that are used to transport milk or milk products. “Milk tank truck cleaning facility” means a place, premises, or establishment, separate from a milk plant, receiving station, or transfer station, where a milk tank truck is cleaned and sanitized. “Milk tank truck driver” means an individual who transports raw or pasteurized milk or milk products to or from a milk plant, receiving station, or transfer station and does not sample producer raw milk. “Milk transport container” means a vessel meeting 3-A Sanitary Standards or equivalent standards used by on-farm processors to transport milk from the dairy farm to the milk plant. “National Conference on Interstate Milk Shipments (NCIMS)” means a nonprofit organization made up of persons involved in the dairy industry, who make the laws governing all aspects of the milk sanitation program. Nonfat. “Nonfat” means a product contains less than 0.5 percent fat. “Nonfat” has the same meaning as skim or fat free. “Official laboratory” means a biological, chemical, or physical laboratory that is operated by the Department. “Officially designated laboratory” means a commercial laboratory authorized to conduct testing of milk and milk products on behalf of the Department or a milk industry laboratory officially designated by the Department for the examination, pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, of: Producer samples of Grade “A” raw milk for pasteurization; or Comingled milk tank truck samples of Grade “A” raw milk. “On-farm processor” means a licensed milk plant that is located on the same premises as a licensed milk producer. “Pasteurization” means the process of heating every particle of milk or milk product, in approved and properly designed equipment, by: Heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time: 63°C (145°F) for 30 minutes; 72°C (161°F) for 15 seconds; 89°C (191°F) for 1 second; 90°C (194°F) for 0.5 seconds; 94°C (201°F) for 0.1 seconds; 96°C (204°F) for 0.05 seconds; or 100°C (212°F) for 0.01 seconds; For milk or milk products with fat content of 10 percent or greater, a total solids of 18 percent or greater, or containing added sweeteners, heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time: 66°C (150°F) for 30 minutes; 75°C (166°F) for 15 seconds; or The temperatures and times listed in §B(34)(a)(iii)—(vii) of this regulation; For milk or milk products that the USDA requires a specific product pasteurization temperature for, heating the product to the temperature requirement outlined in the USDA Milk for Manufacturing Purposes and its Production and Processing, Recommend Requirements; or Utilizing another process found equivalent to pasteurization for milk and milk products, which has been recognized and approved by FDA as provided in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §343(h)(3). “Permit” means an official document with a manufactured grade classification issued by the Secretary in accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, that authorizes the holder of the permit to do an act that is within the scope of the permit. “Permittee” means a person who holds a permit as defined in this chapter. Person. “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. “Person” includes: An operator of a facility that is owned by a State or local unit of government; or A State or local unit of government if the State or local unit of government is the operator of the facility. “Raw milk” means unpasteurized milk, which includes: Heat treated nonfat skim milk; Heat treated reduced fat milk; Heat treated lowfat milk; and Heat treated cream. “Receiving station” means a place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting. “Recombined” means that a milk or a milk product is made by combining water and nonfat dry milk solids with: Cream; Butterfat; or Milk fat. “Reconstituted” means that a milk or a milk product has resulted from either: Combining dry whole milk solids with the appropriate amount of water; or Adding water to evaporated milk. “Retort processed after packaging” means that the milk or milk product, or both, have been subjected to sufficient heat processing after being packaged in a hermetically sealed container, to: Conform with applicable requirements under 21 CFR Parts 108, 113, and 117; and Maintain commercial sterility of the milk or milk products under nonrefrigerated conditions. “Sale” means a transaction that involves the: Transfer, dispensing, or serving of milk and milk products with or without charge; or Right to acquire milk and milk products: Through barter or contractual arrangement; or In exchange for another form of compensation including, but not limited to, an agistment agreement. “Sanitization” means the application of an effective method or substance to clean surfaces to destroy pathogens and other microorganisms that does not damage the surface or adversely affect the milk or milk product that may come into contact with the surface. “Seasonal milk producer” means a milk producer that holds a permit to produce milk seasonally and stops producing milk for 30 days or more and then starts producing milk again within 12 months year after year. “Secretary” means the Secretary of Health or the Secretary’s designee. “Sell” means to offer for sale. Skim. “Skim” means a product contains less than 0.5 percent fat. “Skim” has the same meaning as nonfat or fat free. “Transfer station” means a place, premises, or establishment where milk or milk products are transferred directly from one milk tank truck to another. “Whey” means the liquid substance obtained by separating the coagulum from milk, cream, or nonfat milk in cheese making that meets the requirements of 21 CFR §184.1979. In this chapter the following documents are incorporated by reference: Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§321—350f, as amended; Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended; Bulk Milk Hauler/Sampler Manual, 2016 (Center for Milk & Dairy Product Safety, Office of Food Protection, Maryland Department of Health), which has been incorporated by reference in COMAR 10.15.06.03; Maryland Laboratory Evaluation Program Manual, 2017 (Center for Milk and Dairy Product Safety, Office of Food Protection, Maryland Department of Health); 21 CFR Parts 100—101, as amended; 21 CFR Part 117; 21 CFR Parts 130—133, as amended; 21 CFR Parts 170—189, as amended; FDA Food Safety Modernization Act, 21 U.S.C <S2?2201—2252, as amended; Evaluation of Milk Laboratories, 2015 Revision (Food and Drug Administration and the National Conference on Interstate Milk Shipments, U.S. Department of Health and Human Services); Grade “A” Pasteurized Milk Ordinance, 2017 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), only: Section 5. Inspection of Dairy Farms and Milk Plants; Section 6. The Examination of Milk and/or Milk Products; Standards for Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging, all Items except for Item 9r. Administrative Procedures 1.a.; Standards for Grade “A” Pasteurized, Ultra-Pasteurized, Aseptically Processed and Packaged Low-Acid Milk and/or Milk Products, and Retort Processed after Packaged Low-Acid Milk and/or Milk Products, all Items except for Item 10p. Administrative Procedures 2.a., Item 11p. Administrative Procedures 2.a. and 6., Item 18p., and Item 19p.; Section 8. Animal Health; Section 12. Plans for Construction and Reconstruction; Section 13. Personnel Health; Section 14. Procedure when Infection or High Risk of Infection is Discovered; Section 15. Enforcement; Section 18. Separability Clause; Appendix A. Animal Disease Control; Appendix B. Milk Sampling, Hauling, and Transportation; Appendix C. Dairy Farm Construction Standards and Milk Production; Appendix D. Standards for Water Sources; Appendix E. Examples of 3-out-of-5 Compliance Enforcement Procedures; Appendix F. Cleaning and Sanitization; Appendix G. Chemical and Bacteriological Tests; Appendix H. Pasteurization Equipment and Procedures and Other Equipment; Appendix I. Pasteurization Equipment and Controls — Tests; Appendix K. HACCP Program; Appendix L. Applicable Regulations, Standards of Identity for Milk and Milk Products, The Federal Food, Drug, and Cosmetic Act, and the Federal Insecticide, Fungicide, and Rodenticide Act; Appendix M. Reports and Records; Appendix N. Drug Residue Testing and Farm Surveillance; Appendix O. Vitamin Fortification of Fluid Milk Products; Appendix Q. Operation of Automatic Milking Installations for the Production of Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging; Appendix R. Determination of Time/Temperature Control for Safety Milk and/or Milk Products; and Appendix S. Aseptic Processing and Packaging Program and Retort Processed after Packaging Program; Milk for Manufacturing Purposes and its Production and Processing, Recommended Requirements, Effective July 21, 2011 (United States Department of Agriculture, Agricultural Marketing Service, Dairy Programs), only: Subpart C, Sec. C12(a)(2)(ii) and C12(a)(3)(ii); Subpart E, Sec. E1, E 1.4(a)—(e); Subpart E, Sec. E1, E 1.15; Subpart E, Sec. E1, E 1.16; Subpart E, Sec. E 2, except for E 2.2.5, E 2.4.2, E 2.4.8, and E 2.4.9; Subpart E, Sec. E 3; Subpart E, Sec. E 4, except for E 4.3.2; and Subpart E, Sec. E 6; and Standard Methods for the Examination of Dairy Products (American Public Health Association, Seventeenth Edition, 2004). The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth in and in compliance with the standards, requirements, and procedures specified at: Health-General Article, Title 21, Annotated Code of Maryland; Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§321—350f; Nutrition Labeling and Education Act of 1990 (Public Law 101-535); Bulk Milk Hauler/Sampler Manual; Maryland Laboratory Evaluation Program Manual; Grade “A” Pasteurized Milk Ordinance, only: Sections 5.—6.; Standards for Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging, all Items except for Item 9r. Administrative Procedures 1.a.; Standards for Grade “A” Pasteurized, Ultra-Pasteurized, Aseptically Processed and Packaged Low-Acid Milk and/or Milk Products, and Retort Processed after Packaged Low-Acid Milk and/or Milk Products, all Items except for Item 10p. Administrative Procedures 2.a., Item 11p. Administrative Procedures 2.a. and 6., Item 18p., and Item 19p.; Section 8.; Sections 12.—15.; Section 18.; Appendices A.—I.; Appendices K.—O.; and Appendices R.—S.; Milk for Manufacturing Purposes and its Production and Processing, Recommended Requirements, only: Subpart C, Sec. C12(a)(2)(ii) and C12(a)(3)(ii); Subpart E, Sec. E1, E 1.4(a)—(e); Subpart E, Sec. E1, E 1.15; Subpart E, Sec. E1, E 1.16; Subpart E, Sec. E 2, except for E 2.2.5, E 2.4.2, E 2.4.8, and E 2.4.9; Subpart E, Sec. E 3; Subpart E, Sec. E 4, except for E 4.3.2; and Subpart E, Sec. E 6; and Beginning January 1, 2019, FDA Food Safety Modernization Act, 21 U.S.C. §§2201—2252, as amended. A person engaged in an occupation involving manufactured grade milk and milk products shall conduct all activities as set forth in and in compliance with the standards, requirements, and procedures specified in §A of this regulation. Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, to the Department before that person may: Be a: Bobtailer; Bulk milk hauler/sampler; Certified industry dairy farm inspector; Milk processor; Milk producer; or Seasonal milk producer; or Operate a: Distribution station; Milk tank truck cleaning facility; Milk transportation company; Receiving station; or Transfer station. Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17 for a milk tank truck. Decals. When issued a permit, a permittee shall supply and display a decal. The permittee’s decal shall display the following at a height of at least 3 inches: The milk tank truck Maryland permit number; and The words “MD Milk Trans.” in a circle around the permit number. The permittee’s decal shall be displayed on the rear tank of each milk tank truck. Under Health-General Article, §21-410(c), Annotated Code of Maryland, a permit is not required for: A milk producer who is outside the departmental inspection area if the raw milk from that milk producer is processed by a milk processor who holds a permit issued under this chapter; A bulk milk hauler/sampler who receives raw milk from outside the departmental inspection area; A grocery store, restaurant, soda fountain, or similar establishment where milk products are served or sold at retail if: The establishment complies with all applicable provisions of Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, and all applicable rules or regulations; and The milk product is received from a permittee; or An individual who only transports milk in a sealed tanker to a milk plant. Except as otherwise provided in Health-General Article, §§21-410 and 21-411, Annotated Code of Maryland, a person shall obtain a permit from the Secretary before that person may: Bring, send, or receive a milk product into the State for sale; Offer a milk product for sale; Give away a milk product; Store a milk product; Transport a milk product; or Collect official milk samples. Per Health-General Article, §§21-411, 21-412 and 21-417, Annotated Code of Maryland, an applicant for a permit shall: Submit a complete application to the Secretary for each place of operation on the form that the Secretary provides; Pay to the Secretary an annual fee established by the Secretary under Health-General Article, §2-104, Annotated Code of Maryland, and COMAR 10.01.17; and Be an employee of a milk transportation company, if applying for a Maryland Bulk Milk Hauler license, or be an owner of a milk transportation company, if applying for a Milk Transportation Company permit. The Secretary shall issue a permit to an applicant who: Submits a complete application; and Meets the requirements of this chapter for each place of operation. A permit issued by the Secretary: Is not transferable; and Is not valid if there is a change of owner, corporation, partnership, or physical location. A bulk milk hauler/sampler who holds a permit in another state and picks up and samples raw milk at fewer than three Maryland farms shall obtain a Maryland milk hauler/sampler permit by providing: Documentation of a current bulk hauler/sampler permit from the licensing state, which clearly states the permit expiration date; Documentation of a current field evaluation from the licensing state; and A statement concerning the number of Maryland dairy farms from which the bulk milk hauler/sampler will pick up. A bulk milk hauler/sampler who holds a permit from another state may pick up and sample raw milk from no more than three Maryland farms without a Maryland field evaluation or written exam. If a bulk milk hauler/sampler who holds a permit from another state routinely picks up and samples raw milk at three or more Maryland farms, a Maryland field evaluation shall be conducted. Under Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell or give away raw milk for human consumption. A permitted milk producer may sell raw milk from the milk producer’s dairy farm only to a permitted: Receiving station; Transfer station; Milk plant; or Milk marketing agency. The individual in charge of an official laboratory or officially designated laboratory shall ensure that: The laboratory is operated according to the requirements established by the Maryland Laboratory Evaluation Program Manual; and Testing required for raw milk for pasteurization, pasteurized milk products, and dairy product containers and lids is performed according to the requirements established by the Maryland Laboratory Evaluation Program Manual. A permittee shall ensure that all raw milk for pasteurization and all pasteurized milk and milk products conform to the standards and requirements established by: The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f; The Nutrition Labeling and Education Act of 1990 (Public Law 101-535); Health-General Article, §§21-422 and 21-434, Annotated Code of Maryland; 21 CFR Parts 100—101 Food for Human Consumption, General and Food Labeling; 21 CFR Parts 131—133 Milk and Cream, Cheeses and Related Cheese Products; and The standards in the following table: Under the standards set forth in Section 5 of the Grade “A” Pasteurized Milk Ordinance, the Secretary shall inspect a: Milk plant; Milk producer; Milk tank truck; Milk tank truck cleaning facility; Receiving station; Seasonal milk producer; and Transfer station. The Secretary shall inspect a distribution station at least once every 6 months. The Secretary shall inspect a bobtailer at least once every 12 months. The Secretary shall inspect a seasonal milk producer before the first shipment of milk and at least every 6 months until milk production for sale has ceased. Under the standards set forth in Health-General Article, §21-809, Annotated Code of Maryland, and the Grade “A” Pasteurized Milk Ordinance Item 16p.(D)2, the Secretary shall perform equipment tests and examinations at least once every 3 months. The Secretary shall inspect a milk plant without a pasteurizer at least once every 6 months. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B, the Secretary shall evaluate the: Ability of the certified industry dairy farm inspector to perform dairy farm inspections and raw milk sampling; Pick-up and sampling procedures that a bulk milk hauler/sampler performs; and Sampling procedures of the industry plant sampler. The Secretary shall inspect and evaluate the bulk milk hauler/sampler as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B, Sections I through III. The Secretary shall inspect each milk tank truck as set forth in the Grade “A” Pasteurized Milk Ordinance, Appendix B, Section IV. Under the standards set forth in the Maryland Laboratory Evaluation Program Manual, Evaluation of Milk Laboratories, Standard Methods for the Examination of Dairy Products, and the forms required by the Department, the Secretary shall evaluate a: Laboratory performing manufactured grade milk product testing for official use; Laboratory performing tests for drug residue screening, or tests for both drug residue screening and confirmation; and Laboratory analyst performing required testing. Reinspections. If an inspection discloses the existence of a violation of a requirement set forth in this chapter, the Secretary shall re-inspect within 30 days, but not before 3 days, to determine compliance with the requirements of Regulation .13 of this chapter. If the Secretary finds on the second inspection a violation of the same requirement in this chapter, the Secretary shall issue a notice of intent to suspend the permit. If the Secretary finds a violation of the same requirement as specified on the notice of intent to suspend the permit on an inspection following the date of compliance as specified in the notice of intent to suspend the permit, the Secretary shall suspend the permit in accordance with Regulation .21 of this chapter and Health-General Article, §§21-418 and 21-419, Annotated Code of Maryland, or initiate appropriate court action. Inspection Reports. The Secretary shall: Give one copy of the inspection report to the permittee or other responsible individual; or Post the inspection report in a conspicuous place on an inside wall of the establishment immediately after the conclusion of the inspection. The permittee may not deface the inspection report and shall make the inspection report available to the Department upon request. The Secretary shall keep a copy of the inspection report on file for 3 years. Access Required. Upon request of the Secretary, a milk producer, milk hauler, distributor, milk processor, receiving station operator, transfer station operator, or bobtailer shall permit the Secretary access to all parts of the milk establishment, facility, or transporting vehicle to determine compliance with the provisions of this chapter and Health-General Article, Title 21, Subtitles 2 and 4, Annotated Code of Maryland. Information Required. Upon request, a milk producer, milk hauler, distributor, milk processor, receiving station operator, transfer station operator, or bobtailer shall furnish the Secretary: A statement of quantities of milk and milk product of each grade purchased and sold; A list of all sources of this milk and milk product; and Records of inspections, tests, and pasteurization times and temperatures. The following individuals may collect official samples: A dairy plant sampler; An industry plant sampler; A bulk milk hauler/sampler; and A certified Industry Dairy Farm Inspector. An individual collecting official milk samples shall collect samples in accordance with the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix B. The Secretary shall evaluate the sampling and examination procedures of manufactured grade milk and milk products to ensure that the sampling and examination procedures are conducted according to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix B. Can milk shall be sampled and analyzed in accordance with Milk for Manufacturing Purpose and Processing, Section C12(2)(ii) and C12(3)(ii). Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Item 7p. Administrative Procedures, and Appendix D, the Secretary shall conduct bacteriological testing of individual water supplies: Upon initial approval of the physical structure; Every 6 months after initial approval; and When a repair or alteration of the water supply system has been made. The Secretary shall record and retain for at least 5 years all sample analysis results required under this regulation. A bulk milk hauler/sampler shall: Carry a bulk milk hauler’s permit when operating a milk tank truck, except when a raw milk producer is hauling raw milk from the producer’s farm only to the milk processing plant; Ensure that no interval greater than 2 hours elapses between milk pick-ups from farm to farm, and no more than 24 hours elapses from the first pick-up to delivery of the raw milk to the processing plant; Ensure bulk raw milk is picked up from every dairy farm at least every 3 days; Ensure bulk raw milk is delivered or received by the processor or receiving station within 84 hours of the initial milking; Ensure the temperature of the bulk raw milk does not exceed 50°F; Ensure operations are in accordance with the Bulk Milk Hauler/Sampler Manual; and In accordance with Standard Methods for the Examination of Dairy Products, 3.042, A, ensure proper agitation of the farm bulk tank raw milk. A person may not transfer milk or milk products from a milk transport container or milk tank truck to another container or milk tank truck unless the transfer occurs: From a bulk milk tank to another permitted bulk milk tank truck on the dairy farm where the milk is produced; In a receiving station; In a transfer station; or In a milk plant. Vehicles used for the transportation of can milk or cream shall be enclosed and constructed to protect the product from extreme temperature, dust, or other adverse conditions. Stainless steel cans used in transporting milk from the dairy farm to a milk facility shall be constructed according to 3-A Sanitary Standards. Milk transport containers used in transporting milk from the dairy farm to a milk facility shall be approved by the Secretary. Vehicles used for the transportation of milk from the dairy farms to a milk facility may not be used for any other purpose. Vehicles used for the transportation of milk shall be equipped with decking boards or racks when more than one tier of milk containers are carried. The milk tank truck driver shall take responsibility for any official samples that may accompany the milk tank truck. Under Health-General Article, §21-428, Annotated Code of Maryland, the Secretary shall impound improperly handled milk or milk products that are intended for human consumption. After impounding the milk or milk product, the Secretary may issue an order requiring one or more of the following actions: Disposing of the milk or milk product; Making the milk or milk product unusable for consumption; or Under Health-General Article, §21-428, Annotated Code of Maryland, imposing a civil monetary penalty, as set forth in §C of this regulation. The Secretary shall determine the amount of the civil monetary penalty by multiplying the current milk price, as announced by the Federal Milk Market Administrator, on the date of the impounding by the volume of the milk listed on the shipping documents. A person subject to an impoundment order may seek legal recourse as set forth in Health-General Article, §21-428, Annotated Code of Maryland, by: Appealing a civil penalty; or Bringing an action for damages. A permittee shall ensure that milk product labels conform to the standards and requirements established by: The Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §§341—350f; The Nutrition Labeling and Education Act of 1990 (Public Law 101-535); 21 CFR Parts 101, 130, 131, 133, and 170§189; The Grade “A” Pasteurized Milk Ordinance Section 4; and Health-General Article, §§21-422, 21-424, and 21-425, Annotated Code of Maryland. A milk processor shall conspicuously mark each package containing manufactured milk products with: The name of the product; The name of the manufacturer; The address of the manufacturer: If listed in the local phone book, the address may consist of the city and state; If not listed in the local phone book, the street address shall be included; Each ingredient in order of predominance; The net weight of the product in English and metric units; The batch identification of the product; Required nutritional information; If the product is made by reconstitution or recombination, the word “reconstituted” or “recombined” as applicable; If the product is or is made from milk from a hooved mammal other than cattle, the common name of the hooved mammal producing the milk preceding the name of the milk or milk product; In the case of condensed or dry milk products, if distributed by another party, the name and address of the distributor shown by a statement such as “Distributed by”; and The word “Heat-Treated” for heat-treated milk and milk products. A milk producer shall label all cans of raw milk from the producer’s dairy farm with the milk producer’s name or permit number. All raw milk and milk products produced, processed, packaged, and stored under this chapter shall meet the Animal Health requirements as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 8. Pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 12, for construction, reconstruction, or extensive alteration of a dairy farm, a person shall submit to the Department: A plan and specifications before: Constructing or reconstructing a: Milk house; Milking barn; Milking stable; or Milking parlor; Converting or remodeling an existing building or structure for use as a: Milk house; Milking barn; Milking stable; or Milking parlor; or Adding, modifying, or replacing: A bulk milk tank; An entire milking system; Any part of a milking system; A washing system; Any part of a washing system; or A cooling system, including a plate cooler or bulk tank cooling system; A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work; Contact information for the dairy farm, including: The full name, title, and telephone number of each applicant; The name of the dairy farm; The mailing address; The location; and Directions to the site; A site drawing showing: The location of: The milk house; The milking barn; The milking stable; The milking parlor; and Each animal housing area; and Approximate distances in feet from the locations in §D(1) of this regulation, to: Cow yards; Ditches; Frost free style watering hydrants; Manure pits; Septic systems; Silos; Streams; and Wells or other approved water systems; A detailed drawing: Of the interior, indicating dimensions, of: The milk house; The milking barn; The milking stable; The milking parlor; and Each animal housing area; and Showing the location of: Backflow prevention devices; Chemical dispensers; Compressors; Equipment; Floor drains; Frost free style watering hydrants; Hose bibs; Lighting; Pre-coolers; Toilets; Washing systems; and Watering troughs; For pipeline and milking system installations: The make, model number, quantity, and specifications of milking equipment including pipeline and milking units; The make and model number of pumps used in the milking system, including specifications such as horsepower and cubic feet per minute; A drawing of the parlor or barn showing the location of: Milking equipment; Pipelines, including size and length of the piping; Wash lines, including size and length of each wash line; Receivers, if applicable; Pre-coolers, if applicable; Any other milk equipment; and The milk house, bulk tank, and animal housing area in relation to the milking parlor or milking barn; A description and diagram of the location of the backflow protection methods or devices that will be installed to protect the: Potable water supply on all plate coolers; Chemical pumps: Water lines; and Other fixtures; The type, such as gas or electric, and capacity of the hot water heating system; and Information and specifications for booster or supplemental heating systems, if utilized; and For bulk tank or milk cooling systems installation: A drawing of the milk house with bulk tank location, floor drain locations, and clearance dimensions on both sides, in front, and above the manhole of the bulk tank; If part of a new installation, specific floor, wall, and ceiling finishes; Bulk tank specifications and cooling system specifications, including: Make; Model number; and Capacity; and Pre-cooler type and British thermal units capability, if applicable. The inspection area for a dairy farm includes the: Adjacent storage areas; Cow yard and cattle housing areas; Milk house; Milking barn, stable, or parlor; Surrounding area; Waste disposal areas; and Water supply and its distribution system. A milk producer shall ensure that: Construction of all equipment, milking barns, stables, parlors, milk houses, and each animal housing area complies with the requirements of the Grade “A” Pasteurized Milk Ordinance and Regulation .15 of this chapter, as applicable; Water used at a dairy farm: Be obtained from a water supply system that complies with: Environment Article, Title 9, Annotated Code of Maryland; COMAR 26.04.04.; and The Grade “A” Pasteurized Milk Ordinance; Be installed in a manner that prevents backflow or back-siphoning; Be separate from a nonpotable water supply system so that nonpotable water cannot be drawn or discharged into the potable water supply system; Provide hot and cold running water in areas where milk processing equipment is washed; and Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system; Hand sinks have: Either: Hot and cold running water under pressure; or Warm running water; A supply of hand-cleaning soap or detergent; and A sanitary means of drying hands, such as individual towels or a hand-drying device; A sewage system is constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance; Toilet facilities are constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance; Plumbing is sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and Electrical systems and lighting requirements comply with State and local electrical laws, ordinances, and regulations, and the Grade “A” Pasteurized Milk Ordinance. Pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 12 for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department: A plan and specifications before: Constructing, reconstructing, or extensively altering a milk facility; Converting or remodeling an existing building or structure for use as a milk facility; Adding, replacing, relocating, or modifying a milk facility process; or Adding, modifying, or replacing a clean-in-place (CIP) or other washing system or any part of a clean-in-place or other washing system; Plans and drawings bearing the name of a professional engineer or a representative of the company performing the work; Contact information for the facility, including: The full name, title, and telephone number of each applicant; The name of the plant; The mailing address; The location; and Directions to the site; A narrative describing the scope and purpose of the project, including a projected timeline from start to completion; An estimate of finished product output per day; Sample product labels for each product; A list of: All products to be produced; Raw cream and nonfat, condensed, or any other milk or milk products to be sold; and Single service container sources; A scale drawing showing the layout and arrangement of areas within and around the milk facility, including areas for: Processing; Chemical storage; Dry storage; Ingredient and product storage; Receiving; Load out; Laboratories; Offices; Restroom facilities; Lockers or a facility for the storage of personal items; and Employees to eat and drink beverages; A scale drawing showing the location of all equipment, including: Pasteurizers and sterile systems; Milk processing equipment; Fillers; Raw and pasteurized tanks and silos; Clean-in-place (CIP) systems; Glycol water tanks; Recirculating cooling water tanks; Boilers; Boiler makeup tanks; Culinary steam systems; and Blow mold systems; A scale drawing showing the location of plumbing and plumbing fixtures, including: Water lines; Sewer lines; Hand sinks; Toilets; Utility sinks; Utensil washing sinks; Floor drains; Floor sinks; Hose stations; and All backflow prevention devices; A legend for each drawing; Specifications for: Ventilation including, but not limited to, the type and location of: An air filter; An air pump; and A compressor; Construction materials for the building and interior finishes; and Pasteurizer plate coolers, if separate from the pasteurization system; A list and description of all boiler, glycol, and recirculating water additives and water treatment; A description of the: Type of disposal for wastewater and sewage; Source and system for the facility’s potable water supply; Lighting fixtures and placement; and Recirculating cooling system; Specification sheets, including manufacturer and model number of all milk facility equipment; A document that lists the flow for all products through the plant, grouped in categories, identifying each functional piece of equipment and each process used in processing and packaging, including: Reclamation systems; Standardization procedures or formulation procedures, or both; Vitamin addition protocol; and Draining of product lines; Plans, specifications, drawings, and flow diagrams for each high temperature short time (HTST) and higher heat short time (HHST) system, showing each functional component; Clean-in-place (CIP) flow diagrams from the makeup tanks through all equipment; If applicable, information and drawings on how separation from product lines will be accomplished; Written step-by-step standard operating procedures (SOPs and SSOPs) for the following, if not included in §W of this regulation: Receiving, processing, storing, and packaging of each product; Drug residue testing; Cleaning and sanitization for all equipment; Cleaning and sanitization for the facility; and Product trace back, inclusive of production/make sheet; A pest control program; Employee training and personal hygiene practices; and A food safety plan that complies with 21 CFR Part 117 and at a minimum includes: A written hazard analysis; Written preventive controls that address: Process preventive controls; Food allergens; Sanitation; Supply-chain controls; A product recall plan; and Other hazards identified in the hazard analysis as requiring a preventive control; Written procedures for monitoring the implementation of the preventive controls as appropriate to the nature of the preventative control and its role in the facility’s food safety system; Written corrective action procedures as appropriate to the nature of the hazard and the nature of the preventive control; and Written verification procedures as appropriate to the nature of the preventative control and its role in the facility’s food safety system. Water used at the facility shall: Be obtained from a potable water supply system that complies with: Environment Article, Title 9, Annotated Code of Maryland; COMAR 26.04.04; and The Grade “A” Pasteurized Milk Ordinance; Be installed in a manner that prevents backflow or back-siphoning; Be separate from a nonpotable water supply system so that nonpotable water can be drawn or discharged into the potable water supply system; Provide hot and cold running water in areas where milk processing equipment is washed; and Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system. Hand sinks shall have: Either: Hot and cold running water under pressure; or Warm running water; A supply of hand-cleaning soap or detergent; and A sanitary means of drying hands, such as individual towels or a hand-drying device. A sewage system shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance. Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations. Toilet facilities shall: Be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance; For a milk plant that is not an on-farm processor, be available within the physical plant for use by employees; and For a milk plant that is an on-farm processor, if not located within the physical plant building: Be located within 500 feet of the physical plant building; Be accessible at all times that the plant is in operation; Have documented and implemented measures for re-entry into the plant to protect against facility and product contamination; and Have documentation from the local approval authority that an on-site sewage disposal system, if present, is adequate for the total number of users and meets all other requirements of 26.04.02. All electrical systems at the facility shall: Comply with State and local electrical laws, ordinances, and regulations; Provide adequate lighting sources that furnish at least 40 foot-candles of light in all working areas in all rooms where: Milk or milk products are handled, processed, packaged, or stored; or Containers, utensils, and equipment are washed; and Provide adequate lighting sources that furnish at least 20 foot-candles of light in dry storage and cold storage rooms. An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department. An applicant for a permit shall submit a plan to the Department that includes the requirements set forth in: Regulations .15 and .16 of this chapter for a dairy farm permit; or Regulations .17 and .18 of this chapter for a milk facilities permit. The Department shall: Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .15, .16, .17, and .18 of this chapter; and Inform the applicant: That the plan has been received; If additional information is required to complete the plan review; Whether the plan is approved or denied; and Of the appeals process if the plan is denied. The Department shall maintain confidentiality of records submitted by a person in accordance with General Provisions Article, §4-335, Annotated Code of Maryland. When a permittee is found in violation of this chapter and the Grade “A” Pasteurized Milk Ordinance, the Secretary may suspend or revoke a permit as set forth in this regulation and Health-General Article, §§21-211, 21-418, or 21-419, Annotated Code of Maryland, or the Grade “A” Pasteurized Milk Ordinance. Except as otherwise provided in this regulation, before suspending a permit, the Secretary shall give to the permittee notice of intent to suspend as provided by Health-General Article, §21-418, Annotated Code of Maryland. The Department may suspend a permit if the permittee fails or neglects to correct a violation within the specified time period. If a permit has been suspended more than once, the Secretary may revoke the permit. The Department shall ensure that an opportunity for a hearing is provided to a person whose permit has been suspended or revoked. When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to Health-General Article, §21-418(c), and State Government Article, §10-226(c)(2), Annotated Code of Maryland, the: Department shall: Summarily suspend the permit; Order the permittee to cease operation immediately; and Promptly provide the permittee with: A written notice of the suspension of the permit; The reasons for the suspension; and An opportunity to be heard; and Permittee shall immediately cease operation upon the receipt of the summary suspension order. In accordance with the Administrative Procedures Act and Health-General Article, §21-419, Annotated Code of Maryland, the Department shall ensure that an opportunity for a hearing is provided to a permittee whose plan review or permit has been: Denied; Suspended; or Revoked. Health-General Article, §§2-104, 2-105, 21-207, 21-208, 21-210, 21-211, 21-405, 21-406, 21-428, Annotated Code of Maryland Effective date: April 10, 1995 (22:7 Md. R. 536) Regulations .01—.20 repealed and new Regulations .01—.22 adopted effective May 20, 2019 (46:10 Md. R. 488) All provisions of 21 CFR 123 and §§1240.3(r) — (u) and 1240.60 are incorporated by reference. Health-General Article, §21-234, Annotated Code of Maryland Effective date: October 6, 1997 (24:20 Md. R. 1404) In this chapter, the following terms have the meanings indicated. Terms Defined. “Approved source” has the meaning stated in Health-General Article, §21-336(a), Annotated Code of Maryland. “Approving authority” means the agency designated in the laws of another state or country to license or permit a source water, public water supply system, or bottled water plant if that source water, public water supply system, or bottled water plant is located outside the State. “Aquifer” means a formation of soil, sand, rock, gravel, limestone, sandstone, or other geologic material that contains ground water available for collection. “Artesian water” means the product that meets the standard of identity as set forth in 21 CFR §165.110(a)(2)(i). “Borehole” means a well tapped into an aquifer for the purpose of removing water from the aquifer for bottling or dispensing. Bottled Water. “Bottled water” means: Any water that is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water; and The product that meets the standards of identity set forth at 21 CFR §165.110(a). “Bottled water” does not include: Soft drinks; and A beverage labeled as club soda or seltzer water. “Bottled water plant” means a food processing plant that: Manufactures, packages, or labels bottled water; or Stores water before bottling. “Certified laboratory” means a laboratory certified by: A state's laboratory certification program in accordance with the United States Environmental Protection Agency's primacy conditions under the Agency's Public Water System Supervision Program; The National Environmental Laboratory Accreditation Program; or The United States Environmental Protection Agency. “Community water system” means a public water supply system that: Services at least 15 service connections used by year-round residents; or Regularly serves at least 25 residents throughout the year. “Contaminant” means a physical, chemical, biological, or radiological substance or matter in water. “Department” means the Maryland Department of Health or the Department's designee. “Drinking water” means water that is intended for human consumption. “Finished product water” means drinking water in the form in which it is provided to the consumer. “Ground water” means water from a subsurface saturated zone that is under a pressure equal to or greater than atmospheric pressure. “Ground water under the direct influence of surface water” means ground water with: Significant occurrence of insects and other macroorganisms, algae, or other large diameter pathogens such as Giardia lamblia or Cryptosporidium; or Significant and relatively rapid shifts in water characteristics such as turbidity, temperature, conductivity, or pH that closely correlate to climatological or surface water conditions. “Mineral water” means the product that meets the standard of identity set forth in 21 CFR §165.110(a)(2)(iii). “Person-in-charge” means a licensee or other individual responsible for the operation of a bottled water plant. Public Water Supply System. “Public water supply system” means a system providing piped water to the public for human consumption, if the system: Has at least 15 service connections; or Regularly serves an average of 25 individuals daily at least 60 days out of the year. “Public water supply system” includes a collection, treatment, storage, and distribution facility that is: Under the control of the operator of the system and used primarily in conjunction with the system; and A collection or pretreatment storage facility not under the control of the operator of the system that is used primarily in connection with the system. “Public water supply system” does not include a special irrigation district. “Source water” means the water that is processed into finished product water. “Spring” means a source of water issuing naturally from the ground, a rock formation, or a fracture onto the land or into a body of water. “Spring water” means the product that meets the standard of identity set forth in 21 CFR §165.110(a)(2)(vi). “Statement of acceptability” means the approval issued by the approving authority in a state or country in which the water is collected that demonstrates that a source water quality and a method of handling the water pose no threat to the public health. “Type of water” means a product that meets one of the standards of identity set forth in 21 CFR §165.110(a)(2). “Waiver of filtration and disinfection” means written approval from the Department that allows a person to bottle water without filtering and disinfecting the water to exclude and kill microorganisms. “Well” means a hole made in the ground to: Explore for ground water; Obtain or monitor ground water; or Inject water into an underground formation from which ground water can be produced. In this chapter, the following documents are incorporated by reference: 21 CFR Part 129, as amended; 21 CFR §165.110, as amended; and 21 CFR §165.3, as amended. The person-in-charge shall comply with this chapter and COMAR 10.15.04 to: Process finished product water; and Design, operate, and maintain a bottled water plant and equipment. If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 regarding bottled water plants and the processing of drinking water, this chapter takes precedence. The person-in-charge shall obtain a food processing plant license to operate a bottled water plant pursuant to the provisions of: Health-General Article, §21-305, Annotated Code of Maryland; COMAR 10.15.04; and This chapter. The Department shall specify on a food processing plant license the types of bottled water product that the licensee is authorized to process, package, or label. The person-in-charge shall ensure that: A bottled water plant is not operated without the license required by Health-General Article, §21-305, Annotated Code of Maryland; The required food processing plant license is conspicuously posted in a bottled water plant; and The operations in a bottled water plant are limited to the types of water specified on the license, pursuant to §B of this regulation. A person seeking to bottle water in the State shall: Apply for an annual license in accordance with Health-General Article, §§21-305, 21-306, and 21-336, Annotated Code of Maryland; Submit to the Department: Plans and specifications for a bottled water plant in accordance with Health-General Article, §21-321, Annotated Code of Maryland; and Any applicable requirements as outlined in §§E and F of this regulation; and Pay an annual license fee as specified in COMAR 10.01.17.02. Specific Application Requirements — Initial License. A person seeking an initial license in accordance with Health-General Article, §§21-305, 21-306, and 21-336, Annotated Code of Maryland, shall submit to the Department the following specific information: A microbiological analysis of each source water completed in accordance with Regulation .06 of this chapter that is dated within 30 days of the Department's receipt of an initial license application; A chemical and radiological analysis of each source water completed in accordance with Regulation .06 of this chapter that is dated within 1 year of the Department's receipt of an initial license application; For a source water located outside the State, a statement of acceptability; and For a type of water manufactured from a source water without filtration or disinfection, a request for a waiver of filtration and disinfection that includes: Analyses of the source water covering a period of at least 3 years that indicate compliance with Regulation .06 of this chapter; Detailed information on methods to protect the source water; The procedures and process for bottling the source water in a sanitary manner; A hydrogeological survey with an assessment conducted by a hydrogeologist, professional engineer, or the approving authority that determines that the source of water is not under the direct influence of surface water and meets the requirements set forth in this chapter; A sanitary survey conducted by a hydrogeologist, professional engineer, or the approving authority that documents an evaluation of the drainage area, reservoir, and transmission and storage facilities for the source water and identifies and determines the significance of probable sources of contamination; and A statement that the bottler will notify the Department not later than 5 days from the date of any change in conditions under which the waiver was granted. Specific Application Requirements — Renewal Application. A person seeking to renew a license in accordance with Health-General Article, §§21-305, 21-306, and 21-336, Annotated Code of Maryland, shall submit to the Department: A microbiological analysis of each source water and type of water in accordance with Regulation .06 of this chapter that is dated within 30 days of the Department's receipt of a license renewal application; A chemical analysis of each source water and type of water completed in accordance with Regulation .06 of this chapter that is dated within 1 year of the Department's receipt of the license renewal application; A radiological analysis of each source water and type of water completed in accordance with Regulation .06 of this chapter that is dated within 4 years of the Department's receipt of the license renewal application; For a source water located outside the State, a statement of acceptability; and If the renewal application includes a waiver of filtration and disinfection previously approved by the Department, a letter of compliance to the Department certifying under personal knowledge and penalty of perjury that the conditions on which the waiver was granted have not changed. After receiving an initial license and before selling or distributing finished product water, the person-in-charge shall: Have a microbiological, chemical, and radiological analysis of each type of water completed in accordance with Regulation .06 of this chapter; Ensure that each type of water meets the water quality standards in Regulation .06 of this chapter; and Submit the analyses to the Department. The Department shall deny an application for a license if the applicant: Does not meet the requirements of, or a regulation promulgated under, Health-General Article, Title 21, Subtitles 1 — 3, Annotated Code of Maryland; Fraudulently or deceptively attempts to obtain a license; or Has not demonstrated that each type of water: Is from an approved source; Meets the water quality standards in Regulation .06A of this chapter; and Is not injurious to the public health. The Department may suspend or revoke a license if the licensee: Violates or fails to meet the requirements of, or a regulation adopted under, Health-General Article, Title 21, Subtitles 1— 3, Annotated Code of Maryland; or Fraudulently or deceptively obtains a license. The person-in-charge shall ensure that: A source of water for finished product water is an approved source; Within the State, a ground water appropriation permit is obtained from the Maryland Department of the Environment as required in COMAR 26.17.06; and A spring is constructed, developed, or improved in accordance with §B of this regulation. Spring Requirements. The person-in-charge shall ensure that: A spring is constructed, developed, or improved in accordance with the following requirements: A fissure or opening in the geologic formation from which the water flows into the spring is: Enclosed within an encasement of concrete, tile, steel, or another impervious material; or Otherwise tapped in a manner that ensures the capture of only ground water flowing from the geologic formation; The walls of a spring encasement penetrate the geologic formation from which the water flows to intercept and contain ground water; A spring encasement is provided a cover; The material used in the construction or improvement of the spring does not impart a toxic or deleterious substance to the water; A fence or other physical barrier is used to exclude animals and unauthorized persons from the area within 100 feet of the spring; Water in the spring is transported to the point of bottling or into bulk storage by: Gravity; or When pumping is required, first flowing by gravity to a separate holding reservoir from which it is extracted and delivered to the point of bottling by use of a pump; A spring is protected from direct surface water intrusion and other sources of contamination; and A spring does not contain ground water under the direct influence of surface water; A spring is constructed, developed, or improved in accordance with a plan made by a registered professional engineer or professionally qualified hydrogeologist that: Contains a hydrogeological study and a sanitary survey as set forth in Regulation .04E(4)(d) and (e) of this chapter; and Is approved by the approving authority or the Department; and A borehole used to obtain spring water: Is hydraulically connected to an aquifer that supplies a constantly flowing spring; Contains only water that has all the physical properties before treatment as the water that flows naturally to the surface of the earth or into a body of water; Is shown to comply with §B(1)(g) and (h) of this regulation by a hydrogeological study submitted to the Department; and Is constructed in compliance with §B(2) of this regulation. The person-in-charge shall ensure that: A well within the State that is used as a source of finished product water is permitted, constructed, and installed in conformance with COMAR 26.04.04; When bottling artesian water, a hydrogeological report is kept at the plant that shows that the static water level in the well is at some height above the aquifer; When ground water is a source of finished product water, the ground water is not under the direct influence of surface water; A statement of acceptability for a source of water is kept on file at the plant and available for inspection by the Department; and A public water supply system in the State that is used as a source of finished product water is a community water system that complies with COMAR 26.04.01. The person-in-charge shall ensure that: Except as provided in §B(4) of this regulation, contaminant levels in source water and finished product water do not exceed the maximum allowable concentration for contaminants set forth in 21 CFR §165.110(b); Except as provided in §A(8) of this regulation, the analyses for all contaminants in source water and finished product water are performed by a certified laboratory using a representative sample and methods set forth in 21 CFR §§165.110(b) and 165.3; Except as provided in §B of this regulation, a representative sample of source water and finished product water is taken and tested for: Microbiological contaminants at least once per week; Chemical contaminants at least once per year; and Radiological contaminants at least once every 4 years; The analyses results for sampling required in §A(3) of this regulation are submitted to the Department: At the time of application for a license pursuant to Regulation .04E(1), (2), (4)(a), F(1) — (3), and G(1) of this chapter; Upon request within 10 days for microbiological contaminants; and Except as provided in §B of this regulation, upon request within 30 days for chemical and every 4 years for radiological contaminants; When a sample is positive for total coliforms: The total coliforms positive culture medium is analyzed to determine if fecal coliforms are present, except that Escherichia coli may be tested for in lieu of fecal coliforms; and A resample is taken and submitted for testing within 24 hours; Except as provided in §B(4) of this regulation, source water that does not meet the water quality standards in §A of this regulation is not bottled or processed as drinking water; Finished product water that does not meet the water quality standards in §A of this regulation is not offered for human consumption; A representative sample of source water and drinking water for testing is: Taken at a location and time that makes the test results indicative of the quality of the source water or drinking water; Of sufficient volume to allow testing; and At least 100 milliliters in volume for microbiological testing, regardless of analytical method; A source water is sampled and tested before any treatment or filtration of the source water; Drinking water and source water that are not filtered or disinfected during processing do not contain coliform bacteria; The microbiological contaminants in source water that is filtered or disinfected during processing do not include: Coliform in excess of 36 most probable number of organisms per 100 milliliters; Fecal coliform; Escherichia coli; and Organisms that by number or type indicate the direct influence of or contamination by surface water; and The contaminant concentration of trihalomethanes in bottled water does not exceed 10 parts per billion. Exceptions. If a source water is from a public water supply system in the State or outside the State, the person-in-charge may use public water supply system analyses results or a certificate from the Maryland Department of the Environment or the approving authority to demonstrate compliance with the water quality standards for source water set forth in §A of this regulation. The Department may waive the requirement for a weekly microbiological analysis of source water that is from a public water supply system in the State or outside the State, if public water supply system analyses results or a certificate from the Maryland Department of the Environment or the approving authority demonstrates compliance with the water quality standards set forth in §A of this regulation. Mineral water is exempt from the maximum allowable concentration of chloride, iron, manganese, total dissolved solids, and zinc as provided in 21 CFR §165.110(b)(4)(i)(A). Except for a microbiological contaminant, the Department may approve a source water that contains a contaminant at a level that exceeds the maximum allowable concentration for finished product water based on a review that demonstrates that a treatment of the source water is: Effective in reducing the contaminant level in the finished product water below the maximum allowable concentration; and Interlocked with the bottling system so that: Failure in the treatment inactivates the bottling system; and Water is prevented from being bottled. Except for a microbiological contaminant, a person may not process or bottle water from a source water that contains a contaminant at a level that exceeds the maximum allowable concentration for a finished product water, as set forth in §A of this regulation, without written approval from the Department. The person-in-charge shall: Maintain at the plant: While processing or bottling a source water as set forth in §§B(4) and C of this regulation, the Department's written approval; and A record of the required water sampling and analytical results for at least 2 years; and Make the records available for inspection by the Department. The person-in-charge shall ensure that: The equipment and facilities needed to store, convey, transport, and bottle drinking water and wash and sanitize bottled water containers and bottling equipment and utensils in accordance with this chapter are provided and maintained in a sanitary condition; The water supplied to a fixture is potable and meets the requirements in COMAR 26.04.01; The sewage disposal system for the plant: Meets all applicable State and local codes; and Properly disposes of all wastewater; Toilet rooms: Are separate for men and women; Are provided at the rate of one toilet for every 15 employees; and Do not open directly into an area in which: Source water or finished product water is handled, processed, or held; and Containers, utensils, or pieces of equipment are washed or held; A bottling room: Is separated from other plant operations and storage areas by: Tight fitting walls; Ceilings; and Self closing doors; Has conveyor openings only large enough to allow passage of containers; Is mechanically ventilated using exhaust and supply air fans so that: Filtered air is supplied to provide a positive air pressure in the room; and Condensation does not accumulate on room surfaces and equipment; Has a floor sloped to floor drains; Has a floor, walls, and a ceiling that are: Smooth; Easily cleanable; and Impervious to water; Has a hand sink: In the room; or Directly adjacent to the room; and Has lighting that provides a minimum of 40 foot candles on all work surfaces; A bottle washing room, if present: Meets the requirements in §E of this regulation; and Is situated in the plant and has equipment located within the room to minimize postsanitizing contamination of the containers before the containers enter the bottling room; Clean and uncapped containers are protected from overhead contamination before and after filling with water by: Conveyor covers that meet the design specifications in Regulation .08 of this chapter; or Being held in rooms that have finished ceilings that are: Smooth; Easily cleanable; and Free of filth and condensation; and Before making a change, alteration, or addition to equipment or facilities that convey, treat, or bottle drinking water, plans for the change, alteration, or addition are submitted to and approved by the Department, in accordance with Health-General Article, §21-321, Annotated Code of Maryland. The person-in-charge shall ensure that: Equipment for processing drinking water is: Maintained in a sanitary and working condition; Provided with instrumentation to allow: Process control; and Monitoring; Monitored to verify that process requirements are met; and Durable and impervious to water; Materials used as water contact surfaces of equipment and utensils: Are nontoxic and inert to water under the conditions of use; Do not migrate to or adulterate drinking water; Are nonporous and nonabsorbent; and Are corrosion resistant; Water contact surfaces of equipment and utensils are: Designed, constructed, and maintained to be: Smooth; Easily cleanable; Free of difficult to clean internal surfaces; Self-emptying or self-draining if an interior surface; Visible for inspection or the equipment is readily disassembled for inspection; If manually cleaned: Readily accessible for cleaning without tools; or If not readily accessible, readily disassembled for cleaning with the use of simple tools kept available at the equipment; and If cleaned and sanitized by pressurized cleaning-in-place, readily accessible to the cleaning and sanitizing solutions without disassembly; and Cleaned and sanitized: In accordance with 21 CFR §129.80(c) and (d); and As often as necessary to maintain sanitary conditions and prevent the adulteration of drinking water; When pressurized clean-in-place is used: A cleaning and sanitizing solution is: Fully circulated through a fixed system to contact all interior water contact surfaces; Effective in cleaning and sanitizing water contact surfaces; Used in accordance with the chemical manufacturer's instructions; and Removed from equipment and water contact surfaces prior to drinking water for bottling or dispensing coming into contact with the equipment or water contact surface by: Rinsing the equipment or water contact surface with drinking water that is diverted to waste until the cleaning and sanitizing solutions are evacuated; or Other means to evacuate the cleaning and sanitizing solutions and prevent the adulteration of finished product water; The design, construction, and maintenance of a clean-in-place piping system prevents the contamination of drinking water by cleaning and sanitizing chemicals; and The operation of a clean-in-place system using chemicals that are potentially hazardous to public health is controlled and monitored; A record is made that: Documents the: Proper cleaning and sanitizing of: Water contact surfaces; and Filling and dispensing machines and equipment; Evacuation of cleaning and sanitizing solutions from equipment and water contact surfaces; and Inspection and maintenance of equipment associated with cleaning and sanitizing water contact surfaces; Is maintained for at least 2 years after the cleaning, sanitizing, inspection, maintenance, or monitoring activity; and Is available for inspection by the Department; and Before new or remodeled bottling equipment is used to produce finished product water, a plan for the equipment design, construction, installation, and maintenance of the equipment is submitted to and approved by the Department. The person-in-charge shall ensure that: A processing operation that involves the source, transport, storage, treatment, or bottling of drinking water is controlled to prevent a hazard; and A record is made that: Documents the type and quantity of finished product water produced; Identifies the initial distribution of the finished product water to facilitate, when necessary, the segregation of specific finished product water that may be adulterated or otherwise unfit for human consumption; Is maintained for at least 2 years after the control, observation, or monitoring is done; and Is available for inspection by the Department. The person-in-charge shall ensure that: Water stored in bulk or transported for bottling is from an approved source; A storage tank, hose, pump, and piping used for loading, transporting, and unloading water meet the requirements set forth in Regulation .08 of this chapter; A tank used to store drinking water is: Not used for storage of a nonfood product; Closed to exclude all foreign matter; Vented in a sanitary manner; and Sampled weekly and analyzed for coliform bacteria and standard plate count; The openings in a storage tank and tank truck are: Protected from contamination; Kept sealed or locked when water for bottling is not being transferred; and Not susceptible to damage or tampering; A tank truck used to transport drinking water is: Cleaned and sanitized as often as necessary to maintain a sanitary condition and at least once per week; and Provided a number or other marking on the outside of the truck; and A record is made that: Provides the following information for each batch of drinking water delivered: Name of the water hauler; Tanker truck number; Date of shipment; Name of seller; Location of the source water; and Date of delivery; Is maintained for at least 2 years after the record is made; and Is available for inspection by the Department. The person-in-charge shall ensure that: Containers are: Protected from contamination; and If multiservice, adequately cleaned, sanitized, and inspected prior to filling in accordance with 21 CFR §129.80(b)(1), (c), and (d); Container caps are: Stored in a sanitary manner; and Before use: Examined for cleanliness; and Washed, rinsed, and sanitized as necessary to prevent contamination of finished product water; and Records are made at the plant that: Document the proper cleaning and sanitization of containers; Are maintained for at least 2 years; and Are available for inspection by the Department. The person-in-charge shall ensure that: Unless a waiver of filtration and disinfection is granted by the Department in accordance with Health-General Article, §21-336.1(b), Annotated Code of Maryland, and this chapter, finished product water has undergone: Ozonation, exposure to ultraviolet light, or an equivalent disinfection process approved by the Department; and Filtration or other treatment that is necessary for the water to comply with the standards in Regulation .06 of this chapter; A drinking water treatment: Is effective in providing the required or intended result; Is controlled; Is monitored; and Uses chemicals, materials, and methods that do not impart substances to the water in a concentration that is toxic, harmful, or deleterious; and If filtration or disinfection of water is used to treat product water, the filtration or disinfection system is: Proven through a review of scientific study to reduce the target microorganisms to an acceptable level; Approved by the Department; Controlled; Monitored; and Interlocked with the bottling system so that a failure in the filtration or disinfection system inactivates the bottling system and water is prevented from being bottled. The person-in-charge shall ensure that: Finished product water meets the water quality standards set forth in Regulation .06 of this chapter; Containers used in bottling are: Made of food-grade materials; Clean and sanitary when filled with finished product water; and Properly sealed to prevent the contamination of the water after bottling; Caps and closures are: Made of food-grade materials; Clean and sanitary when used; and Properly sealed onto containers to prevent the contamination of the water after bottling; Water is bottled in a room that meets the standards set forth in Regulation .07E of this chapter; and During bottling, access into the bottling room is limited to persons needed for the bottling process. The person-in-charge shall ensure that: The information required on a container of bottled water is placed on a label attached to the container or marked directly on the container in a way that ensures the information is clear and available to the consumer for the entire shelf life of the bottled water; The following information is placed on a container of bottled water: The type of water as set forth in Health-General Article, §21-336(c), (f)(2), and (g), Annotated Code of Maryland, 21 CFR §165.110(a), and this chapter; The name and address of the manufacturer or distributor; The net fluid measure of the contents of the container in common and metric units; and A production code as required in Health-General Article, §21-336(f)(1), Annotated Code of Maryland, and 21 CFR §129.80(e); and The label includes all the information required in 21 CFR §165.110(a). Health-General Article, §§18-102, 21-211, 21-234, 21-304, 21-305, 21-306, 21-334, 21-336, and 21-336.1, Annotated Code of Maryland Effective date: March 23, 2009 (36:6 Md. R. 491) This chapter: Provides the HACCP requirements for juice processors as defined by this chapter. Does not apply to a retail establishment or a food processing plant that: Makes and sells juice directly to consumers; and Does not sell or distribute juice to another business. All provisions of 21 CFR 120 are incorporated by reference. A juice processor, as defined in this chapter, shall comply with all of the requirements of 21 CFR 120. Health-General Article, §§21-234 and 21-304, Annotated Code of Maryland Effective date: March 16, 2012 (39:4 Md. R. 337) This chapter establishes guidelines for periodic inspections and annual maintenance of AEDs at grocery stores and restaurants. This chapter does not apply to: A grocery store that has an annual gross income of $10,000,000 or less in a calendar year; or A restaurant with: An annual gross income of $1,000,000 or less in a calendar year, exclusive of sales for off-premises consumption; or A seating capacity of less than 100 individuals based on a fire marshal’s determination. In this chapter, the following terms have the meanings indicated. Terms Defined. “AED” means automated external defibrillator as defined in COMAR 30.06.01.01. “Department” means the Maryland Department of Health. “Grocery store” means a store that has: All major food departments, including produce, meat, seafood, dairy, and canned and packaged goods; or At least one of the major food departments and at least 12,000 square feet of floor space. “MIEMSS” means the Maryland Institute for Emergency Medical Services Systems. “Restaurant” means a food service facility licensed under COMAR 10.15.03 that prepares food for on-site consumption. Beginning January 1, 2025, each owner and operator of a grocery store or restaurant subject to this chapter shall: Place an AED in a prominent area, accessible to employees and customers; and Maintain the functionality of the AED. Each grocery store or restaurant subject to this chapter shall register with MIEMSS using a form prescribed by MIEMSS in order to: Make its location publicly available to emergency dispatchers; and Receive maintenance and recall notices from MIEMSS. An owner or operator of a grocery store or restaurant subject to this chapter shall: Maintain: Each AED and all related equipment and supplies in accordance with the standards established by the device manufacturer and the U.S. Food and Drug Administration; and Supplemental equipment with the AED at all times, including: Two sets of defibrillator chest pads that are compatible with the AED; Disposable gloves; and The Maryland Facility AED Report Forms for Cardiac Arrest; and Submit to MIEMSS: A report for each incident of suspected cardiac arrest at the restaurant or grocery store on the Maryland Facility AED Report Form for Cardiac Arrests, including: Contact information for any necessary follow-up; and If created by the AED, any available event code, summary code, recording, or tape; and If the AED fails when operated, in addition to submitting the required report to the federal Food and Drug Administration, a copy of the report provided to the federal Food and Drug Administration. The Department shall: Monitor a grocery store or restaurant subject to this chapter for compliance with this chapter; and Inspect the grocery store or restaurant as necessary for the enforcement of this chapter. Right to Inspect. The Department may enter, at reasonable times, the property of a grocery store or restaurant for the purposes of inspecting, monitoring, and verifying information relative to the enforcement of this chapter. A person may not deny or interfere with the Department’s entry into a grocery store or restaurant under this chapter. An operator shall permit a representative of the Department to examine and copy records of the grocery store or restaurant to verify information relative to the enforcement of this chapter. Report of Inspection. During a grocery store or restaurant inspection, the Department shall: Record the inspection results on an inspection form provided by the Department; Identify on the inspection form the conditions found that violate the provisions of this chapter; Notify the grocery store or restaurant operator on the inspection form to correct violations by a specific date; Provide one copy of the inspection report to the grocery store or restaurant operator; and Provide one copy of the inspection report to MIEMSS. The completed inspection report is a public document that is available for public disclosure in accordance with General Provisions Article, §§4-101—4-601, Annotated Code of Maryland. Health-General Article, §§2-104 and 21-330.3, Annotated Code of Maryland Effective date: February 16, 2026 (53:3 Md. R. 122)