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)