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)