Chapter 04. Food and Drink Processing and Transportation

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Regulation .01 Scope.Link Copy Citation

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.

Regulation .02 Definitions.Link Copy Citation

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In this chapter, the following terms have the meanings indicated.

Terms Defined.

(1)

Adulterated Food.

(a)

“Adulterated food” has the meaning stated in Health-General Article, §21-207, Annotated Code of Maryland.

(b)

“Adulterated food” includes food that is:

(i)

Is diseased;

(ii)

Is contaminated;

(iii)

Is filthy;

(iv)

Is putrid;

(v)

Has decomposed;

(vi)

Contains any poisonous or otherwise deleterious substance that, in the quantity present, reasonably would be expected to make it injurious to health;

(vii)

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;

(viii)

Was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have contaminated it with filth;

(ix)

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;

(x)

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

(xi)

Is misbranded so that the food is unsafe for human consumption.

(2)

“Allergen cross-contact” means the unintentional incorporation of a food allergen into a food that has not been identified as containing it.

(3)

“Approving authority” means the agency designated in the laws of another state or country to license or permit a food processing plant.

(4)

“Approved source” means a source of food or food ingredients accepted by the Department because the food or food ingredients from the source:

(a)

Are not adulterated foods or misbranded as defined in §B(1) and (21) of this regulation; and

(b)

Where required, are regulated by the approving authority.

(5)

“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.

(6)

“Contamination” means the process or state that potentially renders a food unsafe for human consumption due to the adulteration of the food with:

(a)

Pathogens;

(b)

Chemicals;

(c)

Allergens;

(d)

Foreign objects; or

(e)

Filth.

(7)

“Corrective action” means the documented steps taken when a deviation occurs at a control point to:

(a)

Address the cause of the deviation;

(b)

Restore control; and

(c)

Prevent the affected food from entering commerce.

(8)

“Critical control point” means a step or procedure in a food process at which control can be applied, and is essential to:

(a)

Prevent a food safety hazard;

(b)

Eliminate a food safety hazard; or

(c)

Reduce a hazard to an acceptable level.

(9)

Critical Item.

(a)

“Critical item” means a food safety requirement that if violated requires:

(i)

Immediate correction;

(ii)

The cessation of some or all processing operations; or

(iii)

Plant closure.

(b)

“Critical item” includes the following requirements:

(i)

Food is obtained from an approved source;

(ii)

Food is protected from contamination and allergen cross-contact;

(iii)

Food processes provide safe food with proper control at critical control points;

(iv)

Food is protected by ensuring that all personnel wash hands thoroughly as often as necessary to prevent food contamination by hand contact;

(v)

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;

(vi)

Food is packaged and labeled for safety with allergens properly identified on the label;

(vii)

A sufficient volume of potable hot and cold water supply under pressure is available; and

(viii)

Sewage is discharged in compliance with applicable laws and regulations.

(10)

“Department” means the Maryland Department of Health or the Department's designee.

(11)

Farm.

(a)

“Farm” means a place where agricultural commodities are grown, raised, or harvested for commercial purposes.

(b)

“Farm” includes a place where, for commercial purposes:

(i)

Crops are grown and harvested;

(ii)

Fruit, nuts, or other agricultural commodities are harvested from trees; or

(iii)

Animals are raised, fed, and managed for meat or other agricultural commodities.

(12)

“Food” means:

(a)

Articles used for food or drink for humans or other animals;

(b)

Chewing gum; and

(c)

Individual components of such articles.

(13)

“Food allergen” means an ingredient that contains protein derived from one of the following foods or food groups:

(a)

Milk;

(b)

Egg;

(c)

Fish;

(d)

Crustacean shellfish;

(e)

Tree nuts;

(f)

Wheat;

(g)

Peanuts;

(h)

Soybeans; or

(i)

Sesame.

(14)

Food Processing Plant.

(a)

“Food processing plant” means a place used for or in connection with commercial food:

(i)

Manufacturing;

(ii)

Processing;

(iii)

Packing;

(iv)

Repacking;

(v)

Storage; or

(vi)

Distribution.

(b)

“Food processing plant” includes a:

(i)

Crab meat picking plant;

(ii)

Food manufacturing plant;

(iii)

Cold food warehouse;

(iv)

Ambient food warehouse, except as specified in §B(14)(c) of this regulation;

(v)

Shellfish plant or dealer;

(vi)

Bottled water plant;

(vii)

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;

(viii)

Cider plant;

(ix)

Charity deer processing plant; and

(x)

Producer mobile farmer’s market unit.

(c)

“Food processing plant” does not include a warehouse or distribution center that:

(i)

Stores only sealed containers pre-packaged, ready-to-eat snack foods that do not require temperature control for safety;

(ii)

Stores only bottled beverages that do not require temperature control for safety;

(iii)

Stores only packaged ice;

(iv)

Stores only whole bean, ground or instant coffee, or leaf or instant teas;

(v)

Stores only nondairy dehydrated whiteners, sugar, or sugar-free sweeteners; or

(vi)

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.

(15)

“Generally recognized as safe (GRAS)” means that a substance is:

(a)

Not harmful to humans consuming the substance under the intended conditions of use; and

(b)

In accordance with 21 CFR §170.30.

(16)

“Hazard” means any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury

(17)

“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:

(a)

COMAR 10.15.10 Procedures for the Safe Handling and Processing of Seafood;

(b)

COMAR 10.15.12 Procedures for the Safe Handling and Processing of Juice;

(c)

21 CFR Part 123 Fish and Fishery Products; or

(d)

The National Advisory Committee on the Microbiological Criteria for Food.

(18)

“Indirect food additive” means a substance that is unintentionally incorporated into food due to processing, holding, or packaging.

(19)

“Label” means a display of written or graphic matter on the container, other than the package liner, of a food.

(20)

“Labeling” means any label or other written or graphic material that:

(a)

Is on a:

(i)

Food;

(ii)

Food container; or

(iii)

Food wrapping; or

(b)

Accompanies a food.

(21)

“Misbranded” has the meaning stated in Health-General Article, §21-210, Annotated Code of Maryland.

(22)

“Person-in-charge” means:

(a)

The licensee; or

(b)

Another person responsible for the operation of the food processing plant.

(23)

“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).

(24)

“Poultry” means any domesticated bird.

(25)

Preventive Controls.

(a)

“Preventive controls” means a step or combination of steps that are taken to minimize, prevent, or eliminate:

(i)

Identified food safety hazards; or

(ii)

Food safety hazards that are reasonably likely to occur.

(b)

“Preventive controls” includes:

(i)

Process controls;

(ii)

Allergen controls;

(iii)

Sanitation controls; and

(iv)

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.

(26)

“Preventive controls qualified individual (PCQI)” means an individual who has:

(a)

Successfully completed training in the development and application of risk-based preventive controls; or

(b)

The education, experience, and knowledge to develop and implement a food safety system.

(27)

“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.

(28)

“Process” means a specific set of operations or procedures used to manufacture a food.

(29)

“Process authority” means an individual having expert knowledge of specialized food processes acquired through :

(a)

Training; and

(b)

Experience.

(30)

Producer Mobile Farmer’s Market Unit.

(a)

“Producer mobile farmer’s market unit” means a unit designed to ensure that food is:

(i)

Protected from contamination during transportation from farm to farmer’s market or public festival or event; and

(ii)

Kept at temperatures that support the safety and wholesomeness of the food.

(b)

“Producer mobile farmer’s market unit” does not include a unit used to deliver:

(i)

Prepackaged foods to fill an order of a customer;

(ii)

Raw agricultural products; or

(iii)

On-farm home processed foods that do not require temperature control for safety.

(31)

“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:

(a)

Education;

(b)

Training; or

(c)

Experience.

(32)

“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:

(a)

Education;

(b)

Training; or

(c)

Experience.

(33)

“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.

(34)

“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.

(35)

“Shell eggs” means raw or treated eggs produced by poultry for human consumption.

(36)

“Snack foods” means chips, pretzels, candy, and other novelty snacks.

(37)

“Temperature control for safety (TCS)” means a food requires specific time and temperature control to limit pathogenic microorganism growth or toxin formation for safety.

Regulation .03 Incorporation by Reference.Link Copy Citation

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In this chapter, the following documents are incorporated by reference.

Documents Incorporated.

(1)

9 CFR, as amended;

(2)

21 CFR, as amended;

(3)

21 U.S.C. §343, as amended;

(4)

21 U.S.C. §§451 — 471, as amended; and

(5)

21 U.S.C. §§601 — 695, as amended.

Regulation .04 Compliance with Other Chapters.Link Copy Citation

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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.

Regulation .05 Personnel.Link Copy Citation

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The person-in-charge shall ensure that:

Individuals do not cause contamination of:

(1)

Food;

(2)

Food-contact surfaces; and

(3)

Food-packaging material;

Individuals are excluded from working with food, food-contact surfaces, and food-packaging materials:

(1)

As provided in COMAR 10.06.01.06E; and

(2)

When an individual has an:

(a)

Illness transmissible through food; or

(b)

Exposed and open sore or cut;

Individuals working in direct contact with food, food-contact surfaces, and food-packaging material:

(1)

Wear suitable, clean outerwear garments in a manner that protects the food, food-contact surfaces, and food-packaging material against contamination;

(2)

Wear hair nets, beard covers, or other effective hair restraints;

(3)

Keep fingernails clean and neatly trimmed;

(4)

Prevent fingernail polish or artificial fingernails from coming into contact with food, food-contact surfaces, and food-packaging material;

(5)

Remove all unsecured jewelry and other objects that may fall into food, equipment, or containers;

(6)

Secure any jewelry that cannot be removed with material which can be maintained in an intact, clean, and sanitary condition;

(7)

Wash hands and exposed arm areas thoroughly with soap and warm water:

(a)

At a hand washing facility in compliance with regulation .12G of this chapter;

(b)

Before starting work;

(c)

After each absence from the workstation; and

(d)

At any other time when hands may have become soiled or contaminated or as often as required to remove soil and contamination; and

(8)

Apply sanitizer as necessary to protect against contamination with undesirable microorganisms;

Individuals wearing gloves while working with food or food-contact surfaces shall:

(1)

Use gloves that are intended for food contact;

(2)

Maintain gloves in an intact, clean, and sanitary condition;

(3)

Wash hands thoroughly before putting on gloves;

(4)

Clean and sanitize reusable gloves using approved methods or equipment.

(5)

Replace gloves:

(a)

When the gloves are damaged or soiled;

(b)

Between unrelated tasks; and

(c)

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:

(1)

Food processing;

(2)

Equipment or utensil washing;

(3)

Storage of:

(a)

Food;

(b)

Food-contact surfaces; or

(c)

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:

(1)

Each individual engaged in food handling or in the supervision of one or more individuals be qualified by:

(a)

Education;

(b)

Training;

(c)

Experience; or

(d)

A combination of education, training, and experience;

(2)

Responsibility for education and training shall be clearly assigned to qualified supervisory personnel; and

(3)

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.

Regulation .06 General Record Keeping.Link Copy Citation

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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.

Regulation .07 Food Protection, Processes, and Controls.Link Copy Citation

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The person-in-charge shall ensure that:

All food and food ingredients processed in a food processing plant:

(1)

Are from an approved source;

(2)

Are GRAS;

(3)

If applicable, conform to a standard of identity, as defined in 21 CFR Part 130;

(4)

Comply with FDA regulations for poisonous or deleterious substances; and

(5)

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:

(1)

Made from potable water; and

(2)

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:

(1)

Are inspected at receipt to ensure that they are acceptable for use; and

(2)

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:

(1)

Contamination; and

(2)

Allergen cross-contact;

The potential for contamination and allergen cross-contact is reduced by:

(1)

Food safety controls;

(2)

Operating practices; and

(3)

Separation of operations by:

(a)

Location;

(b)

Time; or

(c)

Effective design;

Food is processed and stored at temperatures that:

(1)

Minimize the potential for the growth of microorganisms; and

(2)

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:

(1)

Minimize the potential for the growth of microorganisms; and

(2)

Prevent adulteration;

Foods that require temperature control for safety are maintained at the temperature:

(1)

38°F or less for foods with a non-proteolytic Clostridium botulinum potential hazard;

(2)

40°F or less;

(3)

45°F or less for molluscan shellfish or shell eggs;

(4)

135°F or higher; or

(5)

As otherwise approved by the Department;

Food that relies principally on the control of a_w 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:

(1)

Rejected upon receipt;

(2)

Treated or processed to eliminate the contamination;

(3)

Destroyed in a manner that protects against the contamination and allergen cross-contact of other food;

(4)

Stored only in a designated area that is:

(a)

Separated from all other food and food process operations; and

(b)

Conspicuously marked with the intended disposition;

(5)

Reconditioned using a method that is safe and effective;

(6)

Reexamined following reconditioning and subsequently found not to be adulterated;

(7)

Not mixed with another lot of food that is not adulterated; and

(8)

If detained by the Department:

(a)

Reconditioned; or

(b)

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:

(1)

Establishes and implements temperature controls that significantly minimize or prevent the growth of, or toxin production by, pathogens;

(2)

Monitors the temperature controls with adequate frequency;

(3)

Takes appropriate corrective actions if there is a loss of temperature control that may impact the safety of the food;

(4)

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;

(5)

Reviews records of monitoring and corrective actions taken to correct a problem with the control of temperature within:

(a)

7 working days after the records are created; or

(b)

A reasonable time frame; and

(6)

Reviews records of calibration or accuracy checks within a reasonable time frame after the records are created;

Written standard operating procedures are:

(1)

Available to employees in a format they understand;

(2)

Implemented; and

(3)

Reflective of current manufacturing procedures;

When the Department requires a scheduled process, the scheduled process is:

(1)

Established by a process authority;

(2)

Used to manufacture the target food;

(3)

Not changed without approval of the process authority;

(4)

Documented by:

(a)

Production records; and

(b)

Process deviation records; and

(5)

Verified by:

(a)

Production records review;

(b)

Equipment calibration; or

(c)

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:

(1)

Accurately identified when stored;

(2)

Stored under conditions that protect against contamination; and

(3)

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.

Regulation .08 Hazard Analysis and Risk-Based Preventive Controls.Link Copy Citation

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The person-in-charge:

Is exempt from this regulation if:

(1)

They meet the definition of a qualified facility in 21 CFR §117.3; or

(2)

They meet the qualifications defined in:

(a)

21 CFR §§117.5—117.8;

(b)

21 CFR §117.201;

(c)

21 CFR §§117.251—117.287; and

(d)

21 CFR §117.315(a)(2);

Shall ensure that a food safety plan:

(1)

Is prepared, implemented, and managed by one or more individuals qualified in preventative controls;

(2)

Is signed and dated by the owner, operator, or agent in charge:

(a)

Upon initial completion;

(b)

When any modification takes place; and

(c)

At least once every 3 years;

(3)

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;

(4)

Includes written procedures for:

(a)

Preventive controls;

(b)

Process controls with parameters and values;

(c)

Allergen controls;

(d)

Sanitation controls;

(e)

Other controls necessary as identified in the hazard analysis;

(f)

Monitoring and record keeping for each preventive control identified in the hazard analysis that include an adequate frequency to control the hazard;

(g)

Corrective actions that:

(i)

Identify and correct the problem;

(ii)

Reduce the likelihood the problem will recur;

(iii)

Evaluate all affected food for safety; and

(iv)

Prevent all affected food from entering commerce;

(h)

Verification activities that ensure that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards;

(i)

Validation for process controls;

(j)

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

(k)

A recall plan for a food with a hazard requiring a preventive control, that includes:

(i)

Maintaining accurate records to identify the initial distribution of the food;

(ii)

Direct notification of the consignees of the food being recalled, including how to return or dispose of the affected food;

(iii)

Public notification about any hazard presented by the food when appropriate to protect public health; and

(iv)

Effectiveness checks to account for all products affected;

(5)

Is implemented to prevent, eliminate, or reduce to an acceptable level, all identified hazards;

(6)

Includes records that document implementation of:

(a)

The food safety plan monitoring;

(b)

Corrective actions; and

(c)

Supply chain, verification, validation, and applicable training for the preventive controls qualified individual and the qualified auditor;

(7)

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

(8)

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.

Regulation .09 Plant and Grounds.Link Copy Citation

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The person-in-charge shall ensure that:

The food processing plant and grounds around a food processing plant are:

(1)

Maintained free of attractants, breeding places, or harborage for pests and insects, including:

(a)

Unused equipment;

(b)

Debris;

(c)

Litter;

(d)

Waste; or

(e)

High weeds or grass; and

(2)

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:

(1)

Is suitable in size;

(2)

Affords protection against the weather; and

(3)

Minimizes the potential for contamination and allergen cross-contact by providing:

(a)

Adequate space for the placement of:

(i)

Equipment;

(ii)

Utensils; and

(iii)

Materials storage; and

(b)

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:

(1)

Is separated from other rooms or areas in the plant to preclude allergen cross-contact and contamination by:

(a)

A distance that precludes allergen cross-contact and contamination; or

(b)

Tight fitting:

(i)

Walls;

(ii)

Ceilings; and

(iii)

Self-closing doors;

(2)

Is, if not refrigerated, mechanically ventilated using exhaust and supply fans to ensure:

(a)

Filtered air is supplied to provide a positive air pressure in the room;

(b)

Condensation and grease do not accumulate on room surfaces and equipment; and

(c)

Removal of excessive:

(i)

Grease vapors;

(ii)

Steam;

(iii)

Heat; and

(iv)

Odors;

(3)

Has a floor, walls, and ceiling that are:

(a)

Smooth;

(b)

Washable;

(c)

Easily cleanable; and

(d)

Impervious to water;

(4)

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;

(5)

Has floor-wall junctures that are:

(a)

Coved; and

(b)

Impervious to water;

(6)

Has aisles or working spaces between equipment and walls that:

(a)

Are unobstructed;

(b)

Of adequate width to permit employees to perform their duties; and

(c)

Protect against the contamination of food, food-contact surfaces, or food-packaging materials by clothing or personal contact;

(7)

Provides adequate lighting in all areas that:

(a)

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

(b)

Otherwise protects against food contamination in case of glass breakage; and

(8)

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:

(1)

Utensils;

(2)

Equipment; or

(3)

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:

(1)

Provide for adequate food safety, food protection, and sanitation; and

(2)

Are equivalent to regulatory and industry standards.

Regulation .10 Equipment and Utensils.Link Copy Citation

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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:

(1)

National Sanitation Foundation (NSF);

(2)

The ETL SEMKO division of Intertek Group PLC (Intertek ETL SEMKO);

(3)

Canadian Standards Association (CSA);

(4)

Underwriters Laboratories (UL);

(5)

Bakery Industry Sanitation Standards Committee;

(6)

National Automatic Merchandising Association;

(7)

International Association of Food Protection;

(8)

American Society of Mechanical Engineers;

(9)

U.S. Department of Agriculture; or

(10)

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:

(1)

Designed and constructed to allow for adequate cleaning and sanitizing;

(2)

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;

(3)

Designed and constructed to prevent contamination and allergen cross-contact; and

(4)

Maintained in:

(a)

Proper working condition; and

(b)

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:

(1)

Maintains temperatures that ensure food safety and protect against spoilage;

(2)

Is fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device that is:

(a)

Calibrated to be accurate to within plus or minus 2°F; and

(b)

Placed in a conspicuous location to show the temperature accurately within the unit;

All food-contact surfaces are designed, constructed, and maintained to be:

(1)

Smooth;

(2)

Easily cleanable;

(3)

Durable;

(4)

Non-absorbent;

(5)

Constructed of food grade material where applicable;

(6)

Corrosion resistant;

(7)

Made of nontoxic material that does not impart toxic or deleterious matter to the food;

(8)

Inert to food and do not migrate into or adulterate food; and

(9)

Smoothly bonded at the seams and maintained to minimize accumulation of:

(a)

Food particles;

(b)

Dirt; and

(c)

Organic matter;

Food-packaging material:

(1)

Is food grade;

(2)

Is safe;

(3)

Is able to maintain food safety and integrity;

(4)

Is appropriate for the food item and the intended use;

(5)

Is not reused if intended for single-service;

(6)

Meets the labeling requirements in Regulation .13B(2) of this chapter;

(7)

Does not migrate to or have the potential to be absorbed by food; and

(8)

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:

(1)

Smooth;

(2)

Easily cleanable;

(3)

Durable; and

(4)

Non-absorbent;

The food storage area of a transportation vehicle is maintained in:

(1)

Good repair;

(2)

Working condition; and

(3)

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:

(1)

Not harmful to public health; and

(2)

Consistent with industry standards and practice.

Regulation .11 Sanitary Operation.Link Copy Citation

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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:

(1)

Food;

(2)

Food-contact surfaces; and

(3)

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:

(1)

Clean;

(2)

Dry; and

(3)

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:

(1)

Each sink compartment is sized to allow sufficient immersion of the equipment or utensils; and

(2)

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:

(1)

Safe and adequate under the conditions of use;

(2)

Used in accordance with the manufacturer’s instructions and applicable State laws and regulations; and

(3)

Identified and stored in a manner that protects against contaminating:

(a)

Food;

(b)

Food-contact surfaces; or

(c)

Food-packaging materials;

All processing and storage areas are maintained free of pests;

Effective measures are taken to:

(1)

Monitor for and exclude pests from processing and storage areas; and

(2)

Protect against the contamination of food by pests;

The food storage area of a transportation vehicle is:

(1)

Maintained in a clean and sanitary condition; and

(2)

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:

(1)

Cleaned as necessary;

(2)

Examined prior to use to protect against contamination from the container or vehicle; and

(3)

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.

Regulation .12 Sanitary Facilities and Controls.Link Copy Citation

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The person-in-charge shall ensure that:

The water supply is adequate for the operations intended and is:

(1)

From an approved potable source;

(2)

At an adequate temperature;

(3)

Under adequate pressure; and

(4)

Protected against backflow;

All plumbing is of adequate size and is designed, installed, and maintained to:

(1)

Carry adequate quantities of water to required locations throughout the plant;

(2)

Convey sewage and liquid waste from the plant;

(3)

Prevent contamination of:

(a)

Food;

(b)

Water supplies;

(c)

Equipment;

(d)

Utensils; and

(e)

Food-packaging materials;

(4)

Ensure sanitary conditions;

(5)

Prevent backflow from, or cross-connection between, piping systems that carry wastewater and potable water; and

(6)

Be in compliance with State and local codes;

Adequate floor drainage is provided in all areas where:

(1)

Floors are subject to water accumulation during cleaning; or

(2)

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:

(1)

In compliance with applicable laws and regulations;

(2)

Into a sewage disposal system that meets all applicable State and local codes; or

(3)

Through other acceptable means approved by the Department;

Toilet facilities:

(1)

Are readily accessible and adequate in number for employee use;

(2)

Are kept clean and are not a potential source of contamination of:

(a)

Food;

(b)

Food-contact surfaces; and

(c)

Food-packaging materials; and

(3)

Are provided with:

(a)

Signage that instructs individuals to wash their hands before returning to work;

(b)

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;

(c)

Floors, walls, and a ceiling that are:

(i)

Smooth;

(ii)

Washable;

(iii)

Easily cleanable; and

(iv)

Impervious to water;

(d)

Floor-wall junctures that are sealed to be impervious to water;

(e)

Adequate lighting; and

(f)

Hand washing facilities as specified in §G of this regulation;

Hand washing facilities:

(1)

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

(2)

Are supplied with:

(a)

Soap;

(b)

Warm water of sufficient volume, under pressure for effective hand washing;

(c)

Paper towels or warm air hand drying device;

(d)

A conveniently located trash receptacle; and

(e)

Hand sanitizer, if necessary to protect against contamination; and

Solid waste:

(1)

Is handled and disposed of using waste containers that are:

(a)

Adequate in number and size to maintain sanitary conditions;

(b)

Conveniently located where waste is generated;

(c)

Easily cleanable;

(d)

Leak proof; and

(e)

Emptied and cleaned at a frequency that maintains sanitary conditions; and

(2)

Is handled, stored, and disposed of in a manner that:

(a)

Minimizes the development of odors;

(b)

Minimizes the potential for becoming an attractant or harborage for pests;

(c)

Meets all applicable State and local codes; and

(d)

Protects against contamination of:

(i)

Food;

(ii)

Food-contact surfaces;

(iii)

Food-packaging materials;

(iv)

Water supplies; and

(v)

Plant and grounds.

Regulation .13 Labeling.Link Copy Citation

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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:

(1)

Except as provided in §A of this regulation, food labeling meets the requirements in 21 CFR Part 101;

(2)

Except as provided in §A of this regulation, the following information is provided on a label of food in packaged form:

(a)

Common or usual name of the food;

(b)

Statement of ingredients that gives the common or usual names of the ingredients in descending order of prominence with sub-ingredients listed;

(c)

Name and address of the manufacturer or distributor with:

(i)

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

(ii)

A minimum of the town and zip code if the manufacturer or distributor is listed on a website, current city directory, or telephone directory;

(d)

Net quantity in terms of:

(i)

Weight in U.S. Customary units and equivalent metric units;

(ii)

Fluid measure in U.S. Customary units and equivalent metric units;

(iii)

Numerical count; or

(iv)

Combination of numerical count and weight;

(e)

If a food coloring has been added, the food coloring in the statement of ingredients;

(f)

If a chemical preservative has been added, a label declaration stating:

(i)

The common or usual name of the ingredient; and

(ii)

A separate description of its function such as “preservative” or “mold inhibitor”;

(g)

Major food allergens in accordance with 21 U.S.C. §343(w);

(h)

For a food that requires refrigeration for safety, the words “keep refrigerated” or equivalent;

(i)

For a food that requires refrigeration for safety after the food’s packaging is opened, the words “refrigerate after opening” or equivalent;

(j)

For a food that is frozen for safety or quality, the words “keep frozen” or equivalent;

(k)

A “use by date” if the package contains a food whose safety is assured only until the date specified on the label;

(l)

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

(m)

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;

(3)

A food label and the labeling information in §B(1) of this regulation are:

(a)

Durable;

(b)

Conspicuous;

(c)

Legible;

(d)

Able to remain on a container for the shelf life of the food; and

(e)

Placed on the food container by:

(i)

Imprinting;

(ii)

Embossing;

(iii)

Lithography;

(iv)

Ink jetting; or

(v)

Another method set forth in 21 CFR Parts 100 and 101 or in conformance with §B(2) of this regulation;

(4)

The information required in §B(2) of this regulation is located on the principal display panel;

(5)

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”;

(6)

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;

(7)

A food’s labeling or packaging is not false or misleading in any way; and

(8)

A food that has been frozen or thermally processed is not labeled “fresh”.

The person-in-charge may forego:

(1)

Declaring on the label the common or usual name of each ingredient for incidental additives that:

(a)

Have no technical or functional effect in the food; and

(b)

Are not required by a federal rule to be declared; and

(2)

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:

(a)

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

(b)

The shipment or delivery to the establishment is made under a written agreement as set forth in 21 CFR §101.100(d).

Regulation .14 Facility Process and Plan Review.Link Copy Citation

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The person-in-charge shall ensure that plans and specifications are submitted to the Department:

(1)

Before:

(a)

A food processing plant is:

(i)

Constructed;

(ii)

Remodeled; or

(iii)

Materially altered;

(b)

An existing building or structure is converted or remodeled for use as a food processing plant;

(c)

A food or process is added or significantly modified; or

(d)

A new scheduled process or shelf life study is used; and

(2)

That include the following information, as applicable:

(a)

A scale drawing in horizontal view that identifies the:

(i)

Layout and arrangement of work areas;

(ii)

Location of food equipment including exhaust ventilation hoods; and

(iii)

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;

(b)

Specifications for the:

(i)

Construction materials for the building and interior finishes;

(ii)

Disposal of sewage;

(iii)

Provision of potable water;

(iv)

Exclusion and control of pests;

(v)

Ventilation of the plant and individual areas within the plant;

(vi)

Methods and facilities for waste storage and disposal; and

(vii)

Lighting;

(c)

A complete list of specifications for the proposed equipment;

(d)

A written description of the foods to be processed, stored, or distributed;

(e)

Written standard operating procedures for:

(i)

Processing foods named in §A(2)(d) of this regulation;

(ii)

Employee health and personal hygiene; and

(iii)

Plant sanitation;

(f)

When required by Regulation .02, .07, .10, or .12 of this chapter, a HACCP plan;

(g)

When required by the Department, a scheduled process or shelf life study, performed by a process authority;

(h)

When required by the Department, a laboratory analysis, performed by a laboratory with a current accreditation to the ISO/IEC 17025;

(i)

A hazard analysis and food safety plan as required by Regulation .08B and C of this chapter; and

(j)

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:

(1)

Review the plans and specifications to ensure compliance with the applicable regulations;

(2)

Inform in writing the individual who submitted the plans and specifications:

(a)

Of additional information that may be required; and

(b)

Following the review, whether the plans and specifications are approved or denied; and

(3)

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:

(1)

The Department schedules and completes an inspection;

(2)

The Department issues written approval for the use of the new or remodeled plant; and

(3)

For a new plant, a food processing license is obtained.

The Department shall:

(1)

Review the plans and specifications to ensure compliance with the applicable regulations;

(2)

Conduct a priority assessment of the facility based on the information obtained pursuant to §A(2)(d) and (e) of this regulation; and

(3)

Classify a food processing plant as a:

(a)

High priority facility, if the food processing plant manufactures food:

(i)

Using specialized processes that require a scheduled process or a HACCP Plan;

(ii)

Using ingredients that require temperature control for safety; or

(iii)

That is temperature controlled for safety;

(b)

Moderate priority facility, if the food processing plant:

(i)

Manufactures food using ingredients that do not require temperature control for safety;

(ii)

Manufactures food that is not temperature controlled for safety; or

(iii)

Is a food warehouse that stores and distributes food that requires temperature control for safety; or

(c)

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:

(1)

Not harmful to public health; and

(2)

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:

(1)

Provides for adequate food safety, food protection, and sanitation; and

(2)

Is equivalent to regulatory and industry standards.

Regulation .15 On-Farm Home Processing.Link Copy Citation

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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:

(1)

Comply with this chapter except for:

(a)

Regulation .09C(2)(a), D, and E; and

(b)

Regulation .12D, F(3), and G(1);

(2)

Limit processed food production to:

(a)

An amount of food that can safely be produced in the domestic kitchen as evidenced by:

(i)

Sanitation;

(ii)

Process; and

(iii)

Cross-contamination control; and

(b)

$50,000 or less of sales other than foods processed under §§E and F of this regulation;

(3)

Process commercially only during times when the kitchen is not being used for domestic purposes;

(4)

Clean and sanitize all food-contact surfaces, equipment, and utensils, immediately before and after processing commercially;

(5)

While processing commercially:

(a)

Use only building areas, equipment, and utensils that the Department has reviewed or inspected and approved; and

(b)

Remove all animals and individuals not involved in food processing from the kitchen; and

(6)

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:

(1)

Baked cakes, muffins, or cookies with a water activity of .85 or less;

(2)

Fruit pies with an equilibrated pH of 4.6 or less;

(3)

Canned acid foods with an equilibrated pH of 4.6 or less;

(4)

Herbs in vinegar with an equilibrated pH of 4.6 or less;

(5)

Honey and herb mixtures;

(6)

Dried fruits and vegetables; and

(7)

Acidified foods.

An individual licensed in accordance with this regulation may not process:

(1)

Low-acid canned foods;

(2)

Cured or fermented foods;

(3)

Except as provided in §E(6) of this regulation, seafood;

(4)

Apple cider or other juices;

(5)

Grade A milk product or manufactured grade milk product as defined in Health-General Article, §21-401, Annotated Code of Maryland; and

(6)

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:

(1)

Weigh, label, and sell raw meat and poultry that is under the jurisdiction of the United States Department of Agriculture;

(2)

Distribute raw meat or poultry that is under the jurisdiction of the United States Department of Agriculture;

(3)

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;

(4)

Distribute raw meat or poultry that is inspected by the Maryland Department of Agriculture in accordance with Regulation .20 of this chapter;

(5)

Process only animals that were:

(a)

Commercially raised, fed, or managed on the farm; and

(b)

Slaughtered and processed in accordance with Regulation .17 of this chapter;

(6)

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

(7)

Use shared equipment and utensils for both domestic and commercial uses provided that the equipment and utensils are:

(a)

Designed and constructed as set forth in Regulation .10 of this chapter; and

(b)

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:

(1)

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

(2)

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.

Regulation .16 Producer Mobile Farmer’s Market Unit.Link Copy Citation

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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:

(1)

Produced or stored on the farm by the licensee under an on-farm home processing plant license;

(2)

Produced or stored on the farm by the licensee, as authorized by the Department in regulation; or

(3)

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:

(1)

Complies with Regulations .07G, N, and O and .10D, H, and K of this chapter; and

(2)

Displays the license on the unit during operation.

A local health department shall:

(1)

Enforce §B of this regulation;

(2)

Levy fines as established in local law, ordinance, or regulation;

(3)

Notify the Department of any violations occurring in the county; and

(4)

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.

Regulation .17 Animal Slaughtering, Meat Processing, and Poultry Processing.Link Copy Citation

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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:

(1)

Federal laws;

(2)

Federal regulations;

(3)

State laws;

(4)

State regulations;

(5)

Local laws; and

(6)

Local regulations;

Cattle, sheep, swine, goats, horses, mules, and other equine are slaughtered and processed in accordance with:

(1)

The Federal Meat Inspection Act, 21 U.S.C. §§601—695; and

(2)

Applicable federal, State, and local laws and regulations;

Poultry are slaughtered and processed in accordance with:

(1)

The Poultry Products Inspection Act, 21 U.S.C. §§451—471; and

(2)

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:

(1)

Inspected by the:

(a)

United States Department of Agriculture under a voluntary inspection program; or

(b)

Maryland Department of Agriculture under a voluntary inspection program; and

(2)

Processed into human food while being regulated by:

(a)

The United States Department of Agriculture under a voluntary inspection program; or

(b)

A meat inspection program or poultry inspection program administered by the Maryland Department of Agriculture; and

When processing deer meat for charitable donation:

(1)

Any processed deer is legally harvested;

(2)

Gutting and skinning of the deer and butchering operations shall be separated by:

(a)

Time; or

(b)

Distance;

(3)

Processing other animal species is separated by:

(a)

Time; or

(b)

Distance;

(4)

Hanging meat carcasses are stored at an internal temperature of 41°F or less;

(5)

Deer is processed for distribution only as fresh or frozen:

(a)

Raw whole cuts; or

(b)

Raw, ground 100 percent venison;

(6)

Organ meat is not donated; and

(7)

A label containing cooking instructions is included.

Regulation .18 Licensing.Link Copy Citation

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In order to operate a food processing plant, a person shall obtain a food processing license pursuant to the provisions of:

(1)

Health-General Article, §§21-211 and 21-305, Annotated Code of Maryland; and

(2)

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:

(1)

Does not meet the requirements of:

(a)

Health-General Article, §21-211, or Title 21, Subtitle 3, Annotated Code of Maryland; or

(b)

A regulation promulgated under Health-General Article, §21-211, or Title 21, Subtitle 3, Annotated Code of Maryland; or

(2)

Fraudulently or deceptively attempts to obtain a license.

The Department may suspend or revoke a license if the licensee:

(1)

Violates or fails to meet the requirements of §C of this regulation; or

(2)

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:

(1)

Health-General Article, §§21-211, 21-311, and 21-314—21-317, Annotated Code of Maryland; and

(2)

State Government Article, §10-226, Annotated Code of Maryland.

The person-in-charge shall ensure that:

(1)

Food is not processed without the license required by Health-General Article, §21-305, Annotated Code of Maryland;

(2)

The required food processing license is conspicuously posted in the plant; and

(3)

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:

(1)

An application is filed in accordance with Health-General Article, §21-306, Annotated Code of Maryland; and

(2)

Written evidence establishes that the applicant’s relationship with the deceased was as a:

(a)

Spouse of the deceased licensee;

(b)

Blood relative to the first degree of consanguinity; or

(c)

Current officer or surviving partner in the business operating the food processing plant.

Regulation .19 Vacant.Link Copy Citation

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Regulation .20 Inspections.Link Copy Citation

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The person-in-charge shall permit a representative of the Department to:

(1)

Enter a food processing plant at a reasonable time for the purpose of making inspections to determine compliance with this chapter; and

(2)

Examine the records of the facility that pertain to information regarding food and supplies:

(a)

Purchased;

(b)

Received;

(c)

Manufactured;

(d)

Sold; or

(e)

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:

(1)

An immediate and substantial danger to public health exists involving the food ingredient or recipe; or

(2)

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:

(1)

Compliance with this chapter is continuous;

(2)

Violations are corrected within the time for correction given by the Department;

(3)

When a violation of a critical item exists:

(a)

The violation is corrected immediately;

(b)

Food processing affected by the critical item violation ceases; or

(c)

The food processing plant is closed immediately; and

(4)

For a food processing plant that operates seasonally or intermittently, inspection and regulation by the Department is facilitated by notifying the Department of:

(a)

The dates and times of operation; or

(b)

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:

(1)

Complete an inspection report that identifies the:

(a)

Conditions found that violate the provisions of this chapter; and

(b)

Critical item violations, noted separately from all other violations;

(2)

Provide a copy of the inspection report to the person-in-charge of the plant; and

(3)

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:

(1)

As determined by the Department or by statute for the enforcement of this chapter;

(2)

At a minimum of the frequency required by COMAR 10.15.07.01 for any shellfish:

(a)

Shucker-packer; or

(b)

Repacker;

(3)

At a minimum of two times per year for any shellfish:

(a)

Shipper; or

(b)

Reshipper;

(4)

At another frequency for shellfish required by COMAR 10.15.07.01; or

(5)

When a:

(a)

High priority plant, at a minimum of once per 12 months;

(b)

Moderate priority plant, at a minimum of once per 24 months; and

(c)

Low priority plant, at a minimum of once every 36 months.

Regulation .21 Enforcement.Link Copy Citation

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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:

(1)

Of the specific:

(a)

Findings; and

(b)

Date by which the licensee shall correct the violations or deficiencies; and

(2)

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:

(1)

Make a request for a hearing in writing; and

(2)

Submit the request to the approving authority that issued the order or inspection report:

(a)

Within 10 days of receipt of the order;

(b)

Sooner if specified in the order; or

(c)

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:

(1)

Correct a:

(a)

Violation within the specified time period; or

(b)

Violation of a critical item immediately; or

(2)

Comply with an approved written schedule of compliance.

The approving authority shall ensure that:

(1)

An action to suspend or revoke a license, complies with the provisions of:

(a)

State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; and

(b)

Health-General Article, §21-315, Annotated Code of Maryland; and

(2)

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:

(1)

Approving authority shall:

(a)

Summarily suspend the license at the food processing plant;

(b)

Order the food processing plant to cease operation immediately; and

(c)

Promptly provide the licensee with:

(i)

A written notice of suspension of the license;

(ii)

The reasons for the suspension; and

(iii)

Instructions on requesting an administrative hearing if desired; and

(2)

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:

(1)

Taking and keeping physical possession of the license until the license is reinstated; and

(2)

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.

Regulation .22 Foodborne Disease Investigation and Control.Link Copy Citation

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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:

(1)

Identify:

(a)

Potential points of food contamination in the facility;

(b)

Whether employee illness may have contributed; and

(c)

Whether a contaminated ingredient was used to process a food; and

(2)

Determine if affected food has been distributed into commerce; and

The appropriate follow-up action is taken, which may include immediate:

(1)

Closing of the food processing plant, or a portion of the plant that is used to process the implicated product; or

(2)

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.

Regulation .23 Traceability, Sampling, and Detention.Link Copy Citation

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The person-in-charge shall ensure that:

(1)

Records are maintained that allow for traceability of food or food ingredients received by the food processing plant that include the:

(a)

Date received; and

(b)

Previous source’s:

(i)

Name;

(ii)

Address; and

(iii)

Contact information;

(2)

Records are maintained that allow for traceability of food and food ingredients that identify the initial distribution of the food that include:

(a)

The date the food was released;

(b)

A lot code number or other identifier, if available;

(c)

The type of food released, including brand name and specific variety; and

(d)

For the transporter of the food and the intended immediate recipient, the:

(i)

Name;

(ii)

Address; and

(iii)

Contact information;

(3)

All records maintained that allow for traceability are made available to the Department for review and copying upon request; and

(4)

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:

(1)

Collect food and environmental samples as often as necessary for enforcement of this chapter;

(2)

Sample food in accordance with Health-General Article, §§21-249 and 21-251, Annotated Code of Maryland; and

(3)

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:

(a)

Issuing a detention order;

(b)

Seeking voluntary destruction; or

(c)

Filing a petition for an order of forfeiture for destruction.

Chapter annotations

Authority: 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

History: Effective date: November 18, 1960

History: Amended effective January 1, 1964; June 8, 1965; July 1, 1966; April 1, 1967; December 1, 1970

History: Regulation .29 adopted effective September 21, 1979 (6:19 Md. R. 1519)

History: Regulation .29 amended effective December 14, 1979 (6:25 Md. R. 1980)

History: 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)

History: Regulation .01B amended effective September 28, 1992 (19:19 Md. R. 1708)

History: Regulation .02B amended effective September 28, 1992 (19:19 Md. R. 1708); April 3, 2000 (27:6 Md. R. 641)

History: Regulation .31 amended effective September 28, 1992 (19:19 Md. R. 1708)

History: 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)

History: Regulations .01 — .37 repealed and new Regulations .01 — .20 adopted effective November 22, 2004 (31:23 Md. R. 1652)

History: Regulation .02B amended effective May 4, 2009 (36:9 Md. R. 651)

History: Regulation .03B amended effective May 4, 2009 (36:9 Md. R. 651)

History: Regulation .08A amended effective May 4, 2009 (36:9 Md. R. 651)

History: Regulation .09B amended effective May 4, 2009 (36:9 Md. R. 651)

History: Regulation .10D amended effective May 4, 2009 (36:9 Md. R. 651)

History: Regulation .17A amended effective May 4, 2009 (36:9 Md. R. 651)

History: Regulation .19C, D amended effective May 4, 2009 (36:9 Md. R. 651)

History: Regulation .19G adopted effective May 4, 2009 (36:9 Md. R. 651)

History: Regulation .21 adopted effective May 4, 2009 (36:9 Md. R. 651)

History: 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)

History: 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)

History: Regulation .03B amended effective February 15, 2016 (43:3 Md. R. 272)

History: Regulation .04 amended effective March 5, 2012 (39:4 Md. R. 337)

History: Regulation .05 amended effective March 5, 2012 (39:4 Md. R. 337)

History: Regulation .07B amended effective March 5, 2012 (39:4 Md. R. 337)

History: Regulation .08A amended effective March 5, 2012 (39:4 Md. R. 337)

History: Regulation .09D amended effective March 5, 2012 (39:4 Md. R. 337); February 15, 2016 (43:3 Md. R. 272)

History: Regulation .13A amended effective February 15, 2016 (43:3 Md. R. 272)

History: Regulation .14 amended effective March 5, 2012 (39:4 Md. R. 337)

History: Regulation .14B amended effective February 15, 2016 (43:3 Md. R. 272)

History: Regulation .15A, D amended effective February 15, 2016 (43:3 Md. R. 272)

History: Regulation .16A amended effective March 5, 2012 (39:4 Md. R. 337); February 15, 2016 (43:3 Md. R. 272)

History: Regulation .17A amended effective March 5, 2012 (39:4 Md. R. 337)

History: Regulation .17D, E adopted effective March 5, 2012 (39:4 Md. R. 337)

History: Regulation .17E amended effective January 6, 2014 (40:26 Md. R. 2163)

History: Regulation .18 amended effective February 15, 2016 (43:3 Md. R. 272)

History: Regulation .19A amended effective March 5, 2012 (39:4 Md. R. 337)

History: Regulation .20C, D amended effective March 5, 2012 (39:4 Md. R. 337); January 6, 2014 (40:26 Md. R. 2163)

History: Regulation .20E adopted effective January 6, 2014 (40:26 Md. R. 2163)

History: Regulation .20E adopted effective March 5, 2012 (39:4 Md. R. 337)

History: Regulation .22 repealed effective March 5, 2012 (39:4 Md. R. 337)

History: Regulation .23G amended effective January 6, 2014 (40:26 Md. R. 2163)

History: Regulation .28C amended effective February 15, 2016 (43:3 Md. R. 272)

History: Chapter revised effective August 5, 2024 (51:15 Md. R. 708)

History: Regulation 15A, B, F amended effective January 5, 2026 (52:26 Md. R. 1309)

History: Regulation .16A, C amended effective January 5, 2026 (52:26 Md. R. 1309)

Chapter 04. Food and Drink Processing and Transportation

Regulation .01 Scope.LinkCopy Citation

Regulation .02 Definitions.LinkCopy Citation

Regulation .03 Incorporation by Reference.LinkCopy Citation

Regulation .04 Compliance with Other Chapters.LinkCopy Citation

Regulation .05 Personnel.LinkCopy Citation

Regulation .06 General Record Keeping.LinkCopy Citation

Regulation .07 Food Protection, Processes, and Controls.LinkCopy Citation

Regulation .08 Hazard Analysis and Risk-Based Preventive Controls.LinkCopy Citation

Regulation .09 Plant and Grounds.LinkCopy Citation

Regulation .10 Equipment and Utensils.LinkCopy Citation

Regulation .11 Sanitary Operation.LinkCopy Citation

Regulation .12 Sanitary Facilities and Controls.LinkCopy Citation

Regulation .13 Labeling.LinkCopy Citation

Regulation .14 Facility Process and Plan Review.LinkCopy Citation

Regulation .15 On-Farm Home Processing.LinkCopy Citation

Regulation .16 Producer Mobile Farmer’s Market Unit.LinkCopy Citation

Regulation .17 Animal Slaughtering, Meat Processing, and Poultry Processing.LinkCopy Citation

Regulation .18 Licensing.LinkCopy Citation

Regulation .19 Vacant.LinkCopy Citation

Regulation .20 Inspections.LinkCopy Citation

Regulation .21 Enforcement.LinkCopy Citation

Regulation .22 Foodborne Disease Investigation and Control.LinkCopy Citation

Regulation .23 Traceability, Sampling, and Detention.LinkCopy Citation

Regulation .01 Scope.Link Copy Citation

Regulation .02 Definitions.Link Copy Citation

Regulation .03 Incorporation by Reference.Link Copy Citation

Regulation .04 Compliance with Other Chapters.Link Copy Citation

Regulation .05 Personnel.Link Copy Citation

Regulation .06 General Record Keeping.Link Copy Citation

Regulation .07 Food Protection, Processes, and Controls.Link Copy Citation

Regulation .08 Hazard Analysis and Risk-Based Preventive Controls.Link Copy Citation

Regulation .09 Plant and Grounds.Link Copy Citation

Regulation .10 Equipment and Utensils.Link Copy Citation

Regulation .11 Sanitary Operation.Link Copy Citation

Regulation .12 Sanitary Facilities and Controls.Link Copy Citation

Regulation .13 Labeling.Link Copy Citation

Regulation .14 Facility Process and Plan Review.Link Copy Citation

Regulation .15 On-Farm Home Processing.Link Copy Citation

Regulation .16 Producer Mobile Farmer’s Market Unit.Link Copy Citation

Regulation .17 Animal Slaughtering, Meat Processing, and Poultry Processing.Link Copy Citation

Regulation .18 Licensing.Link Copy Citation

Regulation .19 Vacant.Link Copy Citation

Regulation .20 Inspections.Link Copy Citation

Regulation .21 Enforcement.Link Copy Citation

Regulation .22 Foodborne Disease Investigation and Control.Link Copy Citation

Regulation .23 Traceability, Sampling, and Detention.Link Copy Citation