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

2. B. Terms Defined.

   1. (1) Adulterated Food.

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

      2. (b) “Adulterated food” includes food that is:

         1. (i) Is diseased;
         2. (ii) Is contaminated;
         3. (iii) Is filthy;
         4. (iv) Is putrid;
         5. (v) Has decomposed;
         6. (vi) Contains any poisonous or otherwise deleterious substance that, in the quantity present, reasonably would be expected to make it injurious to health;
         7. (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;
         8. (viii) Was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have contaminated it with filth;
         9. (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;
         10. (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
         11. (xi) Is misbranded so that the food is unsafe for human consumption.
   2. (2) “Allergen cross-contact” means the unintentional incorporation of a food allergen into a food that has not been identified as containing it.
   3. (3) “Approving authority” means the agency designated in the laws of another state or country to license or permit a food processing plant.

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

      1. (a) Are not adulterated foods or misbranded as defined in §B(1) and (21) of this regulation; and
      2. (b) Where required, are regulated by the approving authority.
   5. (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. (6) “Contamination” means the process or state that potentially renders a food unsafe for human consumption due to the adulteration of the food with:

      1. (a) Pathogens;
      2. (b) Chemicals;
      3. (c) Allergens;
      4. (d) Foreign objects; or
      5. (e) Filth.

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

      1. (a) Address the cause of the deviation;
      2. (b) Restore control; and
      3. (c) Prevent the affected food from entering commerce.

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

      1. (a) Prevent a food safety hazard;
      2. (b) Eliminate a food safety hazard; or
      3. (c) Reduce a hazard to an acceptable level.

   9. (9) Critical Item.

      1. (a) “Critical item” means a food safety requirement that if violated requires:

         1. (i) Immediate correction;
         2. (ii) The cessation of some or all processing operations; or
         3. (iii) Plant closure.

      2. (b) “Critical item” includes the following requirements:

         1. (i) Food is obtained from an approved source;
         2. (ii) Food is protected from contamination and allergen cross-contact;
         3. (iii) Food processes provide safe food with proper control at critical control points;
         4. (iv) Food is protected by ensuring that all personnel wash hands thoroughly as often as necessary to prevent food contamination by hand contact;
         5. (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;
         6. (vi) Food is packaged and labeled for safety with allergens properly identified on the label;
         7. (vii) A sufficient volume of potable hot and cold water supply under pressure is available; and
         8. (viii) Sewage is discharged in compliance with applicable laws and regulations.
   10. (10) “Department” means the Maryland Department of Health or the Department's designee.

   11. (11) Farm.

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

       2. (b) “Farm” includes a place where, for commercial purposes:

          1. (i) Crops are grown and harvested;
          2. (ii) Fruit, nuts, or other agricultural commodities are harvested from trees; or
          3. (iii) Animals are raised, fed, and managed for meat or other agricultural commodities.

   12. (12) “Food” means:

       1. (a) Articles used for food or drink for humans or other animals;
       2. (b) Chewing gum; and
       3. (c) Individual components of such articles.

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

       1. (a) Milk;
       2. (b) Egg;
       3. (c) Fish;
       4. (d) Crustacean shellfish;
       5. (e) Tree nuts;
       6. (f) Wheat;
       7. (g) Peanuts;
       8. (h) Soybeans; or
       9. (i) Sesame.

   14. (14) Food Processing Plant.

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

          1. (i) Manufacturing;
          2. (ii) Processing;
          3. (iii) Packing;
          4. (iv) Repacking;
          5. (v) Storage; or
          6. (vi) Distribution.

       2. (b) “Food processing plant” includes a:

          1. (i) Crab meat picking plant;
          2. (ii) Food manufacturing plant;
          3. (iii) Cold food warehouse;
          4. (iv) Ambient food warehouse, except as specified in §B(14)(c) of this regulation;
          5. (v) Shellfish plant or dealer;
          6. (vi) Bottled water plant;
          7. (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;
          8. (viii) Cider plant;
          9. (ix) Charity deer processing plant; and
          10. (x) Producer mobile farmer’s market unit.

       3. (c) “Food processing plant” does not include a warehouse or distribution center that:

          1. (i) Stores only sealed containers pre-packaged, ready-to-eat snack foods that do not require temperature control for safety;
          2. (ii) Stores only bottled beverages that do not require temperature control for safety;
          3. (iii) Stores only packaged ice;
          4. (iv) Stores only whole bean, ground or instant coffee, or leaf or instant teas;
          5. (v) Stores only nondairy dehydrated whiteners, sugar, or sugar-free sweeteners; or
          6. (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. (15) “Generally recognized as safe (GRAS)” means that a substance is:

       1. (a) Not harmful to humans consuming the substance under the intended conditions of use; and
       2. (b) In accordance with 21 CFR §170.30.
   16. (16) “Hazard” means any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury

   17. (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:

       1. (a) COMAR 10.15.10 Procedures for the Safe Handling and Processing of Seafood;
       2. (b) COMAR 10.15.12 Procedures for the Safe Handling and Processing of Juice;
       3. (c) 21 CFR Part 123 Fish and Fishery Products; or
       4. (d) The National Advisory Committee on the Microbiological Criteria for Food.
   18. (18) “Indirect food additive” means a substance that is unintentionally incorporated into food due to processing, holding, or packaging.
   19. (19) “Label” means a display of written or graphic matter on the container, other than the package liner, of a food.

   20. (20) “Labeling” means any label or other written or graphic material that:

       1. (a) Is on a:

          1. (i) Food;
          2. (ii) Food container; or
          3. (iii) Food wrapping; or
       2. (b) Accompanies a food.
   21. (21) “Misbranded” has the meaning stated in Health-General Article, §21-210, Annotated Code of Maryland.

   22. (22) “Person-in-charge” means:

       1. (a) The licensee; or
       2. (b) Another person responsible for the operation of the food processing plant.
   23. (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. (24) “Poultry” means any domesticated bird.

   25. (25) Preventive Controls.

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

          1. (i) Identified food safety hazards; or
          2. (ii) Food safety hazards that are reasonably likely to occur.

       2. (b) “Preventive controls” includes:

          1. (i) Process controls;
          2. (ii) Allergen controls;
          3. (iii) Sanitation controls; and
          4. (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. (26) “Preventive controls qualified individual (PCQI)” means an individual who has:

       1. (a) Successfully completed training in the development and application of risk-based preventive controls; or
       2. (b) The education, experience, and knowledge to develop and implement a food safety system.
   27. (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. (28) “Process” means a specific set of operations or procedures used to manufacture a food.

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

       1. (a) Training; and
       2. (b) Experience.

   30. (30) Producer Mobile Farmer’s Market Unit.

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

          1. (i) Protected from contamination during transportation from farm to farmer’s market or public festival or event; and
          2. (ii) Kept at temperatures that support the safety and wholesomeness of the food.

       2. (b) “Producer mobile farmer’s market unit” does not include a unit used to deliver:

          1. (i) Prepackaged foods to fill an order of a customer;
          2. (ii) Raw agricultural products; or
          3. (iii) On-farm home processed foods that do not require temperature control for safety.

   31. (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:

       1. (a) Education;
       2. (b) Training; or
       3. (c) Experience.

   32. (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:

       1. (a) Education;
       2. (b) Training; or
       3. (c) Experience.
   33. (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. (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. (35) “Shell eggs” means raw or treated eggs produced by poultry for human consumption.
   36. (36) “Snack foods” means chips, pretzels, candy, and other novelty snacks.
   37. (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.

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

Effective date: November 18, 1960

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

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

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

Chapter revised as an emergency provision effective August 2, 1989 (16:17 Md. R. 1882); adopted permanently effective December 25, 1989 (16:25 Md. R. 2711)

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

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

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

Regulation .33A amended effective March 4, 1991 (18:4 Md. R. 447); September 28, 1992 (19:19 Md. R. 1708); October 6, 1997 (24:20 Md. R. 1404)

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

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

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

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

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

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

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

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

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

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

Chapter revised as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); revised permanently effective January 24, 2011 (38:2 Md. R. 83)

Regulation .02B amended effective March 5, 2012 (39:4 Md. R. 337); January 6, 2014 (40:26 Md. R. 2163); February 15, 2016 (43:3 Md. R. 272)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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