The person-in-charge shall ensure that:

1. A. All food and food ingredients processed in a food processing plant:

   1. (1) Are from an approved source;
   2. (2) Are GRAS;
   3. (3) If applicable, conform to a standard of identity, as defined in 21 CFR Part 130;
   4. (4) Comply with FDA regulations for poisonous or deleterious substances; and
   5. (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;

2. B. When ice is used in contact with food, it shall be:

   1. (1) Made from potable water; and
   2. (2) Manufactured and stored in accordance with this chapter;
3. C. Compressed air or other gasses mechanically introduced into food do not contaminate the food with unlawful indirect food additives;

4. D. Raw materials and other ingredients:

   1. (1) Are inspected at receipt to ensure that they are acceptable for use; and
   2. (2) Are washed or cleaned as necessary to remove soil or other contamination;

5. E. Food is processed and stored under conditions and control procedures that prevent and protect from:

   1. (1) Contamination; and
   2. (2) Allergen cross-contact;

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

   1. (1) Food safety controls;
   2. (2) Operating practices; and

   3. (3) Separation of operations by:

      1. (a) Location;
      2. (b) Time; or
      3. (c) Effective design;

7. G. Food is processed and stored at temperatures that:

   1. (1) Minimize the potential for the growth of microorganisms; and
   2. (2) Prevent adulteration;
8. H. The thermal processing of food eliminates or reduces the number of pathogens in the food so that the food is safe for human consumption;

9. I. The cooling of foods is conducted using methods that:

   1. (1) Minimize the potential for the growth of microorganisms; and
   2. (2) Prevent adulteration;

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

    1. (1) 38°F or less for foods with a non-proteolytic Clostridium botulinum potential hazard;
    2. (2) 40°F or less;
    3. (3) 45°F or less for molluscan shellfish or shell eggs;
    4. (4) 135°F or higher; or
    5. (5) As otherwise approved by the Department;
11. K. 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;
12. L. 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;
13. M. Adequate measures are taken to protect against the inclusion of metal or other extraneous material in food;
14. N. Frozen food remains frozen when stored or removed from refrigeration in order to be segregated, organized, or moved;
15. O. Frozen foods are thawed in a manner that prevents contamination;

16. P. Any food, raw material, or ingredient that is adulterated is not offered to human beings and is:

    1. (1) Rejected upon receipt;
    2. (2) Treated or processed to eliminate the contamination;
    3. (3) Destroyed in a manner that protects against the contamination and allergen cross-contact of other food;

    4. (4) Stored only in a designated area that is:

       1. (a) Separated from all other food and food process operations; and
       2. (b) Conspicuously marked with the intended disposition;
    5. (5) Reconditioned using a method that is safe and effective;
    6. (6) Reexamined following reconditioning and subsequently found not to be adulterated;
    7. (7) Not mixed with another lot of food that is not adulterated; and

    8. (8) If detained by the Department:

       1. (a) Reconditioned; or
       2. (b) Destroyed in a manner approved by the Department;

17. Q. A facility that only stores unexposed packaged foods that require time and temperature control to significantly minimize or prevent pathogens:

    1. (1) Establishes and implements temperature controls that significantly minimize or prevent the growth of, or toxin production by, pathogens;
    2. (2) Monitors the temperature controls with adequate frequency;
    3. (3) Takes appropriate corrective actions if there is a loss of temperature control that may impact the safety of the food;
    4. (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. (5) Reviews records of monitoring and corrective actions taken to correct a problem with the control of temperature within:

       1. (a) 7 working days after the records are created; or
       2. (b) A reasonable time frame; and
    6. (6) Reviews records of calibration or accuracy checks within a reasonable time frame after the records are created;

18. R. Written standard operating procedures are:

    1. (1) Available to employees in a format they understand;
    2. (2) Implemented; and
    3. (3) Reflective of current manufacturing procedures;

19. S. When the Department requires a scheduled process, the scheduled process is:

    1. (1) Established by a process authority;
    2. (2) Used to manufacture the target food;
    3. (3) Not changed without approval of the process authority;

    4. (4) Documented by:

       1. (a) Production records; and
       2. (b) Process deviation records; and

    5. (5) Verified by:

       1. (a) Production records review;
       2. (b) Equipment calibration; or
       3. (c) Laboratory testing;
20. T. Records that document compliance with this regulation are maintained in accordance with Regulation .06 of this chapter;

21. U. Human food by-products for use or distribution as animal food without additional manufacturing or processing are:

    1. (1) Accurately identified when stored;
    2. (2) Stored under conditions that protect against contamination; and
    3. (3) Labeled or accompanied by a label identifying the by-product by the common or usual name when distributed;
22. V. 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
23. W. 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.

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)