Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department:

1. A. Plans and specifications before:

   1. (1) Constructing, reconstructing, or extensively altering a milk facility;
   2. (2) Converting or remodeling an existing building or structure for use as a milk facility;
   3. (3) Adding, replacing, relocating, or modifying a milk facility process; or
   4. (4) Adding, modifying, or replacing a clean-in-place (CIP) or other washing system or any part of a clean-in-place or other washing system;
2. B. Plans and drawings bearing the name of a professional engineer or a representative of the company performing the work.

3. C. Contact information for the facility, including:

   1. (1) The full name, title, and telephone number of each applicant;
   2. (2) The name of the plant;
   3. (3) The mailing address;
   4. (4) The location; and
   5. (5) Directions to the site;
4. D. A narrative describing the scope and purpose of the project, including a projected time line from start to completion;
5. E. An estimate of finished product output per day;
6. F. Sample product labels for each product;

7. G. A list of:

   1. (1) All products to be produced;
   2. (2) Raw cream and skim, condensed, or any other milk or milk products to be sold; and
   3. (3) Single service container sources;

8. H. A scale drawing showing the layout and arrangement of areas within and around the milk facility, including areas for:

   1. (1) Processing;
   2. (2) Chemical storage;
   3. (3) Dry storage;
   4. (4) Ingredient and product storage;
   5. (5) Receiving;
   6. (6) Load out;
   7. (7) Laboratories;
   8. (8) Offices;
   9. (9) Restroom facilities;
   10. (10) Lockers or a facility for the storage of personal items; and
   11. (11) Employees to eat and drink beverages;

9. I. A scale drawing showing the location of all equipment, including:

   1. (1) Pasteurizers and sterile systems;
   2. (2) Milk processing equipment;
   3. (3) Fillers;
   4. (4) Raw and pasteurized tanks and silos;
   5. (5) Clean-in-place (CIP) systems;
   6. (6) Glycol water tanks;
   7. (7) Recirculating cooling water tanks;
   8. (8) Boilers;
   9. (9) Boiler makeup tanks;
   10. (10) Culinary steam systems; and
   11. (11) Blow mold systems;

10. J. A scale drawing showing the location of plumbing and plumbing fixtures, including:

    1. (1) Water lines;
    2. (2) Sewer lines;
    3. (3) Hand sinks;
    4. (4) Toilets;
    5. (5) Utility sinks;
    6. (6) Utensil washing sinks;
    7. (7) Floor drains;
    8. (8) Floor sinks;
    9. (9) Hose stations; and
    10. (10) All back flow prevention devices;
11. K. A legend for each drawing;

12. L. Specifications for:

    1. (1) Ventilation including, but not limited to, the type and location of:

       1. (a) An air filter;
       2. (b) An air pump; and
       3. (c) A compressor;
    2. (2) Construction materials for the building and interior finishes; and
    3. (3) Pasteurizer plate coolers, if separate from the pasteurization system;
13. M. A list and description of all boiler, glycol, and recirculating water additives and water treatment;

14. N. A description of the:

    1. (1) Type of disposal for wastewater and sewage;
    2. (2) Source and system for the facility’s potable water supply;
    3. (3) Lighting fixtures and placement; and
    4. (4) Recirculating cooling system;
15. O. Specification sheets, including manufacturer and model number of all milk facility equipment;

16. P. A document that lists the flow for all products through the plant, grouped in categories, identifying each functional piece of equipment and each process used in processing and packaging, including:

    1. (1) Reclamation systems;
    2. (2) Standardization procedures or formulation procedures, or both;
    3. (3) Vitamin addition protocol; and
    4. (4) Draining of product lines;
17. Q. Plans, specifications, drawings, and flow diagrams for each high temperature short time (HTST) and higher heat short time (HHST) system, showing each functional component;
18. R. Clean-in-place (CIP) flow diagrams from the makeup tanks through all equipment;
19. S. Information and drawings on how separation from product lines will be accomplished, if applicable;

20. T. Written step-by-step standard operating procedures for:

    1. (1) Receiving, processing, storing, and packaging of each project;
    2. (2) Drug residue testing;
    3. (3) Cleaning and sanitization for all equipment;
    4. (4) Cleaning and sanitization for the facility;
    5. (5) Product trace back, inclusive of production or make sheet; and
    6. (6) Product recall;
21. U. A pest control program; and
22. V. Employee training and personal hygiene practices.

Authority: Health-General Article, §§2-104, 2-105, 21-207, 21-208, 21-210, 21-211, 21-406, and 21-428, Annotated Code of Maryland

Effective date: July 1, 1972

Regulations .01 and .03A amended effective February 2, 1977 (4:3 Md. R. 145)

Regulation .01AA, FF adopted effective August 25, 1978 (5:17 Md. R. 1330)

Regulation .01-1 adopted effective February 12, 2007 (34:3 Md. R. 299)

Regulation .01-2 adopted effective February 12, 2007 (34:3 Md. R. 299)

Regulation .03A amended effective October 20, 1997 (24:21 Md. R. 1449)

Regulation .03C amended effective August 25, 1978 (5:17 Md. R. 1330)

Regulation .03D, E effective September 6, 1974

Regulation .03F adopted effective January 11, 1980 (7:1 Md. R. 44)

Regulation .03F repealed effective October 20, 1997 (24:21 Md. R. 1449)

Regulation .06 amended as an emergency provision effective April 6, 2006 (33:9 Md. R. 795); amended permanently effective August 28, 2006 (33:17 Md. R. 1436)

Regulation .06C amended effective September 5, 1988 (15:18 Md. R. 2148); September 13, 1993 (20:18 Md. R. 1430)

Regulation .08B amended effective August 24, 1979 (6:17 Md. R. 1394)

Regulations .01—.11 repealed and new Regulations .01—.19 adopted effective March 19, 2010 (37:4 Md. R. 341)

Regulation .03A amended effective March 7, 2011 (38:5 Md. R. 317)

Regulation .03A amended effective October 15, 2012 (39:20 Md. R. 1306)

Chapter revised effective February 27, 2017 (44:4 Md. R. 254)

Regulation .02B amended effective May 18, 2020 (47:10 Md. R. 517); August 5, 2024 (51:15 Md. R. 708)

Regulation .03 amended effective August 5, 2024 (51:15 Md. R. 708)

Regulation .03A amended effective May 18, 2020 (47:10 Md. R. 517)

Regulation .03B amended effective February 16, 2026 (53:3 Md. R. 122)

Regulation .05B amended effective August 5, 2024 (51:15 Md. R. 708)

Regulation .10D amended effective August 5, 2024 (51:15 Md. R. 708)

Regulation .11 amended effective August 5, 2024 (51:15 Md. R. 708)

Regulation .16E adopted effective May 18, 2020 (47:10 Md. R. 517)

Regulation .16F amended effective May 18, 2020 (47:10 Md. R. 517)