Pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 12 for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department:

1. A. A plan 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 timeline 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 nonfat, 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 backflow 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. If applicable, information and drawings on how separation from product lines will be accomplished;

20. T. Written step-by-step standard operating procedures (SOPs and SSOPs) for the following, if not included in §W of this regulation:

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

23. W. A food safety plan that complies with 21 CFR Part 117 and at a minimum includes:

    1. (1) A written hazard analysis;

    2. (2) Written preventive controls that address:

       1. (a) Process preventive controls;
       2. (b) Food allergens;
       3. (c) Sanitation;
       4. (d) Supply-chain controls;
       5. (e) A product recall plan; and
       6. (f) Other hazards identified in the hazard analysis as requiring a preventive control;
    3. (3) Written procedures for monitoring the implementation of the preventive controls as appropriate to the nature of the preventative control and its role in the facility’s food safety system;
    4. (4) Written corrective action procedures as appropriate to the nature of the hazard and the nature of the preventive control; and
    5. (5) Written verification procedures as appropriate to the nature of the preventative control and its role in the facility’s food safety system.

Authority: Health-General Article, §§2-104, 2-105, 21-207, 21-208, 21-210, 21-211, 21-405, 21-406, 21-428, Annotated Code of Maryland

Effective date: April 10, 1995 (22:7 Md. R. 536)

Regulations .01—.20 repealed and new Regulations .01—.22 adopted effective May 20, 2019 (46:10 Md. R. 488)