Md. Code Regs. - Milk Facility Construction and Plan Submission

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:

A. A plan and specifications before:
(1) Constructing, reconstructing, or extensively altering a milk facility;
(2) Converting or remodeling an existing building or structure for use as a milk facility;
(3) Adding, replacing, relocating, or modifying a milk facility process; or
(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;
B. Plans and drawings bearing the name of a professional engineer or a representative of the company performing the work;
C. Contact information for the facility, including:
(1) The full name, title, and telephone number of each applicant;
(2) The name of the plant;
(3) The mailing address;
(4) The location; and
(5) Directions to the site;
D. A narrative describing the scope and purpose of the project, including a projected timeline from start to completion;
E. An estimate of finished product output per day;
F. Sample product labels for each product;
G. A list of:
(1) All products to be produced;
(2) Raw cream and nonfat, condensed, or any other milk or milk products to be sold; and
(3) Single service container sources;
H. A scale drawing showing the layout and arrangement of areas within and around the milk facility, including areas for:
(1) Processing;
(2) Chemical storage;
(3) Dry storage;
(4) Ingredient and product storage;
(5) Receiving;
(6) Load out;
(7) Laboratories;
(8) Offices;
(9) Restroom facilities;
(10) Lockers or a facility for the storage of personal items; and
(11) Employees to eat and drink beverages;
I. A scale drawing showing the location of all equipment, including:
(1) Pasteurizers and sterile systems;
(2) Milk processing equipment;
(3) Fillers;
(4) Raw and pasteurized tanks and silos;
(5) Clean-in-place (CIP) systems;
(6) Glycol water tanks;
(7) Recirculating cooling water tanks;
(8) Boilers;
(9) Boiler makeup tanks;
(10) Culinary steam systems; and
(11) Blow mold systems;
J. A scale drawing showing the location of plumbing and plumbing fixtures, including:
(1) Water lines;
(2) Sewer lines;
(3) Hand sinks;
(4) Toilets;
(5) Utility sinks;
(6) Utensil washing sinks;
(7) Floor drains;
(8) Floor sinks;
(9) Hose stations; and
(10) All backflow prevention devices;
K. A legend for each drawing;
L. Specifications for:
(1) Ventilation including, but not limited to, the type and location of:
(a) An air filter;
(b) An air pump; and
(c) A compressor;
(2) Construction materials for the building and interior finishes; and
(3) Pasteurizer plate coolers, if separate from the pasteurization system;
M. A list and description of all boiler, glycol, and recirculating water additives and water treatment;
N. A description of the:
(1) Type of disposal for wastewater and sewage;
(2) Source and system for the facility's potable water supply;
(3) Lighting fixtures and placement; and
(4) Recirculating cooling system;
O. Specification sheets, including manufacturer and model number of all milk facility equipment;
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) Reclamation systems;
(2) Standardization procedures or formulation procedures, or both;
(3) Vitamin addition protocol; and
(4) Draining of product lines;
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;
R. Clean-in-place (CIP) flow diagrams from the makeup tanks through all equipment;
S. If applicable, information and drawings on how separation from product lines will be accomplished;
T. Written step-by-step standard operating procedures (SOPs and SSOPs) for the following, if not included in §W of this regulation:
(1) Receiving, processing, storing, and packaging of each product;
(2) Drug residue testing;
(3) Cleaning and sanitization for all equipment;
(4) Cleaning and sanitization for the facility; and
(5) Product trace back, inclusive of production/make sheet;
U. A pest control program;
V. Employee training and personal hygiene practices; and
W. A food safety plan that complies with 21 CFR Part 117 and at a minimum includes:
(1) A written hazard analysis;
(2) Written preventive controls that address:
(a) Process preventive controls;
(b) Food allergens;
(c) Sanitation;
(d) Supply-chain controls;
(e) A product recall plan; and
(f) Other hazards identified in the hazard analysis as requiring a preventive control;
(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) Written corrective action procedures as appropriate to the nature of the hazard and the nature of the preventive control; and
(5) Written verification procedures as appropriate to the nature of the preventative control and its role in the facility's food safety system.


Md. Code Regs.
Regulation .17 adopted effective 46:10 Md. R. 485, eff. 5/20/2019

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