Code of Maryland Regulations (Last Updated: April 6, 2021) |
Title 10. Maryland Department of Health |
Part 3. |
Subtitle 15. FOOD |
Chapter 10.15.09. Production, Processing, Transportation, Storage, and Distribution of Manufactured Grade Milk |
Sec. 10.15.09.17. Milk Facility Construction and Plan Submission
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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 facilitys 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 facilitys 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 facilitys food safety system.