# COMAR Title 10 — Maryland Department of Health

## Subtitle 15 — Food

### Chapter 06 — Production, Processing, Transportation, Storage, and Distribution of Grade “A” Milk

**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

**Administrative History:** Effective date: July 1, 1972

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

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

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

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

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

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

**Administrative History:** Regulation .03D, E effective September 6, 1974

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

**Administrative History:** Regulation .03F repealed effective October 20, 1997 (24:21 Md.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

**Administrative History:** 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)

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

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

**Administrative History:** Regulations .01—.11 repealed and new Regulations .01—.19 adopted effective March 19, 2010 (37:4 Md.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

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

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

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

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

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

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

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

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

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

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

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

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

#### Regulation .01 Scope.

*COMAR 10.15.06.01*

This chapter:

A. Governs permits for the sale of Grade “A” milk and milk products, as set forth in Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland;

B. Requires a permit for the sale of Grade “A” milk and milk products;

C. Regulates the inspection of Grade “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products; and

D. Sets forth:

  (1) Standards for Grade “A” milk and milk products;

  (2) The enforcement process for the examination, labeling, pasteurization, aseptic processing, retort processing, packaging, and distribution and sale of Grade “A” milk and milk products;

  (3) Penalties pursuant Health-General Article, §§21-211, 21-252— 21-256, 21-418, 21-419, 21-428, 21-1202, and 21-1203, Annotated Code of Maryland; and

  (4) Requirements for Grade “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products.

#### Regulation .02 Definitions.

*COMAR 10.15.06.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Bobtailer” means a person who operates or controls a Grade “A” milk route, and distributes Grade “A” pasteurized milk products that the person buys from a Grade “A” distributor or milk processor.

  (2) “Bulk milk hauler/sampler” means a person who:

    (a) Collects official samples;

    (b) Transports raw milk from a farm or raw milk products to or from a milk plant, receiving station, or transfer station;

    (c) Possesses a permit from any state to sample raw milk or raw milk products; and

    (d) Possesses a Maryland Bulk Milk Hauler license if they are sampling milk or raw milk products in Maryland.

  (3) “Certified industry dairy farm inspector” means an individual who is certified by the Secretary under Health-General Article, §21-414, Annotated Code of Maryland, to carry out the inspections of dairy farms.

  (4) “Dairy farm” means a place where at least one cow, goat, or other hoofed mammal is kept, and from which the milk is sold or offered for sale.

  (5) “Department” means the Maryland Department of Health or the Department's designee.

  (6) “Extensive alteration” means the adding or tearing down of walls, plumbing, or other structural components of a dairy farm or milk plant.

  (7) “Grade “A” distribution station” means a place or vehicle where, for redistribution and sale, Grade “A” pasteurized milk products routinely are received, stored, or transferred.

  (8) “Grade “A” fluid milk” means pasteurized homogenized or pasteurized non-homogenized Grade “A” milk, cream, or half and half that has been processed to produce whole milk, low fat milk, or nonfat milk.

  (9) “Grade “A” milk or milk products” means the milk of a cow, goat, or other hoofed mammal that is produced, processed, pasteurized, bottled, packaged, or prepared in accordance with the Grade “A” Pasteurized Milk Ordinance.

  (10) “Impound” means to detain and hold milk or milk products under the authority of the Secretary, as provided under Health-General Article, §21-428, Annotated Code of Maryland.

  (11) “Improper handling” means Grade “A” milk or a milk product intended for human consumption that:

    (a) Has been adulterated;

    (b) Has been misbranded;

    (c) Has not been kept at the required temperature;

    (d) Is injurious to health if consumed; or

    (e) Is otherwise unsafe.

  (12) “Industry plant sampler” means a person employed at a milk plant, a receiving station, or a transfer station who is responsible for the collection of official samples for regulatory purposes at the milk plant, receiving station, or transfer station.

  (13) “Milk” means the milk of a cow, goat, or other hoofed mammal that is produced, processed, pasteurized, bottled, packaged, or prepared in accordance with the Grade “A” Pasteurized Milk Ordinance.

  (14) “Milk facility” means a:

    (a) Milk plant;

    (b) Grade “A” distribution station;

    (c) Receiving station;

    (d) Transfer station;

    (e) Milk processor; or

    (f) Milk tank truck cleaning facility.

  (15) “Milk marketing agency” means a person who negotiates the price of milk to be offered for sale and supplies milk.

  (16) Milk Plant.

    (a) “Milk plant” means a place where, for distribution, milk products are:

      (i) Processed;

      (ii) Pasteurized;

      (iii) Bottled or packaged; or

      (iv) Prepared.

    (b) “Milk plant” does not include a place where milk products are sold at retail only.

  (17) “Milk processor” means a person who owns, operates, or controls a milk plant.

  (18) “Milk producer” means a person who:

    (a) Operates a dairy farm; and

    (b) Provides, sells, or offers milk for sale to a:

      (i) Milk plant;

      (ii) Receiving station; or

      (iii) Transfer station.

  (19) “Milk tank truck” means a truck and its equipment that are used to transport milk or milk products.

  (20) “Milk tank truck cleaning facility” means a place, premises, or establishment, separate from a milk plant, receiving station, or transfer station, where a milk tank truck is cleaned and sanitized.

  (21) “Milk transportation company” means a person who is responsible for a milk tank truck.

  (22) “Official laboratory” means a biological, chemical, or physical laboratory that is operated by the Department.

  (23) “Officially designated laboratory” means a commercial laboratory authorized to conduct testing of milk and milk products on behalf of the Department or a milk industry laboratory officially designated by the Department for the examination, pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, of:

    (a) Producer samples of Grade “A” raw milk for pasteurization; or

    (b) Commingled milk tank truck samples of Grade “A” raw milk.

  (23-1) “On-farm processor” means a licensed milk plant that is located on the same premises as a licensed milk producer.

  (23-2) Pasteurization.

    (a) “Pasteurization” has the meaning stated in 21 CFR §131.3.

    (b) “Pasteurization” includes any other process found equivalent to pasteurization for milk and milk products as stated in 21 U.S.C. §343(h)

  (24) “Permit” means an official document issued by the Secretary in accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, that authorizes the holder of the permit to do an act that is within the scope of the permit.

  (25) “Permittee” means a person who holds a permit.

  (26) Person.

    (a) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.

    (b) “Person” includes:

      (i) An operator of a facility that is owned by a State or local unit of government; or

      (ii) A State or local unit of government if the State or local unit of government is the operator of the facility.

  (27) “Raw milk” means unpasteurized milk.

  (28) “Receiving station” means a place where, for delivery to a milk plant, raw milk is collected, cooled, and stored.

  (29) “Sale” or “sell” means a transaction that involves the:

    (a) Transfer, dispensing, or serving of milk and milk products with or without charge; or

    (b) Right to acquire milk and milk products:

      (i) Through barter or contractual arrangement; or

      (ii) In exchange for any other form of compensation including, but not limited to, an agistment agreement, which is the sale of shares or interest in a cow, goat, or other lactating hoofed mammal, or herd of cows, goats, or other lactating hoofed mammals.

  (30) “Sanitization” means the application of an effective method or substance to clean surfaces to destroy pathogens and other microorganisms.

  (31) “Seasonal milk producer” means a milk producer that holds a permit to produce milk seasonally and stops producing milk for 30 days or more and then starts producing milk again within 12 months year after year.

  (32) “Secretary” means the Secretary of Health or the Secretary's designee.

  (33) “Sell-by date” means the end of the sell-by period.

  (34) “Transfer station” means a place where milk is transferred directly from a milk tank truck to another milk tank truck for delivery to a milk plant.

  (35) “Ultra-pasteurization” means the process of heating milk or milk product in properly designed and operated equipment to a minimum of 280°F for at minimum two seconds, either before or after packaging, so as to produce a milk or milk product which has an extended shelf-life under refrigerated conditions.

#### Regulation .03 Incorporation by Reference.

*COMAR 10.15.06.03*

In this chapter the following documents are incorporated by reference:

A. Grade “A” Pasteurized Milk Ordinance, 20239evision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration);

B. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f, as amended;

C. Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended;

D. FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252, as amended; and;

E. 21 CFR §§130—131, as amended.

#### Regulation .04 General Requirements.

*COMAR 10.15.06.04*

A. The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth at and in compliance with the standards, requirements, and procedures specified at:

  (1) Health-General Article, Title 21, Annotated Code of Maryland;

  (2) Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f;

  (3) Nutrition Labeling and Education Act of 1990 (Public Law 101-535);

  (4) Grade “A” Pasteurized Milk Ordinance; and

  (5) FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252.

B. A person engaged in an occupation involving Grade “A” milk shall conduct all Grade “A” milk activities as set forth at and in compliance with the standards, requirements, and procedures specified at:

  (1) Health-General Article, Title 21, Annotated Code of Maryland;

  (2) Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f;

  (3) Nutrition Labeling and Education Act of 1990 (Public Law 101-535); and

  (4) Grade “A” Pasteurized Milk Ordinance.

#### Regulation .05 Standards for Milk Products.

*COMAR 10.15.06.05*

A. A permittee shall ensure that all raw milk for pasteurization and all pasteurized milk and milk products conform to the standards, requirements, and procedures established by the:

  (1) Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f;

  (2) Nutrition Labeling and Education Act of 1990 (Public Law 101-535);

  (3) Health-General Article, §§21-422 and 21-434, Annotated Code of Maryland; and

  (4) Grade “A” Pasteurized Milk Ordinance.

B. A bulk milk hauler/sampler shall ensure that:

  (1) Bulk raw milk is delivered or received by the processor or receiving station within 12  hours of  pickup route completion;

  (2) Bulk raw milk is picked up from every dairy farm at least once every 72 hours; and;

  (3) The temperature of the bulk raw milk does not exceed 45F.

C. The person in charge of an official laboratory or officially designated laboratory shall ensure that:

  (1) The laboratory is operated according to the requirements established by the Grade “A” Pasteurized Milk Ordinance; and

  (2) All raw milk for pasteurization, all pasteurized milk and milk products, and all dairy product containers and lids are tested according to the requirements established by the Grade “A” Pasteurized Milk Ordinance.

#### Regulation .06 Permits Required.

*COMAR 10.15.06.06*

A. Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, to the Department before that person may:

  (1) Be a:

    (a) Bobtailer;

    (b) Bulk milk hauler/sampler;

    (c) Certified industry dairy farm inspector;

    (d) Milk processor;

    (e) Milk producer; or

    (f) Seasonal milk producer; or

  (2) Operate a:

    (a) Grade “A” distribution station;

    (b) Milk tank truck cleaning facility;

    (c) Milk transportation company;

    (d) Receiving station; or

    (e) Transfer station.

B. Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, for a milk tank truck.

C. Under Health-General Article, §21-410(c), Annotated Code of Maryland, a permit is not required for:

  (1) A milk producer who is outside the departmental inspection area if the raw milk from that milk producer is processed by a milk processor who holds a permit issued under this chapter;

  (2) A bulk milk hauler/sampler who receives raw milk from outside the departmental inspection area;

  (3) A grocery store, restaurant, soda fountain, or similar establishment where milk products are served or sold at retail if:

    (i) The establishment complies with all applicable provisions of Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, and all applicable rules or regulations; and

    (ii) The milk product is received from a permittee; or

  (4) An individual who only transports milk in a sealed tanker to a milk plant, receiving station, or transfer station and not producers’ samples.

#### Regulation .07 Inspection and Evaluation of Milk Production and Transportation.

*COMAR 10.15.06.07*

A. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall inspect:

  (1) A milk tank truck;

  (2) A milk producer;

  (3) A seasonal milk producer;

  (4) A transfer station;

  (5) A milk tank truck cleaning facility;

  (6) A milk plant; and

  (7) A receiving station.

B. The Secretary shall inspect a seasonal milk producer before the first shipment of milk and at least every 6 months until production of milk for sale has ceased.

C. The Secretary shall inspect a Grade “A” distribution station at least once every 6 months.

D. The Secretary shall inspect a bobtailer at least once every 12 months.

E. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall evaluate:

  (1) The ability of the certified industry dairy farm inspector to perform dairy farm inspections and raw milk sampling;

  (2) The pick-up and sampling procedures that a bulk milk hauler/sampler performs; and

  (3) The sampling procedures of the industry plant sampler.

F. The Secretary shall inspect and evaluate a bulk milk hauler/sampler as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B.

G. The Secretary shall inspect a milk tank truck as set forth in the Grade “A” Pasteurized Milk Ordinance and Appendix B.

H. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix N, the Secretary shall evaluate:

  (1) Laboratories performing Grade “A” milk product testing for official use;

  (2) Laboratories performing drug residue testing; and

  (3) Laboratory analysts performing testing as required by the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix N.

#### Regulation .08 Improper Handling of Milk Products.

*COMAR 10.15.06.08*

A. Under Health-General Article, §21-428, Annotated Code of Maryland, and to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall impound Grade A milk or milk products intended for human consumption due to improper handling.

B. After impounding the Grade A milk or milk product, the Secretary may issue an order to:

  (1) Dispose of the milk or milk product;

  (2) Make the milk or milk product unusable for consumption; or

  (3) Under Health-General Article, §21-428, Annotated Code of Maryland, impose a civil monetary penalty, as set forth in §C of this regulation.

C. The Secretary shall determine the amount of the civil monetary penalty by multiplying the current milk price, as announced by the Federal Milk Market Administrator, on the date of the impounding by the volume of the milk listed on the shipping documents.

D. A person subject to an impoundment order may seek legal recourse as set forth at Health-General Article, §21-428, Annotated Code of Maryland, by:

  (1) Appealing a civil penalty; or

  (2) Bringing an action for damages.

#### Regulation .09 Labeling of Milk.

*COMAR 10.15.06.09*

A permittee shall ensure that milk product labels conform to the standards and requirements established by the:

A. Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §§341—350f;

B. Nutrition Labeling and Education Act of 1990 (Public Law 101-535);

C. Grade “A” Pasteurized Milk Ordinance; and

D. Health-General Article, §§21-422, 21-424, and 21-425, Annotated Code of Maryland.

#### Regulation .10 Dating of Grade “A” Fluid Milk.

*COMAR 10.15.06.10*

A. Unless approved by the Department as described in §B of this regulation, a person may not sell, deliver, or offer Grade “A” milk or milk products that are cooled to, packaged, and stored at 45°F or less for sale after 18 days from the date of processing.

B. In order to sell, deliver, or offer Grade “A” milk or milk products that are cooled to, packaged, and stored at 45°F or less for sale after 18 days from the date of processing, an applicant shall:

  (1) Submit to the Department:

    (a) A written request; and

    (b) A shelf life study to show that the product meets standards set forth in this chapter; and

  (2) Be approved by the Department.

C. A permittee shall conspicuously and legibly mark the cap or non-glass container of Grade “A” fluid milk with the words “Sell by”, followed by the designation of the month and the day of the month after which the product may not be sold, delivered, or offered for sale.

D. Milk products exempt from dating requirements are:

  (1) Cultured milk products and eggnog;

  (2) Milk and dairy products as defined by 21 CFR §§130—131, which have been subjected to aseptic processing and packaging; and

  (3) Milk and dairy products as defined in 21 CFR §131.3(c), which have been subjected to ultra-pasteurization.

#### Regulation .11 Sale and Handling of Milk by Food Service Facilities.

*COMAR 10.15.06.11*

A. Except as provided in §B of this regulation, a person may not offer Grade “A” fluid milk for sale beyond the sell-by date.

B. The following establishments may use or serve Grade “A” fluid milk up to 4 days beyond the sell-by date:

  (1) Food service facilities;

  (2) Hospitals;

  (3) Schools;

  (4) Institutions; and

  (5) Places where milk is consumed on the premises.

C. An establishment listed in §B of this regulation shall ensure that Grade “A” fluid milk is used by the establishment not later than 4 days beyond the sell-by date.

#### Regulation .12 Sale of Raw Milk.

*COMAR 10.15.06.12*

A. Under Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell raw milk for human consumption.

B. A permitted milk producer may sell raw milk from the milk producer’s dairy farm only to a permitted:

  (1) Receiving station;

  (2) Transfer station;

  (3) Milk plant; or

  (4) Milk marketing agency.

#### Regulation .13 Dairy Farm Construction and Plan Submission.

*COMAR 10.15.06.13*

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

A. A plan and specifications before:

  (1) Constructing or reconstructing a milk house, milking barn, milking stable, or milking parlor;

  (2) Converting or remodeling an existing building or structure for use as a milk house, milking barn, milking stable, or milking parlor; or

  (3) Adding, modifying, or replacing:

    (a) A bulk milk tank;

    (b) A milking system;

    (c) Any part of a milking system;

    (d) A washing system;

    (e) Any part of a washing system; or

    (f) A cooling system, including a plate cooler or bulk tank cooling system; and

B. A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work;

C. Contact information for the dairy farm, including:

  (1) The full name, title, and telephone number of each applicant;

  (2) The name of the dairy farm;

  (3) The mailing address;

  (4) The location; and

  (5) Directions to the site;

D. A site drawing showing the location of the milk house, milking barn, milking stable, milking parlor, and each animal housing area, with approximate distances in feet, to:

  (1) Manure pits;

  (2) Cow yards;

  (3) Silos;

  (4) Wells or other approved water systems;

  (5) Septic systems;

  (6) Frost free style watering hydrants;

  (7) Ditches; and

  (8) Streams;

E. A detailed drawing of the interior of the milk house, milking barn, milking stable, milking parlor, and each animal housing area indicating dimensions and showing the location of:

  (1) Equipment;

  (2) Pre-coolers;

  (3) Floor drains;

  (4) Lighting;

  (5) Hose bibs;

  (6) Watering troughs;

  (7) Frost free style watering hydrants;

  (8) Washing systems;

  (9) Chemical dispensers;

  (10) Compressors;

  (11) Back flow prevention devices; and

  (12) Toilets;

F. For pipeline and milking system installations:

  (1) The make, model number, quantity, and specifications of milking equipment including pipeline and milking units;

  (2) The make and model number of pumps used in the milking system, including specifications such as horsepower and cubic feet per minute;

  (3) A drawing of the parlor or barn showing the location of:

    (a) Milking equipment;

    (b) Pipeline, including size and length of the piping;

    (c) Wash line, including size and length of the wash line;

    (d) Receiver, if applicable;

    (e) Pre-cooler, if applicable;

    (f) Any other milk equipment; and

    (g) The milk house, bulk tank, and animal housing area in relation to the milking parlor or milking barn;

  (4) A description and diagram of the location of the back flow protection methods or devices that will be installed to protect the potable water supply on all plate coolers, chemical pumps, water lines, and other fixtures;

  (5) The type, such as gas or electric, and capacity of the hot water heating system; and

  (6) Information and specifications for booster or supplemental heating systems, if utilized;

G. For bulk tank/milk cooling systems installation:

  (1) A drawing of the milk house with bulk tank location, floor drain locations, and clearance dimensions on both sides, in front, and above the manhole of the bulk tank;

  (2) Specific floor, wall, and ceiling finishes, if part of a new installation;

  (3) Bulk tank specifications, including make, model number, and capacity;

  (4) Cooling system specifications, including make, model number, and capacity; and

  (5) Pre-cooler type and British thermal units capability, if applicable.

#### Regulation .14 Dairy Farm Requirements.

*COMAR 10.15.06.14*

A milk producer shall ensure that:

A. Construction of all equipment, milking barns, stables, parlors, milk houses, and each animal housing area complies with the requirements of the Grade “A” Pasteurized Milk Ordinance and Regulation .13 of this chapter, as applicable;

B. Water used at a dairy farm shall:

  (1) Be obtained from a water supply system that complies with:

    (a) Environment Article, Title 9, Annotated Code of Maryland;

    (b) COMAR 26.04.04; and

    (c) The Grade “A” Pasteurized Milk Ordinance;

  (2) Be installed in a manner that prevents backflow or back-siphoning;

  (3) Be separate from a non-potable water supply system so that non-potable water cannot be drawn or discharged into the potable water supply system;

  (4) Provide hot and cold running water in areas where milk processing equipment is washed; and

  (5) Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system;

C. Hand sinks shall have:

  (1) Either:

    (a) Hot and cold running water under pressure; or

    (b) Warm running water;

  (2) A supply of hand-cleaning soap or detergent; and

  (3) A sanitary means of drying hands, such as individual towels or a hand-drying device;

D. A sewage system is constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;

E. Toilet facilities, if any, are constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;

F. Plumbing is sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and

G. Electrical systems comply with State and local electrical laws, ordinances, and regulations, and the Grade “A” Pasteurized Milk Ordinance.

#### Regulation .15 Milk Facility Construction and Plan Submission.

*COMAR 10.15.06.15*

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:

A. Plans 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 time line 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 skim, 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 back flow 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. Information and drawings on how separation from product lines will be accomplished, if applicable;

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

  (1) Receiving, processing, storing, and packaging of each project;

  (2) Drug residue testing;

  (3) Cleaning and sanitization for all equipment;

  (4) Cleaning and sanitization for the facility;

  (5) Product trace back, inclusive of production or make sheet; and

  (6) Product recall;

U. A pest control program; and

V. Employee training and personal hygiene practices.

#### Regulation .16 Milk Physical Plant Requirements.

*COMAR 10.15.06.16*

A. Water used at a milk facility shall:

  (1) Be obtained from a potable water supply system that complies with:

    (a) Environment Article, Title 9, Annotated Code of Maryland;

    (b) COMAR 26.04.04; and

    (c) The Grade “A” Pasteurized Milk Ordinance;

  (2) Be installed in a manner that prevents backflow or back-siphoning; and

  (3) Be separate from a non-potable water supply system so that non-potable water cannot be drawn or discharged into the potable water supply system;

  (4) Provide hot and cold running water in areas where milk processing equipment is washed; and

  (5) Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system.

B. Hand sinks shall have:

  (1) Either:

    (a) Hot and cold running water under pressure; or

    (b) Warm running water;

  (2) A supply of hand-cleaning soap or detergent; and

  (3) A sanitary means of drying hands, such as individual towels or a hand-drying device.

C. A sewage system shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance.

D. Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations.

E. Toilet facilities shall:

  (1) Be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;

  (2) For a milk plant that is not an on-farm processor, be available within the physical plant for use by employees; and

  (3) For a milk plant that is an on-farm processor, if not located within the physical plant building:

    (a) Be located within 500 feet of the physical plant building;

    (b) Be accessible at all times that the plant is in operation;

    (c) Have documented and implemented measures for re-entry into the plant to protect against facility and product contamination; and

    (d) Have documentation from the local approval authority that an on-site sewage disposal system, if present, is adequate for the total number of users and meets all other requirements of COMAR 26.04.02.

F. Electrical systems at the facility shall:

  (1) Comply with State and local electrical laws, ordinances, and regulations;

  (2) Provide adequate lighting sources that furnish at least 40 foot-candles of light in all working areas in all rooms where:

    (a) Milk or milk products are handled, processed, packaged, or stored; or

    (b) Containers, utensils, and equipment are washed; and

  (3) Provide adequate lighting sources that furnish at least 20 foot-candles of light in dry storage and cold storage rooms.

#### Regulation .17 Plan Review Approval.

*COMAR 10.15.06.17*

A. An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department.

B. An applicant for a permit shall submit a plan to the Department that includes the requirements set forth in Regulations .13—.16 of this chapter.

C. The Department shall:

  (1) Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .13—.16 of this chapter; and

  (2) Inform the applicant:

    (a) That the plan has been received;

    (b) If additional information is required to complete the plant review;

    (c) Whether the plan is approved or denied; and

    (d) Of the appeal process if the plan is denied.

#### Regulation .18 Confidentiality.

*COMAR 10.15.06.18*

The Department shall maintain confidentiality of records submitted by a person in accordance with General Provisions Article, §4-335, Annotated Code of Maryland.

#### Regulation .19 Suspension and Revocation of Permits.

*COMAR 10.15.06.19*

A. When a permittee is found in violation of this chapter and the Grade “A” Pasteurized Milk Ordinance, the Secretary may suspend or revoke a permit as set forth in this regulation and Health-General Article, §21-211, 21-418, or 21-419, Annotated Code of Maryland or the Grade “A” Pasteurized Milk Ordinance.

B. Except as otherwise provided in this regulation, before suspending a permit, the Secretary shall give to the permittee notice of intent to suspend as provided by Health-General Article, §21-418, Annotated Code of Maryland.

C. The Department may suspend a permit if the permittee fails or neglects to correct a violation within the specified time period.

D. If a permit has been suspended more than once, the Secretary may revoke the permit.

E. The Department shall ensure that an opportunity for a hearing is provided to a person whose permit has been suspended or revoked.

F. When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to Health-General Article, §21-418(c) and State Government Article, §10-226(c)(2), Annotated Code of Maryland, the:

  (1) Department shall:

    (a) Summarily suspend the permit;

    (b) Order the permittee to cease operation immediately; and

    (c) Promptly provide the permittee with:

      (i) A written notice of the suspension of the permit;

      (ii) The reasons for the suspension; and

      (iii) An opportunity to be heard; and

  (2) Permittee shall immediately cease operation upon the receipt of the summary suspension order.

#### Regulation .20 Appeals Process.

*COMAR 10.15.06.20*

In accordance with the Administrative Procedures Act and Health-General Article, §21-419, Annotated Code of Maryland, the Department shall ensure that an opportunity for a hearing is provided to a permittee whose plan review or permit has been:

A. Denied;

B. Suspended; or

C. Revoked.