PROPOSAL
Maryland Register
Issue Date: December 9, 2016
Volume 43 • Issue 25• Pages 1407—1414
Title 10
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Notice of Proposed Action
[16-310-P-I]
The Secretary of Health and Mental Hygiene proposes to:
(1) Adopt new Regulations .01, .26-1, and .26-2, recodify existing Regulation .01 to be Regulation .01-1, amend Regulations .13, .14, .20-1, .21, .24—.25, repeal existing Regulation .26, and adopt new Regulation .26 under COMAR 10.15.05 Manufacture and Sale of Frozen Dairy Foods and Ices Manufactured for Sale in Maryland;
(2) Amend Regulations .01—.07, .10, .12—.16, .18 and .19, repeal existing Regulation .17, and adopt new Regulations .17 and .20 under COMAR 10.15.06 Production, Processing, Transportation, Storage, and Distribution of Grade A Milk; and
(3) Amend Regulations .02 and .03 under COMAR 10.15.08 Farmstead Cheese Program.
Statement of Purpose
The purpose of this action is to:
(1) Update incorporation by reference for The Grade “A” Pasteurized Milk Ordinance to reflect the most recent version of this document from 2015;
(2) Incorporate by reference 21 CFR §§130—131 and two additional documents in COMAR 10.15.06: the 2016 Bulk Milk Hauler/Sampler Manual, and the FDA Food Safety Modernization Act;
(3) Recodify Regulation .01 to be Regulation .01-1 under COMAR 10.15.05 to account for the addition of a new Incorporation by Reference regulation and update references throughout the chapter;
(4) Update the number of days after processing milk or milk products can be offered for sale from 30 to 18 days;
(5) Remove the word “Pilot” from the chapter title of COMAR 10.15.08;
(6) Update the definition of “bulk milk hauler/sampler” in COMAR 10.15.06.02 to include that a bulk milk hauler/sampler possesses a Maryland Bulk Milk Hauler license if they are sampling milk or raw milk products in Maryland;
(7) Update the definition of “sale” or “sell” in COMAR 10.15.06.02 to include the serving of milk and milk products, and to include language that the transfer, dispensing or serving of milk or milk products is considered a sale with or without charge;
(8) Add the requirement that a person must obtain a permit for a milk tank truck, and that a permit is not needed for an individual transporting milk in a sealed tanker to a milk plant whether or not they have accompanying producers’ samples in COMAR 10.15.06.06;
(9) Add requirements for the Secretary to inspect milk producers, bulk milk hauler/samplers, milk tank trucks, and laboratories in COMAR 10.15.06.07;
(10) Add language on how applicants can request an extension for a sell by date and on products exempt from dating requirements in COMAR 10.15.06.10;
(11) Add requirements in COMAR 10.15.06.13 for construction, reconstruction, or extensive alteration of a dairy farm to submit to the Department a plan and drawing bearing the name of a professional engineer or representative of the company performing work and to submit the name of a dairy farm;
(12) Add requirements in COMAR 10.15.06.15 for construction, reconstruction, or extensive alteration of a milk facility to submit the full name of the plant, to include areas for lockers or a facility for storing personal items and an area for employees to eat and drink in the submitted scale drawing showing the layout, to submit step-by-step operation procedures for cleaning and sanitization of the facility and for product trace back, to submit a pest control program, and to submit employee training and personal hygiene practices to the Department in order to comply with the FDA Food Safety Modernization Act;
(13) Remove the guidelines for preserving the right to a hearing under any provision of COMAR 10.15.06.19;
(14) Add a new regulation COMAR 10.15.06.20 on the appeals process for a permittee whose plan review or permit has been denied, suspended, or revoked; and
(15) Other editorial, clarifying changes, and re-codifications.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through January 9, 2017. A public hearing has not been scheduled.
Editor’s Note on Incorporation by Reference
Pursuant to State Government Article, §7-207, Annotated Code of Maryland, the Grade “A” Pasteurized Milk Ordinance, 2015 Revision (U.S. Department of Health and Human Services, Public Health Services, Food and Drug Administration) and Bulk Milk Hauler/Sampler Manual, 2016 have been declared documents generally available to the public and appropriate for incorporation by reference. For this reason, they will not be printed in the Maryland Register or the Code of Maryland Regulations (COMAR). Copies of these documents are filed in special public depositories located throughout the State. A list of these depositories was published in 43:1 Md. R. 10 (January 8, 2016), and is available online at www.dsd.state.md.us. The documents may also be inspected at the office of the Division of State Documents, 16 Francis Street, Annapolis, Maryland 21401.
10.15.05 Manufacture and Sale of Frozen Dairy Foods and Ices Manufactured for Sale in Maryland
Authority: Health-General Article, §21-804, Annotated Code of Maryland
.01 Incorporation by Reference.
The Grade “A” Pasteurized Milk Ordinance, 2015 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), Item 10p., Item 11p., Appendix H, Appendix I, and Appendix N only, is incorporated by reference.
.13 Frozen Dietary Dairy Dessert.
A. Description. Frozen dietary dairy dessert means a frozen dessert prepared for persons who wish to restrict their intake of ordinary sweetening ingredients. It is produced by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Regulation [.01] .01-1 of this chapter. The minimum fat content shall be 3 percent, it shall contain no sugars other than those naturally present in the milk solids or flavoring agents which have been added to it, and it may contain edible carbohydrates other than sugars. The edible carbohydrates must be approved by the Department. The product may not be sold in any manner other than in sealed or unbroken packages or containers.
B.—C. (text unchanged)
.14 Dietary Frozen Dessert or Lowfat Frozen Dairy Desserts.
A. Description.
(1) Dietary frozen dessert or lowfat frozen dairy dessert is the food prepared by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Regulation [.01] .01-1 of this chapter. The finished product contains less than 2 percent by weight of ether extractable fat: its content of total milk solids is not less than 7 percent by weight. The product weighs no less than 4.5 pounds per gallon and the quantity of food solids per gallon is not less than 1.1 pounds or more than 1.9 pounds, exclusive of any microcrystalline cellulose used as an ingredient.
(2)—(3) (text unchanged)
B.—C. (text unchanged)
.20-1 Lactose Reduced Ice Cream.
A. Description. “Lactose reduced ice cream” means the product resulting from the treatment of ice cream, as defined in Regulation [.01] .01-1 of this chapter, by the addition of a safe and suitable enzyme, or enzymes, so that the lactose remaining is 30 percent or less than lactose in ice cream.
B.—C. (text unchanged)
.21 Definitions.
A. In Regulations .21—.34 of this chapter, the following terms have the meanings indicated[:].
B. Terms Defined.
(1)—(5) (text unchanged)
(6) “Frozen desserts” means any of the products enumerated in the law, Health-General Article, Title 21, Subtitle 8, and as provided in Regulations [.01] .01-1—.20-3 of this chapter.
(7)—(9) (text unchanged)
(10) “Milk products” include milk, cream, and all other products listed under optional dairy ingredients as provided in Regulation [.01] .01-1 of this chapter.
(11)—(20) (text unchanged)
.24 Labeling.
A. All labeling shall comply with the regulations promulgated under the Fair Packaging and Labeling Act and the Federal Food, Drug and Cosmetic Act, as contained in the Code of Federal Regulations, Title 21 Food and Drugs, and in addition shall contain:
(1) The name of the product, and shall conform with product standards of identity as provided in Regulations [.01-----.20] .01-1—.20 of this chapter.
(2)—(4) (text unchanged)
B.—C. (text unchanged)
.25 Quality Standards and Examination of Frozen Desserts Ingredients, Frozen Desserts, and Frozen Desserts Mix.
A. All milk and milk products used as ingredients in frozen desserts and frozen desserts mix shall be produced, processed, and pasteurized to conform with the following chemical, bacteriological, and temperature standards:
|
(1) Milk and Milk Products as Ingredients |
Temperature |
Cooled at 45°F or less and maintained at that temperature until processed. |
|
|
Bacterial Limit |
Not exceeding 300,000 per m/l as commingled milk before pasteurization. |
|
|
Antibiotics |
No detectable zone with the Bacillus subtilis method or equivalent as set forth in Appendix N of the Grade “A” Pasteurized Milk Ordinance. |
(2)—(3) (text unchanged)
B. A process or manipulation, other than pasteurization processing methods [integral with it], and appropriate refrigeration, may not be applied to milk and milk products for the purpose of removing or deactivating microorganisms.
C.—F. (text unchanged)
G. Frozen dessert mix samples for determining the wholesale frozen dessert manufacturer’s compliance with bacteriological and temperature standards shall be collected while in [his] the possession of the wholesale frozen dessert manufacturer before final delivery.
H. Frozen dessert mix samples for chemical and physical analysis may be taken at any time.
I. The wholesale frozen desserts manufacturer shall be held responsible only for those samples taken from unopened containers.
[I.] J. (text unchanged)
[J.] K. [Re-use of Mix.] Mix once drawn from a dispensing freezer shall not be re-used.
.26 Frozen Desserts Plants— Construction Requirements.
A. Floors—Construction.
(1) The floors of all rooms shall be kept in good repair subject to the following provisions:
(a) Rooms used for storing milk products or frozen desserts ingredients need not be provided with floor drains when the floors are sloped to drain to one or more exits;
(b) Rooms used for the hardening and storage of frozen desserts are not required to have floor drains or sloped floors;
(c) Storage rooms for storing dry ingredients, dry milk products, or packaging materials need not be provided with drains, and the floors may be constructed of tightly joined wood; and
(d) Construction of establishments which freeze and sell only at retail on the premises, shall require that the portion of the room in which the freezer is installed and the room in which containers or utensils are washed have solid impervious floors of an approved washable material;
(2) The floors of all rooms except as provided in §A(1)(a)—(c) of this regulation shall be:
(a) Constructed of concrete or other equally impervious and easily cleaned material;
(b) Smooth;
(c) Properly sloped; and
(d) Provided with trapped drains.
B. Walls and Ceilings—Construction. Walls and ceilings of rooms in which milk products, frozen desserts ingredients, and frozen desserts are handled, processed, packaged, or stored, or in which product-contact containers, utensils, and equipment are washed, shall have a surface that is:
(1) Smooth;
(2) Washable;
(3) Light colored; and
(4) In good repair.
C. Doors and Windows.
(1) Effective means shall be provided to prevent the access of flies and rodents.
(2) Air screens and flaps may be used where they effectively prevent the entrance of insects.
(3) Openings to the outside shall have solid doors or glazed windows which shall be closed during dusty weather.
(4) Outside doors shall be self-closing where practicable.
D. Lighting and Ventilation. Rooms in which milk products, frozen desserts ingredients, or frozen desserts are handled, processed, stored, and packaged, or in which product-contact containers, utensils, and equipment are washed shall be well lit and well ventilated.
E. Separate Rooms.
(1) There shall be separate rooms for the following:
(a) Pasteurizing, processing, cooling, freezing, and packaging;
(b) Freezer-storage;
(c) Cleaning of milk cans and containers; and
(d) Boiler rooms.
(2) Receiving Rooms.
(a) A plant receiving milk products or mix in bulk transport tanks shall provide a receiving room for receiving, cleaning, and sanitizing transport tanks.
(b) Unless all milk products and mix are received in bulk transport tanks, a receiving room separate from the rooms listed in §E(1) of this regulation, is required.
(3) Rooms in which milk products, frozen dessert ingredients, or frozen desserts are handled, processed, stored, or packaged, or in which product-contact containers, utensils, and equipment are washed or stored, may not open directly into any room for domestic purposes.
F. Sanitary Piping.
(1) Sanitary piping, fittings, and connections which are exposed to milk products, frozen dessert ingredients, and frozen desserts mix, or from which liquids may drip, drain, or be drawn into the product, shall be constructed of material that is:
(a) Smooth;
(b) Impervious;
(c) Corrosion-resistant;
(d) Nontoxic; and
(e) Easily cleanable.
(2) Piping shall be kept in good repair.
(3) Pasteurized milk products, frozen dessert ingredients, and frozen desserts mix shall be conducted from one piece of equipment to another only through sanitary piping as described in Items 10p. and 11p. in the Grade “A” Pasteurized Milk Ordinance.
.26-1 Frozen Desserts Plants—Water and Sanitation Requirements.
A. Toilet-Sewage Disposal Facilities.
(1) A frozen desserts plant shall provide toilet facilities.
(2) Toilet rooms may not open directly into any room in which milk products, frozen dessert ingredients, or frozen desserts are processed or packaged.
(3) Toilet rooms shall:
(a) Be completely enclosed; and
(b) Have tight-fitting, self-closing doors.
(4) Dressing rooms, toilet rooms, and fixtures shall be kept in a clean condition, in good repair, and shall be well ventilated and well lit.
(5) Sewage and other liquid wastes shall be disposed of as approved by the Secretary.
B. Water Supply.
(1) Water for frozen desserts plant purposes shall be:
(a) Obtained from a properly located, protected, and operated supply;
(b) Easily accessible;
(c) Adequate;
(d) Of a safe sanitary quality; and
(e) Approved by the Secretary.
(2) Both hot and cold water shall be available in sufficient quantity for all plant operations and facilities.
C. Handwashing Facilities.
(1) Convenient handwashing facilities shall be provided, including:
(a) Hot and cold or warm running water;
(b) Soap; and
(c) Individual sanitary towels or other approved hand-drying devices.
(2) Handwashing facilities shall be kept in a clean condition and in good repair.
D. Plant Cleanliness.
(1) Rooms in which milk products, frozen dessert ingredients, and frozen desserts are handled, processed, stored, or packaged or in which containers, utensils, or equipment are washed or stored, shall be kept clean, neat, and free of evidence of insects and rodents.
(2) Only properly applied pesticides, approved by the State and federal agencies for pesticide control, shall be used.
(3) Only equipment directly related to processing and packaging operations, or to handling of containers, utensils, and equipment shall be permitted in the pasteurizing, processing, cooling, packaging, and bulk milk storage rooms.
E. Construction and Repair of Containers and Equipment.
(1) Multiuse containers and equipment with which milk products, frozen dessert ingredients, and frozen desserts come into contact shall be:
(a) Of smooth, impervious, corrosion-resistant, nontoxic material;
(b) Constructed and installed for ease of cleaning; and
(c) Kept in good repair.
(2) Single-service Containers.
(a) Single-service containers, closures, gaskets, and other articles with which milk products, frozen dessert ingredients, or frozen desserts come into contact shall:
(i) Be nontoxic; and
(ii) Have been manufactured, packaged, transported, and handled in a sanitary manner.
(b) Articles intended for single-service use may not be reused.
(c) Equipment pertaining to materials, design, and finish shall comply with applicable 3-A Sanitary Standards.
F. Cleaning and Sanitizing of Containers and Equipment. The product-contact surface of all multiuse containers, utensils, and equipment used in the transportation, processing, handling, freezing, packaging, and storage of milk products, frozen dessert ingredients and frozen desserts mix shall be effectively cleaned and sanitized before each use.
G. Storage of Cleaned Multiuse Containers and Equipment. After cleaning, multiuse milk products, frozen dessert ingredients, and frozen dessert containers, utensils, and equipment shall be:
(1) Transported and stored to assure complete drainage; and
(2) Protected from contamination before use.
H. Storage of Single-Service Containers, Utensils and Materials. Single-service parchment papers, containers, gaskets, and other single-service articles for use in contact with milk products, frozen dessert ingredients, or frozen desserts shall be:
(1) Purchased and stored in sanitary wrappings or cartons;
(2) Kept in a clean dry place until used; and
(3) Handled in a sanitary manner.
I. Protection from Contamination.
(1) Frozen desserts plant operations, equipment, and facilities shall be located and conducted to prevent any contamination of:
(a) Milk products;
(b) Frozen dessert ingredients;
(c) Frozen desserts;
(d) Equipment;
(e) Containers; and
(f) Utensils.
(2) Unless the equipment has first been properly washed and subjected to a satisfactory bactericidal treatment, pasteurized mix or frozen desserts may not be permitted to come in contact with equipment or containers with which unpasteurized mix, frozen desserts, milk, or milk products have been in contact.
(3) In a frozen desserts plant, processing and handling shall be performed to preclude the contamination of the products.
J. Pasteurization.
(1) Frozen desserts shall be made from pasteurized mixes.
(2) After formulation of the entire mix except for flavoring, ingredients shall be pasteurized as provided in Regulation .21B(13) of this chapter.
(3) The design and operation of all pasteurization equipment and all appurtenances to it shall comply with the applicable specifications and operational procedures as outlined in Appendices H and I of the Grade “A” Pasteurized Milk Ordinance.
K. Cooling of Milk Products and Frozen Desserts Mix.
(1) Raw milk products shall be maintained at 45°F or less until processed.
(2) Pasteurized milk products and frozen desserts mix shall be cooled immediately, in approved equipment, to a temperature of 45°F or less.
(3) Pasteurized milk and frozen desserts mix shall be stored at a temperature of 45°F or less and maintained at that temperature until further processed.
(4) A room or tank in which products or frozen desserts mix are stored shall be equipped with an accurate thermometer.
(5) A mix which is not frozen at the plant at which it is pasteurized shall be:
(a) Transported to the place of manufacturing or freezing in sealed containers;
(b) Handled in a sanitary manner; and
(c) Stored at a temperature of 45°F or less until frozen.
(6) Except for sampling, dipping from containers of pasteurized mix is prohibited.
L. Container Packaging, Closure, Sealing, and Storage.
(1) Closing or sealing of frozen desserts containers shall be done in a sanitary manner.
(2) The closing or sealing of individual containers of frozen desserts shall be done by methods which preclude product contamination.
(3) Frozen desserts shall be stored in a sanitary manner.
M. Personnel Cleanliness.
(1) Hand Washing.
(a) Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination.
(b) An employee may not resume work after visiting the toilet room without thoroughly washing the employee’s hands.
(2) Garments and Hair Coverings.
(a) An individual engaged in processing, pasteurization, handling, storage, transportation, or packaging of milk products, frozen dessert ingredients or frozen desserts, containers, utensils, or equipment shall wear clean outer garments and a head covering.
(b) An employee with long hair shall wear hair restraints.
(3) The use of tobacco by any person while engaged in the processing of milk products, frozen desserts ingredients, or frozen desserts is prohibited.
.26-2 Frozen Desserts Plants—Operation and Transportation Requirements.
A. Packaging, Overflow, and Spillage.
(1) Packaging.
(a) The filling of frozen desserts containers shall be done only by approved mechanical equipment or by methods which preclude contamination.
(b) Frozen desserts shall be packaged in containers which protect the contents from contamination.
(c) Frozen desserts or frozen desserts mix:
(i) May be transported in sealed containers in a sanitary manner from one plant to another for further processing or packaging; and
(ii) Shall be stored in a sanitary manner.
(2) Milk products, frozen desserts, or their ingredients which have been spilled, overflowed, or leaked shall be discarded and may not be sold for human consumption.
B. Vehicles.
(1) Vehicles used for transportation of frozen desserts mix shall be constructed and operated so that the frozen desserts mix is:
(a) Maintained at 45°F or less; and
(b) Protected from;
(i) Sun;
(ii) Freezing; and
(iii) Contamination.
(2) Vehicles used for transportation of frozen desserts mix shall be kept clean.
(3) Substances capable of contaminating mix or frozen desserts or their ingredients may not be transported with frozen desserts mixes in a manner which permits contamination.
(4) Vehicles transporting frozen desserts or mix to wholesale or retail outlets shall have the name and address of the distributor prominently displayed on them.
C. Transferring and Dispensing Frozen Desserts.
(1) Except for in a sanitary room or enclosure under approved conditions a person may not:
(a) Transfer frozen desserts from one container to another; or
(b) Package frozen desserts:
(i) On the street; or
(ii) In any open vehicle.
(2) The direct sale of frozen desserts in packages, cones, or servings to the consumer may take place at roadside stands or concessions where the sanitary conditions are approved by the Secretary.
D. Surroundings.
(1) Frozen desserts plant surroundings shall be kept clean, neat, and free from conditions which might attract or harbor flies or other insects and rodents, or which otherwise constitute a nuisance.
(2) Roads, driveways, yards, and parking areas adjacent to the plant shall be:
(a) Paved or otherwise treated to prevent dust; and
(b) Smooth and well drained to prevent accumulation of stagnant liquid.
10.15.06 Production, Processing, Transportation, Storage, and Distribution of Grade [A] “A” Milk
Authority: Health-General Article, §§2-104, 2-105, 21-207, 21-208, 21-210, 21-211, 21-406, 21-410, 21-412, 21-413, 21-415, 21-426, and 21-428, Annotated Code of Maryland
.01 Scope.
This chapter:
A.—B. (text unchanged)
C. Regulates the inspection of Grade [A] “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products; and
D. Sets forth:
(1) (text unchanged)
(2) The enforcement process for the examination, labeling, pasteurization, aseptic processing [and], retort processing, packaging, and distribution and sale of Grade [A] “A” milk and milk products;
(3) Penalties pursuant Health-General Article, §§21-211, 21-252— 21-256, 21-418, 21-419, [and] 21-428, 21-1202, and 21-1203, Annotated Code of Maryland; and
(4) Requirements for Grade [A] “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products.
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1) (text unchanged)
(2) “Bulk milk hauler/sampler” means a person who:
(a) (text unchanged)
(b) Transports raw milk from a farm or raw milk products to or from a milk plant, receiving station, or transfer station; [and]
(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)—(6) (text unchanged)
(7) “Grade [A] ‘A’ distribution station” means a place or vehicle where, for redistribution and sale, Grade [A] “A” pasteurized milk products routinely are received, stored, or transferred.
(8)—(14) (text unchanged)
(15) “Milk marketing agency” means a person who negotiates the price of [Grade A] milk to be
offered for sale and supplies [Grade A] milk.
(16)—(21) (text unchanged)
(22) “Official laboratory” means a biological, chemical, or physical laboratory that is operated by the Department [of Health and Mental Hygiene].
(23) “Officially designated laboratory” means a commercial laboratory authorized to conduct testing of milk and milk products on behalf of the Department [of Health and Mental Hygiene] or a milk industry laboratory officially designated by the Department [of Health and Mental Hygiene] for the examination, pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, of:
(a)—(b) (text unchanged)
(24) “Permit” means [a permit] 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)—(28) (text unchanged)
(29) “Sale” or “sell” means a transaction that involves the:
(a) Transfer [or], dispensing, or serving of milk and milk products with or without charge; or
(b) (text unchanged)
(30) (text unchanged)
(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)—(35) (text unchanged)
.03 Incorporation by Reference.
In this chapter the following documents are incorporated by reference:
A. Grade “A” Pasteurized Milk Ordinance, [2011] 2015 Revision (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; [and]
C. Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended;
D. Bulk Milk Hauler/Sampler Manual, 2016 (Center for Milk & Dairy Product Safety, Office of Food Protection, Maryland Department of Health & Mental Hygiene); and
E. FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252, as amended.
F. 21 CFR §§130—131, as amended.
.04 General Requirements.
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)—(2) (text unchanged)
(3) Nutrition Labeling and Education Act of 1990 (Public Law 101-535); [and]
(4) Grade “A” Pasteurized Milk Ordinance; and
(5) FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252.
B. (text unchanged)
.05 Standards for Milk Products.
A. (text unchanged)
B. A bulk milk hauler/sampler shall ensure that:
(1) (text unchanged)
(2) Bulk raw milk is picked up from every dairy farm at least every other day; [and]
(3) The temperature of the bulk raw milk does not exceed 45F; and
(4) Operations are in accordance with the Bulk Milk Hauler/Sampler Manual.
C. (text unchanged)
.06 Permits Required.
A. (text unchanged)
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.
[B.] C. Under Health-General Article, §21-410(c), Annotated Code of Maryland, a permit is not required for:
(1)—(3) (text unchanged)
(4) [A bulk milk hauler/sampler] An individual who [is transporting] only transports milk in a sealed tanker to a milk plant, receiving station, or transfer station and not producers’ samples.
.07 Inspection and Evaluation of Milk Production and Transportation.
A. (text unchanged)
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.
[B.] C.—[D.] E. (text unchanged)
[E. The Secretary shall evaluate the sampling and examination procedures of Grade A milk and milk products to ensure that the sampling and examination procedures are conducted according to the standards set forth in the Grade “A” Pasteurized Milk Ordinance.]
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.
.10 Dating of Grade [A] “A” Fluid Milk.
A. [Under Health-General Article, §21-426, Annotated Code of Maryland,] Unless approved by the Department as described in §B of this regulation, a person may not sell, deliver, or offer Grade [A fluid] “A” milk or milk products that are cooled to, packaged, and stored at 45°F or less for sale after [30] 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.
[B.] C. (text unchanged)
D. Milk products exempt from dating requirements are:
(1) Cultured milk products and eggnog; and
(2) Milk and dairy products as defined by 21 CFR §§130—131, which have been subjected to aseptic processing and packaging.
.12 Sale of Raw Milk.
A. (text unchanged)
B. A permitted milk producer may sell raw milk from the milk producer’s dairy farm only to a permitted:
(1)—(4) (text unchanged)
.13 Dairy Farm Construction and Plan Submission.
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. [Plans] A plan and specifications [to the Department] before:
(1)—(3) (text unchanged)
B. [The following information to the Department:] A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work;
[(1)] C. Contact information for the dairy farm, including:
[(a)] (1) The full [names] name, [titles] title, and [telephone numbers] telephone number of [the] each applicant;
(2) The name of the dairy farm;
[(b)] (3)—[(d)] (5) (text unchanged)
[(2)] 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:
[(a)] (1)—[(h)] (8) (text unchanged)
[(3)] 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:
[(a)] (1)—[(l)] (12) (text unchanged)
[(4)] F. For pipeline and milking system installations:
[(a)] (1)—[(c)] (3) (text unchanged)
[(i)] (a)—[(vii)] (g) (text unchanged)
[(d)] (4)— [(e)] (5) (text unchanged)
[(f)] (6) Information and specifications for booster or supplemental heating systems, if utilized; [and]
[(5)] G. For bulk tank/milk cooling systems installation:
[(a)] (1)—[(e)] (5) (text unchanged)
.14 Dairy Farm Requirements.
A milk producer shall ensure that:
A. (text unchanged)
B. [Potable water] Water used at a dairy farm shall:
(1) [Is] Be obtained from a water supply system that complies with:
(a)—(b) (text unchanged)
(c) The Grade “A” Pasteurized Milk Ordinance; [and]
[(2) Meets the standards of quality specified in:
(a) Environment Article, Title 9, Annotated Code of Maryland;
(b) COMAR 26.04.01; and
(c) The Grade “A” Pasteurized Milk Ordinance;
C. A potable water system is:]
[(1)] (2) [Installed] Be installed in a manner that prevents backflow or back-siphoning; [and]
[(2)] (3) [Not directly connected with] Be separate from a non-potable water supply system [by which] so that non-potable water [can] cannot be drawn or discharged into the potable water supply system;
[D.] (4) [Hot] Provide hot and cold running water [are provided] in [all] areas where [milking] milk processing equipment is washed; and
[E.] (5) [Sufficient] Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system;
[F.] C. [A hand sink is located at the dairy farm milk house and is equipped with] Hand sinks shall have:
(1) Either:
[(1)] (a) Hot and cold running water under pressure; or
(b) Warm running water;
(2)—(3) (text unchanged)
[G.] D.—[H.] E. (text unchanged)
[I.] F. [All plumbing] Plumbing is sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and
[J.] G. (text unchanged)
.15 Milk Facility Construction and Plan Submission.
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) [A] Constructing, reconstructing, or extensively altering a milk facility [is constructed, reconstructed, or extensively altered];
(2) [An] Converting or remodeling an existing building or structure [is converted or remodeled] for use as a milk facility;
(3) [A] Adding, replacing, relocating, or modifying a milk facility process [is added, replaced, relocated, or modified]; or
(4) [A] Adding, modifying, or replacing a clean-in-place (CIP) or other washing system or any part of a [CIP] clean-in-place or other washing system [is added, modified, or replaced];
B. [The following information:] Plans and drawings bearing the name of a professional engineer or a representative of the company performing the work.
[(1)] C. Contact information for the facility, including:
[(a)] (1) The full [names] name, [titles] title, and [telephone numbers] telephone number of [the] each applicant;
(2) The name of the plant;
[(b)] (3)—[(d)] (5) (text unchanged)
[(2)] D.—[(3)] E. (text unchanged)
[(4) A list of all products to be produced;]
[(5)] F. (text unchanged)
G. A list of:
(1) All products to be produced;
[(6)] (2) [A list of raw] Raw cream and skim, condensed, or any other milk or milk products to be sold; and
[(7)] (3) [A list of single] Single service container sources; [and]
[(8) Pest control and preventive maintenance plans;]
[C.] H. A scale drawing showing the layout and arrangement of areas within and around the milk facility, including areas for:
(1) Processing [areas];
(2)—(4) (text unchanged)
(5) Receiving [areas];
(6) Load out [areas];
(7) [Laboratory space] Laboratories;
(8) Offices; [and]
(9) (text unchanged)
(10) Lockers or a facility for the storage of personal items; and
(11) Employees to eat and drink beverages;
[D.] I. (text unchanged)
[E.] J. A scale drawing showing the location of plumbing and plumbing fixtures, including:
(1)—(2) (text unchanged)
(3) [Hands] Hand sinks;
(4)—(10) (text unchanged)
[F.] K. A legend for [all drawings] each drawing;
[G.] L. Specifications [including the following] for:
(1) Ventilation [specifications] including, but not limited to, [types] the type and location of:
(a) [Air filters] An air filter;
(b) [Air pumps] An air pump; and
(c) [Compressors] A compressor;
(2) Construction [material specifications] materials for the building and interior finishes; and
(3) Pasteurizer plate [cooler specifications] coolers, if separate from the pasteurization system;
[H.] M. (text unchanged)
[I.] N. A description of the:
(1) (text unchanged)
(2) Source and system for the facility’s potable water supply; [and]
(3) Lighting fixtures and placement; and
(4) Recirculating cooling system;
[J. The following for milk equipment and controls:]
[(1)] O. Specification sheets, including manufacturer and model number of all milk facility equipment; [and]
[(2) A list of recirculating cooling systems;]
[K.] P.—[N.] S. (text unchanged)
[O. Procedures for manual cleaning, including clean-out-of-place (COP) tank usage, if applicable;]
[P.] T. Written [policies] step-by-step standard operating procedures for:
(1) Receiving, processing, storing, and packaging of each project;
[(1)] (2) [Antibiotic testing procedures, if applicable] Drug residue testing;
[(2)] (3) [Sanitization procedures] Cleaning and sanitization for all equipment; [and]
(4) Cleaning and sanitization for the facility;
(5) Product trace back, inclusive of production or make sheet; and
[(3)] (6) [Recall or trace back procedures; and] Product recall;
U. A pest control program; and
V. Employee training and personal hygiene practices.
[Q. Milk facility plans and drawings bearing the name of a professional engineer or a representative of the company performing the work.]
.16 Milk [Facility] Physical Plant Requirements.
[A milk facility permittee shall ensure that:]
A. Water used at [the] a milk facility shall:
(1) [Is] Be obtained from a potable water supply system that complies with:
(a)—(b) (text unchanged)
(c) The Grade “A” Pasteurized Milk Ordinance; [and]
[(2) Meets the standards of quality specified in:
(a) Environment Article, Title 9, Annotated Code of Maryland;
(b) COMAR 26.04.01; and
(c) The Grade “A” Pasteurized Milk Ordinance;
B. The milk facility’s water system is:]
[(1)] (2) [Installed] Be installed in a manner that prevents backflow or back-siphoning; and
[(2)] (3) [Not directly connected with] Be separate from a non-potable water supply system [by which] so that non-potable water [can] cannot be drawn or discharged into the potable water supply system[.];
[C.] (4) [Hot] Provide hot and cold running water [is provided] in [all] areas where [milking] milk processing equipment is washed; and
[D.] (5) [Sufficient] Have sufficient water capacity, pressure, and hot water generation and distribution [are] available to meet peak demands throughout the washing system[;].
[E.] B. Hand sinks [are equipped with] shall have:
(1) Either:
[(1)] (a) Hot and cold running water under pressure; or
(b) Warm running water;
(2) (text unchanged)
(3) A sanitary means of drying hands, such as individual towels or a hand-drying device[;] .
[F.] C. A sewage system [is] shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance[;] .
[G.] D. [All plumbing is] Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations[; and]
[H.] E. [All electrical] Electrical systems at the facility shall:
(1)—(3) (text unchanged)
.17 Plan Review Approval.
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.
.18 Confidentiality.
The Department shall maintain confidentiality of records submitted by a person [as required by Maryland statute and regulation.] in accordance with General Provisions Article, §4-335, Annotated Code of Maryland.
.19 Suspension and Revocation of Permits.
A.—E. (text unchanged)
[F. In order to preserve a right to a hearing under any provision of this regulation, a person shall:
(1) Make a request for a hearing in writing; and
(2) Submit the request to the Department that issued the order or inspection report:
(a) Within 10 days of receipt of the order or inspection report; or
(b) Sooner if specified in the order or inspection report.]
[G.] F. (text unchanged)
(1)—(2) (text unchanged)
.20 Appeals Process.
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.
10.15.08 [Pilot] Farmstead Cheese Program
Authority: Health General Article, §§21-211, 21-234, 21-406, 21-416.1, and 21-434, Annotated Code of Maryland
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1)—(12) (text unchanged)
(13) “Plant” means any place, premise[.], or establishment where milk or milk products are collected, handled, processed, stored, packaged or otherwise prepared for distribution as a farmstead cheese.
(14)—(16) (text unchanged)
.03 Incorporation by Reference.
In this chapter, the following documents are incorporated by reference:
A.—G. (text unchanged)
H. Grade “A” Pasteurized Milk Ordinance, [2013] 2015 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), Section 8, Appendix D, Appendix G[,] Section I, Appendix H Section II, and Appendix N only.
VAN T. MITCHELL
Secretary of Health and Mental Hygiene
