Maryland Department of Health 10.15.09 Production, Processing, Transportation, Storage, and Distribution of Manufactured Grade Milk (PHPA)

PROPOSAL

Maryland Register

Issue Date: February 1, 2019

Volume 46 • Issue 3 • Page 114-126

Title 10
MARYLAND DEPARTMENT OF HEALTH

Subtitle 15 FOOD

10.15.09 Production, Processing, Transportation, Storage, and Distribution of Manufactured Grade Milk

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

Notice of Proposed Action

[19-048-P-I]

The Secretary of Health proposes to repeal existing Regulations .01—.20 and adopt new Regulations .01—.22 under COMAR 10.15.09 Production, Processing, Transportation, Storage, and Distribution of Manufactured Grade Milk.

Statement of Purpose

The purpose of this action is to amend COMAR 10.15.09 in order to update language to match other similar regulations and to align with the most recent guidelines including the Federal Food, Drug, and Cosmetic Act; the Nutrition Labeling and Education Act of 1990; Evaluation of Milk Laboratories; the Bulk Milk Hauler/Sampler Manual; the Grade “A” Pasteurized Milk Ordinance; Milk for Manufacturing Purposes and its Production and Processing; the Maryland Laboratory Evaluation Program Manual; and Standard Methods for the Examination of Dairy Products, which are being added to the incorporation by reference regulation of this chapter. The proposal also phases in certain new requirements of the FDA Food Safety Modernization Act.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. These changes will not have an impact on the Maryland Department of Health, but will have an indeterminable economic impact on the regulated dairy industry. Some businesses may incur costs as a result of bringing their business practices into alignment with new requirements of the updated Food Safety Modernization Act.

	Revenue (R+/R-)
II. Types of Economic Impact.	Expenditure (E+/E-)	Magnitude


A. On issuing agency:	NONE
B. On other State agencies:	NONE
C. On local governments:	NONE

	Benefit (+) Cost (-)	Magnitude


D. On regulated industries or trade groups:	(-)	Indeterminable
E. On other industries or trade groups:	NONE
F. Direct and indirect effects on public:	NONE

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

D. This proposal will have an indeterminable economic impact on the regulated dairy industry. Some businesses may incur costs associated with changes that will bring their business practices into alignment with new requirements of the updated Food Safety Modernization Act. Some of these new requirements include conducting risk assessments, constructing a food safety plan, writing standard operating procedures, designing environmental sampling programs, and new ingredient requirements. Because of variations in current equipment and practices at each business, it is not possible to predict what the overall impact of these changes will be.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. 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 following have been declared documents generally available to the public and appropriate for incorporation by reference:

(1) Maryland Laboratory Evaluation Program Manual 2017 (Center for Milk & Dairy Product Safety, Office of Food Protections, Maryland Department of Health);

(2) Evaluation of Milk Laboratories, 2015 Revision.

(3) Grade “A” Pasteurized Milk Ordinance, 2015 Revision, only: Sections 5-6; Standards for Grade “A” Raw Milk Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging, all items except for Item 9r Administrative Procedures 1.a; Standards for Grade “A” Pasteurized, Ultra-Pasteurized AsepticallyProcessed and Packaged Low-Acid Milk and/or Milk Products and Retort Processed after Packaged Low-Acid Milk and/or Milk Products, all Items except for Item 10p, Administrative Procedures 2.1. Item 11p Administrative Procedures 2.and 6, Item 18p, and Item 19p; Section 8; Section 12-15; Section 18; Appendices A-I; Appendices K-O; and Appendices Q-S;

(4) Milk for Manufacturing Purposes and its Production and Processing, Recommended Requirements, Effective July 21, 2011, only: Subpart C, Sec. C 12(a)(2)(ii) and C 12(a)(3)(ii); Subpart E, Sec. E 1, E 1.4(2)-(e); Subpart E, Sec. E 1, E1.15; Subpart E, Sec. E 1, E1.16; Subpart E, Sec. E 2, except for E.2.2.5, E2.4.8, and E2.4.9; Subpart E, Sec. E 3; Subpart E, Sec. E 4, except for E.4.3.2; and Subpart E, Sec. E 6;

(5) Standard Methods for the Examination of Dairy Products, 17th Edition 2004 (American Public Health Association); and

For this reason, these documents 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 46:1 Md. R. 9 (January 4, 2019), and is available online at www.dsd.state.md.us. These documents may also be inspected at the office of the Division of State Documents, 16 Francis Street, Annapolis, Maryland 21401.

.01 Scope.

A. In accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, this chapter:

(1) Governs permits for the sale of milk for manufacturing processes;

(2) Describes the requirement for a permit for the sale of milk for manufacturing purposes; and

(3) Regulates the inspection of manufactured grade dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products.

B. This chapter also sets forth:

(1) Standards for milk manufacturing;

(2) The plan review process for manufactured grade dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products;

(3) The enforcement process for the examination, labeling, pasteurization, aseptic processing, retort processing, packaging, and distribution and sale of manufactured grade milk and milk products;

(4) Penalties pursuant to 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

(5) Requirements for dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products.

.02 Definitions.

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

B. Terms Defined.

(1) “3-A Sanitary Standards” means the standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committee representing the:

(a) American Dairy Products Institute;

(b) International Dairy Foods Association;

(c) Food Processing Suppliers Association; and

(d) International Association for Food Protection.

(2) “Agistment agreement” means the sale of shares or interest in a:

(a) Cow, goat, or other lactating hooved mammal; or

(b) Herd of cows, goats, or other lactating hooved mammals.

(3) “Approved” means meeting the criteria set forth in this chapter.

(4) “Aseptic processing and packaging” means the filling of a commercially sterilized cooled product into pre-sterilized containers, followed by aseptic hermetical sealing, with a pre-sterilized closure, in an atmosphere free of microorganisms.

(5) “Bobtailer” means a person who operates or controls a manufactured milk product route and distributes a manufactured milk product that the person buys from a distributer or manufactured milk processor.

(6) “Bulk milk hauler/sampler” means an individual who:

(a) Collects official samples;

(b) Transports raw milk from a farm, or raw milk products to or from a:

(i) Milk plant;

(ii) Receiving station; or

(iii) Transfer station;

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

(d) If they are sampling raw milk in the State, possesses a Maryland Bulk Milk Hauler license.

(7) “Butter” means the food product that is made exclusively from milk or cream, or both, with or without salt, and with or without additional coloring matter, and that contains not less than 80 percent by weight of milk fat.

(8) “Certified industry dairy farm inspector” means a person who is certified by the Secretary under Health-General Article, §21-414, Annotated Code of Maryland, to perform as specified in that section.

(9) “Cheese” means the fresh or matured product that:

(a) Is obtained by draining after coagulation of milk, cream, skimmed or partly skimmed milk, or a combination of some or all of these products; and

(b) Meets the standards of identity in 21 CFR Part 133.

(10) “Commercial sterility” means the condition achieved by a treatment that renders equipment, containers, and food free of viable microorganisms that are capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.

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

(12) “Dairy plant sampler” mean a person responsible for the collection of official samples for regulatory purposes outlined in Section 6 of the Pasteurized Milk Ordinance.

(13) “Department” means the Maryland Department of Health or its designee.

(14) “Departmental inspection area” means the area in which the Department routinely makes inspections, which consists of that area within the boundaries of Maryland and any other area as may be designated by the Secretary.

(15) “Distribution station” means a place or vehicle where, for redistribution and resale, a manufactured grade milk product routinely is received, stored, or transferred.

(16) “Distributor” means a person who offers for sale a manufactured grade milk product.

(17) “Heat treated cream” means milk that has been heated during separation to temperatures greater than 52ºC (125ºF) but less than 75ºC (166ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping cream for bulk shipments.

(18) “Heat treated milk” means milk that has been heated one time during separation to temperatures greater than 52ºC (125ºF) but less than 72ºC (161ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping heat treated nonfat skim milk, reduced fat milk, or lowfat milk for bulk shipments.

(19) “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.

(20) “Instant nonfat dry milk” means nonfat dry milk that has been produced in such a manner as to substantially improve its dispersing and reconstitution characteristics over that produced by the conventional processes.

(21) “Manufactured grade milk” means the milk of a cow, goat, or other hooved mammal that is produced, processed, pasteurized, packaged, or prepared for human consumption in accordance with the standards set forth in this chapter.

(22) “Manufactured grade milk product” means:

(a) Butter;

(b) Cheese, natural or processed;

(c) Condensed skim milk, plain or sweetened;

(d) Condensed whole milk;

(e) Cream;

(f) Dry buttermilk;

(g) Dry whey;

(h) Dry whole milk;

(i) Evaporated milk, whole or skim;

(j) Nonfat dry milk;

(k) Quark; or

(l) Any other product made with manufactured grade milk that is regulated by the Department.

(23) “Milk” means the lacteal secretion of a cow, goat, or other hooved mammal, practically free from colostrum, obtained by the complete milking of one or more healthyhooved mammals.

(24) “Milk facility” means a:

(a) Distribution station;

(b) Milk plant;

(c) Milk processor;

(d) Milk tank truck cleaning facility;

(e) Receiving station; or

(f) Transfer station.

(25) “Milk hauler” means an individual who is in charge of a milk tank truck while it is receiving, transporting, or delivering milk or a milk product.

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

(27) Milk Plant.

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

(i) Received and stored;

(ii) Processed;

(iii) Pasteurized;

(iv) Packaged; or

(v) Prepared for distribution.

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

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

(29) “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.

(30) “Milk product” means butter, cream, natural or processed cheese, dry milk or whey product, whole or skim evaporated milk, condensed whole milk, and plain or sweetened condensed skim milk, all of which are defined or described in this chapter, or at 21 CFR 131, 133, and 184, and any other product that may be developed and made from manufactured grade milk.

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

(32) “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.

(33) “Milk tank truck driver” means an individual who transports raw or pasteurized milk or milk products to or from a milk plant, receiving station, or transfer station and does not sample producer raw milk.

(34) “Milk transport container” means a vessel meeting 3-A Sanitary Standards or equivalent standards used by on-farm processors to transport milk from the dairy farm to the milk plant.

(35) “National Conference on Interstate Milk Shipments (NCIMS)” means a nonprofit organization made up of persons involved in the dairy industry, who make the laws governing all aspects of the milk sanitation program.

(36) Nonfat.

(a) “Nonfat” means a product contains less than 0.5 percent fat.

(b) “Nonfat” has the same meaning as skim or fat free.

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

(38) “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) Comingled milk tank truck samples of Grade “A” raw milk.

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

(40) “Pasteurization” means the process of heating every particle of milk or milk product, in approved and properly designed equipment, by:

(a) Heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time:

(i) 63°C (145°F) for 30 minutes;

(ii) 72°C (161°F) for 15 seconds;

(iii) 89°C (191°F) for 1 second;

(iv) 90°C (194°F) for 0.5 seconds;

(v) 94°C (201°F) for 0.1 seconds;

(vi) 96°C (204°F) for 0.05 seconds; or

(vii) 100°C (212°F) for 0.01 seconds;

(b) For milk or milk products with fat content of 10 percent or greater, a total solids of 18 percent or greater, or containing added sweeteners, heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time:

(i) 66°C (150°F) for 30 minutes;

(ii) 75°C (166°F) for 15 seconds; or

(iii) The temperatures and times listed in §B(34)(a)(iii)—(vii) of this regulation;

(c) For milk or milk products that the USDA requires a specific product pasteurization temperature for, heating the product to the temperature requirement outlined in the USDA Milk for Manufacturing Purposes and its Production and Processing, Recommend Requirements; or

(d) Utilizing another process found equivalent to pasteurization for milk and milk products, which has been recognized and approved by FDA as provided in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §343(h)(3).

(41) “Permit” means an official document with a manufactured grade classification 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.

(42) “Permittee” means a person who holds a permit as defined in this chapter.

(43) 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.

(44) “Raw milk” means unpasteurized milk, which includes:

(a) Heat treated nonfat skim milk;

(b) Heat treated reduced fat milk;

(c) Heat treated lowfat milk; and

(d) Heat treated cream.

(45) “Receiving station” means a place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.

(46) “Recombined” means that a milk or a milk product is made by combining water and nonfat dry milk solids with:

(a) Cream;

(b) Butterfat; or

(c) Milk fat.

(47) “Reconstituted” means that a milk or a milk product has resulted from either:

(a) Combining dry whole milk solids with the appropriate amount of water; or

(b) Adding water to evaporated milk.

(48) “Retort processed after packaging” means that the milk or milk product, or both, have been subjected to sufficient heat processing after being packaged in a hermetically sealed container, to:

(a) Conform with applicable requirements under 21 CFR Parts 108, 113, and 117; and

(b) Maintain commercial sterility of the milk or milk products under nonrefrigerated conditions.

(49) “Sale” 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 another form of compensation including, but not limited to, an agistment agreement.

(50) “Sanitization” means the application of an effective method or substance to clean surfaces to destroy pathogens and other microorganisms that does not damage the surface or adversely affect the milk or milk product that may come into contact with the surface.

(51) “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.

(52) “Secretary” means the Secretary of Health or the Secretary’s designee.

(53) “Sell” means to offer for sale.

(54) Skim.

(a) “Skim” means a product contains less than 0.5 percent fat.

(b) “Skim” has the same meaning as nonfat or fat free.

(55) “Transfer station” means a place, premises, or establishment where milk or milk products are transferred directly from one milk tank truck to another.

(56) “Whey” means the liquid substance obtained by separating the coagulum from milk, cream, or nonfat milk in cheese making that meets the requirements of 21 CFR §184.1979.

.03 Incorporation by Reference.

In this chapter the following documents are incorporated by reference:

A. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§321—350f, as amended;

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

C. Bulk Milk Hauler/Sampler Manual, 2016 (Center for Milk & Dairy Product Safety, Office of Food Protection, Maryland Department of Health), which has been incorporated by reference in COMAR 10.15.06.03;

D. Maryland Laboratory Evaluation Program Manual, 2017 (Center for Milk and Dairy Product Safety, Office of Food Protection, Maryland Department of Health);

E. 21 CFR Parts 100—101, as amended;

F. 21 CFR Part 117;

G. 21 CFR Parts 130—133, as amended;

H. 21 CFR Parts 170—189, as amended;

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

J. Evaluation of Milk Laboratories, 2015 Revision (Food and Drug Administration and the National Conference on Interstate Milk Shipments, U.S. Department of Health and Human Services);

K. Grade “A” Pasteurized Milk Ordinance, 2017 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), only:

(1) Section 5. Inspection of Dairy Farms and Milk Plants;

(2) Section 6. The Examination of Milk and/or Milk Products;

(3) Standards for Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging, all Items except for Item 9r. Administrative Procedures 1.a.;

(4) Standards for Grade “A” Pasteurized, Ultra-Pasteurized, Aseptically Processed and Packaged Low-Acid Milk and/or Milk Products, and Retort Processed after Packaged Low-Acid Milk and/or Milk Products, all Items except for Item 10p. Administrative Procedures 2.a., Item 11p. Administrative Procedures 2.a. and 6., Item 18p., and Item 19p.;

(5) Section 8. Animal Health;

(6) Section 12. Plans for Construction and Reconstruction;

(7) Section 13. Personnel Health;

(8) Section 14. Procedure when Infection or High Risk of Infection is Discovered;

(9) Section 15. Enforcement;

(10) Section 18. Separability Clause;

(11) Appendix A. Animal Disease Control;

(12) Appendix B. Milk Sampling, Hauling, and Transportation;

(13) Appendix C. Dairy Farm Construction Standards and Milk Production;

(14) Appendix D. Standards for Water Sources;

(15) Appendix E. Examples of 3-out-of-5 Compliance Enforcement Procedures;

(16) Appendix F. Cleaning and Sanitization;

(17) Appendix G. Chemical and Bacteriological Tests;

(18) Appendix H. Pasteurization Equipment and Procedures and Other Equipment;

(19) Appendix I. Pasteurization Equipment and Controls — Tests;

(20) Appendix K. HACCP Program;

(21) Appendix L. Applicable Regulations, Standards of Identity for Milk and Milk Products, The Federal Food, Drug, and Cosmetic Act, and the Federal Insecticide, Fungicide, and Rodenticide Act;

(22) Appendix M. Reports and Records;

(23) Appendix N. Drug Residue Testing and Farm Surveillance;

(24) Appendix O. Vitamin Fortification of Fluid Milk Products;

(25) Appendix Q. Operation of Automatic Milking Installations for the Production of Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging;

(26) Appendix R. Determination of Time/Temperature Control for Safety Milk and/or Milk Products; and

(27) Appendix S. Aseptic Processing and Packaging Program and Retort Processed after Packaging Program;

L. Milk for Manufacturing Purposes and its Production and Processing, Recommended Requirements, Effective July 21, 2011 (United States Department of Agriculture, Agricultural Marketing Service, Dairy Programs), only:

(1) Subpart C, Sec. C12(a)(2)(ii) and C12(a)(3)(ii);

(2) Subpart E, Sec. E1, E 1.4(a)—(e);

(3) Subpart E, Sec. E1, E 1.15;

(4) Subpart E, Sec. E1, E 1.16;

(5) Subpart E, Sec. E 2, except for E 2.2.5, E 2.4.2, E 2.4.8, and E 2.4.9;

(6) Subpart E, Sec. E 3;

(7) Subpart E, Sec. E 4, except for E 4.3.2; and

(8) Subpart E, Sec. E 6; and

M. Standard Methods for the Examination of Dairy Products (American Public Health Association, Seventeenth Edition, 2004).

.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 in 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. §§321—350f;

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

(4) Bulk Milk Hauler/Sampler Manual;

(5) Maryland Laboratory Evaluation Program Manual;

(6) Grade “A” Pasteurized Milk Ordinance, only:

(a) Sections 5.—6.;

(b) Standards for Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging, all Items except for Item 9r. Administrative Procedures 1.a.;

(c) Standards for Grade “A” Pasteurized, Ultra-Pasteurized, Aseptically Processed and Packaged Low-Acid Milk and/or Milk Products, and Retort Processed after Packaged Low-Acid Milk and/or Milk Products, all Items except for Item 10p. Administrative Procedures 2.a., Item 11p. Administrative Procedures 2.a. and 6., Item 18p., and Item 19p.;

(d) Section 8.;

(e) Sections 12.—15.;

(f) Section 18.;

(g) Appendices A.—I.;

(h) Appendices K.—O.; and

(i) Appendices R.—S.;

(7) Milk for Manufacturing Purposes and its Production and Processing, Recommended Requirements, only:

(a) Subpart C, Sec. C12(a)(2)(ii) and C12(a)(3)(ii);

(b) Subpart E, Sec. E1, E 1.4(a)—(e);

(c) Subpart E, Sec. E1, E 1.15;

(d) Subpart E, Sec. E1, E 1.16;

(e) Subpart E, Sec. E 2, except for E 2.2.5, E 2.4.2, E 2.4.8, and E 2.4.9;

(f) Subpart E, Sec. E 3;

(g) Subpart E, Sec. E 4, except for E 4.3.2; and

(h) Subpart E, Sec. E 6; and

(8) Beginning January 1, 2019, FDA Food Safety Modernization Act, 21 U.S.C. §§2201—2252, as amended.

B. A person engaged in an occupation involving manufactured grade milk and milk products shall conduct all activities as set forth in and in compliance with the standards, requirements, and procedures specified in §A of this regulation.

.05 Permits Required.

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) 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. Decals.

(1) When issued a permit, a permittee shall supply and display a decal.

(2) The permittee’s decal shall display the following at a height of at least 3 inches:

(a) The milk tank truck Maryland permit number; and

(b) The words “MD Milk Trans.” in a circle around the permit number.

(3) The permittee’s decal shall be displayed on the rear tank of each milk tank truck.

D. 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:

(a) 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

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

(4) An individual who only transports milk in a sealed tanker to a milk plant.

.06 Permitting Process.

A. Except as otherwise provided in Health-General Article, §§21-410 and 21-411, Annotated Code of Maryland, a person shall obtain a permit from the Secretary before that person may:

(1) Bring, send, or receive a milk product into the State for sale;

(2) Offer a milk product for sale;

(3) Give away a milk product;

(4) Store a milk product;

(5) Transport a milk product; or

(6) Collect official milk samples.

B. Per Health-General Article, §§21-411, 21-412 and 21-417, Annotated Code of Maryland, an applicant for a permit shall:

(1) Submit a complete application to the Secretary for each place of operation on the form that the Secretary provides;

(2) Pay to the Secretary an annual fee established by the Secretary under Health-General Article, §2-104, Annotated Code of Maryland, and COMAR 10.01.17; and

(3) Be an employee of a milk transportation company, if applying for a Maryland Bulk Milk Hauler license, or be an owner of a milk transportation company, if applying for a Milk Transportation Company permit.

C. The Secretary shall issue a permit to an applicant who:

(1) Submits a complete application; and

(2) Meets the requirements of this chapter for each place of operation.

D. A permit issued by the Secretary:

(1) Is not transferable; and

(2) Is not valid if there is a change of owner, corporation, partnership, or physical location.

E. A bulk milk hauler/sampler who holds a permit in another state and picks up and samples raw milk at fewer than three Maryland farms shall obtain a Maryland milk hauler/sampler permit by providing:

(1) Documentation of a current bulk hauler/sampler permit from the licensing state, which clearly states the permit expiration date;

(2) Documentation of a current field evaluation from the licensing state; and

(3) A statement concerning the number of Maryland dairy farms from which the bulk milk hauler/sampler will pick up.

F. A bulk milk hauler/sampler who holds a permit from another state may pick up and sample raw milk from no more than three Maryland farms without a Maryland field evaluation or written exam.

G. If a bulk milk hauler/sampler who holds a permit from another state routinely picks up and samples raw milk at three or more Maryland farms, a Maryland field evaluation shall be conducted.

.07 Sale of Raw Milk.

A. Under Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell or give away 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.

.08 Standards for Milk for Manufacturing Purposes.

A. The individual 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 Maryland Laboratory Evaluation Program Manual; and

(2) Testing required for raw milk for pasteurization, pasteurized milk products, and dairy product containers and lids is performed according to the requirements established by the Maryland Laboratory Evaluation Program Manual.

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

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

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

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

(4) 21 CFR Parts 100—101 Food for Human Consumption, General and Food Labeling;

(5) 21 CFR Parts 131—133 Milk and Cream, Cheeses and Related Cheese Products; and

(6) The standards in the following table:

Product	Measure	Standard
Buttermilk (Condensed)	Temperature	7˚C (45˚F) or less
Buttermilk (Condensed)	Coliform	Less than or equal to 10/gram
Cream Condensed	Temperature	Less than or equal to 7˚C (45˚F)
Cream Condensed	Coliform	Less than or equal to 10/gram
Cream (Dry)	Bacteria	Less than or equal to 50,000/gram
Cream (Dry)	Coliform	Less than or equal to 10/gram
Dry Buttermilk and Dry Buttermilk Products	Coliform	Less than or equal to 10/gram
Dry Milk and Milk Products	Bacteria	Less than or equal to 50,000/gram
Dry Milk and Milk Products	Coliform	Less than or equal to 10/gram
Instant Nonfat Dry Milk	Bacteria	Less than or equal to 30,000/gram
Instant Nonfat Dry Milk	Coliform	Less than or equal to 10/gram
Manufactured Grade Raw Milk and Milk Products for Pasteurization, Ultra-Pasteurization or Aseptic Processing	Temperature	Bulk cooled to 10ºC (50ºF) or less within 4 hours or less of the commencement of the first milking, and to 7°C (45ºF) or less within 2 hours after the completion of milking. Provided that the blend temperature after the first milking and subsequent milkings does not exceed 10ºC (50ºF). Milk transported in cans maintained at 7ºC (45ºF) or less. Note: Milk sample submitted for testing cooled and maintained at 0ºC (32ºF) to 4.5ºC (40ºF), where sample temperature is greater than 4.5 ºC (40ºF), but less than or equal to 7.0ºC (45oF) and less than 3 hours after collection has not increased in temperature.
	Bacterial Limits	Individual producer milk not to exceed 500,000 per mL before commingling with other producer milk. Not to exceed 1,000,000 per mL as commingled milk before pasteurization. Note: Tested in conjunction with the drug residue test.
	Drugs	No positive results on drug residue detection methods as referenced in Grade “A” Pasteurized Milk Ordinance, Section 6 — Laboratory Techniques.
	Somatic Cell Count	Individual producer milk not to exceed 750,000 per mL except for individual producer goat milk, which is not to exceed 1,500,000 per mL.
	Abnormalities	Has normal odor and appearance. Free from excessive coarse sediment visually. Milk may not show any abnormal condition (such as, but not limited to curded, ropy, bloody, or mastitic) as indicated by sight or test procedures.
	Odor	The odor shall be fresh, sweet, and free from objectionable feed or other off odors that adversely affect the finished product.
Modified Whey Products (Condensed)	Temperature	7˚C (45˚F) or less
Modified Whey Products (Condensed)	Coliform	Less than or equal to 10/gram
Modified Whey Products (Dry)	Coliform	Less than or equal to 10/gram
Nonfat Dry Milk (NFDM)	Bacteria	Less than or equal to 75,000/gram
Nonfat Dry Milk (NFDM)	Coliform	Less than or equal to 10/gram
Pasteurized Condensed Milk and Milk Products	Temperature	7˚C (45˚F) or less
Pasteurized Condensed Milk and Milk Products	Coliform	Less than or equal to 10/gram
Pasteurized Whey (Condensed) or Whey Products	Temperature	7˚C (45˚F) or less
Pasteurized Whey (Condensed) or Whey Products	Coliform	Less than or equal to 10/gram, or less than or equal to 100/gram in the case of bulk transport tank shipments.
Whey Cream	Temperature	Less than or equal to 7˚C (45˚ F)
Whey Cream	Coliform	Less than or equal to 10/gram
Whey Cream Blends	Temperature	Less than or equal to 7˚C (45˚ F)
Whey Cream Blends	Coliform	Less than or equal to 10/gram
Whey (Dry)	Coliform	Less than or equal to 10/gram
Whey (Liquid) for Condensing or Drying	Temperature	7˚C (45˚F) or less

.09 Inspection and Evaluation of Milk Production, Milk Processing, and Milk Transportation.

A. Under the standards set forth in Section 5 of the Grade “A” Pasteurized Milk Ordinance, the Secretary shall inspect a:

(1) Milk plant;

(2) Milk producer;

(3) Milk tank truck;

(4) Milk tank truck cleaning facility;

(5) Receiving station;

(6) Seasonal milk producer; and

(7) Transfer station.

B. The Secretary shall inspect a distribution station at least once every 6 months.

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

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

E. Under the standards set forth in Health-General Article, §21-809, Annotated Code of Maryland, and the Grade “A” Pasteurized Milk Ordinance Item 16p.(D)2, the Secretary shall perform equipment tests and examinations at least once every 3 months.

F. The Secretary shall inspect a milk plant without a pasteurizer at least once every 6 months.

G. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B, the Secretary shall evaluate the:

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

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

(3) Sampling procedures of the industry plant sampler.

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

I. The Secretary shall inspect each milk tank truck as set forth in the Grade “A” Pasteurized Milk Ordinance, Appendix B, Section IV.

J. Under the standards set forth in the Maryland Laboratory Evaluation Program Manual, Evaluation of Milk Laboratories, Standard Methods for the Examination of Dairy Products, and the forms required by the Department, the Secretary shall evaluate a:

(1) Laboratory performing manufactured grade milk product testing for official use;

(2) Laboratory performing tests for drug residue screening, or tests for both drug residue screening and confirmation; and

(3) Laboratory analyst performing required testing.

K. Reinspections.

(1) If an inspection discloses the existence of a violation of a requirement set forth in this chapter, the Secretary shall re-inspect within 30 days, but not before 3 days, to determine compliance with the requirements of Regulation .13 of this chapter.

(2) If the Secretary finds on the second inspection a violation of the same requirement in this chapter, the Secretary shall issue a notice of intent to suspend the permit.

(3) If the Secretary finds a violation of the same requirement as specified on the notice of intent to suspend the permit on an inspection following the date of compliance as specified in the notice of intent to suspend the permit, the Secretary shall suspend the permit in accordance with Regulation .21 of this chapter and Health-General Article, §§21-418 and 21-419, Annotated Code of Maryland, or initiate appropriate court action.

L. Inspection Reports.

(1) The Secretary shall:

(a) Give one copy of the inspection report to the permittee or other responsible individual; or

(b) Post the inspection report in a conspicuous place on an inside wall of the establishment immediately after the conclusion of the inspection.

(2) The permittee may not deface the inspection report and shall make the inspection report available to the Department upon request.

(3) The Secretary shall keep a copy of the inspection report on file for 3 years.

M. Access Required. Upon request of the Secretary, a milk producer, milk hauler, distributor, milk processor, receiving station operator, transfer station operator, or bobtailer shall permit the Secretary access to all parts of the milk establishment, facility, or transporting vehicle to determine compliance with the provisions of this chapter and Health-General Article, Title 21, Subtitles 2 and 4, Annotated Code of Maryland.

N. Information Required. Upon request, a milk producer, milk hauler, distributor, milk processor, receiving station operator, transfer station operator, or bobtailer shall furnish the Secretary:

(1) A statement of quantities of milk and milk product of each grade purchased and sold;

(2) A list of all sources of this milk and milk product; and

(3) Records of inspections, tests, and pasteurization times and temperatures.

.10 Sampling and Evaluation.

A. The following individuals may collect official samples:

(1) A dairy plant sampler;

(2) An industry plant sampler;

(3) A bulk milk hauler/sampler; and

(4) A certified Industry Dairy Farm Inspector.

B. An individual collecting official milk samples shall collect samples in accordance with the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix B.

C. The Secretary shall evaluate the sampling and examination procedures of manufactured grade 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, Section 6 and Appendix B.

D. Can milk shall be sampled and analyzed in accordance with Milk for Manufacturing Purpose and Processing, Section C12(2)(ii) and C12(3)(ii).

E. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Item 7p. Administrative Procedures, and Appendix D, the Secretary shall conduct bacteriological testing of individual water supplies:

(1) Upon initial approval of the physical structure;

(2) Every 6 months after initial approval; and

(3) When a repair or alteration of the water supply system has been made.

F. The Secretary shall record and retain for at least 5 years all sample analysis results required under this regulation.

.11 Additional Requirements for Transporting of Manufactured Grade Milk.

A. A bulk milk hauler/sampler shall:

(1) Carry a bulk milk hauler’s permit when operating a milk tank truck, except when a raw milk producer is hauling raw milk from the producer’s farm only to the milk processing plant;

(2) Ensure that no interval greater than 2 hours elapses between milk pick-ups from farm to farm, and no more than 24 hours elapses from the first pick-up to delivery of the raw milk to the processing plant;

(3) Ensure bulk raw milk is picked up from every dairy farm at least every 3 days;

(4) Ensure bulk raw milk is delivered or received by the processor or receiving station within 84 hours of the initial milking;

(5) Ensure the temperature of the bulk raw milk does not exceed 50°F;

(6) Ensure operations are in accordance with the Bulk Milk Hauler/Sampler Manual; and

(7) In accordance with Standard Methods for the Examination of Dairy Products, 3.042, A, ensure proper agitation of the farm bulk tank raw milk.

B. A person may not transfer milk or milk products from a milk transport container or milk tank truck to another container or milk tank truck unless the transfer occurs:

(1) From a bulk milk tank to another permitted bulk milk tank truck on the dairy farm where the milk is produced;

(2) In a receiving station;

(3) In a transfer station; or

(4) In a milk plant.

C. Vehicles used for the transportation of can milk or cream shall be enclosed and constructed to protect the product from extreme temperature, dust, or other adverse conditions.

D. Stainless steel cans used in transporting milk from the dairy farm to a milk facility shall be constructed according to 3-A Sanitary Standards.

E. Milk transport containers used in transporting milk from the dairy farm to a milk facility shall be approved by the Secretary.

F. Vehicles used for the transportation of milk from the dairy farms to a milk facility may not be used for any other purpose.

G. Vehicles used for the transportation of milk shall be equipped with decking boards or racks when more than one tier of milk containers are carried.

H. The milk tank truck driver shall take responsibility for any official samples that may accompany the milk tank truck.

.12 Improper Handling of Milk Products.

A. Under Health-General Article, §21-428, Annotated Code of Maryland, the Secretary shall impound improperly handled milk or milk products that are intended for human consumption.

B. After impounding the milk or milk product, the Secretary may issue an order requiring one or more of the following actions:

(1) Disposing of the milk or milk product;

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

(3) Under Health-General Article, §21-428, Annotated Code of Maryland, imposing 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 in Health-General Article, §21-428, Annotated Code of Maryland, by:

(1) Appealing a civil penalty; or

(2) Bringing an action for damages.

.13 Labeling.

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

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

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

(3) 21 CFR Parts 101, 130, 131, 133, and 170—189;

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

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

B. A milk processor shall conspicuously mark each package containing manufactured milk products with:

(1) The name of the product;

(2) The name of the manufacturer;

(3) The address of the manufacturer:

(a) If listed in the local phone book, the address may consist of the city and state;

(b) If not listed in the local phone book, the street address shall be included;

(4) Each ingredient in order of predominance;

(5) The net weight of the product in English and metric units;

(6) The batch identification of the product;

(7) Required nutritional information;

(8) If the product is made by reconstitution or recombination, the word “reconstituted” or “recombined” as applicable;

(9) If the product is or is made from milk from a hooved mammal other than cattle, the common name of the hooved mammal producing the milk preceding the name of the milk or milk product;

(10) In the case of condensed or dry milk products, if distributed by another party, the name and address of the distributor shown by a statement such as “Distributed by”; and

(11) The word “Heat-Treated” for heat-treated milk and milk products.

C. A milk producer shall label all cans of raw milk from the producer’s dairy farm with the milk producer’s name or permit number.

.14 Animal Health.

All raw milk and milk products produced, processed, packaged, and stored under this chapter shall meet the Animal Health requirements as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 8.

.15 Dairy Farm 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 dairy farm, a person shall submit to the Department:

A. A plan and specifications before:

(1) Constructing or reconstructing a:

(a) Milk house;

(b) Milking barn;

(c) Milking stable; or

(d) Milking parlor;

(2) Converting or remodeling an existing building or structure for use as a:

(a) Milk house;

(b) Milking barn;

(c) Milking stable; or

(d) Milking parlor; or

(3) Adding, modifying, or replacing:

(a) A bulk milk tank;

(b) An entire 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;

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:

(1) The location of:

(a) The milk house;

(b) The milking barn;

(c) The milking stable;

(d) The milking parlor; and

(e) Each animal housing area; and

(2) Approximate distances in feet from the locations in §D(1) of this regulation, to:

(a) Cow yards;

(b) Ditches;

(c) Frost free style watering hydrants;

(d) Manure pits;

(e) Septic systems;

(f) Silos;

(g) Streams; and

(h) Wells or other approved water systems;

E. A detailed drawing:

(1) Of the interior, indicating dimensions, of:

(a) The milk house;

(b) The milking barn;

(c) The milking stable;

(d) The milking parlor; and

(e) Each animal housing area; and

(2) Showing the location of:

(a) Backflow prevention devices;

(b) Chemical dispensers;

(c) Compressors;

(d) Equipment;

(e) Floor drains;

(f) Frost free style watering hydrants;

(g) Hose bibs;

(h) Lighting;

(i) Pre-coolers;

(j) Toilets;

(k) Washing systems; and

(l) Watering troughs;

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) Pipelines, including size and length of the piping;

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

(d) Receivers, if applicable;

(e) Pre-coolers, 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 backflow protection methods or devices that will be installed to protect the:

(a) Potable water supply on all plate coolers;

(b) Chemical pumps:

(c) Water lines; and

(d) 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; and

G. For bulk tank or 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) If part of a new installation, specific floor, wall, and ceiling finishes;

(3) Bulk tank specifications and cooling system specifications, including:

(a) Make;

(b) Model number; and

(c) Capacity; and

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

.16 Dairy Farm Requirements.

A. The inspection area for a dairy farm includes the:

(1) Adjacent storage areas;

(2) Cow yard and cattle housing areas;

(3) Milk house;

(4) Milking barn, stable, or parlor;

(5) Surrounding area;

(6) Waste disposal areas; and

(7) Water supply and its distribution system.

B. A milk producer shall ensure that:

(1) 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 .15 of this chapter, as applicable;

(2) Water used at a dairy farm:

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

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

(ii) COMAR 26.04.04.; and

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

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

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

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

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

(3) Hand sinks have:

(a) Either:

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

(ii) Warm running water;

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

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

(4) 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;

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

(6) Plumbing is sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and

(7) Electrical systems and lighting requirements comply with State and local electrical laws, ordinances, and regulations, and the Grade “A” Pasteurized Milk Ordinance.

.17 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.

.18 Milk Physical Plant Requirements.

A. Water used at the 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;

(3) Be separate from a nonpotable water supply system so that nonpotable water can 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 26.04.02.

F. All 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.

.19 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:

(1) Regulations .15 and .16 of this chapter for a dairy farm permit; or

(2) Regulations .17 and .18 of this chapter for a milk facilities permit.

C. The Department shall:

(1) Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .15, .16, .17, and .18 of this chapter; and

(2) Inform the applicant:

(a) That the plan has been received;

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

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

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

.20 Confidentiality.

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

.21 Suspension and Revocation of Permits.

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 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

Revoked.

ROBERT NEALL
Secretary of Health

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Maryland Department of Health
Regulations