In this chapter the following documents are incorporated by reference:

1. A. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§321—350f, as amended;
2. B. Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended;
3. 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;
4. D. Maryland Laboratory Evaluation Program Manual, 2017 (Center for Milk and Dairy Product Safety, Office of Food Protection, Maryland Department of Health);
5. E. 21 CFR Parts 100—101, as amended;
6. F. 21 CFR Part 117;
7. G. 21 CFR Parts 130—133, as amended;
8. H. 21 CFR Parts 170—189, as amended;
9. I. FDA Food Safety Modernization Act, 21 U.S.C <S2?2201—2252, as amended;
10. 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);

11. 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. (1) Section 5. Inspection of Dairy Farms and Milk Plants;
    2. (2) Section 6. The Examination of Milk and/or Milk Products;
    3. (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. (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. (5) Section 8. Animal Health;
    6. (6) Section 12. Plans for Construction and Reconstruction;
    7. (7) Section 13. Personnel Health;
    8. (8) Section 14. Procedure when Infection or High Risk of Infection is Discovered;
    9. (9) Section 15. Enforcement;
    10. (10) Section 18. Separability Clause;
    11. (11) Appendix A. Animal Disease Control;
    12. (12) Appendix B. Milk Sampling, Hauling, and Transportation;
    13. (13) Appendix C. Dairy Farm Construction Standards and Milk Production;
    14. (14) Appendix D. Standards for Water Sources;
    15. (15) Appendix E. Examples of 3-out-of-5 Compliance Enforcement Procedures;
    16. (16) Appendix F. Cleaning and Sanitization;
    17. (17) Appendix G. Chemical and Bacteriological Tests;
    18. (18) Appendix H. Pasteurization Equipment and Procedures and Other Equipment;
    19. (19) Appendix I. Pasteurization Equipment and Controls — Tests;
    20. (20) Appendix K. HACCP Program;
    21. (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. (22) Appendix M. Reports and Records;
    23. (23) Appendix N. Drug Residue Testing and Farm Surveillance;
    24. (24) Appendix O. Vitamin Fortification of Fluid Milk Products;
    25. (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. (26) Appendix R. Determination of Time/Temperature Control for Safety Milk and/or Milk Products; and
    27. (27) Appendix S. Aseptic Processing and Packaging Program and Retort Processed after Packaging Program;

12. 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. (1) Subpart C, Sec. C12(a)(2)(ii) and C12(a)(3)(ii);
    2. (2) Subpart E, Sec. E1, E 1.4(a)—(e);
    3. (3) Subpart E, Sec. E1, E 1.15;
    4. (4) Subpart E, Sec. E1, E 1.16;
    5. (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. (6) Subpart E, Sec. E 3;
    7. (7) Subpart E, Sec. E 4, except for E 4.3.2; and
    8. (8) Subpart E, Sec. E 6; and
13. M. Standard Methods for the Examination of Dairy Products (American Public Health Association, Seventeenth Edition, 2004).

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

Effective date: April 10, 1995 (22:7 Md. R. 536)

Regulations .01—.20 repealed and new Regulations .01—.22 adopted effective May 20, 2019 (46:10 Md. R. 488)