# COMAR Title 10 — Maryland Department of Health

## Subtitle 15 — Food

### Chapter 09 — Production, Processing, Transportation, Storage, and Distribution of Manufactured Grade Milk

#### Regulation .03 Incorporation by Reference.

*COMAR 10.15.09.03*

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 <S2?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).