Maryland Administrative Code

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Aging of cheese” means the storing and maturing of cheese under controlled conditions of temperature and humidity. (2) “Aging period” means the aging of raw milk cheese fo…

.03 Incorporation by Reference. In this chapter, the following documents are incorporated by reference: A. 21 CFR Part 101, as amended; B. 21 CFR Part 110, as amended; C. 21 CFR Part 133, as amended; D. Nutrition Labeling and Education Act of 1990 (Public Law 101-535), 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 and in compliance with the standards, requirements, and procedures specified in: (1) Health-General Articl…

.05 Permitting Requirements. A. Pursuant to 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 the person may be a: (1) Milk…

.06 Sanitation Inspection Frequencies and Reports for Plants. A. A farmstead cheese processor shall meet the standards set forth in this chapter. B. The Department shall conduct sanitation inspections of a plant within the Departmental Inspection Area and any other area designate…

.07 Sanitation Inspection Standards for a Plant. A plant shall meet the sanitation inspection standards set forth in this regulation: A. Floor — Construction. (1) The floor of each room in which product containers, utensils, equipment, milk, or cheese products are handled, proces…

.08 Examination and Standards of Raw Milk, Farmstead Cheese Finished Products, and Water Supply. A. Raw Milk Sampling and Testing Standards. (1) The farmstead cheese processor is responsible for the collection and cost associated with the sampling and testing of raw milk used for…

.09 Enforcement Actions. A. Raw Milk Enforcement. (1) When two of the last four consecutive bacterial count or cooling temperatures, taken on separate days, exceed the limit for raw milk, as set forth in this chapter, the Department shall: (a) Send to the permit holder a written …

.10 Improper Handling of Milk Products. A. Pursuant to Health-General Article, §21-428, Annotated Code of Maryland, the Department shall impound milk or a milk product intended for human consumption due to improper handling. B. The Department may: (1) Issue an order to make the m…

.11 Labeling of Farmstead Cheese. A farmstead cheese processor shall: A. Ensure all labels for a farmstead cheese product conform to the standards and requirements established by: (1) The Federal Food, Drug, and Cosmetic Act, 21 USC, §§341—350f; (2) The Nutrition Labeling and Edu…

.12 Sale of Raw Milk. Pursuant to Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell raw milk for human consumption.

.13 Animal Health. All raw milk for farmstead cheese shall meet the Animal Health requirements as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 8, incorporated by reference in Regulation .03 of this chapter.

.14 Plant Construction and Plan Submission. Pursuant to Health-General Article, §§21-410, 21-411, and 21-413 for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department: A. A plan and specification before: (1) A plant is c…

.15 Physical Plant Requirements for Plants. A. Water used at a farmstead cheese 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” Pasteuriz…

.16 Plan Review and Approval Process. 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 Regul…

.17 Personnel Health. No individual affected with any disease capable of being transmitted to others through the contamination of food shall work at a plant in any capacity which brings them into direct contact with: A. Raw milk, a farmstead cheese product, and a food ingredient;…

.18 Procedure When Infection or High Risk of Infection is Suspected or Discovered. In accordance with Health-General Article, §§18-102, 21-253, 21-254, and 21-435, Annotated Code of Maryland, when an individual working at a plant has a communicable disease or is a carrier of a co…

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

.20 Suspension and Revocation of Permits. A. When a farmstead cheese processor is found in violation of this chapter, the Department 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.…

.21 Appeals Process. In accordance with the Administrative Procedures Act and Health-General Article, §21-419 the Department shall ensure that an opportunity for a hearing is provided to a farmstead cheese processor whose plan review or permit has been: A. Denied; B. Suspended; o…

.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 purpose…

.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 Da…

.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/…

.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 Art…

.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; …

.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) Of…

.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 sta…

.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 M…

.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 t…

.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 s…

.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 proc…

.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 …

.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 …

.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 specific…

.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 …

.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 spe…

.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…

.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 …

.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, …

.22 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. …

.01 Incorporation by Reference. All provisions of 21 CFR 123 and §§1240.3(r) — (u) and 1240.60 are incorporated by reference.

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Approved source” has the meaning stated in Health-General Article, §21-336(a), Annotated Code of Maryland. (2) “Approving authority” means the agency designated in the law…

.02 Incorporation by Reference. In this chapter, the following documents are incorporated by reference: A. 21 CFR Part 129, as amended; B. 21 CFR §165.110, as amended; and C. 21 CFR §165.3, as amended.

.03 Compliance with Other Chapter. A. The person-in-charge shall comply with this chapter and COMAR 10.15.04 to: (1) Process finished product water; and (2) Design, operate, and maintain a bottled water plant and equipment. B. If a conflict occurs between the requirements of this…

.04 Licenses. A. The person-in-charge shall obtain a food processing plant license to operate a bottled water plant pursuant to the provisions of: (1) Health-General Article, §21-305, Annotated Code of Maryland; (2) COMAR 10.15.04; and (3) This chapter. B. The Department shall sp…