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10.15.04.00.htm 10.15.04.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 15 FOOD Chapter 04 Food and Drink Processing and Transportation Authority: Agriculture Article, §4-311; Health-General Article, §18-102, 21-101, 21-102, 21-211, 21-234, 21-301, 21-304, 21-308, 21-309.1, 21-309.2, and 21-336; Annotated Code of Maryland
10.15.04.01.htm 10.15.04.01. 01 Scope.. This chapter:. A. Provides the minimum food safety and sanitation requirements for food processing plants, including warehouses and transfer stations, and the transportation of food;B. Establishes, along with COMAR 10.15.03, the standards of the Maryland Department of Health's part of a program jointly administered with the Department of Agriculture under COMAR 15.04.01 and 15.11.11 to control Salmonella Enteritidis in shell eggs and egg-producing chickens; and
10.15.04.02.htm 10.15.04.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) Adulterated Food.. a) "Adulterated food" has the meaning stated in Health-General Article, §21-207, Annotated Code of Maryland.b) "Adulterated food" includes food that is:. i) Spoiled;. ii) Contaminated; or. iii) Misbranded so that the food is unsafe for human consumption.. 2) "Approving authority" means the agency designated in the laws of another state or country to lice
10.15.04.03.htm 10.15.04.03. 03 Incorporation by Reference.. A. In this chapter, the following documents are incorporated by reference.. B. Documents Incorporated.. 1) 9 CFR, as amended;. 2) 21 CFR, as amended;. 3) 21 U.S.C. §343, as amended;. 4) 21 U.S.C. §451―471, as amended; and. 5) 21 U.S.C. §601―695, as amended..
10.15.04.04.htm 10.15.04.04. 04 Compliance with Other Chapters.. The person-in-charge shall process, store, and transport food and design, operate, and maintain a food processing plant and the facilities and equipment associated with a food processing plant in compliance with this chapter and with COMAR 10.15.01, 10.15.02, 10.15.07, 10.15.10, and 10.15.12, as applicable.
10.15.04.05.htm 10.15.04.05. 05 Wholesomeness of Food.. The person-in-charge shall ensure that:. A. All food and food ingredients processed in a food processing plant:. 1) Are safe for human consumption;. 2) Are clean;. 3) Are free of spoilage;. 4) Are from an approved source;. 5) Are GRAS; and. 6) If applicable, conform to a standard of identity;. B. Shell eggs:. 1) Are produced by flocks that meet the standards established under COMAR 15.11.11.05A;. 2) That are received, used, or provided to the con
10.15.04.06.htm 10.15.04.06. 06 Food Protection.. The person-in-charge shall ensure that:. A. Food is protected at all times from contamination and sources of contamination including:. 1) Pathogenic microorganisms;. 2) Toxic or deleterious chemicals;. 3) Foreign matter;. 4) Dust;. 5) Vermin;. 6) Insects;. 7) Unnecessary hand contact or other handling;. 8) Overhead leakage; and. 9) Animals;. B. During storage, transportation, processing, and transfer, including the time at a food transfer s
10.15.04.07.htm 10.15.04.07. 07 Processing Practices.. A. The person-in-charge shall ensure that:. 1) Food is processed using procedures, sanitary practices, and process controls that produce only safe and wholesome food;2) When required by the Department in accordance with §B of this regulation:. a) A scheduled process is used to manufacture a food; and. b) Except as set forth in §A(3) of this regulation, a scheduled process or shelf life approved by the Department is not changed;
10.15.04.08.htm 10.15.04.08. 08 Process Control, Monitoring, and Record Keeping.. A. The Department may require a processor to conduct a process hazard analysis, establish and monitor critical control points, and provide verification based on:1) The requirements in COMAR 10.15.01, 10.15.02, 10.15.07, 10.15.10, and 10.15.12 and this chapter; and2) Potential hazards associated with a food.. B. While complying with §A of this regulation, the person-in-charge shall ensure that:. 1) Each processing operat
10.15.04.09.htm 10.15.04.09. 09 Plant and Facilities ― Design and Construction.. A. The person-in-charge shall ensure that the equipment and facilities needed to process food in accordance with the requirements of this chapter are provided and maintained in a sanitary and working condition.B. The person-in-charge shall ensure that the water supplied to a fixture:. 1) Is potable;. 2) Meets the requirements of the Environment Article, Annotated Code of Maryland, and COMAR 26.04.01; and
10.15.04.10.htm 10.15.04.10. 10 Equipment and Utensils ― Design and Construction.. A. The person-in-charge shall ensure that:. 1) Equipment for processing food is:. a) Designed to provide for food safety, food protection, and sanitation;. b) When associated with a critical control point, provided with instrumentation to allow:. i) The control of critical factors;. ii) The monitoring of critical factor control and implementation; and. iii) Verification of process control;.
10.15.04.11.htm 10.15.04.11. 11 Worker Sanitation.. The person-in-charge shall ensure that:. A. An individual in the plant:. 1) Practices good personal hygiene so that the individual does not contaminate the food;. 2) Is excluded from working with food and food contact surfaces:. a) As provided in COMAR 10.06.01.06E; and. b) When the individual has an:. i) Illness transmissible through food; or. ii) Exposed and open sore or cut;. 3) While working with food or handling food contact surfaces, washes the in
10.15.04.12.htm 10.15.04.12. 12 Plant and Equipment Sanitation.. The person-in-charge shall ensure that:. A. The grounds around a food processing plant are:. 1) Maintained free of unused equipment, debris, litter, waste, high weeds, or grass that provide an attractant, breeding place, or harborage for vermin and insects; and2) Adequately drained to:. a) Promote sanitation; and. b) Prevent breeding places for pests and insects;. B. Food contact surfaces are cleaned and sanitized:.
10.15.04.13.htm 10.15.04.13. 13 Unit Processing Operations ― Storage and Transportation.. A. The person-in-charge shall ensure that:. 1) Except as provided in §C of this regulation, a stored item and a stationary bulk storage rack are:a) Away from walls;. b) At least 6 inches off the floor; and. c) Maintained to allow:. i) Inspection;. ii) Cleaning;. iii) Repair to walls; and. iv) Vermin and insect control;. 2) Incoming food is inspected for:. a) Spoilage;. b) Wholesomeness;. c) Damage; and.
10.15.04.14.htm 10.15.04.14. 14 Unit Processing Operations ― Processing Food for Safety and Shelf Life.. The person-in-charge shall ensure that:. A. Food pathogens are excluded or eliminated from food before offering the food for human consumption;B. The thermal processing of food:. 1) Eliminates or reduces the number of pathogens in the food so that the food is safe for human consumption;2) Achieves the necessary reduction in spoilage organisms for a stated or desired shelf life under n
10.15.04.15.htm 10.15.04.15. 15 Unit Processing Operations ― Packaging Food.. The person-in-charge shall ensure that:. A. Food packaging is:. 1) Designed and installed to maintain food:. a) Safety; and. b) Integrity;. 2) Made from materials that:. a) Are safe;. b) Are appropriate for the intended use;. c) Do not migrate to or might be absorbed by food; and. d) Comply with the requirements of the United States Food and Drug Administration in 21 CFR Parts 174―178 for indirect food additives;
10.15.04.16.htm 10.15.04.16. 16 Unit Processing Operations ― Food Labeling.. A. The person-in-charge shall ensure that:. 1) Except as provided in §B of this regulation, or as otherwise stipulated in COMAR 10.15.01, 10.15.02, 10.15.04, 10.15.07, or 10.15.10 food labeling is accomplished by:a) Placing the information required in §A(2) of this regulation on the food container by:. i) Imprinting;. ii) Embossing;. iii) Lithography; or. iv) Ink jetting; or. b) Another method:.
10.15.04.17.htm 10.15.04.17. 17 Facility and Process Plan Review.. A. The person-in-charge shall ensure that properly prepared plans and specifications are submitted to the Department:1) Before:. a) A food processing plant is:. i) Constructed;. ii) Remodeled; or. iii) Materially altered;. b) An existing building or structure is converted or remodeled for use as a food processing plant; orc) A food process is added or modified so that:. i) A plant or plant facilities require modification; and.
10.15.04.18.htm 10.15.04.18. 18 On-Farm Home Processing.. A. The Department may issue a food processing plant license to an individual who owns a farm to process food in a home or domestic kitchen located on the individual's farm as set forth in this regulation.B. While operating with a license issued in accordance with §A of this regulation, the person-in-charge shall:1) Comply with this chapter except for:. a) Regulation .09D(2)b) (4) and (5) of this chapter;.
10.15.04.19.htm 10.15.04.19. 19 Producer Mobile Farmer’s Market Unit.. A. The Department may issue a food processing plant license to operate a producer mobile farmer’s market unit to transport for sale at a farmer's market potentially hazardous food products:1) Produced or stored on the farm by the licensee under an on-farm home processing plant license;. 2) Produced or stored on the farm by the licensee, as authorized by the Department in regulation; or. 3) That have been inspected, licensed, or certifie
10.15.04.20.htm 10.15.04.20. 20 Animal Slaughtering, Meat Processing, and Poultry Processing.. A person that slaughters animals and processes meat shall ensure that:. A. Animal slaughtering, meat processing, poultry processing, meat sales, and poultry sales are regulated and inspected in conformance with the applicable federal, State, and local laws and regulations;B. Cattle, sheep, swine, goats, horses, mules, and other equine are slaughtered and processed in accordance with:
10.15.04.21.htm 10.15.04.21. 21 Licensing.. A. In order to operate a food processing plant, a person shall obtain a food processing license pursuant to the provisions of:1) Health-General Article, §21-211 and 21-305, Annotated Code of Maryland; and. 2) This chapter.. B. The Department shall specify on the food processing license what foods or food types the licensee is authorized to process.C. The Department shall deny an application for a license if the applicant:. 1) Does not meet the requirements of:.
10.15.04.22.htm 10.15.04.22. 22 Repealed..
10.15.04.23.htm 10.15.04.23. 23 Inspections.. A. The person-in-charge shall permit a representative of the approving authority to:. 1) Enter a food processing plant at a reasonable time for the purpose of making inspections to determine compliance with this chapter; and2) Examine the records of the facility that pertain to information regarding food and supplies purchased, received, or used.B. The person-in-charge shall inform the approving authority of a food ingredient or a recipe that t
10.15.04.24.htm 10.15.04.24. 24 Enforcement Procedures.. A. The approving authority shall ensure that when a food processing plant is found in violation of any provision of this chapter, the licensee is notified:1) Of the specific findings;. 2) Of a specific date by which the licensee shall correct the violations or deficiencies; and. 3) That, if the licensee fails to correct the violation by the date specified, the approving authority may suspend or revoke the license.B. When a person is viola
10.15.04.25.htm 10.15.04.25. 25 Foodborne Disease Investigation and Control.. The approving authority shall ensure that:. A. When there is reasonable cause to suspect foodborne disease transmission from a food processing plant employee:1) A morbidity history of the suspected employee is taken;. 2) An investigation is conducted; and. 3) The appropriate follow-up action is taken that may include:. a) Immediate exclusion of the employee from all food handling positions within the plant; and.
10.15.04.26.htm 10.15.04.26. 26 Sampling, Detention, and Condemnation of Food.. The approving authority shall:. A. Sample and examine food as often as necessary for enforcement of this chapter;. B. Sample food in accordance with Health-General Article, §21-249 and 21-251, Annotated Code of Maryland; andC. Take action on a food in accordance with Health-General Article, §21-211, 21-253, and 21-254, Annotated Code of Maryland, by:1) Issuing a detention order;. 2) Destroying the food; or.
10.15.04.27.htm 10.15.04.27. 27 Penalties.. A person who violates any of the provisions of this chapter or refuses, neglects, or fails to comply with the provisions and requirements of this chapter is subject to penalties, fines, and imprisonment as set forth in Health-General Article, 21-309.1(f)1)3) 21-1214, and 21-1215, Annotated Code of Maryland.
10.15.04.28.htm 10.15.04.28. 28 Federal Compliance.. In addition to the other requirements set forth in this chapter, the person in charge shall ensure that the food processing plant meets all of the requirements applicable to food sources, storage, and preparation that are set forth at:A. 9 CFR, as amended;. B. 21 CFR, as amended;. C. 21 U.S.C. §343, as amended;. D. 21 U.S.C. §451—471, as amended; and. E. 21 U.S.C. §601—695, as amended..
10.15.04.9999.htm 10.15.04.9999. Administrative History Effective date: November 18, 1960. Amended effective January 1, 1964; June 8, 1965; July 1, 1966; April 1, 1967; December 1, 1970. Regulation .29 adopted effective September 21, 1979 (6:19 Md. R. 1519). Regulation .29 amended effective December 14, 1979 (6:25 Md. R. 1980) ―. Chapter revised as an emergency provision effective August 2, 1989 (16:17 Md. R. 1882) adopted permanently effective December 25, 1989 (16:25 Md. R. 2711)
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