Md. Code Regs. 10.15.04.14

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.15.04.14 - Facility Process and Plan Review

A. The person-in-charge shall ensure that 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;

(c) A food or process is added or significantly modified; or

(d) A new scheduled process or shelf life study is used; and

(2) That include the following information, as applicable:

(a) A scale drawing in horizontal view that identifies the:

(i) Layout and arrangement of work areas;

(ii) Location of food equipment including exhaust ventilation hoods; and

(iii) Location of plumbing and plumbing fixtures such as water lines, sewer lines, hand sinks, toilets, utility sinks, utensil washing sinks, floor drains, floor sinks, and hose stations;

(b) Specifications for the:

(i) Construction materials for the building and interior finishes;

(ii) Disposal of sewage;

(iii) Provision of potable water;

(iv) Exclusion and control of pests;

(v) Ventilation of the plant and individual areas within the plant;

(vi) Methods and facilities for waste storage and disposal; and

(vii) Lighting;

(c) A complete list of specifications for the proposed equipment;

(d) A written description of the foods to be processed, stored, or distributed;

(e) Written standard operating procedures for:

(i) Processing foods named in §A(2)(d) of this regulation;

(ii) Employee health and personal hygiene; and

(iii) Plant sanitation;

(f) When required by Regulation .02, .07, .10, or .12 of this chapter, a HACCP plan;

(g) When required by the Department, a scheduled process or shelf life study, performed by a process authority;

(h) When required by the Department, a laboratory analysis, performed by a laboratory with a current accreditation to the ISO/IEC 17025;

(i) A hazard analysis and food safety plan as required by Regulation .08B and C of this chapter; and

(j) Any other information that may be required by the Department to ascertain compliance of the plans and specifications with all applicable federal, State and local laws, regulations, and ordinances.

B. The person-in-charge may not construct a new food processing plant, remodel an existing food processing plant, or manufacture a food using a new or modified process before receiving written approval of the plans and specifications from the Department.

C. The Department shall:

(1) Review the plans and specifications to ensure compliance with the applicable regulations;

(2) Inform in writing the individual who submitted the plans and specifications:

(a) Of additional information that may be required; and

(b) Following the review, whether the plans and specifications are approved or denied; and

(3) If the plans are denied, provide the individual in writing who submitted the plans and specifications with information on how to appeal the decision, as set forth in State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.

D. The person-in-charge shall ensure that before a new or remodeled food processing plant is operated:

(1) The Department schedules and completes an inspection;

(2) The Department issues written approval for the use of the new or remodeled plant; and

(3) For a new plant, a food processing license is obtained.

E. The Department shall:

(1) Review the plans and specifications to ensure compliance with the applicable regulations;

(2) Conduct a priority assessment of the facility based on the information obtained pursuant to §A(2)(d) and (e) of this regulation; and

(3) Classify a food processing plant as a:

(a) High priority facility, if the food processing plant manufactures food:

(i) Using specialized processes that require a scheduled process or a HACCP Plan;

(ii) Using ingredients that require temperature control for safety; or

(iii) That is temperature controlled for safety;

(b) Moderate priority facility, if the food processing plant:

(i) Manufactures food using ingredients that do not require temperature control for safety;

(ii) Manufactures food that is not temperature controlled for safety; or

(iii) Is a food warehouse that stores and distributes food that requires temperature control for safety; or

(c) Low priority facility, if the food processing plant is a food warehouse that stores food or ingredients that do not require temperature control for safety.

F. The Department may allow the use of equipment that meets the requirements of Regulation .10C-E of this chapter but fails to comply with Regulation .10A of this chapter if a review indicates the equipment and its use are:

(1) Not harmful to public health; and

(2) Consistent with industry standards and practices.

G. The Department may accept plant, facilities, and grounds design and construction other than those that are provided for in Regulation .09 of this chapter based on a review that shows the alternative plant, facilities, and grounds design:

(1) Provides for adequate food safety, food protection, and sanitation; and

(2) Is equivalent to regulatory and industry standards.

Md. Code Regs. 10.15.04.14

Regulations .14 adopted effective November 22, 2004 (31:23 Md. R. 1652)
Regulation .14 amended effective March 5, 2012 (39:4 Md. R. 337); amended effective 43:03 Md. R. 272, eff.2/15/2016; adopted effective 51:15 Md. R. 708, eff. 8/5/2024.