REQUIREMENTS FOR OPERATION
§ 46.1141. License requirement.
(a) General requirement. A person may not operate a retail food facility without a valid license issued by the Department or licensor, unless otherwise provided in subsection (b).
(b) Exemptions. The following retail food facilities are exempt from licensure requirements under the Retail Food Facility Safety Act but remain subject to the inspection provisions and all other provisions of the Retail Food Facility Safety Act:
(1) A retail food facility in which only prepackaged, nonpotentially hazardous food or beverages are sold.
(2) A retail food facility that sells only raw agricultural commodities.
(3) A retail food facility that is exempt from licensure by an order of the Secretary that has been published in the Pennsylvania Bulletin in accordance with section 5703(b)(1) of the Retail Food Facility Safety Act (relating to license required) if the licensor is the Department.
(4) A retail food facility that is exempt from licensure by an order of the local government unit or units having licensing authority in accordance with section 5703(b)(1) of the Retail Food Facility Safety Act if the licensor is an entity other than the Department.
(c) License interval. A license certificate issued by the Department under this chapter sets forth the license expiration date. The license interval varies, in accordance with the risk-based factors identified in Subpart 8-401 of the Model Food Code, regarding frequency, and Annex 5 of the Model Food Code, regarding conducting risk-based inspections, as follows:
(1) 24-month license interval.
(i) The license interval is 24 months with a respect to a retail food facility that:
(A) Serves or sells only prepackaged, nonpotentially hazardous foods (nontime/temperature control for safety foods).
(B) Prepares only nonpotentially hazardous foods (nontime/temperature control for safety foods).
(C) Heats only commercially processed, potentially hazardous foods (time/temperature Control for Safety Food (TCS foods)) for hot holding.
(D) Does not cool potentially hazardous foods (TCS foods) for hot holding.
(ii) Examples of the type of retail food facility that would typically be subject to the 24-month license interval in subparagraph (i) are convenience store operations, hot dog carts and coffee shops.
(iii) The license interval for a retail food facility is 24 months if the retail food facility would otherwise be subject to the 18-month license interval in paragraph (2) but demonstrates to the Department, through historical documentation, that it has achieved and documented active managerial control of foodborne illness risk factors identified in Subpart 8-401 of the Model Food Code. These risk factors include:
(A) A history of noncompliance with provisions regarding foodborne illness risk factors or critical items.
(B) Specialized processes conducted.
(C) Food preparation a day in advance of service.
(D) Large numbers of people served.
(E) A history of foodborne illnesses or complaints, or both.
(F) Highly susceptible population served.
(iv) Active managerial control is achieved and documented when the conditions in subsection (d) are achieved by the licensee.
(2) 18-month license interval.
(i) The license interval is 18 months with respect to a retail food facility that:
(A) Has a limited menu.
(B) Prepares/cooks and serves most products immediately.
(C) May involve hot and cold holding of potentially hazardous foods (TCS foods) after preparation or cooking.
(D) Limits complex preparation of potentially hazardous foods (TCS foods) requiring cooking, cooling and reheating for hot holding to only a few potentially hazardous foods (TCS foods).
(ii) Examples of the type of retail food facility that would typically be subject to the 18-month license interval in subparagraph (i) are retail food store operations that have only a limited number of separate departments (such as deli, bakery, produce, seafood or meat areas), institutional facilities that do not serve a highly susceptible population and quick food service operations.
(iii) The license interval for a retail food facility is 18 months if the retail food facility would otherwise be subject to the 12-month license interval in paragraph (3) but demonstrates to the Department, through historical documentation, that it has achieved and documented active managerial control of the foodborne illness risk factors in paragraph (1).
(iv) The license interval for a retail food facility is 18 months if the retail food facility would otherwise be subject to the 24-month license interval in paragraph (1), but the retail food facility is newly-licensed or has not yet demonstrated to the Department, through historical documentation, that it has achieved and documented active managerial control of the foodborne illness risk factors in paragraph (1). Active managerial control is achieved and documented when the conditions in subsection (d) are achieved by the licensee.
(3) 12-month license interval.
(i) The license interval is 12 months with respect to a retail food facility that:
(A) Has an extensive menu that entails handling of raw ingredients.
(B) Has complex preparation including cooking, cooling and reheating for hot holding that involves many potentially hazardous foods (TCS foods).
(C) Uses a variety of processes that require hot and cold holding of potentially hazardous food (TCS food).
(ii) Examples of the type of retail food facility that would typically be subject to the 12-month license interval in subparagraph (i) are full service restaurants or retail food stores with a full range of separate departments (such as deli, bakery, produce, seafood or meat areas) that include ready-to-eat foods from a caf[eacute], salad bar or hot food bar.
(iii) The license interval for a retail food facility is 12 months if the retail food facility would otherwise be subject to the 6-month license interval in paragraph (4) but demonstrates to the Department, through historical documentation, that it has achieved and documented active managerial control of the foodborne illness risk factors in paragraph (1).
(iv) The license interval for a retail food facility is 12 months if the retail food facility would otherwise be subject to the 18-month license interval in paragraph (2), but the retail food facility is newly-licensed or has not yet demonstrated to the Department, through historical documentation, that it has achieved and documented active managerial control of the foodborne illness risk factors in paragraph (1). Active managerial control is achieved and documented when the conditions in subsection (d) are achieved by the licensee.
(4) 6-month license interval.
(i) The license interval is 6 months with respect to a retail food facility that serves a highly susceptible population or that conducts specialized processes such as smoking, curing or reduced oxygen packaging to extend shelf life.
(ii) Examples of the type of retail food facility that would typically be subject to the 6-month license interval in subparagraph (i) are preschools, hospitals, nursing homes and establishments conducting processing at retail.
(iii) The license interval for a retail food facility is 6 months if the retail food facility would otherwise be subject to the 12-month license interval in paragraph (3) but the retail food facility is newly-licensed or has not yet demonstrated to the Department, through historical documentation, that it has achieved and documented active managerial control of the foodborne illness risk factors in paragraph (1). Active managerial control is achieved and documented when the conditions in subsection (d) are achieved by the licensee.
(d) Achieving and documenting active managerial control. Active managerial control is achieved and documented when all of the following conditions are met:
(1) The previous three inspections of the retail food facility, conducted at the appropriate risk-based licensing inspection interval as described in subsection (c), document through the licensee’s inspection reports that:
(i) The retail food facility was in overall compliance.
(ii) There have not been repeats of previously-identified risk-factor violations among those three inspection reports.
(iii) If an HACCP plan is required under § 46.1122 (relating to HACCP plans), there have not been violations of that HACCP plan.
(2) Within the previous three inspections of the retail food facility, conducted at the appropriate risk-based licensing inspection interval as described in subsection (c), there have been no founded consumer complaints regarding food safety.
(3) Within the previous three inspections of the retail food facility, conducted at the appropriate risk-based licensing inspection interval as described in subsection (c), there have been no reported and confirmed incidents of foodborne illness associated with the facility.
(4) The retail food facility is in compliance with the Food Employee Certification Act.
(5) The retail food facility has written procedures that, at a minimum, address all risk factors if the facility does one or more of the following:
(i) Serves large numbers of people or prepares food a day in advance, or both, such as a retail food facility at a sports stadium, entertainment complex, conference center, banquet hall or offsite catering facility.
(ii) Serves transient groups of people such as a mobile retail food facility or temporary food facility at a fair or event.
(iii) Serves consumers which are a highly susceptible population, such as a preschool, nursing home or hospital.
Authority The provisions of this § 46.1141 amended under the Retail Food Facility Safety Act, 3 Pa.C.S. § § 5701—5714; the Food Safety Act, 3 Pa.C.S. § § 5721—5737; the act of July 2, 1935 (P.L. 589, No. 210) (31 P. S. § § 645—660g), known as the Milk Sanitation Law; section 1705(d) of The Administrative Code of 1929 (71 P. S. § 445(d)); and the Food Employee Certification Act, 3 Pa.C.S. § § 6501—6510.
Source The provisions of this § 46.1141 amended April 11, 2014, effective May 12, 2014, 44 Pa.B. 2220. Immediately preceding text appears at serial page (301706) to (301707).
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