§ 46.1101. Access to food facilities.

 After the Department or licensor presents identification, the person in charge shall allow the Department or licensor to determine if the food facility is in compliance with this chapter by allowing access to the facility, allowing inspection and providing information and records specified in this chapter and to which the Department or licensor is entitled under the Public Eating and Drinking Places Law, the Food Act and any other relevant statutory or food regulatory authority during the food facility’s hours of operation and other reasonable times if the facility is not open during normal business hours.

 (a)  General. This section describes the process by which a person may obtain an approval from the Department or a licensor required by any other provision of this chapter.

 (b)  Written request. A person seeking an approval from the Department or a licensor under this chapter shall submit a written request for approval to the entity from which approval is sought. If approval is sought from the Department, the written request shall be mailed or delivered to the following address:

Pennsylvania Department of Agriculture
Bureau of Food Safety and Laboratory Services
Attn: Chief, Division of Food Safety
2301 North Cameron Street
Harrisburg, Pennsylvania 17110-9408

 (c)  Contents of request. The written request for approval described in subsection (b) shall specify the provision of this chapter under which approval is sought, the reason approval is sought and relevant documentation in support of the request.

 (d)  Processing a request. The Department or licensor will, within 30 days of receipt of a written request for approval under this section, mail or otherwise provide the requester with a written grant or denial of the request, or a specific request for additional information. If a written request for additional information is made, the Department or licensor shall have an additional 30 days from the date it receives the additional information within which to mail or otherwise provide the requester with a written grant or denial of the request.

 (a)  Modifications and waivers. The Department may grant a variance by modifying or waiving the requirements of this chapter if—in the opinion of the Department—a health hazard will not result from the variance. If a variance is granted, the Department will retain the information specified in subsection (b) in its records for the food facility.

 (b)  Documentation of proposed variance and justification. Before a variance from a requirement of this chapter is approved, the information that shall be provided by the person requesting the variance and retained in the Department’s file on the food facility includes the following:

   (1)  A statement of the proposed variance of the chapter requirement citing relevant chapter section numbers.

   (2)  An analysis of the rationale for how the potential public health hazards addressed by the relevant chapter sections will be alternatively addressed by the proposal.

   (3)  An HACCP plan—if required as specified in §  46.1122(a)(1) (relating to HACCP plans)—that includes the information specified in §  46.1122(b) as it is relevant to the variance requested.

 (c)  Conformance with approved procedures. If the Department grants a variance as specified in subsection (a), or an HACCP plan is otherwise required as specified in §  46.1122(a), the food facility operator shall do the following:

   (1)  Comply with the HACCP plans and procedures that are submitted as specified in §  46.1122(b) and approved as a basis for the modification or waiver.

   (2)  Maintain and provide to the Department, upon request, records specified in §  46.1122(b)(4) and (5) that demonstrate that the following are routinely employed:

     (i)   Procedures for monitoring critical control points.

     (ii)   Monitoring of the critical control points.

     (iii)   Verification of the effectiveness of an operation or process.

     (iv)   Necessary corrective actions if there is failure at a critical control point.

   This section cited in 7 Pa. Code §  46.3 (relating to definitions); 7 Pa. Code §  46.361 (relating to cooking raw animal-derived foods); 7 Pa. Code §  46.401 (relating to variance requirement for specialized processing methods); 7 Pa. Code §  46.589 ( relating to molluscan shellfish tanks); 7 Pa. Code §  46.1124 (relating to preoperational inspection of construction); and 7 Pa. Code §  46.1144 (relating to conditions of retention: responsibilities of the food facility operator).

PLAN SUBMISSION AND APPROVAL

§ 46.1121. Facility and operating plans.

 (a)  When plans are required. A food facility licensing applicant or food facility operator shall have plans and specifications reviewed by the Department or licensor and will submit these properly prepared plans and specifications (as described in subsection (b)) to the Department or licensor for review and approval (using the procedure described in §  46.1142 (relating to application procedure for appropriate license or registration)) before any of the following:

   (1)  The construction of a food facility.

   (2)  The conversion of an existing structure for use as a food facility.

   (3)  The remodeling of a food facility (including installation and use of any new major food equipment for heating, cooling and hot and cold holding food) or a change of type of food facility or food operation if the Department or licensor determines that plans and specifications are necessary to ensure compliance with this chapter.

   (4)  A change of ownership of a food facility.

 (b)  Contents of the plans and specifications. The plans and specifications for a food facility shall include (as required by the Department or licensor based on the type of operation, type of food preparation and foods prepared) the following information to demonstrate conformance with this chapter:

   (1)  Intended menu and consumer advisory intentions, if a consumer advisory is required under §  46.423 (relating to consumer advisory required with respect to animal-derived foods that are raw, undercooked or not otherwise processed to eliminate pathogens).

   (2)  Anticipated volume of food to be stored, prepared and sold or served.

   (3)  Proposed layout, mechanical schematics, construction materials and finish schedules.

   (4)  Proposed equipment types, manufacturers, model numbers, locations, dimensions, performance capacities and installation specifications.

   (5)  Source of water supply, means of sewage disposal and refuse disposal.

   (6)  An HACCP plan, if required under §  46.1122 (relating to HACCP plans).

   (7)  Other information that may be required by the Department or licensor for the proper review of the proposed construction, conversion or modification of a food facility, and requested by the Department or licensor in writing.

 (a)  When a HACCP plan is required.

   (1)  Before engaging in an activity that requires a HACCP plan, a food facility applicant or food facility operator shall submit to the Department or licensor for approval a properly prepared HACCP plan as specified in subsection (b) and the relevant provisions of this chapter if any of the following occurs:

     (i)   Submission of a HACCP plan is required according to applicable Federal or State laws.

     (ii)   A variance is required as specified in §  46.250(b)(2)(ii), §  46.361(d)(2), §  46.401 or §  46.589(b).

     (iii)   The Department or licensor determines that a food preparation or processing method requires a variance based on a plan submittal specified in §  46.1121(b) (relating to facility and operating plans), an inspectional finding or a variance request.

   (2)  A food facility applicant or food facility operator shall have a properly prepared HACCP plan as specified in §  46.402 (relating to reduced oxygen packaging).

 (b)  Contents of a HACCP plan. For a food facility that is required in subsection (a) to have a HACCP plan, the plan and specifications shall indicate the following:

   (1)  A categorization of the types of potentially hazardous foods that are specified in the menu such as soups and sauces, salads, and bulk, solid foods such as meat roasts, or of other foods that are specified by the Department or licensor.

   (2)  A flow diagram by specific food or category type identifying critical control points and providing information on the following:

     (i)   Ingredients, materials and equipment used in the preparation of that food.

     (ii)   Formulations or recipes that delineate methods and procedural control measures that address the food safety concerns involved.

   (3)  Food employee and supervisory training plan that addresses the food safety issues of concern.

   (4)  A statement of standard operating procedures for the plan under consideration including clearly identifying the following:

     (i)   Each critical control point.

     (ii)   The critical limits for each critical control point.

     (iii)   The method and frequency for monitoring and controlling each critical control point by the food employee designated by the person in charge.

     (iv)   The method and frequency for the person in charge to routinely verify that the food employee is following standard operating procedures and monitoring critical control points.

     (v)   Action to be taken by the person in charge if the critical limits for each critical control point are not met.

     (vi)   Records to be maintained by the person in charge to demonstrate that the HACCP plan is properly operated and managed.

   (5)  Additional scientific data or other information, as required by the Department or licensor, supporting the determination that food safety is not compromised by the proposal.

 The Department or licensor will conduct one or more preoperational inspections to verify that the food facility is constructed and equipped in accordance with the approved plans and approved modifications of those plans, and variances granted under §  46.1103 (relating to variances). The Department or licensor will also verify the food facility is otherwise in compliance with this chapter, the Food Act and the Public Eating and Drinking Places Law.

   This section cited in 7 Pa. Code §  46.1143 (relating to issuance).

REQUIREMENTS FOR OPERATION

§ 46.1141. Requirement: license or registration.

 (a)  General requirement. A person may not operate a food facility without a valid registration issued by the Department, or license issued by the Department or licensor, unless otherwise provided in subsection (b).

 (b)  Exceptions.

   (1)  A building, structure or place owned, leased or otherwise in possession of a person or municipal corporation or public or private organization, used or intended to be used by two or more farmers or an association of farmers for the purpose of selling food directly to consumers—otherwise known as a farmer’s market—shall be considered to be a single retail food establishment for purposes of registration under section 14 of the Food Act (31 P. S. §  20.14).

   (2)  The following food establishments are exempt from registration requirements under section 14 of the Food Act:

     (i)   Vehicles used primarily for the transportation of a consumer commodity in bulk or quantity to manufacturers, packers, processors or wholesale or retail distributors.

     (ii)   A food establishment in which at least 50% of the commodities sold were produced on the farm on which the food establishment is located.

     (iii)   A food establishment in which food or beverages are sold only through a vending machine.

 Prior to the opening of a food facility, the operator shall contact the Department or licensor to obtain the appropriate application form for the required license or registration. The Department or licensor will supply the applicant the appropriate form, based upon the type of food facility involved. If the food facility is a public eating and drinking place, the applicant shall obtain a license. If the food facility is a retail food establishment, the applicant must obtain a registration. A single location (such as a grocery store that also serves hot ready-to-eat foods) might require both a license and a registration.

 (a)  New, converted or remodeled food facilities. For food facilities that are required to submit plans as specified in §  46.1121(a) (relating to facility and operating plans), the Department will issue a registration, or the Department or licensor will issue a license to the applicant after the following occur:

   (1)  The required plans, specifications and information are reviewed and approved.

   (2)  A preoperational inspection, as described in §  46.1124 (relating to preoperational inspection of construction) shows that the facility is built or remodeled in accordance with the approved plans and specifications and that the facility is in compliance with this chapter.

   (3)  A properly completed application is submitted.

   (4)  The required fee is submitted.

 (b)  License or registration renewal. The food facility operator of an existing food facility shall submit an application, the required fee and be in compliance with this chapter prior to issuance by the Department of a renewed registration or license, or the issuance of a renewed license by the Department or a licensor.

 To retain a license or registration issued by the Department or licensor under this chapter, a food facility operator shall do the following:

   (1)  Post the license or registration in a location in the food facility that is conspicuous to consumers and the Department or licensor.

   (2)  Comply with this chapter—including the conditions of a granted variance as specified in §  46.1103(c) (relating to variances)—and approved plans as specified in §  46.1121(b) (relating to facility and operating plans).

   (3)  If a food facility is required in §  46.1122(a) (relating to HACCP plans) to operate under a HACCP plan, comply with the plan as specified in §  46.1103(c).

   (4)  Immediately contact the Department or licensor to report an illness of a food employee as specified in §  46.111(b) (relating to duty to report disease or medical condition).

   (5)  Immediately discontinue operations and notify the Department or licensor if an imminent health hazard may exist because of an emergency such as a fire, flood, extended interruption of electrical or water service, sewage backup, misuse of poisonous or toxic materials, onset of an apparent foodborne illness outbreak, gross unsanitary occurrence or condition or other circumstance that may endanger public health. A food facility operator need not discontinue operations in an area of a facility that is unaffected by the imminent health hazard.

   (6)  Not resume operations discontinued in accordance with paragraph (5) or otherwise according to the Public Eating and Drinking Places Law or the Food Act until approval is obtained from the Department or licensor.

   (7)  Allow representatives of the Department or licensor access to the food facility as specified in §  46.1101 (relating to access to food facilities).

   (8)  Except as specified in paragraph (9), replace existing facilities and equipment with facilities and equipment that comply with this chapter if either of the following occurs:

     (i)   The Department or licensor directs the replacement because the facilities and equipment constitute a public health hazard or no longer comply with the criteria upon which the facilities and equipment were accepted.

     (ii)   The facilities and equipment are replaced in the normal course of operation.

   (9)  Upgrade or replace refrigeration equipment as specified in §  46.385(a)(3) (relating to potentially hazardous food: hot and cold holding), by December 13, 2008, if the circumstances specified in paragraph (8)(i) and (ii) do not occur first, and unless a variance has been approved as specified in §  46.1103.

   (10)  Comply with directives of the Department or licensor including time frames for corrective actions specified in inspection reports, notices, orders, warnings and other directives issued by the Department or licensor in regard to the operator’s food facility or in response to community emergencies.

   (11)  Accept notices issued and served by the Department or licensor according to the Public Eating and Drinking Places Law or the Food Act.