RULES AND REGULATIONS

Title 7—AGRICULTURE

DEPARTMENT OF AGRICULTURE

[ 7 PA. CODE CHS. 46 AND 76 ]

Food Code; Food Employee Certification

[44 Pa.B. 2220]
[Saturday, April 12, 2014]

 The Department of Agriculture (Department) amends Chapter 46 (relating to Food Code) and rescinds Chapter 76 to read as set forth in Annex A.

Statutory Authority

 Sections 5701—5714 of 3 Pa.C.S. (relating to Retail Food Facility Safety Act), 3 Pa.C.S. §§ 5721—5737 (relating to Food Safety Act), 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 3 Pa.C.S. §§ 6501—6510 (relating to Food Employee Certification Act) provide the legal authority for this final-form rulemaking.

 The Retail Food Facility Safety Act charges the Department with responsibilities regarding the licensure, inspection, cleanliness and sanitation of ''retail food facilities'' (such as restaurants) in this Commonwealth. This includes the responsibility to promulgate regulations necessary to implement the Retail Food Facility Safety Act and requires that, in promulgating this final-form rulemaking, the Department ''be guided by the most current edition of the Food Code, published by the United States Department of Health, Food and Drug Administration'' (Model Food Code). See section 5707(a) of the Retail Food Facility Safety Act (relating to powers of department). The Retail Food Facility Safety Act also affords the Department the discretion to establish retail food facility license intervals of more than 1 year, but requires that these license intervals be established by regulation and that the regulation use risk-based factors identified in the Model Food Code as a basis for determining the appropriate license interval.

 The Food Safety Act charges the Department with the responsibility to: (1) regulate, register and inspect ''food establishments'' in this Commonwealth (see section 5734(a) of the Food Safety Act (relating to registration of food establishments)); (2) promulgate regulations and food safety standards necessary to the proper enforcement of the food safety requirements in the Food Safety Act (see section 5733(a) of the Food Safety Act (relating to rules and regulations)); and (3) construe the Food Safety Act and its attendant regulations in a manner that is as consistent with Federal statutory and regulatory authority as practicable (see section 5736 of the Food Safety Act (relating to construction of subchapter)).

 The Milk Sanitation Law requires that a person selling milk, milk products or manufactured dairy products have a Department-issued permit. It also charges the Department with responsibility to promulgate regulations necessary for the proper enforcement of the Milk Sanitation Law. See section 19 of the Milk Sanitation Law (31 P. S. § 660c).

 Section 1705(d) of The Administrative Code of 1929 requires the Department to establish regulatory standards necessary to enforce food safety laws.

 The Food Employee Certification Act requires that a retail food facility have at least one employee who holds a valid certificate evidencing successful completion of a Department-approved food safety training course (see section 6504(a) of the Food Employee Certification Act (relating to certification of employees)) and authorizes the Department to promulgate regulations necessary for the proper enforcement of the Food Employee Certification Act (see section 6505 of the Food Employee Certification Act (relating to rules and regulations)).

Purpose of the Final-Form Rulemaking

 The act of November 23, 2010 (P. L. 1039, No. 106) (Act 106) accomplished a significant overhaul of the food-related statutes administered and enforced by the Department. It repealed the Public Eating or Drinking Places Law and the Food Act, and supplanted these with the Retail Food Facility Safety Act and the Food Safety Act, respectively. It also made substantive changes to the Food Employee Certification Act. Although many of the provisions of these new or revised food-related statutes are similar to provisions of the statutes they replaced, there are also a number of changes that necessitate the regulatory revisions described in this document.

 The final-form rulemaking: (1) adopts the terminology and implements the changes necessitated or authorized by Act 106; (2) incorporates, to the extent practicable, the standards and requirements of the Model Food Code as the food safety standards and requirements for this Commonwealth; (3) establishes retail food facility license intervals of more than 1 year, using risk-based factors identified in the Model Food Code as a basis for determining the appropriate license interval; and (4) streamlines the substance of the food employee certification regulations formerly in Chapter 76 and incorporates them into Chapter 46.

 The Model Food Code is the product of a collaborative effort among the Department, the United States Food and Drug Administration (FDA), the Food Safety Inspection Service, the Centers for Disease Control, various state and local public health and food control agencies, food industry representatives, academia and consumers. It represents the state-of-the-science with respect to food handling and food safety. It is adopted by reference in portions of Chapter 46. The format, layout, section headings and subject matter of much of Chapter 46 track the Model Food Code. The Model Food Code is also a basis for food safety training courses Nationwide. In addition, the Retail Food Facility Safety Act specifically requires that the Department be guided by the Model Food Code in promulgating regulations (see section 5707(a) of the Retail Food Facility Safety Act). Against this backdrop, the Department is satisfied that the regulated community is familiar with the Model Food Code and that the expansive adoption of Model Food Code standards and requirements in the regulations will not have an adverse impact on that regulated community.

 The final-form rulemaking is driven by the substantial changes to underlying food-safety-related statutes accomplished by Act 106.

 The final-form rulemaking is also needed to reduce foodborne illness to the fullest extent possible. This public health and safety objective is the primary reason for the final-form rulemaking.

 The food safety standards in the final-form rulemaking should also serve the regulated community by helping to lower the number of claims and lawsuits related to foodborne illness.

 The provisions of the regulations that prescribe the appropriate license intervals for various types of retail food facilities (based on risk-based factors identified in the Model Food Code) are needed for the Department and other licensors of these facilities to make better use of limited manpower resources involved in accomplishing inspections and processing license paperwork.

 Act 106 also made significant revisions to the Food Employee Certification Act and the final-form rulemaking is needed to implement these changes.

 The Department is satisfied there are no reasonable alternatives to proceeding with the regulations. The Department is also satisfied the regulations meet the requirements of Executive Order No. 1996-1, ''Regulatory Review and Promulgation.''

Comments and Responses

 Notice of proposed rulemaking was published at 42 Pa.B. 5218 (August 11, 2012) affording the public, the General Assembly and the Independent Regulatory Review Commission (IRRC) the opportunity to offer comments.

 Comments were received from IRRC, the Pennsylvania Catholic Conference (PCC) and the Pennsylvania Association for Sustainable Agriculture (PASA). These comments and the Department's responses follow.

Comment 1

 PASA reviewed proposed § 46.3 (relating to definitions) and raised a question regarding the definition of ''commingle.'' PASA observed that the definition refers to the commingling of shellstock (raw, in-shell oyster, clams, mussels and scallops) and not the commingling of other foods.

Response

 The proposed rulemaking reflected that the definition of ''commingle'' was proposed for deletion. The final-form rulemaking deletes the defined term and the term is not used elsewhere in the regulations.

 Section 1-201.10 of the Model Food Code, regarding statement of application and listing of terms, defines ''commingle'' only with respect to the commingling of shellstock and shucked shellfish. In the context of the Model Food Code, the term is only used with respect to these foods. The Department does not believe there is a need to adopt a definition of this term that varies from the definition in the Model Food Code.

Comment 2

 PASA reviewed proposed § 46.3 and offered a revision to the definition of ''foodborne disease outbreak.'' PASA suggested ''case'' be replaced with ''occurrence'' in that definition, but acknowledged that the use of the ''occurrence'' is not the typical language of epidemiological discipline.

Response

 The proposed rulemaking reflected that ''foodborne disease outbreak'' was proposed for deletion. The final-form rulemaking deletes the defined term and the single use of the phrase in the definition of term ''confirmed disease outbreak'' in § 46.3.

 Section 1-201.10 of the Model Food Code defines ''foodborne disease outbreak'' and includes the same ''occurrence of two or more cases'' language the commentator referenced. The Department declines to vary from the Model Food Code on this definition given that the language is clear and has not been the source of known confusion in the many years it has been in effect.

Comment 3

 PASA reviewed proposed § 46.3 and noted that the definition of ''food facility'' exempts certain food establishments that do not ''. . . provide food to the consumer either directly or indirectly (such as through the home delivery of groceries).'' The commentator asked ''how the Department might view a CSA (community shared agriculture) making deliveries to homes, markets or collective drop off points.''

Response

 The proposed rulemaking reflected that ''food facility'' was proposed for deletion. The final-form rulemaking deletes the defined term. The only reference to home delivery of groceries in the final-form rulemaking is in the definition of a ''retail food establishment.'' That definition is verbatim from section 5702 of the Retail Food Facility Safety Act (relating to definitions).

 The Retail Food Facility Safety Act provides for the licensure of retail food facilities. The determination of whether a particular facility is a retail food facility is a fact-driven determination. In the examples provided by the commentator, if a community-shared agriculture business has a market or collective drop-off point, that market or drop-off point would fit within the definition of a retail food facility. If the market or drop-off point provides only raw agricultural commodities, it would be exempt under section 5703(b)(2)(i) of the Retail Food Facility Safety Act (relating to license required) from having to acquire a retail food facility license and pay the attendant license fee, but would remain subject to inspection and would have to comply with all other applicable provisions of the Retail Food Facility Safety Act.

 If a community-shared agriculture business has a home delivery service, that service would not fit within the definition of ''retail food facility.''

 If a community-shared agriculture business consists of a farm that makes deliveries to its customers or shareholders, those direct deliveries would not make the farm a retail food facility. If the farm has a retail storefront from which food for human consumption is sold, it would be a retail food facility. In addition, if a farm conducted on-farm food processing, it would likely be a ''food establishment'' subject to the registration requirements of the Food Safety Act.

Comment 4

 PASA asked that the final-form rulemaking clarify that rabbits (whether captive bred or wild) are considered game in this Commonwealth. PASA also asked that the Department ''offer some clarity about the requirements for slaughter and market of such animals.''

Response

 Although the final-form rulemaking does not specifically reference game animals or rabbits, § 1-201.10 of the Model Food Code defines ''game animal'' as including rabbits and, at § 3-201.17, regarding game animals, presents the legal requirements for the slaughter and legal sale of these animals. These include a requirement that game animals that are commercially raised for food be slaughtered and processed under a United States Department of Agriculture (USDA)-administered or state-administered regulatory inspection program.

 Rabbit processors may choose to operate under a voluntary USDA-administered inspection program or be registered and inspected by the Department in accordance with the Food Safety Act.

Comment 5

 PASA reviewed the proposed definition of ''licensor'' in § 46.3 and asked whether the regulations will supersede ''those of the county (and other) departments of health.''

Response

 Section 5703(e)(2) of the Retail Food Facility Safety Act requires that rules and regulations adopted by a licensor other than the Department meet and not exceed the requirements of Retail Food Facility Safety Act and its attendant regulations. This means that although a licensor other than the Department may enforce its own standards, they may not exceed standards in the Retail Food Facility Safety Act or the final-form rulemaking.

Comment 6

 PASA noted the definition of ''mobile food facility'' in § 46.3 and asked:

Where does the definition of a mobile food facility—particularly that part that states cart, basket, box or similar structure—leave a CSA and that ''basket, box or similar structure'' in which the CSA person might deliver the food directly to the buyer and/or to a drop off location?

Response

 The proposed rulemaking reflected that the definition of ''mobile food facility'' was proposed for deletion. The final-form rulemaking deletes the defined term.

 A delivery truck or other conveyance or container used for delivering food from a farm, retail food facility or food establishment is not, itself, a mobile retail food facility. These vehicles or containers would be subject to the standards that are applicable to the retail food facility or food establishment from which the food originates.

 In general, a vehicle that is being used for food preparation and sale of food directly to consumers (such as a lunch truck) would be considered a retail food facility or a food establishment and would be subject to the applicable legal licensure/registration requirements.

 A basket, box or similar structure that is used by a community-shared agriculture business to deliver food to its customers or shareholders is not, itself, a mobile food facility.

Comment 7

 PASA reviewed the definition of ''person in charge'' in § 46.3 and asked:

What if there is an unannounced inspection? Is the most ''senior'' ''responsible'' person on site at that moment deemed the person in charge? Can the employee/owner ask that the inspector return at another time?

Response

 Section 2-101.11 of the Model Food Code, regarding assignment, requires that the retail food facility operator be the person in charge or that he designates a person in charge and ensures that a person in charge is present at all hours of operation.

 Inspections of retail food facilities and food establishments are (with few exceptions) unannounced. The inspecting entity does not designate who the person in charge is. It is the affirmative obligation of the licensee or operator of the facility to make this designation and to have a person in charge present at the establishment at all hours of operation.

 The regulation requires that the person in charge allow access to the retail food facility and provide information and records to facilitate the inspection. This is tempered by § 46.1101 (relating to access to retail food facilities), which requires that this cooperation be provided ''. . . during the retail food facility's hours of operation and other reasonable times if the facility is not open during normal business hours.''

 In general, a refusal to allow an inspection would constitute a violation of § 46.1101 and would subject the facility to enforcement action such as a civil penalty, a criminal prosecution, an action for injunctive relief or some other action. There might be specific circumstances (such as a medical emergency or death) that might justify a licensor in refraining from enforcement actions.

Comment 8

 PASA offered comments with respect to the definition of ''public water system'' in § 46.3. The commentator sought ''. . . clarification around such situations in which individuals or families might need to have water hauled in situations, be they temporary or permanent, where, for example, their water is not good because of other actions (contaminated wells come to mind).''

Response

 The proposed rulemaking reflected that ''public water system'' was proposed for deletion, as were the provisions that made use of that term. Former § 46.801 required that water be from: (1) a public water system; or (2) a nonpublic water system that meets the Department of Environmental Protection's (DEP) regulatory standards for safe drinking water. Although the final-form regulation deletes this provision, it supplants it with § 5-101.11 of the Model Food Code, regarding approved system, which imposes an identical requirement. In practice, the Department works with DEP on issues regarding the adequacy of water at retail food facilities and, in particular, defers to DEP on questions regarding whether a nonpublic water source is in compliance with applicable DEP regulatory safe water drinking standards.

Comment 9

 IRRC noted that the proposed definition of ''raw agricultural commodity'' in § 46.3 repeats the definition of that term in section 5722 of the Food Safety Act (relating to definitions) but adds ''or as otherwise defined in section 5722 of the Food Safety Act.'' IRRC asked the Department to either explain the reason why this phrase was included or delete it from the final-form rulemaking.

Response

 The Department deleted the referenced phrase from the final-form rulemaking.

Comment 10

 PASA reviewed the definition of ''ready-to-eat food'' in § 46.3 and noted:

. . . there is so much potential for odd interpretations here. One could read this with greens and such in mind—and, in some peoples' minds, the . . . (definition of ''ready-to-eat food'') . . . could make washed veggies ready to eat as opposed to having undergone the basics of field dressing. That potentially opens up a whole bunch of interpretive options (like the difference between field processing including washing and those greens {and other products, be they vegetable or meat/raw animal foods} that are actually sold as ready to eat. . . . . . .). (Clarification added).

Response

 The proposed rulemaking reflected that the definition of ''ready-to-eat food'' was proposed for deletion. The only use of that term in the final-form rulemaking is in § 46.1141(c)(3)(ii) (relating to license requirement). In context, the provision references a retail food facility that includes ''ready-to-eat foods from a café, salad bar or hot food bar.'' The Department believes that the context in which the term is used adds sufficient clarity.

 In addition, § 1-201.10 of the Model Food Code provides a more detailed definition of the term.

 The Department is satisfied it can differentiate among raw agricultural commodities, ready-to-eat foods and other types of foods. In general, if a raw fruit or vegetable is washed so that no further washing is needed before it is eaten by the consumer, it is a ready-to-eat food. An example of this type of food is bagged lettuce or bagged greens.

 A raw fruit or vegetable is not a ready-to-eat food if it is field-washed and the consumer must wash the fruit or vegetable before eating it. An example of this type of food is a head of iceberg lettuce.

 If a raw fruit or vegetable is processed by chopping, cutting or some similar treatment it is no longer a raw agricultural commodity. If a processed food is not to be washed by the consumer before eating, it is a ready-to-eat food.

Comment 11

 PASA reviewed proposed § 46.3 and offered several questions and comments regarding the definition of ''sanitization.''

Please clarify the need for the different types of operations to actually do this testing in said operation. Consider in the response the situation in which individuals actually need to test surfaces before and after cleaning (as opposed to using the recommended cleaning and sanitizing procedures provided by, for example, the product label or another professional).

Is the five log reduction in bacterial load predicated on the type (genus, species or serotype, for example) of organism? Is there any leeway in the log reduction based on the relative risk of the particular/specific organism?

Is the department prepared to be more specific with respect to identifying those organisms which are defined below as ''representative'' disease microorganisms of public health importance?

Response

 The proposed rulemaking reflected that the definition of ''sanitization'' was proposed for deletion. The final-form rulemaking deletes that definition and use of the term throughout the regulations.

 Section 1-201.10 of the Model Food Code defines ''sanitization'' as it was defined in § 46.3. That definition has long been the standard in the food industry and is well known and widely accepted. Manufacturers of commer- cially-available sanitizers are aware of this long-standing sanitization definition, and sanitizing agents that are formulated for food safety applications are, when used in accordance with manufacturer's instructions, capable of cleaning food contact surfaces to meet the standard of sanitization. Chemical sanitizers are evaluated and approved by the United States Environmental Protection Agency for efficacy and, when so approved, meet the referenced standard of sanitization.

 The Department declines to prescribe different sanitization standards for different types of food production operations. Sanitized food contact surfaces help lower the risk of foodborne illness.

 The Department's answer to each of the questions posed in the last two paragraphs of the comment is ''no.''

Comment 12

 PASA reviewed proposed § 46.3 and asked for clarification with respect to the definition of ''sewage.'' Specifically, the commentator asked whether substances that are not currently considered ''sewage,'' such as spray wash off, wash water from floors and milk houses, are deemed ''sewage.''

Response

 The proposed rulemaking reflected that the definition of ''sewage'' was proposed for deletion. The final-form rulemaking references the term in §§ 46.1121(b)(5) and 46.1144(5) (relating to facility and operating plans; and conditions of retention: responsibilities of the retail food facility operator). In context, these provisions require that a facility's operating plan describe how it will dispose of sewage and that a facility report a sewage backup or other unsanitary condition.

 Section 1-201.10 of the Model Food Code defines ''sewage'' in rather broad terms as consisting of ''liquid waste containing animal or vegetable matter in suspension or solution'' and as including ''liquids containing chemicals in solution.'' The substances referenced by the commentator are, under this broad definition, ''sewage.''

Comment 13

 PASA noted that the proposed rulemaking would rescind Chapter 46, Subchapter B and asked ''What will be put in the place of this material, in the sections labeled reserved? Once those blanks have been filled, will there be a second comment period?''

Response

 Regulations will not be adopted to replace this subchapter. There will not be a second comment period as that is not required under the Regulatory Review Act (71 P. S. §§ 745.1—745.12).

 Chapter 46, Subchapter B addressed topics regarding supervision, employee health, personal cleanliness and hygienic practices. These same subjects are addressed in Chapter 2 of the Model Food Code, regarding management and personnel, which also addresses supervision, employee health, personal cleanliness and hygienic practices. Section 46.4 (relating to adoption of Model Food Code) effectively makes these Model Food Code standards those of the Department. As related in more detail in the response to comment 30, the Department revised the final-form rulemaking by incorporating the substance of proposed § 76.21 into final-form § 46.1201 (relating to Food Employee Certification Act compliance).

Comment 14

 IRRC reviewed proposed § 46.212(a) (relating to food prepared in a private home) and noted that it establishes general requirements for food prepared in private homes that is used or offered for human consumption in a retail food facility. IRRC also noted that proposed subsection (a)(3) required an organization that uses this home-prepared food to inform the consumer that the food was prepared in an unlicensed and uninspected private home. IRRC recommended the Department specify what kind of notice is necessary to properly inform consumers that the food was prepared in an unlicensed and uninspected private home.

Response

 The Department implemented IRRC's recommendation in the final-form rulemaking.

 The proposed language in § 46.212(a) essentially restated language from section 5712 of the Retail Food Facility Safety Act (relating to applicability). The Department added language to the final-form regulation to require that consumers be informed through written means at the point of sale. This can be accomplished by a menu, a menu board, a separate sign or through labeling of individual products. In addition, the final-form regulation provides examples of language that is adequate to meet the referenced statutory requirement.

Comment 15

 IRRC and the PCC expressed concern that proposed § 46.212(b) might cause confusion among individuals who prepare food in their homes and seek to donate it to the various charitable organizations identified in proposed subsection (a). Both commentators offered essentially the same solution, recommending that the final-form regulation include language to clarify that subsection (b) relates to foods prepared in private homes ''except as otherwise permitted under subsection (a),'' or explain why clarification is not necessary.

Response

 The Department agrees with the commentators and added the recommended clarifying language in the final-form regulation.

Comment 16

 PASA noted that §§ 46.218—46.461 and Chapter 46, Subchapters D—G are proposed to be rescinded. PASA asked ''What will be put in the place of this material, in the sections labeled reserved? Once those blanks have been filled, will there be a second comment period?''

Response

 Regulations will not be adopted to replace these sections and subchapters. There will not be a second comment period as that is not required under the Regulatory Review Act. In summary, the subject matter of the rescinded provisions is addressed in the Model Food Code.

 The rescinded provisions include portions of Chapter 46, Subchapter C. This subchapter addressed topics that are essentially the same as are addressed in Chapter 3 of the Model Food Code, regarding food. Section 46.4 effectively makes these Model Food Code standards those of the Department.

 The rescinded provisions include Chapter 46, Subchapter D. This subchapter addressed topics that are essentially the same as are addressed in Chapter 4 of the Model Food Code, regarding equipment, utensils and linens. Section 46.4 effectively makes these Model Food Code standards those of the Department.

 The rescinded provisions include Chapter 46, Subchapter E. This subchapter addressed topics that are essentially the same as are addressed in Chapter 5 of the Model Food Code, regarding water, plumbing and waste. Section 46.4 effectively makes these Model Food Code standards those of the Department.

 The rescinded provisions include Chapter 46, Subchapter F. This subchapter addressed topics that are essentially the same as are addressed in Chapter 6 of the Model Food Code, regarding physical facilities. Section 46.4 effectively makes these Model Food Code standards those of the Department.

 The rescinded provisions include Chapter 46, Subchapter G. This subchapter addressed topics that are essentially the same as are addressed in Chapter 7 of the Model Food Code, regarding poisonous or toxic materials. Section 46.4 effectively makes these Model Food Code standards those of the Department.

Comment 17

 PASA reviewed proposed § 46.1101 and asked what the rights of a farm owner, business owner or employee are in the event a licensor conducts an unannounced inspection of a retail food facility.

Response

 If a business entity applies for and obtains a retail food facility license under the Retail Food Facility Safety Act, it has consented to the provisions of the Retail Food Facility Safety Act that require and allow inspection, sampling and analysis by the licensor. Section 5703(e)(1) of the Retail Food Facility Safety Act requires an inspection before a license is issued and section 5703(g)(1) requires an inspection as a condition of license renewal. Section 5704(a) of the Food Facility Safety Act (relating to inspection, sampling and analysis) also requires that an inspector present credentials and inspect ''at reasonable times, within reasonable limits and in a reasonable manner.''

 Section 46.1101 essentially restates the inspection language of the Retail Food Facility Safety Act and suggests that a retail food facility's normal hours of operation are generally a reasonable time for inspections to be conducted.

 Section 46.1101 has been in place for many years and the amendments are not substantive. The Department has applied this provision consistently with respect to those retail food facilities it licenses. The Department believes licensees understand their obligation to allow inspections, and that the Department's inspection staff makes an effort to inspect at reasonable times.

Comment 18

 PASA reviewed proposed § 46.1103 (relating to variances), noted that certain portions of that section were not included in the proposed rulemaking and asked that the Department ''clarify and enhance the continuity'' of that provision.

Response

 The referenced portions of the section were not published because the Department did not propose changes to this text. The material that was not included from § 46.1103(b) reads as follows:

(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.

 The material that was not included in § 46.1103(c) reads as follows:

(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.

Comment 19

 PASA asked several questions with respect to proposed § 46.1121:

What are the implications and responsibilities for review of plans if the ownership is changing, for example, within a family unit? What are the implications and responsibilities if the type/structure of ownership changes, for example, from a private holding to an LLC or other business model?

Response

 Retail food facility licenses are location-specific and proprietor-specific. If either of these changes, a new license is required. Licenses are not transferrable.

 If the location of a licensed retail food facility changes, the licensee, or license applicant, may file a new retail food facility license application with the Department.

 If the ownership of a licensed retail food facility changes and there are not substantial changes to the physical layout of the facility, itself, a license application is required but the application review process is generally faster since the Department does not need to conduct the same plan review it would conduct with respect to licensing a new or remodeled retail food facility.

 In practice, it is not uncommon for a licensee who is a sole proprietor to incorporate his business, to establish a partnership and bring in business partners, transfer ownership to a family member or sell the facility to a third party. Each of these events would trigger the need for a new license.

Comment 20

 PASA asked the Department to clarify proposed § 46.1121(b)(2)—(6).

Response

 The referenced portions of the section were not published because the Department did not propose changes to this text. The referenced material reads as follows:

(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).

Comment 21

 PASA offered several comments with respect to proposed § 46.1122 (relating to HACCP plans). Initially, it presented the following:

There are large sections quoted below in which the material is proposed rescinded. What will be put in the place of this material, in the sections labeled reserved? Once those blanks have been filled, will there be a second comment period?

Response

 The Department believes the commentator is referring to the proposed replacement of several references to sections of the proposed rulemaking that the Department proposed to delete with references to the Model Food Code. To that extent, the blanks in this provision are filled with references to the Model Food Code.

 The Department's response to comment 16 sets forth some general references to the subject matter addressed in the Model Food Code.

 There will not be a second comment period with respect to the proposed rulemaking as that is not required under the Regulatory Review Act.

Comment 22

 With respect to proposed § 46.1122, PASA also asked whether ''any and all situations require HACCP plans.''

Response

 Hazard Analysis Critical Control Point (HACCP) plans are not required in any and all situations. HACCP plans are required if they are also required under Federal or State law or to obtain a variance as described in § 3-502.11 of the Model Food Code, regarding variance requirement. That provision of the Model Food Code requires a variance for a food establishment to conduct any of a number of specialized processing methods. These specialized processing methods include smoking food, curing food, using food additives for certain purposes, packaging food using reduced oxygen packaging, operating a life-support tank to display molluscan shellfish, certain custom processing practices, sprouting seeds or beans, and more.

Comment 23

 With respect to proposed § 46.1122, PASA also offered that ''. . . for some educators, consultants and providers, the language of the discipline has changed/is changing from HACCP to Hazard Analysis Preventive Controls'' and asked ''What is the longer term (and short term) implication/s of this change in nomenclature?''

Response

 ''HACCP'' is defined in § 1-201.10 of the Model Food Code and is used throughout that document. If there is ever a movement to change that terminology in the Model Food Code the Department would have ample notice and a chance to participate in the amendment process, and can consider whether the change to the Model Food Code warrants a change to the Department's regulation.

 The phrase ''Hazard Analysis Preventive Controls'' used by the commentator suggests that the phrase may have originated from separate FDA rules or proposed rules on ''Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' These rules would apply to food manufacturing plants and distributing establishments and would not be applicable to retail food facilities.

Comment 24

 PASA reviewed proposed § 46.1124 (relating to preoperational inspection of construction) and asked whether the preoperational inspections described in that provision are ''in addition to the building permit/local inspections.'' The commentator also asked whether there are fees associated with these inspections.

Response

 The referenced preoperational inspections are separate and distinct from any inspection that a local government unit might require as a condition of the issuance of a building permit or conduct under some other local authority.

 When the licensor is the Department, there will not be a fee for this type of inspection because the Retail Food Facility Safety Act does not authorize a fee. Section 5703(j) of the Retail Food Facility Safety Act addresses the Department's authority to impose fees.

 When the licensor is an entity other than the Department, that type of licensor has the authority to establish its own fee schedule and might establish a fee schedule that imposes a fee for the type of preoperational inspection of construction.

Comment 25

 IRRC raised several concerns regarding the clarity of proposed § 46.1141(c). It noted that proposed § 46.1141 establishes the license requirements necessary to operate as a retail food facility and that subsection (c) establishes the intervals for license expiration for various types of retail food facilities.

 With respect to subsection (c), IRRC noted the 24-month, 18-month, 12-month and 6-month license intervals and asked the Department to explain how it determined that each of these time frames represent the appropriate license expiration date for a retail food facility that meets these criteria.

 IRRC noted that subsection (c)(1)(iii) provides that the intervals between license expirations can increase should a retail food facility demonstrate that it has achieved ''active managerial control of foodborne illness risk factors. . . .'' IRRC asked that the final-form regulation clarify what the Department considers appropriate ''historical documentation'' to validate that a retail food facility has achieved this level of control. IRRC noted that this same terminology is used in subsection (c)(2)(iii), (3)(iii) and (4)(iii).

Response

 With respect to IRRC's inquiry as to the origin of the various license intervals and categories in proposed § 46.1141(c), the Department notes that section 5703(g)(1) of the Retail Food Facility Safety Act allows the Department to establish retail food facility license intervals using risk-based factors identified in the Model Food Code.

 The Department consulted Annex 5 of the Model Food Code, regarding conducting risk-based inspections, in developing the risk-based license intervals presented in proposed § 46.1141. Annex 5 contains a table identified as Annex 5, Table 1, regarding risk categorization of food establishments. That table establishes four separate risk categories for retail food facilities. The proposed regulation essentially incorporated each of these four risk categories and established a different (and risk-based) license interval for each. The referenced table also recommends inspection frequency intervals of from one to four inspections each year, based upon the risk category involved. Although the Department does not have the resources to inspect on this frequent an inspection schedule, the proposed regulation used the same inspection interval ratios presented in that table: namely, that those retail food facilities that present the highest risk of spreading foodborne illness should be inspected four times as often as those retail food facilities that present the lowest risk of spreading foodborne illness.

 Annex 5 of the Model Food Code also recommends the Voluntary National Retail Food Regulatory Program (VNRFRP) Standards established by the FDA as a source of additional recommendations with respect to establishing risk-based inspection programs for retail food facilities. The VNRFRP Standards are part of a National initiative to promote application of effective food safety strategies that are based on risk factors and to promote uniformity among retail food facility regulatory programs. The VNRFRP Standards were developed with input from Federal, state and local regulatory officials, the food industry, food-related trade associations, academia and consumers, and provide common standards by which participating retail food facility regulatory programs can assess their programs. The Department has been a participating jurisdiction with respect to the VNRFRP Standards since 2004 and, as part of that participation, has completed a self-assessment of its retail food facility regulatory program.

 The VNRFRP Standards consist of nine separate standards. Of these, Standard No. 3, inspection based on HACCP principles, recommends that inspection frequency be based on the relative risk posed by a retail food facility and recommends the establishment of at least three categories of retail food facilities based on potential and inherent food safety risks. This allows inspection staff to spend more time in those higher-risk establishments that pose the greatest potential of causing foodborne illness. Standard No. 3 also allows regulatory jurisdictions to consider available resources (such as personnel and funding) in establishing inspection frequencies.

 The Department considered its existing staffing levels and its experience in allocating manpower to meet the current annual inspection requirement for retail food facilities. Under the proposed regulation, most retail food facilities will continue to be subject to this yearly inspection requirement, but the Department's inspection resources can be better-focused on those retail food facilities that present the greatest risk of spreading foodborne illness.

 In summary, the categories of retail food facilities described in proposed § 46.1141(c)(1)—(4) were essentially as recommended in Annex 5 of the Model Food Code and are consistent with the VNRFRP Standards. The license intervals establish an inspection timetable that can be met with current Department or local licensor inspection staff, or both, and that directs inspection resources toward those retail food facilities that present the greatest risk of causing foodborne illness.

 With respect to the second portion of IRRC's comment, the Department revised the referenced provisions to make clear that the ''historical documentation'' that is necessary to demonstrate the active managerial control of foodborne illness risk factors justifying a longer license interval shall consist of: (1) at least three regular inspections at the established risk-based interval that reflect the retail food facility is ''in compliance'' overall; (2) an absence of consumer complaints that prove valid; and (3) an absence of reported foodborne illnesses associated with the facility.

Comment 26

 With respect to proposed § 46.1141, PASA asked for clarification of whether a farmers' market and all individual farmers selling from that market must be licensed. PASA also adds:

Here—as well as in other portions of this (and other documents)—it seems appropriate and clear to substitute the phrase ''compliant at a scale and risk appropriate level'' rather than using the word ''exemption.'' Please comment.

Response

 Proposed § 46.1141(b) repeated the full range of circumstances under which a retail food facility might be exempt from licensure under section 5703(b) of the Retail Food Facility Safety Act.

 A typical farmers' market is not a single ''retail food facility'' in that it does not have a single proprietor that owns and operates all of the retail food facilities located in the market. It is usually a centralized gathering of multiple retail food facilities, each with its own proprietor (similar to a gathering of food vendors at a fair or other event). In this case, each farmers' market stand is a discrete retail food facility. Depending on the type of food operation conducted in the facility, the facility may or may not be exempt from the licensure requirement imposed by the Retail Food Facility Safety Act. This type of determination will be fact driven.

 With respect to the commentator's suggestion that the regulation should reference that a facility is compliant ''at a scale and risk appropriate level,'' the Department maintains it is appropriate to continue to use ''exempt'' and ''exemptions'' in § 46.1141. The Retail Food Facility Safety Act describes the circumstances under which a retail food facility is ''exempt'' from the license requirements (but not the inspection requirements) of that statute. These are in 5703(b) of the Retail Food Facility Safety Act, which describes them as exemptions. Although the Retail Food Facility Safety Act affords a licensor some leeway to determine appropriate maximum license intervals based upon certain risk-based factors (see section 5703(g)(1)), it does not allow the scale of a retail food facility's operation or the risk level posed by that facility to determine whether a facility is exempt from licensure.

Comment 27

 PASA reviewed proposed § 46.1143 (relating to issuance) and noted that certain portions of that section were not included in the proposed rulemaking and asked that the Department ''clarify and enhance the continuity'' of this section.

 PASA also asked for clarification of the need for a new license when there is a change in ownership of the license retail food facility. PASA specifically asked that the response include consideration of events such as ''changes within the family, changes in business structure and category.''

Response

 The referenced portions of the section were not published because the Department did not propose changes to this text. The material that was not included under § 46.1143(a) reads as follows:

(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.

 With respect to the commentator's request for clarification of the circumstances under which a new license would be required, the Department's response to comment 19 is responsive.

Comment 28

 IRRC noted that proposed § 46.1144(4) references a specific subpart of the Model Food Code but that other provisions in the proposed rulemaking contain more general references to the Model Food Code. IRRC referenced proposed §§ 46.3, 46.1121(b)(1), 46.1122, 46.1122(a)(2), 46.1141(c) and 46.1141(c)(iii) as examples. IRRC recommends that the final-form rulemaking include specific cross-references to the Model Food Code or that the Department explain why references are not appropriate.

Response

 IRRC's recommendation has been implemented in the final-form rulemaking.

 Throughout the final-form rulemaking the Department has, where appropriate, changed general references to the Model Food Code to specific references to the applicable subpart of the Model Food Code. Specifically, the sections of the final-form rulemaking that have been revised and the references to the appropriate subparts of the Model Food Code, are as follows:

Section	New Model Food Code Reference
46.3	Subpart 1-201, regarding applicability and terms defined
46.1121(b)(1)	Subpart 3-603, regarding consumer advisory
46.1122(a)(1)(ii)	Subpart 8-201, regarding facility and operating plans
46.1122(a)(2)	Subpart 3-502, regarding specialized processing methods
46.1122(c)(1)(iii)	Subpart 8-401, regarding frequency
46.1141(c)	Subpart 8-401, regarding frequency, and Annex 5, regarding conducting risk-based inspections

 Although the basic subject matter of a subpart of the Model Food Code does not change, individual sections are occasionally revised by the FDA. For this reason the final-form rulemaking does not reference exact sections of the Model Food Code but, instead, the subpart in which that section is located.

Comment 29

 With respect to proposed § 76.20, IRRC recommended that: (1) the phrase ''unless otherwise defined in Chapter 46 (relating to food code)'' be deleted; and (2) the definition of the term ''Department'' in that section ''include the same language pertaining to the Model Food Code as that contained in Section 46.3.''

Response

 The Department agrees with the commentator and revised the final-form rulemaking to effectively accomplish IRRC's recommendations. As explained in response to comment 30, these changes appear in § 46.1201 as proposed § 76.20 was not adopted by the Department.

Comment 30

 PASA noted that §§ 76.1—76.19 were proposed to be rescinded and asked:

What will be put in the place of this material, in the sections labeled reserved? Once those blanks have been filled, will there be a second comment period? Please explain why the collection of these ''odd definitions'' are presented in this portion of the document rather than in the prodromal section with the remainder of the definitions.

Response

 Regulations will not be adopted to replace these sections. There will not be a second comment period as that is not required under the Regulatory Review Act.

 The Food Employee Certification Act is the underlying statutory authority for Chapter 76. Act 106 accomplished a significant and substantive revision of the Food Employee Certification Act, and had the effect of simplifying and streamlining the process by which a retail food facility shall have at least one employee who holds a current certificate evidencing successful completion of an accredited food safety training course. Much of the Food Employee Certification Act is self-executing, without the need for detailed supporting regulations. The final-form rulemaking does nothing more than implement the changes to the Food Employee Certification Act wrought by Act 106.

 With respect to the comment regarding the placement of proposed § 76.20 as a separate section, the Department agrees that the requirements of the Food Employee Certification Act are so intertwined with the subject matter of Chapter 46 that the regulations will be more user-friendly if the substance of proposed Chapter 76 is incorporated into Chapter 46. The Department revised the final-form rulemaking by: (1) incorporating the relevant definitions that appeared in proposed § 76.20 into § 46.3; and (2) incorporating the substance of proposed § 76.21 into § 46.1201.

Affected Individuals and Organizations

 The final-form rulemaking will impact the public by reducing the number of foodborne illness outbreaks originating from retail food facilities and food establishments.

 Retail food facilities and food establishments will also be affected by the final-form rulemaking. Fewer foodborne illness incidents will benefit owners, operators and employees of these businesses who will be spared some costs associated with lawsuits, compensation or business disruption regarding foodborne illness. Also, since the final-form rulemaking brings the Commonwealth's food safety standards into greater alignment with the Model Food Code, and the Model Food Code is the basis for food safety standards in all of the continental United States, there may be some savings associated with operating in a regulatory environment where there is a greater degree of consistency and uniformity in regulatory food safety standards.

Fiscal Impact

Commonwealth

 Aside from an initial expected outlay of approximately $5,000 to revise literature, web sites, forms and its electronic licensing system, the final-form rulemaking will not impose costs and will not have fiscal impact on the Commonwealth. The Department currently registers and inspects food establishments under the Food Safety Act and licenses and inspects retail food facilities under the Retail Food Facility Safety Act. The final-form rulemaking will not appreciable expand or alter the Department's role in administering and enforcing these underlying statutes.

Political subdivisions

 The final-form rulemaking will not impose costs and will not have fiscal impact upon political subdivisions. Although a local government unit may act as the ''licensor'' of retail food facilities within its borders, the final-form rulemaking will not impose any requirement on a local government unit licensor that is not imposed by one or more of the underlying statutes.

Private sector

 The final-form rulemaking is not expected to impose costs on the private sector. Owners of restaurants, food processing operations, other retail food facilities and other food establishments are already familiar with the food safety standards and procedures prescribed under the Model Food Code. Chapter 46 embodies many of the provisions of the Model Food Code; the Model Food Code is the basis for much of the food-safety-related training that is available to these persons and that has been obtained for purposes of compliance with the Food Employee Certification Act.

General public

 The final-form rulemaking will enhance public health and safety. It is expected to reduce the number of cases of foodborne illness attributable to food originating from food facilities in this Commonwealth. This should result in some indeterminate cost savings to the general public.

Paperwork Requirements

 The final-form rulemaking is not likely to appreciably impact upon the paperwork generated by the Department or other retail food facility licensors, or upon retail food facilities or food establishments.

Effective Date

 The final-form rulemaking will be effective on May 12, 2014.

Contact Person

 Individuals who need information about the final-form rulemaking should contact the Department of Agriculture, Bureau of Food Safety and Laboratory Services, 2301 North Cameron Street, Harrisburg, PA 17110-9408, Attention: Sheri Morris.

Regulatory Review

 Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on August 1, 2012, the Department submitted a copy of the notice of proposed rulemaking, published at 42 Pa.B. 5218, to IRRC and the Chairpersons of the House and Senate Standing Committees on Agriculture and Rural Affairs for review and comment.

 Under section 5(c) of the Regulatory Review Act, IRRC and the House and Senate Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the House and Senate Committees and the public.

 Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on February 26, 2014, the final-form rulemaking was deemed approved by the House and Senate Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on February 27, 2014, and approved the final-form rulemaking.

Findings

 The Department finds that:

 (1) Public notice of intention to adopt this final-form regulation has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.

 (2) A public comment period was provided as required by law and the comments that were received were considered.

 (3) The revisions that were made to this final-form rulemaking in response to comments received do not enlarge the purpose of the proposed rulemaking published at 42 Pa.B. 5218.

 (4) The adoption of the final-form rulemaking in the manner provided in this order is necessary and appropriate for the administration of the authorizing statutes.

Order

 The Department, acting under the authorizing statute, orders that:

 (1) The regulations of the Department, 7 Pa. Code Chapters 46 and 76, are amended by adding §§ 46.4 and 46.1201; deleting §§ 46.101, 46.102, 46.111—46.115, 46.131—46.137, 46.151—46.153, 46.201, 46.211, 46.213—46.216, 46.218—46.222, 46.241—46.251, 46.261, 46.262, 46.281—46.286, 46.301—46.307, 46.321—46.323, 46.341—46.344, 46.361—46.366, 46.381—46.385, 46.401, 46.402, 46.421—46.423, 46.441, 46.461, 46.501, 46.521—46.523, 46.541—46.544, 46.561—46.563, 46.581—46.595, 46.611—46.615, 46.631—46.634, 46.651, 46.652, 46.671—46.676, 46.691—46.693, 46.711—46.719, 46.731, 46.751—46.753, 46.771—46.775, 46.801—46.806, 46.821—46.825, 46.841—46.844, 46.861—46.863, 46.881—46.886, 46.901, 46.902, 46.921, 46.922, 46.941—46.946, 46.961—46.965, 46.981, 46.982, 46.1001, 46.1002, 46.1021—46.1029, 46.1041, 76.1—76.17 and 76.19; and amending §§ 46.2, 46.3, 46.212, 46.217, 46.1101—46.1103, 46.1121—46.1124 and 46.1141—46.1144 to read as set forth in Annex A.

 (Editor's Note: Section 46.1201 was not included in the proposed rulemaking published at 42 Pa.B. 5218. Proposed §§ 76.20 and 76.21 have been withdrawn by the Department.)

 (2) The Secretary of Agriculture shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as required by law.

 (3) The Secretary of Agriculture shall certify and deposit this order and Annex A with the Legislative Reference Bureau as required by law.

 (4) This order will take effect on May 12, 2014.

GEORGE D. GREIG, 
Secretary

 (Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 44 Pa.B. 1534 (March 15, 2014).)

 Fiscal Note: Fiscal Note 2-174 remains valid for the final adoption of the subject regulations.

Annex A

TITLE 7. AGRICULTURE.

PART III. BUREAU OF FOOD SAFETY AND LABORATORY SERVICES

Subpart A. SOLID FOODS

CHAPTER 46. FOOD CODE

Subchapter A. PURPOSE; DEFINITIONS; ADOPTION OF MODEL FOOD CODE

§ 46.2. Scope.

 This chapter establishes definitions; sets standards for management and personnel, food operations and equipment and facilities; and provides for retail food facility plan review, licensing, inspection and employee restriction.

§ 46.3. Definitions.

 The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

 Bed and breakfast homestead or inn—A private residence which contains ten or fewer bedrooms used for providing overnight accommodations to the public, and in which breakfast is the only meal served and is included in the charge for the room.

 Conference for Food Protection—An independent National voluntary nonprofit organization to promote food safety and consumer protection. Participants in this organization include Federal, state and local regulatory agencies, universities, test providers, certifying organizations, consumer groups, food service and retail store trade associations, and retail food facility operators. The objectives of the organization include identifying and addressing food safety problems and promoting uniformity of regulations in food protection.

 Department—The Department of Agriculture of the Commonwealth. The term is synonymous with the term ''regulatory authority'' in Subpart 1-201 of the Model Food Code, regarding applicability and terms defined.

 Drinking water, potable water or water—Safe drinking water as defined in the Pennsylvania Safe Drinking Water Act (35 P. S. §§ 721.1—721.17). The term does not include water such as boiler water, mop water, rainwater, wastewater and ''nondrinking'' water.

 Employee—The license holder, person in charge, person having supervisory or management duties, person on the payroll, family member, volunteer, person performing work under contractual agreement or other person working in a retail food facility.

 Food—An article used for food or drink by humans, including chewing gum and articles used for components of any article. The term does not include medicines and drugs.

 Food Employee Certification Act—3 Pa.C.S. §§ 6501—6510 (relating to Food Employee Certification Act).

 Food establishment—

 (i) A room, building or place or portion thereof or vehicle maintained, used or operated for the purpose of commercially storing, packaging, making, cooking, mixing, processing, bottling, baking, canning, freezing, packing or otherwise preparing, transporting or handling food.

 (ii) The term excludes retail food facilities, retail food establishments, public eating and drinking places, and those portions of establishments operating exclusively under milk or milk products permits.

 (iii) The term is synonymous with the term ''food processing plant'' in Subpart 1-201 of the Model Food Code.

 Food Safety Act—3 Pa.C.S. §§ 5721—5737 (relating to Food Safety Act).

 HACCP—Hazard Analysis Critical Control Point—A system developed by the National Advisory Committee on Microbiological Criteria for Foods that identifies and monitors specific foodborne hazards that can adversely affect the safety of the food products.

 License—A grant to a proprietor to operate a retail food facility. The term is synonymous with the term ''permit'' in Subpart 1-201 of the Model Food Code.

 Licensee—The person, (such as a retail food facility operator), who is directly responsible for the operation of a retail food facility and holds a current license. The term is synonymous with the term ''permit holder'' in Subpart 1-201 of the Model Food Code.

 Licensor—The term includes the following:

 (i) The county department of health or joint-county department of health, whenever the retail food facility is located in a political subdivision which is under the jurisdiction of a county department of health or joint-county department of health.

 (ii) The health authorities of cities, boroughs, incorporated towns and first-class townships, whenever the retail food facility is located in a city, borough, incorporated town or first-class township not under the jurisdiction of a county department of health or joint-county department of health.

 (iii) The health authorities of second class townships and second class townships which have adopted a home rule charter which elect to issue licenses under the Retail Food Facility Safety Act whenever a retail food facility is located in a second class township or second class township which has adopted a home rule charter not under the jurisdiction of a county department of health or joint-county department of health.

 (iv) The Department, whenever the retail food facility is located in any other area of this Commonwealth.

 Milk Sanitation Law—The act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. §§ 645—660g).

 Model Food Code—The most current edition of the Food Code published by the Department of Health and Human Services, Food and Drug Administration.

 Organized camp—A combination of programs and facilities established for the primary purpose of providing an outdoor group living experience for children, youth and adults with social, recreational and educational objectives that is operated and used for 5 consecutive days or more during one or more seasons of the year.

 Person in charge—A person designated by a retail food facility operator to be present at a retail food facility and responsible for the operation of the retail food facility at the time of inspection.

 Proprietor—A person, partnership, association or corporation conducting or operating a retail food facility in this Commonwealth. The term is synonymous with the term ''person'' in Subpart 1-201 of the Model Food Code.

 Public eating or drinking place—A place within this Commonwealth where food or drink is served to or provided for the public, with or without charge. The term does not include dining cars operated by a railroad company in interstate commerce or a bed and breakfast homestead or inn.

 Raw agricultural commodity—A food in its raw or natural state, including fruits which are washed, colored or otherwise treated in their unpeeled, natural form prior to marketing.

 Retail food establishment—

 (i) An establishment which stores, prepares, packages, vends, offers for sale or otherwise provides food for human consumption and which relinquishes possession of food to a consumer directly, or indirectly, through a delivery service such as home delivery of grocery orders or delivery service provided by common carriers.

 (ii) The term does not include dining cars operated by a railroad company in interstate commerce or a bed and breakfast homestead or inn.

 Retail food facility—A public eating or drinking place or a retail food establishment. The term is synonymous with the term ''food establishment'' in Subpart 1-201 of the Model Food Code.

 Retail food facility operator—The entity that is legally responsible for the operation of the retail food facility, such as the owner, owner's agent or other person.

 Retail Food Facility Safety Act—3 Pa.C.S. §§ 5701—5714 (relating to Retail Food Facility Safety Act).

 Secretary—The Secretary of the Department or an authorized representative, employee or agent of the Department.

§ 46.4. Adoption of Model Food Code.

 The provisions, terms, procedures, appendices and standards in the current edition of the Model Food Code are adopted to the extent they do not conflict with one or more of the following:

 (1) The Retail Food Facility Safety Act.

 (2) The Food Safety Act.

 (3) This chapter.

Subchapter B. (Reserved)

§ 46.101. (Reserved).

§ 46.102. (Reserved).

§§ 46.111—46.115. (Reserved).

§§ 46.131—46.137. (Reserved).

§§ 46.151—46.153. (Reserved).

Subchapter C. FOOD

§ 46.201. (Reserved).

FOOD SOURCES

§ 46.211. (Reserved).

§ 46.212. Food prepared in a private home.

 (a) General. Food prepared in a private home may not be used or offered for human consumption in a retail food facility unless the private home meets the requirements of subsection (b) or (c).

 (b) Private home that is a registered food establishment. Food prepared in a private home may be used or offered for human consumption in a retail food facility if the private home from which the food originates is registered with the Department as a food establishment under the Food Safety Act.

 (c) Private home that is exempt from licensure or inspection under the Retail Food Facility Safety Act. Food prepared in a private home may be used or offered for human consumption in a retail food facility if the following apply:

 (1) The food is not potentially hazardous food.

 (2) The food is used or offered for human consumption by any of the following organizations:

 (i) A tax-exempt organization under section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C.A. § 501(c)(3)).

 (ii) A volunteer fire company or ambulance, religious, charitable, fraternal, veterans, civic, sportsmen, agricultural fair or agricultural association, or a separately chartered auxiliary of an association on a nonprofit basis.

 (iii) An organization that is established to promote and encourage participation and support for extracurricular recreational activities for youth of primary and secondary public, private and parochial school systems on a nonprofit basis.

 (3) The organization that uses or offers the food for human consumption informs consumers that the organization uses or offers food that has been prepared in private homes that are not licensed or inspected.

 (i) Acceptable means of providing written notice include providing that notice on a menu, a menu board, separate signage posted in a location that is conspicuous for consumers to view or on individual food product labels.

 (ii) The written notice must clearly communicate that the food has been prepared in a private home that is not licensed or inspected. Phrases such as ''These baked goods originate from private homes that are not government-licensed or government-inspected,'' ''The food offered on this table comes from private homes that are not licensed or inspected'' and ''Food offered in this bake sale has been prepared in private homes that are not licensed or inspected'' meet this requirement. Persons may submit proposed written notice language to the Department or other licensor, as applicable, for review.

 (4) The food is donated to an organization described under paragraph (2).

§§ 46.213—46.216. (Reserved).

§ 46.217. Milk and milk products.

 Milk and milk products may be offered for human consumption in a retail food facility if the facility complies with section 2 of the Milk Sanitation Law (31 P. S. § 646).

§§ 46.218—46.222. (Reserved).

§§ 46.241—46.251. (Reserved).

§ 46.261. (Reserved).

§ 46.262. (Reserved).

§§ 46.281—46.286. (Reserved).

§§ 46.301—46.307. (Reserved).

§§ 46.321—46.323. (Reserved).

§§ 46.341—46.344. (Reserved).

§§ 46.361—46.366. (Reserved).

§§ 46.381—46.385. (Reserved).

§ 46.401. (Reserved).

§ 46.402. (Reserved).

§§ 46.421—46.423. (Reserved).

§ 46.441. (Reserved).

§ 46.461. (Reserved).

Subchapter D. (Reserved)

§ 46.501. (Reserved).

§§ 46.521—46.523. (Reserved).

§§ 46.541—46.544. (Reserved).

§§ 46.561—46.563. (Reserved).

§§ 46.581—46.595. (Reserved).

§§ 46.611—46.615. (Reserved).

§§ 46.631—46.634. (Reserved).

§ 46.651. (Reserved).

§ 46.652. (Reserved).

§§ 46.671—46.676. (Reserved).

§§ 46.691—46.693. (Reserved).

§§ 46.711—46.719. (Reserved).

§ 46.731. (Reserved).

§§ 46.751—46.753. (Reserved).

§§ 46.771—46.775. (Reserved).

Subchapter E. (Reserved)

§§ 46.801—46.806. (Reserved).

§§ 46.821—46.825. (Reserved).

§§ 46.841—46.844. (Reserved).

§§ 46.861—46.863. (Reserved).

§§ 46.881—46.886. (Reserved).

Subchapter F. (Reserved)

§ 46.901. (Reserved).

§ 46.902. (Reserved).

§ 46.921. (Reserved).

§ 46.922. (Reserved).

§§ 46.941—46.946. (Reserved).

§§ 46.961—46.965. (Reserved).

§ 46.981. (Reserved).

§ 46.982. (Reserved).

Subchapter G. (Reserved)

§ 46.1001. (Reserved).

§ 46.1002. (Reserved).

§§ 46.1021—46.1029. (Reserved).

§ 46.1041. (Reserved).

Subchapter H. ADMINISTRATIVE PROCEDURES

ACCESS, APPROVALS AND VARIANCES

§ 46.1101. Access to retail food facilities.

 After the Department or licensor presents identification, the person in charge shall allow the Department or licensor to determine if the retail 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 Retail Food Facility Safety Act and any other relevant statutory or food regulatory authority during the retail food facility's hours of operation and other reasonable times if the facility is not open during normal business hours.

§ 46.1102. Obtaining Department or licensor approval.

 (a) General. This section describes the process by which a person may obtain an approval from the Department or a licensor required by another 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
2301 North Cameron Street
Harrisburg, Pennsylvania 17110-9408

 (c) Contents of request. The written request for approval described in subsection (b) must 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 will 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.

 (e) Standard for approval. The Department or licensor will grant approval if it determines the approval would not constitute or cause a violation of the Retail Food Facility Safety Act or this chapter, and that no health hazard would result from the approval.

§ 46.1103. Variances.

 (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 retail food facility and provide a copy of the approved variance to the licensor if the licensor is an entity other than the Department.

 (b) Documentation of proposed variance and justification. Before a variance from a requirement of this chapter is approved, the information provided by the person requesting the variance and retained in the Department's file on the retail 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 retail 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 or licensor, 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.

PLAN SUBMISSION AND APPROVAL

§ 46.1121. Facility and operating plans.

 (a) When plans are required. A retail food facility licensing applicant or retail food facility operator shall have plans and specifications reviewed by the Department or licensor and shall 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) before any of the following:

 (1) The construction of a retail food facility.

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

 (3) The remodeling of a retail 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 retail 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 retail food facility.

 (b) Contents of the plans and specifications. The plans and specifications for a retail 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 Subpart 3-603 of the Model Food Code, regarding consumer advisory, for animal 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 retail food facility, and requested by the Department or licensor in writing.

§ 46.1122. HACCP plans.

 (a) When an HACCP plan is required.

 (1) Before engaging in an activity that requires an HACCP plan, a retail food facility applicant or retail 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 an HACCP plan is required according to applicable Federal or State laws.

 (ii) A variance is required as specified in Subpart 8-201 of the Model Food Code, regarding facility and operating plans.

 (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 retail food facility applicant or retail food facility operator shall have a properly prepared HACCP plan as specified in Subpart 3-502 of the Model Food Code, regarding specialized processing methods, for reduced oxygen packaging.

 (b) Contents of an HACCP plan. For a retail food facility that is required under subsection (a) to have an HACCP plan, the plan and specifications must 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.

§ 46.1123. Confidentiality of trade secrets.

 The Department or licensor will treat as confidential information that meets the criteria specified in law for a trade secret and is contained on inspection report forms and in the plans and specifications submitted as specified in §§ 46.1121(b) and 46.1122(b) (relating to facility and operating plans; and HACCP plans).

§ 46.1124. Preoperational inspection of construction.

 The Department or licensor will conduct one or more preoperational inspections to verify that the retail 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 retail food facility is otherwise in compliance with this chapter and the Retail Food Facility Safety Act.

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 café, 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.

§ 46.1142. Application procedure for appropriate license.

 Prior to the opening of a retail food facility, the operator shall contact the Department or licensor to obtain the appropriate application form for the required license. The Department or licensor will supply the applicant with the appropriate form, based upon the type of retail food facility involved.

§ 46.1143. Issuance.

 (a) New, converted or remodeled retail food facilities. For retail food facilities that are required to submit plans as specified in § 46.1121(a) (relating to facility and operating plans), 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 renewal. The retail food facility operator of an existing retail food facility shall submit an application, the required fee and be in compliance with this chapter prior to issuance of a renewed license by the Department or a licensor.

 (c) Change of ownership. Licenses are nontransferable. New owners shall apply to the Department or licensor in accordance with § 46.1142 (relating to application procedure for appropriate license).

§ 46.1144. Conditions of retention: responsibilities of the retail food facility operator.

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

 (1) Post the license in a location in the retail 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 retail food facility is required in § 46.1122(a) (relating to HACCP plans) to operate under an 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 Subpart 2-201 of the Model Food Code, regarding responsibilities of permit holder, person in charge, food employees, and conditional employees.

 (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 retail food facility operator does not need to 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 Retail Food Facility Safety Act until approval is obtained from the Department or licensor.

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

 (10) Accept notices issued and served by the Department or licensor according to the Retail Food Facility Safety Act.

 (11) Remit a fee owed the Department under section 5703(j) of the Retail Food Facility Safety Act (relating to license required) within the time prescribed by the Department.

 (12) Remit a civil penalty assessed against the retail food facility operator under the Retail Food Facility Safety Act or this chapter within 30 days of the later of either of the following:

 (i) The effective date of the final adjudication assessing the civil penalty.

 (ii) The expiration of the applicable deadline by which the final adjudication could be appealed to an appellate court of the Commonwealth.

Subchapter I. FOOD EMPLOYEE CERTIFICATION ACT COMPLIANCE

Sec.

46.1201.

Food Employee Certification Act compliance.

§ 46.1201. Food Employee Certification Act compliance.

 (a) Statutory requirement. The Food Employee Certification Act requires that a retail food facility have at least one employee who holds a valid certificate present at the retail food facility or immediately accessible at all hours of operation and who is the person in charge of the retail food facility when physically present and on duty.

 (b) General recognition of certification programs. For purposes of compliance with the Food Employee Certification Act, the Department recognizes certification programs, including examinations developed under those programs, that are evaluated and listed by an accrediting agency that has been recognized by the Conference for Food Protection as conforming to the Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification Program. A certificate of completion of a program is a ''certificate'' for purposes of the requirement in subsection (a) and is adequate proof of compliance.

 (c) Posting of certificate. A retail food facility shall post the original certificate of its certified employee in public view at its business location.

 (d) List of acceptable certification programs. The Department will maintain a current list of Department-recognized certification programs. The Department will:

 (1) Publish the current list in the Pennsylvania Bulletin annually and when the list is revised.

 (2) Post the current list on the Department's web site at www.agriculture.state.pa.us.

 (3) Provide a copy of the current list upon request directed to the Department's Bureau of Food Safety and Laboratory Services at (717) 787-4315 or the following mailing address:

Pennsylvania Department of Agriculture
Bureau of Food Safety and Laboratory Services
ATTN: Food Employee Certification
2301 North Cameron Street
Harrisburg, Pennsylvania 17110-9408

Subpart C. MISCELLANEOUS PROVISIONS

CHAPTER 76. (Reserved)

§§ 76.1—76.17. (Reserved).

§ 76.19. (Reserved).

[Pa.B. Doc. No. 14-762. Filed for public inspection April 11, 2014, 9:00 a.m.]

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