[42 Pa.B. 5218]
[Saturday, August 11, 2012]
[Continued from previous Web Page]
Subchapter B. [MANAGEMENT AND PERSONNEL] (Reserved) (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Subchapter B which appears in 7 Pa. Code pages 46-17—46-28, serial pages (356767), (356768) and (301595)—(301604).)
Sec. 46.101. (Reserved). 46.102. (Reserved). 46.111—46.115. (Reserved). 46.131—46.137. (Reserved). 46.151—46.153. (Reserved).
Subchapter C. FOOD
[CHARACTERISTICS] § 46.201. [Food shall be safe, unadulterated and honestly presented] (Reserved).
[Food shall be safe, unadulterated and—in accordance with § 46.421(b) (relating to accurate representation)—honestly presented.]
FOOD SOURCES § 46.211. [Food sources] (Reserved).
[Food shall be obtained from sources that comply with the Food Act, the Public Eating and Drinking Places Law and this chapter. Records of food sources shall be maintained and made available for review upon request by the Department.]
§ 46.212. Food prepared in a private home.
(a) General. Food prepared in a private home[, not approved by the Department, may not] 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.
(4) The food is donated to an organization described under paragraph (2).
(b) Private homes that are registered food establishments under the Food Safety Act. Food prepared in a private home may be offered for human consumption in a retail food facility if the private home is registered with the Department as a food establishment under the Food Safety Act.
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind §§ 46.213—46.216 which appear in 7 Pa. Code pages 46-31—46-32, serial pages (301607) and (301608).)
Sec. 46.213—46.216. (Reserved). § 46.217. Milk and milk products.
Milk and milk products [shall be obtained from sources that comply] 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).
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind §§ 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 and 46.461 which appear in 58 Pa. Code pages 46-32— 46-63, serial pages (301608)—(301639).)
Sec. 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. [EQUIPMENT, UTENSILS AND LINENS] (Reserved) (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Subchapter D which appears in 58 Pa. Code pages 46-63—46-97, serial pages (301639), (301640), (351231), (351232) and (301643)—(301673).)
Sec. 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. [WATER, PLUMBING AND WASTE WATER] (Reserved) (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Subchapter E which appears in 58 Pa. Code pages 46-97—46-110, serial pages (301673)—(301686).)
Sec. 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. [PHYSICAL FACILITIES] (Reserved) (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Subchapter F which appears in 58 Pa. Code pages 46-110—46-120, serial pages (301686)—(301696).)
Sec. 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. [POISONOUS OR TOXIC MATERIALS] (Reserved) (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Subchapter G which appears in 58 Pa. Code pages 46-121—46-125, serial pages (301697)—(301701).)
Sec. 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 [Public Eating and Drinking Places Law, the Food Act] 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.
* * * * * (b) Written request. A person seeking an approval from the Department or a licensor under this chapter shall submit a written request for approval to the entity from which approval is sought. If approval is sought from the Department, the written request shall be mailed or delivered to the following address:
Pennsylvania Department of Agriculture
Bureau of Food Safety and Laboratory Services
[Attn: Chief, Division of Food Safety]
2301 North Cameron Street
Harrisburg, Pennsylvania 17110-9408* * * * * (e) Standard for approval. The Department or licensor shall grant approval if it determines the approval would not constitute or cause a violation of the [Food Act, the Public Eating and Drinking Places Law] 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 that shall be provided by the person requesting the variance and retained in the Department's file on the retail food facility includes the following:
* * * * * (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:
* * * * * (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:
* * * * *
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 will submit these properly prepared plans and specifications (as described in subsection (b)) to the Department or licensor for review and approval (using the procedure described in § 46.1142 (relating to application procedure for appropriate license [or registration])) before any of the following:
(1) The construction of a 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 [§ 46.423 (relating to consumer advisory required with respect to animal-derived] the Model Food Code for animalfoods that are raw, undercooked or not otherwise processed to eliminate pathogens[)].
* * * * * (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 [a] an HACCP plan is required.
(1) Before engaging in an activity that requires [a] 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 [a] an HACCP plan is required according to applicable Federal or State laws.
(ii) A variance is required as specified in [§ 46.250(b)(2)(ii), § 46.361(d)(2), § 46.401 or § 46.589(b)] the Model Food Code.
* * * * * (2) A retail food facility applicant or retail food facility operator shall have a properly prepared HACCP plan as specified in [§ 46.402 (relating to reduced oxygen packaging)] the Model Food Code for reduced oxygen packaging.
(b) Contents of [a] an HACCP plan. For a retail food facility that is required in subsection (a) to have [a] an HACCP plan, the plan and specifications shall indicate the following:
* * * * * § 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[, the Food Act and the Public Eating and Drinking Places Law] and the Retail Food Facility Safety Act.
REQUIREMENTS FOR OPERATION § 46.1141. [Requirement: license or registration] License requirement.
(a) General requirement. A person may not operate a retail food facility without a valid [registration issued by the Department, or] license issued by the Department or licensor, unless otherwise provided in subsection (b).
(b) [Exceptions.
(1) A building, structure or place owned, leased or otherwise in possession of a person or municipal corporation or public or private organization, used or intended to be used by two or more farmers or an association of farmers for the purpose of selling food directly to consumers—otherwise known as a farmer's market—shall be considered to be a single retail food establishment for purposes of registration under section 14 of the Food Act (31 P. S. § 20.14).
(2)] Exemptions. The following [food establishments] retail food facilities are exempt from [registration] licensure requirements under [section 14 of the Food Act] the Retail Food Facility Safety Act but remain subject to the inspection provisions and all other provisions of the Retail Food Facility Safety Act:
[(i) Vehicles used primarily for the transportation of a consumer commodity in bulk or quantity to manufacturers, packers, processors or wholesale or retail distributors.
(ii) A food establishment in which at least 50% of the commodities sold were produced on the farm on which the food establishment is located.
(iii) A food establishment in which food or beverages are sold only through a vending machine.
(iv) A food establishment in which only prepackaged, nonpotentially hazardous food or beverages are sold.]
(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 the Model Food Code, as follows:
(1) 24-month license interval.
(i) The license interval is 24 months with respect to a retail food facility that:
(A) Serves or sells only pre-packaged, nonpoten-tially hazardous foods (non-time/temperature control for safety foods).
(B) Prepares only nonpotentially hazardous foods (non-time/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 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.
(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 area), 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 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 foodborne illness risk factors in paragraph (1).
(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 and entails handling of raw ingredients.
(B) Has complex preparation including cooking, cooling and reheating for hot holding involves many potentially hazardous foods (TCS foods).
(C) Uses a variety of processes that require hot and cold holding of potentially hazardous food (TCS foods).
(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 area) that includes 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 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 foodborne illness risk factors in paragraph (1).
(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 foodborne illness risk factors in paragraph (1).
§ 46.1142. Application procedure for appropriate license [or registration].
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 [or registration]. The Department or licensor will supply the applicant with the appropriate form, based upon the type of retail food facility involved. [If the food facility is a public eating and drinking place, the applicant shall obtain a license. If the food facility is a retail food establishment, the applicant must obtain a registration. A single location (such as a grocery store that also serves hot ready-to-eat foods) might require both a license and a registration.]
§ 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 [will issue a registration, or the Department] or licensor will issue a license to the applicant after the following occur:
* * * * * (b) License [or registration] 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 [by the Department of a renewed registration or license, or the issuance] of a renewed license by the Department or a licensor.
(c) Change of ownership. Licenses [and registrations] are nontransferable. New owners shall apply to the Department or licensor in accordance with § 46.1142 (relating to application procedure for appropriate license [or registration]).
§ 46.1144. Conditions of retention: responsibilities of the retail food facility operator.
To retain a license [or registration] issued by the Department or licensor under this chapter, a retail food facility operator shall do the following:
(1) Post the license [or registration] in a location in the retail food facility that is conspicuous to consumers and the Department or licensor.
* * * * * (3) If a retail food facility is required in § 46.1122(a) (relating to HACCP plans) to operate under [a] 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 [§ 46.111(b) (relating to duty to report disease or medical condition)] Subpart 2-201 of the Model Food Code.
(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 need not discontinue operations in an area of a facility that is unaffected by the imminent health hazard.
(6) Not resume operations discontinued in accordance with paragraph (5) or otherwise according to the [Public Eating and Drinking Places Law or the Food Act] 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).
* * * * * (9) [Upgrade or replace refrigeration equipment as specified in § 46.385(a)(3) (relating to potentially hazardous food: hot and cold holding), by December 13, 2008, if the circumstances specified in paragraph (8)(i) and (ii) do not occur first, and unless a variance has been approved as specified in § 46.1103.
(10)] Comply with directives of the Department or licensor including time frames for corrective actions specified in inspection reports, notices, orders, warnings and other directives issued by the Department or licensor in regard to the operator's retail food facility or in response to community emergencies.
[(11)] (10) Accept notices issued and served by the Department or licensor according to the [Public Eating and Drinking Places Law or the Food Act] Retail Food Facility Safety Act.
(11) Remit a fee owed to 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.
Subpart C. MISCELLANEOUS PROVISIONS
CHAPTER 76. FOOD EMPLOYEE CERTIFICATION (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind §§ 76.1—76.17 and 76.19 which appear in 58 Pa. Code pages 76-1—76-18, serial pages (304941)—(304958).)
Sec.
76.1—76.17. (Reserved). 76.19. (Reserved). (Editor's Note: Sections 76.20 and 79.21 are new and printed in regular type to enhance readability.)
§ 76.20. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless otherwise defined in Chapter 46 (relating to food code):
Act—The Food Employee Certification Act (3 Pa.C.S. §§ 6501—6510).
Certificate—A certificate of completion issued by a certification program that has been evaluated and listed by an accrediting agency that has been recognized by the Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification Program.
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.
Employee—As defined in 3 Pa.C.S. § 5702 (relating to definitions).
§ 76.21. Certification programs.
(a) General recognition of certification programs. For purposes of compliance with the 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.
(b) List of acceptable certification programs. The Department maintains 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
[Pa.B. Doc. No. 12-1514. Filed for public inspection August 10, 2012, 9:00 a.m.]
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