PROPOSED RULEMAKING
DEPARTMENT OF AGRICULTURE
[ 7 PA. CODE CHS. 46 AND 76 ]
Food Code; Food Employee Certification
[42 Pa.B. 5218]
[Saturday, August 11, 2012]The Department of Agriculture (Department) proposes to amend Chapters 46 and 76 (relating to food code; and food employee certification) 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 proposed 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 these regulations, 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'' (see 3 Pa.C.S. § 5707(a) (relating to powers of department)) (Model Food Code). The Retail Food Facility Safety Act also affords the Department the discretion to establish retail food facility license intervals of greater than 1 year, but requires that these license intervals be established by regulation and that the regulations 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 the Commonwealth (see 3 Pa.C.S. § 5734(a) (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 3 Pa.C.S. § 5733(a) (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 3 Pa.C.S. § 5736 (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 3 Pa.C.S. § 6504(a) (relating to certification of employees)) and authorizes the Department to promulgate regulations necessary for the proper enforcement of the Food Employee Certification Act (see 3 Pa.C.S. § 6505 (relating to rules and regulations)).
Purpose
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 and Drinking Places Law and the Food Act and supplanted these statutes 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 the statutes they replaced, there are also a number of changes that necessitate this proposed rulemaking.
The proposed rulemaking seeks to: (1) adopt the terminology and implement the changes necessitated or authorized by Act 106; (2) incorporate, to the extent practicable, the standards and requirements of the Model Food Code as the food safety standards and requirements for this Commonwealth; (3) establish retail food facility license intervals of greater than 1 year using risk-based factors identified in the Model Food Code as a basis for determining the appropriate license interval; and (4) streamline the food employee certification regulations in Chapter 76 to reflect changes produced by Act 106.
Background
The Model Food Code is the product of a collaborative effort among the Department, the United States Food and Drug Administration, the United States Department of Agriculture 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 the current regulations in Chapter 46. It 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 3 Pa.C.S. § 5707(a)). 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 proposed rulemaking will not have an adverse impact on that regulated community.
The other provisions of the proposed rulemaking implement new or revised statutory requirements established by Act 106, which revised or replaced a number of the food-related statutes as previously described.
Need for the Proposed Rulemaking
The proposed rulemaking is driven by the substantial changes to underlying food safety related statutes accomplished by Act 106.
The proposed 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 proposed rulemaking.
The food safety standards in this proposed 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 proposed rulemaking 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. The proposed rulemaking is needed to implement these changes.
The Department is satisfied there are no reasonable alternatives to proceeding with the proposed rulemaking.
Overview of the Major Provisions of the Proposed Rulemaking
Proposed amendments to § 46.3 (relating to definitions) delete a number of terms that are defined in the Model Food Code to maintain a common vocabulary of food safety terminology. When an underlying statute uses a term that is not used in the Model Food Code, but that is synonymous with another term in the Model Food Code, the proposed rulemaking identifies that synonymous Model Food Code term. This occurs in the definitions of ''licensee,'' ''proprietor'' and ''retail food facility.''
Proposed § 46.4 (relating to adoption of Model Food Code) would adopt the standards of the Model Food Code as the regulatory standards of the Department to the extent they do not conflict with an underlying statute or a specific provision of Chapter 46.
The proposed rulemaking would rescind current regulatory provisions when the subject matter of those provisions is adequately addressed in the underlying statutes or the Model Food Code, or when the provisions are no longer necessary. These deletions are throughout the proposed rulemaking and address a wide range of food safety related subjects.
Proposed amendments to § 46.212 (relating to food prepared in a private home) add language to track with 3 Pa.C.S § 5712 (relating to applicability) that generally exempts food that is prepared in private homes and then sold at events such as church suppers and fundraisers for charitable organizations from the requirements of the Retail Food Facility Safety Act.
The list of the types of retail food facilities that are exempt from licensure under the Retail Food Facility Safety Act are proposed to be amended in § 46.1141 (relating to license requirement) to reflect that 3 Pa.C.S. § 5703(b) (relating to license required) affords a licensor (whether the Department or a local government unit) the discretion to issue an order establishing which types of retail food facilities will be exempt. The Department has exercised this discretion and published an order at 41 Pa.B. 524 (January 22, 2011) designating the types of retail food facilities that are exempt. A reference to this order or its date or place of publication is not included in the proposed rulemaking because the order might change and it might cause confusion in those jurisdictions where the licensor is an entity other than the Department.
Proposed amendments to § 46.1141(c) establish retail food facility license intervals based on risk-based factors identified in the Model Food Code as authorized under section 5703(g) of the Retail Food Facility Safety Act.
Proposed § 76.20 (relating to definitions) would establish definitions either included or authorized in the Food Employee Certification Act.
Proposed § 76.21 (relating to certification programs) would implement 3 Pa.C.S. § 6503(c) (relating to certification programs) that the Department recognize certain certification programs as adequate for purposes of meeting the requirements of the Food Employee Certification Act. It would also require the Department to maintain, post on the Department's web site and readily provide copies of that list of acceptable certification programs.
Affected Individuals and Organizations
The proposed rulemaking would 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 would also be affected by the proposed 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 relating to foodborne illness. Also, since the proposed rulemaking would bring 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 the electronic licensing system, the proposed rulemaking would not impose costs or 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 proposed rulemaking would not appreciably expand or alter the Department's role in administering and enforcing these underlying statutes.
Political subdivisions. The proposed rulemaking would not impose costs or have fiscal impact upon political subdivisions. Although a local government unit may act as the ''licensor'' of retail food facilities within its borders, the proposed rulemaking would not impose requirements on a local government unit licensor that is not imposed by one or more of the underlying statutes.
Private sector. The proposed 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 relatedtraining that is available to these persons and that has been obtained for purposes of compliance with the Food Employee Certification Act.
General public. The proposed rulemaking would 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 proposed rulemaking is not likely to appreciably impact upon the paperwork generated by the Department or other retail food facility licensors or retail food facilities or food establishments.
Effective Date
The proposed rulemaking will be effective 1 month following final-form publication in the Pennsylvania Bulletin.
Sunset Date
There is not a sunset date for the proposed rulemaking. The Department will review the efficacy of these regulations on an ongoing basis.
Public Comment Period/Contact Person
Interested persons are invited to submit written comments regarding the proposed rulemaking within 30 days following publication in the Pennsylvania Bulletin. Comments should be submitted to 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 this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House and Senate Standing Committees on Agriculture and Rural Affairs. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Department, the General Assembly and the Governor of comments, recommendations or objections raised.
GEORGE D. GREIG,
SecretaryFiscal Note: 2-174. (1) General Fund; (2) Implementing Year 2011-12 is $5,000; (3) 1st Succeeding Year 2012-13 is $0; 2nd Succeeding Year 2013-14 is $0; 3rd Succeeding Year 2014-15 is $0; 4th Succeeding Year 2015-16 is $0; 5th Succeeding Year 2016-17 is $0; (4) 2010-11 Program—$1,835,780; 2009-10 Program—$1,341,812; 2008-09 Program—$1,088,400; (7) General Government Operations—Bureau of Food Safety; (8) recommends adoption.
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 [AND]; 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, [registration,] 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:
[Additive—A food additive or a color additive.
Adulterated—Food with respect to which one or more of the following is accurate:
(i) The food bears or contains any poisonous or deleterious substance, which may render it injurious to health. However, if the substance is not an added substance, the food will not be considered adulterated if the quantity of the substance in the food does not ordinarily render it injurious to health.
(ii) The food bears or contains any added poisonous or added deleterious substance, which is unsafe within the meaning of section 11 of the Food Act (31 P. S. § 20.11). This subparagraph does not apply to a pesticide chemical in or on a raw agricultural commodity, a food additive or a color additive.
(iii) The food is a raw agricultural commodity and bears or contains a pesticide chemical which is unsafe within the meaning of section 11 of the Food Act, except that, when a pesticide chemical has been used in or on a raw agricultural commodity with an exception granted or tolerance prescribed under section 11 of the Food Act or under any of the Federal acts and the raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating or milling, the residue of the pesticide remaining in or on the processed food will, notwithstanding section 11 of the Food Act and this subparagraph, not be deemed unsafe if the residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice and the concentration of the residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity.
(iv) The food bears or contains any food additive, which is unsafe within the meaning of section 11 of the Food Act or any of the Federal acts.
(v) The food consists in whole or in part of any diseased, contaminated, filthy, putrid or decomposed substance or is otherwise unfit for food.
(vi) The food has been produced, prepared, packed or held under unsanitary conditions so that it may have become contaminated with filth or may have been rendered diseased, unwholesome or injurious to health.
(vii) The food is, in whole or part, the product of a diseased animal or of an animal which has died otherwise than by slaughter.
(viii) The food is in a container composed, in whole or part, of any poisonous or deleterious substance which may render the contents injurious to health, unless the container is fabricated or manufactured with good manufacturing practices as that standard is defined and delineated by any of the Federal acts and their regulations.
(ix) The food has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption under section 11 of the Food Act or under one of the Federal acts.
(x) The food has had any valuable constituent, in whole or part, omitted or abstracted therefrom.
(xi) The food has had any substance substituted wholly or in part.
(xii) Damage or inferiority of the food is concealed in any manner.
(xiii) A substance has been added to the food and it is mixed or packed so as to increase its bulk or weight or reduce its quality or strength or make it appear better or of greater value than it is.
(xiv) The food bears or contains any color additive which is unsafe within the meaning of section 11 of the Food Act or under one of the Federal acts.
(xv) The food bears or contains eggs processed by or egg products derived from a manufacturing, processing or preparing method wherein whole eggs are broken using a centrifuge-type egg breaking machine that separates the egg's liquid interior from the shell.
Approved—Acceptable to the Department based on a determination of conformity with principles, practices and generally recognized standards proven to be scientifically sound that protect public health.]
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.
[Beverage—A liquid for drinking, including water.
Bottled drinking water—Water that is sealed in bottles, packages or other containers and offered for sale for human consumption. The term includes bottled mineral water.
CFR—The most-recently published edition or revision of the Code of Federal Regulations, a compilation of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal government.
CIP—Cleaned in place—
(i) Cleaned in place by the circulation or flowing by mechanical means through a piping system of a detergent solution, water rinse and sanitizing solution onto or over equipment surfaces that require cleaning, such as the method used, in part, to clean and sanitize a frozen dessert machine.
(ii) The term does not include the cleaning of equipment such as band saws, slicers or mixers that are subjected to in-place manual cleaning without the use of a CIP system.
Casing—A tubular container for sausage products made of either natural or artificial (synthetic) material.
Certification number—A unique combination of letters and numbers assigned by the Department or other shellfish control authority having jurisdiction to a molluscan shellfish dealer according to the provisions of the National Shellfish Sanitation Program.
Color additive—A material which is a dye, pigment or other substance made by a process of synthesis or similar artifice or extracted, isolated or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral or other source and when added or applied to a food is capable, alone or through reaction with other substances, of imparting color thereto.
(i) The term includes black, white and intermediate grays.
(ii) The term does not include materials, which the Secretary, by regulation, determines are used, or are intended to be used, solely for a purpose other than coloring.
(iii) The term does not include any pesticide chemical, soil or plant nutrient or other agricultural chemical solely because of its effect in aiding, retarding or otherwise affecting, directly or indirectly, the growth or otherwise natural physiological process of produce of the soil and thereby affecting its color, whether before or after harvest.
Commingle—To combine shellstock harvested on different days or from different growing areas as identified on the tag or label or to combine shucked shellfish from containers with different container codes or different shucking dates.
Comminuted—A food that is reduced in size by methods including chopping, flaking, grinding or mincing. The term includes fish or meat products that are reduced in size and restructured or reformulated such as gefilte fish, gyros, ground beef and sausage; and a mixture of two or more types of meat that have been reduced in size and combined, such as sausages made from two or more meats.
Confirmed disease outbreak—A foodborne disease outbreak in which laboratory analysis of appropriate specimens identifies a causative agent and epidemiological analysis implicates the food as the source of the illness.
Consumer—A person, who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food facility or food processing plant, and does not offer the food for resale.
Controlled atmosphere packaging—A type of reduced oxygen packaging in which the atmosphere of a package of food is modified so that until the package is opened, its composition is different from air, and continuous control is maintained, such as by using oxygen scavengers or a combination of total replacement of oxygen, nonrespiring food and impermeable packaging material.
Corrosion-resistant material—A material that maintains acceptable surface cleanability characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and sanitizing solutions and other conditions of the use environment.
Critical control point—A point or procedure in a specific food system where loss of control may result in an unacceptable health risk.
Critical limit—The maximum or minimum value to which a physical, biological or chemical parameter must be controlled at a critical control point to minimize the risk that the identified food safety hazard may occur.]
Department—The Department of Agriculture of the Commonwealth. The term is synonymous with the term ''regulatory authority'' in the Model Food Code.
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.
[Dry storage area—A room or area designated for the storage of packaged or containerized bulk food that is not potentially hazardous and dry goods such as single service items.
EPA—The United States Environmental Protection Agency.
Easily cleanable—
(i) A characteristic of a surface that:
(A) Allows effective removal of soil by normal cleaning methods.
(B) Is dependent on the material, design, construction and installation of the surface.
(C) Varies with the likelihood of the surface's role in introducing pathogenic or toxigenic agents or other contaminants into food based on the surface's approved placement, purpose and use.
(ii) The term includes a tiered application of the criteria that qualify the surface as easily cleanable as specified in subparagraph (i) to different situations in which varying degrees of cleanability are required, such as one of the following:
(A) The appropriateness of stainless steel for a food preparation surface as opposed to the lack of need for stainless steel to be used for floors or for tables used for consumer dining.
(B) The need for a different degree of cleanability for a utilitarian attachment or accessory in the kitchen as opposed to a decorative attachment or accessory in the consumer dining area.
Easily movable—A unit of equipment that is both of the following:
(i) Portable; mounted on casters, gliders or rollers; or provided with a mechanical means to safely tilt the unit of equipment for cleaning.
(ii) Has no utility connection, a utility connection that disconnects quickly or a flexible utility connection line of sufficient length to allow the equipment to be moved for cleaning of the equipment and adjacent area.
Egg—The shell egg of the domesticated chicken, turkey, duck, goose or guinea.]
Employee—The license [or registration] 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.
[Equipment—
(i) An article that is used in the operation of a food facility such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature measuring device for ambient air, vending machine or warewashing machine.
(ii) The term does not include items used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks and skids.
Exclude—To prevent a person from working as a food employee or entering a food facility except for those areas open to the general public.]
FDA—The United States Food and Drug Administration.
[Federal acts—The Wholesome Meat Act (21 U.S.C.A. §§ 601—641), the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301—399), the Poultry Products Inspection Act (21 U.S.C.A. §§ 451—471), the Fair Packaging and Labeling Act (15 U.S.C.A. §§ 1451—1461), the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.A. § 136—136y) and the Nutrition Labeling and Education Act of 1990 (21 U.S.C.A. § 343-1).
Fish—The term includes:
(i) Fresh or saltwater finfish, crustaceans, all mollusks and other forms of aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of those animals), other than birds or mammals, if the animal life is intended for human consumption.
(ii) The term includes an edible human food product derived in whole or in part from fish, including fish that have been processed in any manner.]
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 Act—The Food Act (31 P. S. §§ 20.1—20.18).
Food additive—
(i) A substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, with respect to which one or more of the following is correct:
(A) The substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use.
(B) The substance has been used in food prior to January 1, 1958, and is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures or experience based on common use in food, to be safe under the conditions of its intended use.
(ii) The term does not include the following:
(A) A pesticide chemical in or on a raw agricultural commodity.
(B) A pesticide chemical to the extent that it is intended for use or is used in the production, storage or transportation of any raw agricultural commodity.
(C) A color additive.
(D) A substance used in accordance with a sanction or approval granted prior to the enactment of this subparagraph under a statute repealed by the Food Act, under the Poultry Products Inspection Act or under the Wholesome Meat Act.
(E) A new animal drug.
Foodborne disease outbreak—The occurrence of two or more cases of a similar illness after ingestion of a common food.
Food-contact surface—One of the following:
(i) A surface of equipment or a utensil with which food normally comes into contact.
(ii) A surface of equipment or a utensil from which food may drain, drip or splash into a food, or onto a surface normally in contact with food.
Food employee—An individual working with unpackaged food, food equipment or utensils, or food-contact surfaces.]
Food establishment—
(i) A [retail food store and 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 or transporting or handling food.
(ii) The term [includes those portions of public eating and drinking licensees which offer food for sale for off-premises consumption, except] 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 the Model Food Code.
[Food facility—A public eating or drinking place or a retail food establishment. The term does not include the following:
(i) A food service facility provided by or at an organized camp or campground.
(ii) A food service facility provided by or at a school.
(iii) A food service facility at an institution such as a nursing home or hospital.
(iv) Any other food service facility that is not a public eating or drinking place.
(v) Food processing plants, warehousing establishments and other food establishments that comply with the following:
(A) Are not retail food establishments.
(B) Do not provide food to the consumer either directly or indirectly (such as through the home delivery of groceries).
(C) Applicable Federal regulations.
Food facility operator—The entity that is legally responsible for the operation of the food facility, such as the owner, owner's agent or other person.
Food facility premises—The food facility, its contents and the contiguous land or property under the control of the food facility operator. If a food facility is a component of a larger operation, such as a hotel, motel, shopping mall or public campground, and that larger operation is also under the control of the food facility operator, that larger operation is part of the food facility premises to the extent it may impact the food facility, its personnel or its operations.
Food processing plant—A commercial operation that manufactures, packages, labels or stores food for human consumption and does not provide food directly to a consumer. The term does not include a food facility.]
Food Safety Act—The Food Safety Act (3 Pa.C.S. §§ 5721—5737).
[Game animal—
(i) An animal, the products of which are food, that is not classified as any of the following:
(A) Fish, as that term is defined in this chapter.
(B) Cattle, sheep, swine, goat, horse, mule or other equine, as those terms are used in 9 CFR Chapter III, Subchapter A (relating to agency organization and terminology; mandatory meat and poultry products inspection and voluntary inspection and certification).
(C) Poultry, as that term is used in 9 CFR Chapter III, Subchapter A.
(D) Ratites, such as ostriches, emus or rheas.
(ii) The term includes mammals such as reindeer, elk, deer, antelope, water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria or muskrat, and nonaquatic reptiles such as land snakes.
General use pesticide—A pesticide that is not classified by the EPA for restricted use as specified in 40 CFR 152.175 (relating to pesticides classified for restricted use).]
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.
[HACCP plan—A written document that delineates the formal procedures for following the HAACP principles developed by the National Advisory Committee on Microbiological Criteria for Foods.
Hazard—A biological, chemical or physical property (such as the presence of pathogens, pesticides, natural toxins, rodent contamination or foreign materials) that may cause an unacceptable consumer health risk.
Hermetically sealed container—A container that is designed and intended to be secure against the entry of microorganisms and, in the case of low acid canned foods, to maintain the commercial sterility of its contents after processing.
High humidity cooking—Cooking in an oven that attains relative humidity of greater than 90% for at least 1 hour as measured in the cooking chamber or exit of the oven, or cooking in a moisture-impermeable bag that provides 100% humidity.
Highly susceptible population—A group of persons who are more likely than other people in the general population to experience foodborne disease because both of the following conditions exist:
(i) The group is comprised of immunocompro- mised persons, preschool-age children or older adults.
(ii) The group obtains food at a facility that provides services such as custodial care, health care, assisted living services, nutritional services or socialization services. Examples of facilities providing these services include child or adult day care centers, health care centers, assisted living facilities, hospitals, nursing homes, kidney dialysis centers and senior centers.
Honestly presented—Food offered for human consumption in a way that does not mislead or misinform the consumer, and without misrepresenting the true appearance, color or quality of the food through the use of food or color additives, colored overwraps, lighting or other means.
Imminent health hazard—A significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on one or more of the following:
(i) The number of potential injuries.
(ii) The nature, severity and duration of the anticipated injury.
Injected—Manipulating a meat so that infectious or toxigenic microorganisms may be introduced from its surface to its interior through tenderizing with deep penetration or injecting the meat such as with juices which may be referred to as ''injecting,'' ''pinning'' or ''stitch pumping.''
Juice—When used in the context of food safety, the term refers to the aqueous liquid expressed or extracted from one or more fruits or vegetables, purées of the edible portions of one or more fruits or vegetables, or any concentrate of the liquid or purée. The term includes juice as a whole beverage, an ingredient of a beverage, and a puree as an ingredient of a beverage. This definition does not apply to standards of identity established by the FDA or USDA.
Kitchenware—Food preparation and storage utensils.]
License—A grant to a [licensee to operate a public eating or drinking place, as defined in the Public Eating and Drinking Places Law] proprietor to operate a retail food facility. The term is synonymous with the term ''permit'' in the Model Food Code.
Licensee—The person, such as a retail food facility operator, that 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 the Model Food Code.
Licensor—Includes the following:
(i) The county department of health or joint-county department of health, whenever the [public eating or drinking place] 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 [public eating or drinking place] 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 [Public Eating and Drinking Places Law] Retail Food Facility Safety Act whenever [the public eating and drinking place] a retail food facility is located in [the] 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 [public eating and drinking place] retail food facility is located in any other area of this Commonwealth.
[Linens—Fabric items such as cloth hampers, cloth napkins, tablecloths, wiping cloths and work garments, including cloth gloves.
mg/L—Milligrams per liter, which is the metric equivalent of parts per million.
Meat—The flesh of animals used as food including the dressed flesh of cattle, swine, sheep or goats and other edible animals. The term does not include fish, poultry and wild game animals as specified under § 46.221(b) and (c) (relating to game animals).]
Milk Sanitation Law—The act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. §§ 645—[660e] 660g).
[Mobile food facility—Any stationary, movable or temporary food facility—such as a stand, vehicle, cart, basket, box or similar structure from which food is stored, prepared, processed, distributed or sold—which physically locates at one site or location for no more than 14 consecutive days, whether operating continuously or not during this time. The term does not include a food facility that is physically located at one site for more than 14 consecutive days.]
Model Food Code—The most current edition of the Food Code published by the Department of Health and Human Services, Food and Drug Administration.
[Modified atmosphere packaging—
(i) A type of reduced oxygen packaging in which the atmosphere of a package of food is modified so that its composition is different from air but the atmosphere may change over time due to the permeability of the packaging material or the respiration of the food.
(ii) The term includes: reduction in the proportion of oxygen, total replacement of oxygen or an increase in the proportion of other gases such as carbon dioxide or nitrogen.
Molluscan shellfish—An edible species of fresh or frozen oysters, clams, mussels and scallops or edible portions thereof, except when the scallop product consists only of the shucked adductor muscle.
Nonpublic water supply—A system for the provision of piped water for human consumption that is not a public water system.
Other food regulatory agency—Local bodies, State bodies other than the Commonwealth or Federal enforcement bodies having jurisdiction over a food establishment or food processing plant. Examples include the USDA with respect to most meat processing plants within this Commonwealth and the FDA having jurisdiction over food products imported from other countries.]
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.
[pH—The symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of acidity or alkalinity of a solution. Values between 0 and 7 indicate acidity and values between 7 and 14 indicate alkalinity. The value for pure distilled water is 7, which is considered neutral.
Packaged—
(i) Bottled, canned, cartoned, securely bagged or securely wrapped in a food facility or a food processing plant.
(ii) The term does not include a wrapper, carryout box or other nondurable container used to containerize food with the purpose of facilitating food protection during service and receipt of the food by the consumer.
Pennsylvania Construction Code Act—35 P. S. §§ 7210.101—7210.1103.
Pennsylvania Sewage Facilities Act—35 P. S. §§ 750.1—750.20a.
Permanent food facility—A food facility—whether stationary or mobile—that is not a temporary food facility operating more than 14 days in a single calendar year—whether these days are consecutive or not.
Person—A corporation, partnership, limited liability company, business trust, other association, government entity (other than the Commonwealth), estate, trust, foundation or natural person.
Personal care items—
(i) Items or substances that may be poisonous, toxic or a source of contamination and are used to maintain or enhance a person's health, hygiene or appearance.
(ii) The term includes items such as medicines, first aid supplies, cosmetics, toiletries (such as toothpaste and mouthwash) and similar items.]
Person in charge—[The individual present at a food facility responsible for the operation at the time of inspection.] 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.
[Physical facilities—The structure and interior surfaces of a food facility, including accessories such as soap and towel dispensers and attachments such as light fixtures and heating or air conditioning system vents.
Plumbing fixture—A receptacle or device that is one or more of the following:
(i) Permanently or temporarily connected to the water distribution system of the premises and demands a supply of water from the system.
(ii) Discharges used water, waste materials or sewage directly or indirectly to the drainage system of the premises.
Plumbing system—The water supply and distribution pipes; plumbing fixtures and traps; soil, waste and vent pipes; sanitary and storm sewers and building drains, including their respective connections, devices and appurtenances within the premises; and water-treating equipment.
Poisonous or toxic material—A substance that is not intended for ingestion and that fits within one or more of the following categories:
(i) Cleaners and sanitizers, including cleaning and sanitizing agents and agents such as caustics, acids, drying agents, polishes and other chemicals.
(ii) Pesticides.
(iii) Substances necessary for the operation and maintenance of the establishment, such as nonfood grade lubricants, solvents and personal care items that may be deleterious to health.
(iv) Substances that are not necessary for the operation and maintenance of the establishment and are on the premises for retail sale, such as petroleum products and paints.
Potentially hazardous food—
(i) A food which consists, in whole or part, of milk or milk products, eggs, meat, poultry, fish, shellfish, edible crustacea or other ingredients, including synthetic ingredients, which is in a form capable of supporting rapid and progressive growth of infectious or toxigenic microorganisms.
(ii) The term does not include foods that have a pH level of 4.6 or below or a water activity of 0.85 or less under standard conditions or food products in hermetically sealed containers processed to maintain commercial sterility.
Poultry—One or more of the following:
(i) A domesticated bird (chickens, turkeys, ducks, geese or guineas), whether live or dead, as defined in 9 CFR Chapter III, Subchapter A, Part 381 (relating to poultry products inspection regulations).
(ii) A migratory waterfowl or game bird, such as pheasant, partridge, quail, grouse, guineas, pigeon or squab, whether live or dead, as defined in the USDA regulations in 9 CFR Part 362 (relating to voluntary poultry inspection regulations).
(iii) The term does not include ratites.
Primal cut—A basic major cut into which carcasses and sides of meat are separated, such as a beef round, pork loin, lamb flank or veal breast.]
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 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.
[Public Eating and Drinking Places Law—The act of May 23, 1945 (P. L. 926, No. 369) (35 P. S. §§ 655.1—655.13).
Public water system—A system which provides water to the public for human consumption, and which has at least 15 service connections or regularly serves an average of at least 25 individuals daily at least 60 days out of the year, or as otherwise specified in 25 Pa. Code Chapter 109 (relating to safe drinking water).
(i) The term includes collection, treatment, storage and distribution facilities under control of the operator of the system and used in connection with the system.
(ii) The term also includes a system which provides water for bottling or bulk hauling for human consumption.
Ratite—An animal belonging to the same family as ostriches, emus and rheas.]
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, or as otherwise defined in section 5722 of the Food Safety Act (relating to definitions).
[Ready-to-eat food—Any of the following types of food:
(i) Food in a form that is edible without additional preparation to achieve food safety, such as raw animal-derived foods that have been cooked in accordance with § 46.361 or § 46.362 (relating to cooking raw animal-derived foods; and microwave cooking), or fish that have been frozen in accordance with § 46.364 (relating to parasite destruction in fish other than molluscan shellfish by freezing), although additional preparation may occur for palatability or aesthetic, epicurean, gastronomic or culinary purposes.
(ii) Food that is raw or partially-undercooked animal-derived food, where the food facility offering the food has complied with § 46.361(d)(1) and the consumer notification requirements of § 46.423 (relating to consumer advisory required with respect to animal-derived foods that are raw, undercooked or not otherwise processed to eliminate pathogens), although additional preparation may occur for palatability or aesthetic, epicurean, gastronomic or culinary purposes.
(iii) Food that is prepared in accordance with a variance issued by the Department under § 46.361(d)(2) and § 46.1103 (relating to variances), although additional preparation may occur for palatability or aesthetic, epicurean, gastronomic or culinary purposes.
(iv) Raw fruits and vegetables that are washed in accordance with § 46.285 (relating to washing raw fruits and vegetables).
(v) Fruits and vegetables that are cooked for hot holding in accordance with § 46.363 (relating to plant food cooking for hot holding).
(vi) Potentially hazardous food that is cooked in accordance with the time and temperature requirements for that specific food in §§ 46.361—46.363, and that is cooled as specified in § 46.384 (relating to potentially hazardous food: cooling).
(vii) Plant food with respect to which further washing, cooking or other processing is not required for food safety, and from which rinds, peels, husks or shells (if naturally present) are removed.
Reduced oxygen packaging—
(i) The reduction of the amount of oxygen in a package by removing oxygen; displacing oxygen and replacing it with another gas or combination of gases; or otherwise controlling the oxygen content to a level below that normally found in the surrounding 21% oxygen atmosphere.
(ii) A process as specified in subparagraph (i) that involves a food for which Clostridium botulinum is identified as a microbiological hazard in the final packaged form.
(iii) The term includes vacuum packaging, modified atmosphere packaging and controlled atmosphere packaging.
Refuse—Solid waste not carried by water through the sewage system.
Registration—A grant to a person to operate a food establishment within this Commonwealth as required by section 14 of the Food Act (31 P. S. § 20.14).
Reg. Penna. Dept. Agr.—An abbreviation connoting that a food bearing that abbreviation on its package label has been processed by a food establishment that is ''registered with the Pennsylvania Department of Agriculture'' in accordance with section 14(a) of the Food Act.
Restrict—To limit the activities of a food employee so that there is no risk of transmitting a disease that is transmissible through food and the food employee does not work with exposed food, clean equipment, utensils, linens and unwrapped single-service or single-use articles.
Restricted egg—Any check, dirty egg, incubator reject, inedible, leaker or loss as defined in Chapter 87 (relating to standards for grading and marketing eggs).
Restricted use pesticide—A pesticide classified for restricted use under section 3(d) of the Federal Insecticide, Fungicide and Rodenticide Act of 1947 (7 U.S.C.A. § 136(d)), or a pesticide designated by the Secretary for restricted use under section 7(b)(6) of the Pennsylvania Pesticide Control Act of 1973 (3 P. S. § 111.27(b)(6)).]
Retail food establishment—[A food]
(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 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—The Retail Food Facility Safety Act (3 Pa.C.S. §§ 5701—5714).
[Risk—The likelihood that an adverse health effect will occur within a population as a result of a hazard in a food.
Safe material—One or more of the following:
(i) An article manufactured from or composed of materials that may not reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of any food.
(ii) An additive that is used as specified in section 409 or section 706 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. §§ 301 and 376).
(iii) A material that is not an additive and that is used in conformity with applicable regulations of the FDA.
Sanitization—The application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of five logs, which is equal to a 99.999% reduction, of representative disease microorganisms of public health importance.
Sealed—Free of cracks or other openings that allow the entry or passage of moisture.]
Secretary—The Secretary of the Department or an authorized representative, employee or agent of the Department.
[Service animal—An animal such as a guide dog, signal dog or other animal individually trained to provide assistance to an individual with a disability.
Servicing area—An operating base location to which a mobile food facility or transportation vehicle returns regularly for things such as discharging liquid or solid wastes, refilling water tanks and ice bins and boarding food.
Sewage—A substance, which contains waste products or excrements or other discharges from the bodies of human beings or animals and any noxious or deleterious substance being harmful or inimical to the public health, or to animal or aquatic life, or to the use of water for domestic water supply or for recreation.
Shellfish control authority—A State, Federal, foreign, tribal or other government entity legally responsible for administering a program that includes certification of molluscan shellfish harvesters and dealers for interstate commerce.
Shellfish permit—A permit issued by the Department in accordance with Chapter 49 (relating to shellfish) and the National Shellfish Sanitation Program, that authorizes a person to operate a food establishment for shellfish.
Shellfish permit holder—The entity that meets the following conditions:
(i) Is legally responsible for the operation of the food establishment such as the owner, owner's agent or other person.
(ii) Possesses a valid shellfish permit to operate a shellfish food establishment.
Shellstock—Raw, in-shell molluscan shellfish.
Shiga toxin-producing Escherichia coli—Any E. coli capable of producing Shiga toxins, also called Verocytotoxins or Shiga-like toxins. This includes, but is not limited to, E. coli serotypes O157:H7, O157:NM and O157:H.
Shucked shellfish—Molluscan shellfish that have one or both shells removed.
Single-service articles—Tableware, carry-out utensils and other items such as bags, containers, place mats, stirrers, straws, toothpicks and wrappers that are designed and constructed for one time, one person consumer use after which they are intended for discard.
Single-use articles—
(i) Utensils and bulk food containers designed and constructed to be used once and discarded.
(ii) The term includes items such as wax paper, butcher paper, plastic wrap, formed aluminum food containers, jars, plastic tubs or buckets, bread wrappers, pickle barrels, ketchup bottles and number 10 cans which do not meet the materials, durability, strength and cleanability specifications in §§ 46.521(a), 46.541(a) and 46.542(a) and (b) (relating to materials in multiuse utensils and food-contact surfaces; durability and strength; and cleanability of multiuse food-contact surfaces and CIP equipment) for multiuse utensils.
(iii) The term does not include formed aluminum containers used in conjunction with pan liners that may be reused to cook nonpotentially hazardous baked goods.
Slacking—The process of moderating the temperature of a food such as allowing a food to gradually increase from a temperature of -23°C (-10°F) to -4°C (25°F) in preparation for deep-fat frying or to facilitate even heat penetration during the cooking of previously block-frozen food such as spinach.
Smooth—One or more of the following:
(i) A food-contact surface having a surface free of pits and inclusions with cleanability equal to or exceeding that of (100 grit) number-3 stainless steel.
(ii) A nonfood-contact surface of equipment having a surface equal to that of commercial grade hot-rolled steel free of visible scale.
(iii) A floor, wall or ceiling having an even or level surface with no roughness or projections that renders it difficult to clean.
Substance—A material intended for use in producing, manufacturing, packaging, processing, preparing, treating, transporting or holding food and any source of radiation intended for any use.
Sulfiting agent—A substance which imparts a residual of sulfur dioxide.
Table—mounted equipment—Equipment that is not portable and is designed to be mounted off the floor on a table, counter or shelf.
Tableware—Eating, drinking and serving utensils for table use such as plates, flatware (including forks, knives and spoons) and hollowware (including bowls, cups, serving dishes and tumblers).
Temperature measuring device—A thermometer, thermocouple, thermistor or other device that indicates the temperature of food, air or water.
Temporary food facility—A food facility that operates for a period of no more than 14 consecutive days in a fixed location and in conjunction with a single event or celebration (such as a fair, festival, carnival or other transitory gathering).
Temporary license—Either of the following:
(i) A license that is the following:
(A) Issued to the operator of a temporary food facility.
(B) Valid for the duration of a particular event or celebration (such as a fair or carnival) of no more than 14 days duration (whether these days are consecutive or nonconsecutive).
(C) Issued to the operator with respect to no more than three events or celebrations in a particular calendar year.
(ii) A license that is the following:
(A) Issued to a food facility operator operating a food facility, whether stationary or mobile.
(B) In operation for a total of no more than 14 days within a particular calendar year.
(C) Not in conjunction with an event or celebration.
USDA—The United States Department of Agriculture.
Utensil—A food-contact implement or container used in the storage, preparation, transportation, dispensing, sale or service of food. The term includes the following:
(i) Kitchenware or tableware that is multiuse, single-service or single-use.
(ii) Gloves used in contact with food.
(iii) The temperature sensing probes of food temperature measuring devices.
(iv) Probe-type price or identification tags used in contact with food.
Utility sink—A sink used for the disposal of mop water or other similar liquid waste.
Vacuum packaging—A type of reduced oxygen packaging in which air is removed from a package of food and the package is hermetically sealed so that a vacuum remains inside the package, such as sous vide.
Variance—A written document issued by the Department that authorizes a modification or waiver of one or more requirements of this chapter if, in the opinion of the Department, a health hazard or nuisance will not result from the modification or waiver.
Vending machine—A self-service device that, upon insertion of a coin, paper currency, token, card or key, dispenses unit servings of food in bulk or in packages without the necessity of replenishing the device between each vending operation.
Vending machine location—The room, enclosure, space or area where one or more vending machines are installed and operated. The term includes the storage areas and areas on the premises that are used to service and maintain the vending machines.
Warewashing—The cleaning and sanitizing of food-contact surfaces of equipment and utensils.
Water activity or aw—A measure of the free moisture in a food, obtained by dividing the water vapor pressure of the substance by the vapor pressure of pure water at the same temperature. Water activity is typically indicated by the symbol aw.
Water for human consumption—The term includes water that is used for drinking, bathing and showering, cooking, dishwashing or maintaining oral hygiene.
Whole-muscle, intact beef—Whole muscle beef that is not injected, mechanically tenderized, reconstructed, or scored and marinated, from which beef steaks may be cut.]
(Editor's Note: The following section is new and printed in regular type to enhance readability.)
§ 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.
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