PROPOSED RULEMAKING
DEPARTMENT OF AGRICULTURE
[7 PA. CODE CHS. 31, 35, 41, 43, 45--47, 49,
53, 55, 61, 63 AND 78-81]
Food Code
[32 Pa.B. 1046] The Department of Agriculture (Department) proposes to adopt Chapter 46 (relating to food code) to read as set forth in Annex A. The Department also proposes to delete Chapters 31 (relating to bakeries and bakery products), 35 (relating to condiments, spices, pickles and related products), 41 (relating to fruit and fruit products, butters, jellies and preserves), 43 (relating to flavoring materials), 45 (relating to general foods), 47 (relating to oleaginous materials; animal and vegetable fats and oils), 49 (relating to shellfish), 53 (relating to cider and vinegar standards), 55 (relating to coffee and tea standards), 61 (relating to packaged nonalcoholic drinks), 63 (relating to salad dressing and related products), 78 (relating to food establishments), 79 (relating to food service), 80 (relating to food vending machines) and 81 (relating to public places).
Statutory Authority
The Food Act (act) (31 P. S. §§ 20.1--20.18), the Public Eating and Drinking Place Law (law) (35 P. S. §§ 655.1--655.13) and section 1705(d) of The Administrative Code of 1929 (71 P. S. § 445(d)) provide the legal authority for this proposed rulemaking.
The act charges the Department with the responsibility to: (1) regulate, register and inspect ''food establishments'' in this Commonwealth under section 14 (a) of the act (31 P. S. § 20.14(a)); (2) promulgate regulations and food safety standards necessary to the proper enforcement of the food safety requirements under section 13(a) of the act (31 P. S. § 20.13(a)); and (3) construe the statute and its attendant regulations in a manner that is as consistent with Federal statutory and regulatory authority as practicable under section 16 of the act (31 P. S. § 20.16).
The law charges the Department with the responsibility to regulate, license and inspect ''public eating and drinking places'' in this Commonwealth under sections 2 and 6(a) of the law (35 P. S. §§ 655.2 and 655.6(a)), and to regulate the cleanliness and sanitation of these public eating and drinking places under section 9 of the law (35 P. S. § 655.9). This responsibility had originally been assigned the former Department of Environmental Resources, but was transferred to the Department by the act of December 12, 1994 (P. L. 903, No. 131).
Section 1705(d) of The Administrative Code of 1929 requires the Department to establish regulatory standards necessary to enforce food safety laws.
Purpose
This proposed rulemaking would draw authority from several food safety statutes to establish a comprehensive Food Code for this Commonwealth. The primary purpose of this proposed rulemaking is to achieve the public health goal of reducing foodborne illness to the fullest extent possible.
This proposed rulemaking would bring the Commonwealth's food safety standards into step with the current National standards for food safety in the 1999 edition of the United States Public Health Service Food Code (1999 Federal Recommended Food Code).
Food safety science is an evolving body of knowledge. It is the Department's intention to adopt regulatory food safety standards that reflect current recommended National standards, and to revise these standards in the future as necessary to track with relevant revisions to these National standards.
Food safety considerations and procedures are essentially the same, whether the entity being regulated is a ''food establishment'' as described in the act or a ''public eating and drinking place'' as described in the law. For this reason, the proposed rulemaking would merge the definitions of these two terms into a single new term--''food facility''--and establish sanitation and food safety standards and procedures for these facilities.
Background
The 1999 Federal Recommended Food Code is the product of a collaborative effort among the Department, the Food and Drug Administration, 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.
The proposed rulemaking would establish the food safety standards, procedures and requirements of the 1999 Federal Recommended Food Code as those of the Commonwealth. The provisions have been reformatted and revised to track with the underlying statutory authority for the proposed rulemaking, as well as the administrative requirements of the Department.
The standards in the proposed rulemaking are consistent with the content of many of the food safety training courses offered to food industry employees over the years. For this reason, the proposed rulemaking presents a set of standards with which a large segment of this Commonwealth's food industry is already familiar.
Need for the Proposed Rulemaking
The proposed rulemaking is 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 the proposed rulemaking should also serve the regulated community by helping to lower the number of claims and lawsuits related to foodborne illness.
The Department is satisfied there are no reasonable alternatives to proceeding with the proposed rulemaking. The Department is also satisfied the proposed rulemaking meets the requirements of Executive Order No. 1996-1, ''Regulatory Review and Promulgation.''
Overview of the Major Provisions of the Proposed Rulemaking
Proposed § 46.3 (relating to definitions) would define numerous terms, including ''food facility.'' The majority of these definitions have their origin in the 1999 Federal Recommended Food Code, the act or the law.
Proposed Subchapter B (relating to management and personnel) would require a food facility have a designated person in charge of the facility, and ascribe specific duties and responsibilities to that person. In addition, the subchapter would prescribe disease/illness reporting standards, personal cleanliness requirements and other hygienic practices to limit incidents of foodborne illness.
Proposed Subchapter C (relating to food) would establish handling and preparation requirements that track food from its point of origin to its point of consumption.
Proposed §§ 46.211--46.221 would establish limitations and restrictions with respect to the sources from which a food facility may obtain various foods.
Proposed §§ 46.241--46.301 (relating to specifications for receiving, original containers and records) would specify the conditions at which various types of food are to be received by a food facility. These conditions include the maximum receiving temperatures for potentially hazardous foods, pasteurization requirements for milk and milk products and mandatory labeling/origin information for shellfish and shellstock.
Proposed §§ 46.261, 46.262, 46.281--46.286 and 46.301--46.307 (relating to preventing contamination by employees; preventing food and ingredient contamination; and preventing contamination from equipment, utensils and linens) would prescribe various practices intended to keep food from being contaminated after it has reached a food facility. These practices include measures to prevent contamination from hands and skin, the commingling of foods, misuse of food preparation equipment, utensils and linens and other potential sources of contamination.
Proposed §§ 46.321--46.323 and 46.341--46.345 (relating to preventing contamination from the premises; and preventing contamination by consumers) would establish requirements to help prevent contamination of food from the premises of the food facility or from contact with consumers.
Proposed §§ 46.361--46.365 (relating to destruction of organisms of public health concern) would establish procedures intended to destroy harmful organisms that can live in food. These provisions would establish minimum time/temperature standards for the cooking of meat and vegetables, for foods cooked by microwave and for cooked foods that are reheated. In addition, proposed § 46.364 (relating to parasite destruction in fish other than molluscan shellfish by freezing) would establish specific freezing time/temperature requirements and recordkeeping requirements for fish.
Proposed §§ 46.381--46.385 (relating to temperature and time control for limitation of growth of organisms of public health concern) would require certain procedures and standards intended to limit the growth of harmful organisms in potentially hazardous foods (foods capable of supporting the rapid growth of infectious or toxic microorganisms), such as, milk, eggs, meat and poultry.
The proposed rulemaking would allow for food to be processed by a specialized method (such as, by smoking or processing in a reduced-oxygen atmosphere) if the processor first obtains a variance from the Department. This would be addressed in proposed § 46.401 (relating to variance requirement for specialized processing methods).
Proposed § 46.422 (relating to labeling) would require particular label information on packaged foods and certain bulk foods. Proposed § 46.423 (relating to consumer advisory required with respect to animal foods that are raw, undercooked or not otherwise processed to eliminate pathogens) would require a vendor to provide a special warning to consumers if it sells a ready-to-eat food that has as a component a food that is raw, undercooked or not otherwise processed to eliminate pathogens. The warning would advise members of certain highly-susceptible populations (the very young, the very old and other immunocompromised groups) of the potential health hazards involved in consuming raw or undercooked foods. In addition, food served to these highly-susceptible populations would have additional requirements imposed under proposed § 46.461 (relating to additional safeguards for a food facility that serves a highly-susceptible population).
In summary, proposed Subchapter D (relating to equipment, utensils and linens) would address the facilities, equipment and articles that come into contact or proximity with food and that have the demonstrated potential to cause or harbor foodborne illness. This includes utensils and surfaces with which food comes into contact. It also includes the design and construction of the food facility, the accuracy of temperature measuring devices, the design and cleanliness of food dispensing equipment, the design and operation of warewashing machines, the maximum capacities of various pieces of equipment, the location of equipment, the maintenance of equipment and the cleaning and sanitization of equipment and utensils.
Proposed Subchapter E (relating to water, plumbing and waste) would establish standards for the quantity and quality of drinking water and water used in food preparation at a food facility. The subchapter would also address the construction, number, location, operation and maintenance of plumbing systems at food facilities, as well as refuse storage.
Proposed Subchapter F (relating to physical facilities) would establish a set of general standards intended to ensure that a food facility is designed and constructed so as to minimize foodborne illness. These standards entail a food facility having cleanable food surfaces, cleanable floors, walls and ceilings, adequate handwashing facilities and adequate lighting and ventilation.
Proposed Subchapter G (relating to poisonous or toxic materials) would establish requirements for the safe labeling, storage and use of toxic substances in a food facility. These substances might include pesticides, medicines, cleaners, lubricants and other materials.
Proposed Subchapter H (relating to administrative provisions) would establish a process by which a food facility might obtain a variance from the Department to allow a practice or procedure not otherwise permitted under the chapter. This would only be done when a health hazard would not result from the variance. The subchapter would also address the process by which a food facility can obtain the registration required of a food establishment under the act or the license required of a public eating or drinking place under the law.
Affected Individuals and Organizations
The proposed rulemaking would impact upon the public by reducing the number of foodborne illness outbreaks originating from food facilities.
Food establishments and public eating or drinking places, collectively referred to as ''food facilities'' in the proposed rulemaking, would also be affected by this proposed rulemaking. These food facilities would be expected to comply with the standards of this chapter.
Fiscal Impact
Commonwealth. The proposed rulemaking would impose no costs and have no fiscal impact on the Commonwealth. The Department currently registers and inspects food establishments under the act and issues licenses allowing the operation of public eating and drinking places under the law. The proposed rulemaking would merge the Department's regulatory functions into a single set of standards applicable to all ''food facilities'' in this Commonwealth.
Political Subdivisions. The proposed rulemaking would impose no costs and have no fiscal impact upon political subdivisions.
Private Sector. The proposed rulemaking might impose some initial cost on the private sector, although this cannot be readily quantified. Since the food safety standards prescribed by the proposed rulemaking reflect rather widely-known food safety concerns, the Department expects most food facilities in operation within this Commonwealth are currently meeting these standards or would have relatively little difficulty meeting them. In addition, the proposed rulemaking is likely to result in a decrease in the number of lawsuits relating to foodborne illness originating from food facilities, with a resultant savings in costs attributable to litigation and awards of damages. These savings are not readily quantifiable.
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 food facilities.
Effective Date
The proposed rulemaking will be effective upon publication in the Pennsylvania Bulletin as final-form rulemaking.
Sunset Date
There is no 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 are to be submitted to the Department of Agriculture, Bureau of Food Safety and Laboratory Services, 2301 North Cameron Street, Harrisburg, PA 17110-9408, Attention: Sheri Dove.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on February 8, 2002, the Department submitted a copy of the proposed rulemaking to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House and Senate Standing Committees on Agriculture and Rural Affairs. The Department also provided IRRC and the Committees a detailed Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, if IRRC has an objection to any portion of the proposed rulemaking, it must so notify the Department within 10 days of the close of the Committees' review period. The notification shall specify the regulatory review criteria that have not been met by that portion. The Regulatory Review Act sets forth detailed procedures for review of these objections by the Department, the General Assembly and the Governor prior to the final publication of the proposed rulemaking.
SAMUEL E. HAYES, Jr.,
SecretaryFiscal Note: 2-137. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 7. AGRICULTURE.
PART III. BUREAU OF FOOD SAFETY AND
LABORATORY SERVICES (Editor's Note: The Department is proposing to delete Chapter 31, Pa. Code pages 31-1 to 31-9, serial pages (217445) to (217453).)
CHAPTER 31. (Reserved) § 31.1. (Reserved).
§§ 31.11--31.23. (Reserved).
§§ 31.31--31.39. (Reserved).
(Editor's Note: The Department proposes to delete Chapter 35, Pa. Code pages 35-1 and 35-2, serial pages (217455) to (217456).)
CHAPTER 35. (Reserved) §§ 35.1--35.11. (Reserved).
(Editor's Note: The Department is proposing to delete Chapter 41, Pa. Code pages 41-1--41-6, serial pages (217537) to (217542).)
CHAPTER 41. (Reserved) §§ 41.1--41.4. (Reserved).
§§ 41.11--41.14. (Reserved).
§§ 41.21--41.24. (Reserved).
(Editor's Note: The Department proposes to delete Chapter 43, Pa. Code pages 43-1--43-5, serial pages (217543) to (217547).)
CHAPTER 43. (Reserved) §§ 43.1--43.8. (Reserved).
(Editor's Note: The Department proposed to delete Chapter 45, Pa. Code pages 45-1--45-11, serial pages (217549) to (217559).)
§§ 45.1--45.7. (Reserved).
§§ 45.21--45.24. (Reserved).
§§ 45.31--45.33. (Reserved).
§§ 45.41--45.44. (Reserved).
§§ 45.51--45.54. (Reserved).
§§ 45.61--45.64. (Reserved).
§ 45.71. (Reserved).
§ 45.72. (Reserved).
§§ 45.81--45.87. (Reserved).
§§ 45.91--45.93. (Reserved).
CHAPTER 46. FOOD CODE Subch.
A. PURPOSE AND DEFINITIONS B. MANAGEMENT AND PERSONNEL C. FOOD D. EQUIPMENT, UTENSILS AND LINENS E. WATER, PLUMBING AND WASTE F. PHYSICAL FACILITIES G. POISONOUS OR TOXIC MATERIALS H. ADMINISTRATIVE PROCEDURES
Subchapter A. PURPOSE AND DEFINITIONS Sec.
46.1. Purpose. 46.2. Scope. 46.3. Definitions. § 46.1. Purpose.
The purpose of this chapter is to safeguard public health and ensure that consumers are provided food that is safe, unadulterated and honestly presented.
§ 46.2. Scope.
This chapter establishes definitions; sets standards for management and personnel, food operations, and equipment and facilities; and provides for food facility plan review, permitting, licensing, registration, inspection and employee restriction.
§ 46.3. Definitions.
The following terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Act--The Food Act (31 P. S. §§ 20.1--20.18).
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 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 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 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 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 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 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 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 that protect public health.
Bed and breakfast homestead or inn--A private residence which contains 10 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.
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.
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 is used, or intends 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.
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.
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.
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 and does not offer the food for resale.
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.
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.
Employee--The permit, 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 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.
FDA--The United States Food and Drug Administration.
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.
Foodborne disease outbreak--One of the following:
(i) An incident in which two or more persons experience a similar illness after ingestion of a common food, and epidemiological analysis implicates the food as the source of the illness.
(ii) An incident in which one or more persons experience illness from botulism or chemical poisoning.
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 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 act, under the Poultry Products Inspection Act (21 U.S.C.A. §§ 451--471) or under the Wholesome Meat Inspection Act (21 U.S.C.A. §§ 476a--467f and 470).
(E) A new animal drug.
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 those portions of establishments operating exclusively under milk or milk products permits.
Food facility--A public eating or drinking place or a food establishment. The term includes food service facilities provided by an organized camp or campground.
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, school or recreation camp, 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.
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), or any subsequent revision or restatement thereof.
(C) Poultry, as that term is used in 9 CFR Chapter III, Subchapter A (relating to mandatory poultry products inspection) or any subsequent revision or restatement thereof.
(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 EPA for restricted use as specified in 40 CFR 152.175 (relating to pesticides classified for restricted use), or any subsequent revision or restatement thereof.
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 Hazard Analysis Critical Control Point principles developed by The National Advisory Committee on Microbiological Criteria for Foods.
Hazard--A biological, chemical or physical property 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 populations to experience foodborne disease because they are immunocompromised.
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. This definition does not apply to standards of identity established by the FDA or USDA.
Kitchenware--Food preparation and storage utensils.
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 (ppm).
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).
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.
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.
(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.
Person--A corporation, partnership, limited liability company, business trust, other association, government entity (other than the Commonwealth), estate, trust, foundation or natural person.
Person in charge--The individual present at a food facility responsible for the operation at the time of inspection.
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.
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.
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