Pennsylvania Code & Bulletin
COMMONWEALTH OF PENNSYLVANIA

• No statutes or acts will be found at this website.

The Pennsylvania Bulletin website includes the following: Rulemakings by State agencies; Proposed Rulemakings by State agencies; State agency notices; the Governor’s Proclamations and Executive Orders; Actions by the General Assembly; and Statewide and local court rules.

PA Bulletin, Doc. No. 02-297a

[32 Pa.B. 1046]

[Continued from previous Web Page]

   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 ingre2dients, 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 or any subsequent revision or restatement thereof.

   (ii)  A migratory waterfowl, game bird or squab such as pheasant, partridge, quail, grouse or guineas, whether live or dead, as defined in the USDA regulations in 9 CFR Chapter III, Subchapter A, Part 362 (relating to voluntary poultry inspection program) or any subsequent revision or restatement thereof.

   (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.

   Private water system--A system for the provision of piped water for human consumption that is not a public water system.

   Public Eating and Drinking Place Law--The act of May 23, 1945 (P. L. 926, No. 369) (35 P. S. §§ 655.1--655.13).

   Public eating and drinking places license--A grant to a licensee to conduct a public eating and drinking place as defined in the Public Eating and Drinking Place Law.

   Public eating or drinking place--

   (i)  A place within this Commonwealth where food or drink is served to or provided for the public, with or without charge.

   (ii)  This provisions does apply to dining cars operated by a railroad company in interstate commerce or a bed and breakfast homestead or inn.

   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.

   (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.

   Ready-to-eat food--

   (i)  Food in a form that is edible without washing, cooking or additional preparation by the food facility or the consumer, and that is reasonably expected to be consumed in that form.

   (ii)  The term includes:

   (A)  Unpackaged potentially hazardous food that is cooked to the temperature and time required for the specific food under § 46.361 (relating to cooking raw animal foods).

   (B)  Raw, washed, cut fruits and vegetables.

   (C)  Whole, raw fruits and vegetables that are presented for consumption without the need for further washing, such as at a buffet.

   (D)  Other food presented for consumption for which further washing or cooking is not required and from which rinds, peels, husks or shells 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.

   Reg. Penna. Dept. Agr.--An abbreviation connoting that a food bearing that abbreviation on its package label has been processed by a food facility that is ''registered with the Pennsylvania Department of Agriculture'' in accordance with section 14(a) of the act (31 P. S. § 20.14(a)).

   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)).

   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.

   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.

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

   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 this chapter 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 facility such as the owner, owner's agent or other person.

   (ii)  Possesses a valid shellfish permit to operate a shellfish food facility.

   Shellstock--Raw, in-shell molluscan shellfish.

   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 substance 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 days a year utilizing a permanent facility or in conjunction with a single 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)  Food temperature measuring devices.

   (iv)  Probe-type price or identification tags used in contact with food.

   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.

Subchapter B.  MANAGEMENT AND PERSONNEL

SUPERVISION

Sec.

46.101.Designation of person in charge.
46.102.Duties of the person in charge.

EMPLOYEE HEALTH

46.111.Duty to report disease or medical condition.
46.112.Diseases or medical conditions that must be reported.
46.113.Duty to impose exclusions and restrictions.
46.114.Duty to comply with exclusions and restrictions.
46.115.Removing exclusions and restrictions.

PERSONAL CLEANLINESS

46.131.Cleanliness of hands and exposed portions of arms.
46.132.Duty of food employees to wash.
46.133.Required washing locations.
46.134.Hand sanitizers.
46.135.Cleanliness of fingernails.
46.136.Jewelry.
46.137.Cleanliness of outer clothing.

HYGIENIC PRACTICES

46.151.Food contamination prevention.
46.152.Hair restraints.
46.153.Animals.

SUPERVISION

§ 46.101.  Designation of person in charge.

   The food facility operator shall be the person in charge or shall designate a person in charge and shall ensure that a person in charge is present at the food facility during all hours of operation.

§ 46.102.  Duties of the person in charge.

   The person in charge shall perform the following duties:

   (1)  Ensure that food facility operations are not conducted in a private home where the food facility has not been approved by the Department, or in a room used as living or sleeping quarters as specified in § 46.922(k) (relating to functionality of various physical facilities of a food facility).

   (2)  Ensure that persons unnecessary to the food facility operation are not allowed in the food preparation, food storage or warewashing areas, except that brief visits and tours may be authorized by the person in charge if steps are taken to ensure that exposed food; clean equipment, utensils, linens and unwrapped single-service and single-use articles are protected from contamination.

   (3)  Ensure that employees and other persons (such as delivery and maintenance persons and pesticide applicators) entering the food preparation, food storage and warewashing areas comply with this chapter.

   (4)  Routinely monitor employee handwashing to ensure that employees effectively clean their hands.

   (5)  Routinely monitor employee observations and periodically evaluate foods upon receipt to ensure that employees visibly observe foods as they are received to determine that they are from approved sources, delivered at the required temperatures, protected from contamination, unadulterated and accurately presented.

   (6)  Conduct daily oversight of the employees' routine monitoring of cooking temperatures using appropriate temperature measuring devices properly scaled and calibrated in accordance with §§ 46.561 and 46.691(b) (relating to accuracy of temperature measuring devices for food; and to utensils and temperature and pressure measuring devices: repair and calibration), to ensure the employees are properly cooking potentially hazardous food, and are being particularly careful in cooking those foods known to cause severe foodborne illness and death, such as eggs and comminuted meats.

   (7)  Conduct daily oversight of the employees' routine monitoring of food temperatures during cooling, to ensure that employees are using proper methods to rapidly cool potentially hazardous foods that are not held hot or are not for consumption within 4 hours.

   (8)  Ensure that consumers who order raw or partially cooked ready-to-eat foods of animal origin are informed, in accordance with § 46.423 (relating to consumer advisory required with respect to animal foods that are raw, undercooked or not otherwise processed to eliminate pathogens), that the food is not cooked sufficiently to ensure its safety.

   (9)  Routinely monitor solution temperature and exposure time for hot water sanitizing, and chemical concentration, pH, temperature, and exposure time for chemical sanitizing, to ensure that employees properly sanitize cleaned multiuse equipment and utensils before they are reused.

   (10)  Ensure that consumers are notified that clean tableware is to be used when they return to self-service areas such as salad bars and buffets, in accordance with § 46.306 (relating to using clean tableware for second portions and refills).

   (11)  Ensure that employees prevent cross-contamination of ready-to-eat food with bare hands by properly using suitable utensils. These utensils may include deli tissue, spatulas, tongs, single-use gloves or dispensing equipment.

   (12)  Ensure that employees are properly trained in food safety as it relates to their assigned duties.

EMPLOYEE HEALTH

§ 46.111.  Duty to report disease or medical condition.

   (a)  Responsibility of a food facility operator to require reporting. A food facility operator shall require a food employee and a food employee applicant to whom a conditional offer of employment is made to report to the person in charge, information about their health and activities as they relate to diseases described in § 46.112 (relating to diseases or medical conditions that must be reported) or diseases that are transmissible through food.

   (b)  Responsibility of a person in charge to report information to Department. The person in charge shall notify the Department that a food employee is diagnosed with an illness due to Salmonella typhi, Shigella spp., Escherichia coli O157:H7 or hepatitis A virus.

   (c)  Responsibilities of a food employee or food employee applicant. A food employee or a person who applies for a job as a food employee shall report to the person in charge the information specified in this section in a manner that allows the person in charge to prevent the likelihood of foodborne disease transmission. This information includes the date of onset of jaundice or the date of onset of any illness or condition specified in § 46.112.

§ 46.112.  Diseases or medical conditions that must be reported.

   A food employee or food employee applicant shall report the following diseases or medical conditions to the person in charge:

   (1)  A diagnosis of an illness due to any of the following:

   (i)  Salmonella typhi.

   (ii)  Shigella spp.

   (iii)  Escherichia coli O157:H7.

   (iv)  Hepatitis A virus.

   (2)  A past illness from any of the infectious agents listed in paragraph (1).

   (3)  A symptom caused by illness, infection or other source, where that symptom is associated with an acute gastrointestinal illness such as any of the following:

   (i)  Diarrhea.

   (ii)  Fever.

   (iii)  Vomiting.

   (iv)  Jaundice.

   (v)  Sore throat with fever.

   (4)  A lesion containing pus such as a boil or infected wound that is open or draining and is any of the following:

   (i)  On the hands or wrists, unless an impermeable cover such as a finger cot or stall protects the lesion and a single-use glove is worn over the impermeable cover.

   (ii)  On exposed portions of the arms, unless the lesion is protected by an impermeable cover.

   (iii)  On other parts of the body, unless the lesion is covered by a dry, durable, tight-fitting bandage.

   (5)  Is suspected of causing a confirmed disease outbreak caused by S. typhi, Shigella spp., E. coli O157:H7 or hepatitis A virus, including an outbreak at an event such as a family meal, church supper or festival because the food employee or applicant prepared food implicated in the outbreak.

   (6)  Is suspected of being exposed to a confirmed disease outbreak caused by S. typhi, Shigella spp., E. coli O157:H7, or hepatitis A virus, including an outbreak at an event such as a family meal, church supper or festival because the food employee or applicant did either of the following:

   (i)  Consumed food implicated in the outbreak.

   (ii)  Consumed food at the event prepared by a person who is infected or ill with the infectious agent that caused the outbreak or who is suspected of being a shedder of the infectious agent.

   (7)  Lives in the same household as a person who is diagnosed with a disease caused by S. typhi, Shigella spp., E. coli O157:H7 or hepatitis A virus.

   (8)  Lives in the same household as a person who attends or works in a setting where there is a confirmed disease outbreak caused by S. typhi, Shigella spp., E. coli O157:H7 or hepatitis A virus.

§ 46.113.  Duty to impose exclusions and restrictions.

   (a)  General exclusions and restrictions. A person in charge shall impose the following exclusions and restrictions:

   (1)  Exclude a food employee from a food facility if the food employee is diagnosed with an infectious agent specified in § 46.112(1) (relating to diseases or medical conditions that must be reported).

   (2)  Restrict a food employee from working with exposed food; clean equipment, utensils, linens and unwrapped single-service and single-use articles, in a food facility if the food employee is either of the following:

   (i)  Experiencing a symptom specified in § 46.112(3) or (4).

   (ii)  Not experiencing a symptom of acute gastroenteritis specified in § 46.112(3), but has a stool that yields a specimen culture that is positive for Salmonella typhi, Shigella spp. or Escherichia coli O157:H7.

   (b)  Special exclusions with respect to a food employee who is jaundiced. If a food employee is jaundiced, the person in charge shall exclude the food employee as a food handler until 7 days after the onset of jaundice. If a food employee is jaundiced more than 7 days after onset, the person in charge shall restrict the food employee from working with exposed food and clean equipment, utensils, linens and unwrapped single service and single use articles in a food facility.

   (c)  Special exclusions with respect to a food facility serving a highly susceptible population. If the population served by the food facility is a highly susceptible population, a person in charge shall impose any exclusions or restrictions required under subsection (a) and also exclude a food employee from the food facility if the food employee is any of the following:

   (1)  Experiencing a symptom of acute gastrointestinal illness specified in § 46.112(3) and meets any of the high-risk conditions specified in § 46.112(5), (6), (7) or (8).

   (2)  Is not experiencing a symptom of acute gastroenteritis specified in § 46.112(3), but has a stool that yields a specimen culture that is positive for S. typhi, Shigella spp. or E. coli O157:H7.

   (3)  Had a past illness from S. typhi within the last 3 months.

   (4)  Had a past illness from Shigella spp. or E. coli O157:H7 within the last month.

   (5)  Jaundiced, regardless of the time of onset.

§ 46.114.  Duty to comply with exclusions and restrictions.

   A food employee or a person who applies for a job as a food employee shall comply with exclusions and restrictions that are imposed by the person in charge under authority of § 46.113 (relating to duty to impose exclusions and restrictions).

§ 46.115.  Removing exclusions and restrictions.

   (a)  Disease or medical condition described in § 46.112(1). A person in charge may remove an exclusion imposed as a result of a disease or medical condition described in § 46.112(1) (relating to diseases or medical conditions that must be reported) if the excluded person provides the person in charge written medical documentation specifying that the excluded person may work in an unrestricted capacity in a food facility, including a facility that serves a highly susceptible population, because the person is free of the infectious agent of concern. This documentation shall be from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician assistant.

   (b)  Disease or medical condition with respect to which restrictions are imposed under § 46.113(a)(2)(i). A person in charge may remove a restriction imposed under authority of § 46.113(a)(2)(i) (relating to duty to impose exclusions and restrictions) as a result of a disease or medical condition if any of the following are accurate:

   (1)  The person is free of the symptoms specified in § 46.112(3) and (4), and no foodborne illness occurs that may have been caused by the restricted person.

   (2)  The person is suspected of causing foodborne illness, but both of the following are true:

   (i)  The person is free of the symptoms specified in § 46.112(3) and (4).

   (ii)  The person provides written medical documentation from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician assistant, stating that the restricted person is free of the infectious agent that is suspected of causing the person's symptoms or causing foodborne illness.

   (3)  The restricted person provides written medical documentation from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician assistant stating that the symptoms experienced result from a chronic noninfectious condition such as Crohn's disease, irritable bowel syndrome or ulcerative colitis.

   (c)  Disease or medical condition with respect to which restrictions are imposed under authority of § 46.113(a)(2)(ii)). A person in charge may remove a restriction imposed as a result of a disease or medical condition imposed under authority of § 46.113(a)(2)(ii) if the restricted person provides written medical documentation from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician assistant that indicates the restricted person's stools are free from Salmonella typhi, Shigella spp. or Escherichia coli O157:H7--whichever is the infectious agent of concern.

   (d)  Disease or medical condition with respect to which exclusions or restrictions are imposed under authority of § 46.113(b). A person in charge may remove an exclusion or restriction imposed as a result of a disease or medical condition described in § 46.113(b) if the excluded or restricted person provides written medical documentation from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician's assistant that specifies that the person is free of hepatitis A virus.

   (e)  Disease or medical condition with respect to which exclusions are imposed under authority of § 46.113(c). A person in charge may remove an exclusion imposed with respect to a food facility serving a highly susceptible population as a result of a disease or medical condition described in § 46.113(c) if the restricted person provides written medical documentation from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician's assistant that states, as applicable, that the person is:

   (1)  Free of the infectious agent of concern.

   (2)  Free of jaundice, if hepatitis A virus is the infectious agent of concern.

   (3)  Experiencing symptoms resulting from a chronic noninfectious condition such as Crohn's disease, irritable bowel syndrome or ulcerative colitis.

PERSONAL CLEANLINESS

§ 46.131.  Cleanliness of hands and exposed portions of arms.

   (a)  Responsibility of food employees. Food employees shall keep their hands and exposed portions of their arms clean.

   (b)  Cleaning procedure.

   (1)  General procedure. Except as specified in paragraph (2), food employees shall clean their hands and exposed portions of their arms with a cleaning compound in a lavatory that is equipped as specified in § 46.822(b) (relating to design, construction and installation of plumbing systems) by vigorously rubbing together the surfaces of their lathered hands and arms for at least 20 seconds and thoroughly rinsing with clean water. Employees shall pay particular attention to the areas underneath the fingernails and between the fingers.

   (2)  Alternative procedure. An automatic handwashing facility may be used by food employees to clean their hands if the facility is approved and capable of removing the types of soils encountered in the food operations involved.

§ 46.132.  Duty of food employees to wash.

   Food employees shall clean their hands and exposed portions of their arms as specified in § 46.131 (relating to cleanliness of hands and exposed portions of arms) as follows:

   (1)  Immediately before engaging in food preparation activities such as working with exposed food, working with clean equipment and utensils, and working with unwrapped single-service and single-use articles.

   (2)  After touching bare human body parts other than clean hands and clean, exposed portions of arms.

   (3)  After using the toilet room.

   (4)  After caring for or handling service animals or aquatic animals as specified in § 46.153(b) (relating to animals).

   (5)  Except as specified in § 46.151(a)(2) (relating to food contamination prevention), after coughing, sneezing, using a handkerchief or disposable tissue, using tobacco, eating, or drinking.

   (6)  After handling soiled equipment or utensils.

   (7)  During food preparation, as often as necessary to remove soil and contamination and to prevent cross contamination when changing tasks.

   (8)  When switching between working with raw food and working with ready-to-eat food.

   (9)  After engaging in other activities that contaminate the hands.

§ 46.133.  Required washing locations.

   Food employees shall clean their hands in a handwashing lavatory or approved automatic handwashing facility. Food employees may not clean their hands in a sink used for food preparation, a utility sink or a curbed cleaning facility used for the disposal of mop water and similar liquid waste.

§ 46.134.  Hand sanitizers.

   (a)  Requirements. A hand sanitizer and a chemical hand sanitizing solution used as a hand dip shall:

   (1)  Comply with one or more of the following:

   (i)  Be an approved drug that is listed in the most current FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations as an approved drug based on safety and effectiveness.

   (ii)  Have active antimicrobial ingredients that are listed in one or more of the following:

   (A)  The most current FDA monograph for OTC Health-Care Antiseptic Drug Products as an antiseptic handwash.

   (B)  The most current USDA List of Proprietary Substances and Nonfood Compounds, Miscellaneous Publication No.1419 or its successor.

   (2)  Comply with one or more of the following:

   (i)  Have components that are exempted from the requirement of being listed in Federal food additive regulations as specified in 21 CFR 170.39 (relating to threshold of regulation for substances used in food-contact articles) or its successor.

   (ii)  Comply with, and be listed in, one or more of the following:

   (A)  21 CFR 178 (relating to indirect food additives: adjuvants, production aids, and sanitizers) as regulated for use as a food additive with conditions of safe use).

   (B)  21 CFR 182 (relating to substances generally recognized as safe), 21 CFR 184 (relating to direct food substances affirmed as generally recognized as safe) or 21 CFR 186 (relating to indirect food substances affirmed as generally recognized as safe for use in contact with food).

   (iii)  Be limited to situations when use is followed by a thorough hand rinsing in clean water before hand contact with food, or when hand contact with food is avoided by the use of gloves, or where there is no direct contact with food by bare hands.

   (3)  Be applied only to hands that are cleaned as specified in § 46.131(b) (relating to cleanliness of hands and exposed portions of arms).

   (b)  Chemical hand sanitizing solution. A chemical hand sanitizing solution used as a hand dip shall be maintained clean and at a strength equivalent to at least 100 mg/L (ppm) chlorine.

§ 46.135.  Cleanliness of fingernails.

   (a)  General. Food employees shall keep their fingernails trimmed, filed and maintained so the edges and surfaces are cleanable and not rough.

   (b)  Fingernail polish and artificial fingernails. Unless wearing intact gloves in good repair, a food employee may not wear fingernail polish or artificial fingernails when working with exposed food.

§ 46.136.  Jewelry.

   Food employees may not wear jewelry on their arms and hands while preparing food. This prohibition does not apply to a plain ring such as a wedding band.

§ 46.137.  Cleanliness of outer clothing.

   Food employees shall wear clean outer clothing to prevent contamination of food, equipment, utensils, linens, single-service articles and single-use articles.

HYGIENIC PRACTICES

§ 46.151.  Food contamination prevention.

   (a)  Eating, drinking or using tobacco.

   (1)  General prohibition. An employee may not eat, drink or use any form of tobacco unless the use occurs in designated areas where the contamination of exposed food; clean equipment, utensils and linens; unwrapped single-service and single-use articles; or other items needing protection can not result. The sole exception to this prohibition is in paragraph (2).

   (2)  Exception for closed beverage containers. A food employee may drink from a closed beverage container if the container is handled to prevent contamination of the following:

   (i)  The employee's hands.

   (ii)  The container.

   (iii)  Exposed food; clean equipment, utensils and linens; and unwrapped single-service and single-use articles.

   (b)  Discharges from the eyes, nose and mouth. Food employees experiencing persistent sneezing, coughing or a runny nose that causes discharges from the eyes, nose or mouth may not work with exposed food; clean equipment, utensils and linens; or unwrapped single-service or single-use articles.

§ 46.152.  Hair restraints.

   (a)  General requirement. Employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints and clothing that covers body hair, that are effectively designed and worn to keep their hair from contacting exposed food; clean equipment, utensils and linens; and unwrapped single-service and single-use articles.

   (b)  Exception. This section does not apply to food employees who present a minimal risk of contaminating exposed food, clean equipment, utensils, linens and unwrapped single-service and single-use articles. These food employees may include employees such as counter staff who only serve beverages and wrapped or packaged foods, hostesses and wait staff.

§ 46.153.  Animals.

   (a)  Circumstances under which handling of animals is prohibited. Food employees may not care for or handle animals that may be present such as patrol dogs, service animals or pets that are allowed as specified in § 46.982 (relating to limitations on animals).

   (b)  Circumstances under which handling of animals is permissible. Employees with service animals may handle or care for their service animals and food employees may handle or care for fish in aquariums or molluscan shellfish or crustacea in display tanks if they wash their hands as specified in §§ 46.131(b) and 46.132 (relating to cleanliness of hands and exposed portions of arms; and duty of food employees to wash).

Subchapter C.  FOOD

CHARACTERISTICS

Sec.

46.201.Food shall be safe, unadulterated and honestly presented.

FOOD SOURCES

46.211.Food sources.
46.212.Food prepared in a private home.
46.213.Packaged food.
46.214.Whole-muscle, intact beef.
46.215.Packaged meat and poultry that is not a ready-to-eat food.
46.216.Food in a hermetically sealed container.
46.217.Milk and milk products.
46.218.Fish.
46.219.Molluscan shellfish.
46.220.Wild mushrooms.
46.221.Game animals.
46.222.Ice.

SPECIFICATIONS FOR RECEIVING, ORIGINAL CONTAINERS AND RECORDS

46.241.Receiving temperature of food.
46.242.Additives.
46.243.Receiving shell eggs.
46.244.Receiving eggs and milk products.
46.245.Package integrity of food upon receipt.
46.246.Receiving shucked shellfish: packaging and identification.
46.247.Shellstock identification.
46.248.Shellstock: condition upon receipt.
46.249.Molluscan shellfish: original container.
46.250.Shellstock: maintaining identification.

PREVENTING CONTAMINATION BY EMPLOYEES

46.261.Preventing contamination from food employees' hands.
46.262.Preventing contamination when tasting.

PREVENTING FOOD AND INGREDIENT CONTAMINATION

46.281.Preventing contamination of packaged and unpackaged food: separation, packaging and segregation.
46.282.Identification of content on food storage containers.
46.283.Substituting pasteurized eggs for raw shell eggs in certain recipes.
46.284.Protection from unapproved additives.
46.285.Washing raw fruits and vegetables.
46.286.Preventing contamination from ice used as a coolant.

PREVENTING CONTAMINATION FROM EQUIPMENT, UTENSILS AND LINENS

46.301.Preventing contamination from food contact with equipment and utensils.
46.302.In-use utensils and between-use storage.
46.303.Linens and napkins: use limitations.
46.304.Wiping cloths: use limitations.
46.305.Gloves: use limitations.
46.306.Using clean tableware for second portions and refills.
46.307.Refilling returnables.

PREVENTING CONTAMINATION FROM THE PREMISES

46.321.Food storage.
46.322.Vended potentially hazardous food: original container.
46.323.Food preparation.

PREVENTING CONTAMINATION BY CONSUMERS

46.341.Food display.
46.342.Protection of condiments.
46.343.Consumer self-service operations.
46.344.Returned food and reservice of food.
46.345.Miscellaneous sources of contamination.

DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN

46.361.Cooking raw animal foods.
46.362.Microwave cooking.
46.363.Plant food cooking for hot holding.
46.364.Parasite destruction in fish other than molluscan shellfish by freezing.
46.365.Reheating food.

TEMPERATURE AND TIME CONTROL FOR LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN

46.381.Stored frozen food.
46.382.Potentially hazardous food: slacking.
46.383.Potentially hazardous food: thawing.
46.384.Potentially hazardous food: cooling.
46.385.Potentially hazardous food: hot and cold holding.

SPECIALIZED PROCESSING METHODS

46.401.Variance requirement for specialized processing methods.
46.402.Reduced oxygen packaging.

FOOD IDENTITY, PRESENTATION AND ON-PREMISES LABELING

46.421.Accurate representation.
46.422.Labeling.
46.423.Consumer advisory required with respect to animal foods that are raw, undercooked or not otherwise processed to eliminate pathogens.

CONTAMINATED FOOD

46.441.Discarding, or reconditioning unsafe, adulterated or contaminated food.

SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS

46.461.Additional safeguards for a food facility that serves a highly susceptible population.

CHARACTERISTICS

§ 46.201.  Food shall be safe, unadulterated and honestly presented.

   Food shall be safe, unadulterated and--in accordance with § 46.421(b) (relating to accurate representation)--honestly presented.

FOOD SOURCES

§ 46.211.  Food sources.

   Food shall be obtained from sources that comply with the act, the Public Eating and Drinking Place Law and this chapter.

§ 46.212.  Food prepared in a private home.

   Food prepared in a private home, not approved by the Department, may not be used or offered for human consumption in a food facility.

§ 46.213.  Packaged food.

   Packaged food shall be labeled as specified in the Food Act, this chapter, 21 CFR 101 (relating to food labeling), 9 CFR 317 (relating to labeling, marking devices, and containers) and 9 CFR 381, Subpart N (relating to labeling and containers).

§ 46.214.  Whole-muscle, intact beef.

   Whole-muscle, intact beef steaks that are intended for consumption in an undercooked form without a consumer advisory as specified in § 46.361(c) (relating to cooking raw animal foods) shall be one of the following:

   (1)  Obtained from a food establishment that packages the steaks and labels them to indicate that they meet the definition of whole-muscle, intact beef.

   (2)  Individually cut in a food facility, and all of the following:

   (i)  Cut from whole-muscle intact beef that is labeled by a food establishment to indicate that the beef meets the definition of ''whole-muscle intact beef.''

   (ii)  Prepared so they remain intact.

   (iii)  If packaged for undercooking in a food facility, labeled to indicate that they meet the definition of ''whole-muscle, intact beef.''

§ 46.215.  Packaged meat and poultry that is not a ready-to-eat food.

   Meat and poultry that is not a ready-to-eat food and is in a packaged form when it is offered for sale or otherwise offered for consumption, shall be labeled to include safe handling instructions as specified in the act, including 9 CFR 317.2(I) (relating to labels: definitions; required features) and 9 CFR 381.125(b) (relating to special handling label requirements).

§ 46.216.  Food in a hermetically sealed container.

   Food in a hermetically sealed container shall be obtained from a food establishment that is regulated by the Department or other food regulatory agency that has jurisdiction over the plant.

§ 46.217.  Milk and milk products.

   Milk and milk products shall be obtained from sources that comply with the Milk Sanitation Law.

§ 46.218.  Fish.

   (a)  Sources. Fish that are received for sale or service shall be one of the following:

   (1)  Commercially and legally caught or harvested.

   (2)  Approved for sale or service.

   (b)  Nonmolluscan fish for raw consumption. Fish, other than molluscan shellfish, that are intended for consumption in their raw form and allowed as specified in § 46.361(d)(1) (relating to cooking of raw animal foods) may be offered for sale or service if they are obtained from a supplier that freezes the fish as specified in § 46.364(a) and (b) (relating to parasite destruction in fish other than molluscan shellfish by freezing); or frozen on the premises as specified in § 46.364(a) and (b) and records are retained as specified in § 46.364(c).

[Continued on next Web Page]



No part of the information on this site may be reproduced for profit or sold for profit.

This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.