[33 Pa.B. 6137]
[Continued from previous Web Page]
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., Shiga toxin-producing Escherichia coli 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, medical conditions or special circumstances to the person in charge:
(1) A diagnosis of an illness due to any of the following:
(i) Salmonella typhi.
(ii) Shigella spp.
(iii) Shiga toxin-producing Escherichia coli.
(iv) Hepatitis A virus.
(2) A past illness from any of the following:
(i) Salmonella typhi within the past 3 months.
(ii) Shigella spp. within the past month.
(iii) Shiga toxin-producing Escherichia coli within the last month.
(iv) Hepatitis A virus.
(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) The food employee or food employee applicant is suspected of causing a confirmed disease outbreak caused by S. typhi, Shigella spp., Shiga toxin-producing Escherichia coli 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) The food employee or food employee applicant is suspected of being exposed to a confirmed disease outbreak caused by S. typhi, Shigella spp., Shiga toxin-producing Escherichia coli 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) The food employee or food employee applicant lives in the same household as a person who is diagnosed with a disease caused by S. typhi, Shigella spp., Shiga toxin-producing Escherichia coli or hepatitis A virus, and knows of that diagnosis.
(8) The food employee or food employee applicant 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., Shiga toxin-producing Escherichia coli or hepatitis A virus, and knows of that outbreak.
§ 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 Shiga toxin-producing Escherichia coli.
(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 Shiga toxin-producing Escherichia coli.
(3) Had a past illness from S. typhi within the last 3 months.
(4) Had a past illness from Shigella spp. or Shiga toxin-producing Escherichia coli 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 not 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) unless 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 not 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 unless at least one of the following is 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 not remove a restriction imposed as a result of a disease or medical condition imposed under authority of § 46.113(a)(2)(ii) unless 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 Shiga toxin-producing Escherichia coli--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 not remove an exclusion or restriction imposed as a result of a disease or medical condition described in § 46.113(b) unless 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 not 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) unless 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 (or surrogate prosthetic devices for hands or arms) for at least 20 seconds using a cleaning compound in a handwashing sink that is equipped as specified in § 46.822(b) (relating to design, construction and installation of plumbing systems) by using the following cleaning procedure:
(i) Create vigorous friction on the surfaces of the lathered fingers, finger tips, areas between the fingers, hands and arms (or by vigorously rubbing the surrogate prosthetic devices for hands and arms) for at least 10--15 seconds.
(ii) Thoroughly rinse under clean running, warm water.
(iii) Immediately follow the rinse with thorough drying of cleaned hands and arms (or surrogate prosthetic devices) using a method specified in § 46.941(c) (relating to handwashing facilities: numbers and capacities).
(iv) Employees shall pay particular attention to the areas underneath the fingernails and between the fingers during this cleaning procedure.
(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) Before donning gloves for working with food.
(10) After engaging in other activities that contaminate the hands.
§ 46.133. Required washing locations.
Food employees shall clean their hands in a handwashing sink or approved automatic handwashing facility. Food employees may not clean their hands in a sink used for food preparation or warewashing, or in 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 the most current FDA monograph for OTC (over-the-counter) Health-Care Antiseptic Drug Products as an antiseptic handwash.
(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).
(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).
(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 (including medical information 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 cannot 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. 46.251. Juice. 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. DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN
46.361. Cooking raw animal-derived 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. 46.366. Treating juice. 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-derived foods that are raw, undercooked or not otherwise processed to eliminate pathogens. UNSAFE, ADULTERATED OR 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 Food Act, the Public Eating and Drinking Places Law and this chapter. Records of food sources shall be maintained and made available for review upon request by the Department.
§ 46.212. Food prepared in a private home.
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 § 46.422 (relating to labeling).
§ 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-derived foods) shall be one of the following:
(1) Obtained from a food establishment that either packages the steaks and labels them to indicate that they meet the definition of whole-muscle, intact beef or provides an invoice or other documentation indicating that the steaks meet that definition.
(2) Individually cut in a food facility, and all of the following:
(i) Cut from whole-muscle intact beef that is labeled or documented by a food establishment to indicate that the beef meets the definition of ''whole-muscle intact beef'' as specified in paragraph (1).
(ii) Prepared so they remain intact.
(iii) If packaged for undercooking in a food facility, labeled or documented to indicate that they meet the definition of ''whole-muscle, intact beef'' as specified in paragraph (1).
§ 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 Food Act, including 9 CFR 317.2(i) (relating to labels: definition; 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 food processing plant.
§ 46.217. Milk and milk products.
Milk and milk products shall be obtained from sources that comply with section 2 of the Milk Sanitation Law (31 P. S. § 646).
§ 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 raw animal-derived foods) may not be offered for sale or service unless 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).
§ 46.219. Molluscan shellfish.
(a) Sources. Molluscan shellfish shall be obtained from sources that are in compliance with section 14 of the Food Act (31 P. S. § 20.14), Chapter 49 (relating to shellfish) and this subchapter, and the requirements specified in the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration, National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.
(b) Molluscan shellfish received or intended for sale in interstate commerce. Molluscan shellfish received or intended for sale in interstate commerce shall be from sources that are listed in the Interstate Certified Shellfish Shippers List.
(c) Molluscan shellfish that are recreationally caught. Molluscan shellfish that are recreationally caught may not be received for sale or service.
§ 46.220. Wild mushrooms.
(a) General source requirement. Mushroom species picked in the wild shall be obtained from sources where each mushroom is individually inspected and found to be safe by a mushroom identification expert. The exceptions to this requirement are in subsection (b).
(b) Exceptions. Subsection (a) does not apply to the following:
(1) Cultivated wild mushroom species that are grown, harvested and processed in an operation that is regulated by the Department or other food regulatory agency that has jurisdiction over the operation.
(2) Wild mushroom species if they are in packaged form and are the product of a food processing plant that is regulated by the Department or other food regulatory agency that has jurisdiction over the food processing plant.
§ 46.221. Game animals.
(a) Game animals commercially raised for food. If game animals commercially raised for food are received for sale or service they shall be at least one of the following:
(1) Raised, slaughtered and processed under a voluntary inspection program administered by the USDA for game animals such as exotic animals (reindeer, elk, deer, antelope, water buffalo or bison) that are ''inspected and approved'' in accordance with the Voluntary Exotic Animal Program in 9 CFR 352 (relating to exotic animals; voluntary inspection) or rabbits that are ''inspected and certified'' in accordance with the Rabbit Inspection Program in 9 CFR 354 (relating to voluntary inspection of rabbits and edible products thereof).
(2) Under a routine inspection program conducted by the Department or other food regulatory agency that has animal health jurisdiction, and raised, slaughtered and processed according to both of the following:
(i) Laws governing meat and poultry, as determined by the Department or other food regulatory agency that has animal health jurisdiction.
(ii) Requirements which are developed by the Department or other food regulatory agency that has animal health jurisdiction, with consideration of factors such as the need for antemortem and postmortem examination by a licensed veterinarian or veterinarian's designee.
(b) Wild game animals that are live-caught. Wild game animals that are live-caught may not be received for sale or service unless all of the following apply:
(1) The animal is under a routine inspection program conducted by the Department or other regulatory agency that has animal health jurisdiction.
(2) The animal is slaughtered and processed according to the following:
(i) Laws governing meat and poultry, as determined by the Department or other food regulatory agency that has animal health jurisdiction.
(ii) Requirements which are developed by the Department or other food regulatory agency that has animal health jurisdiction, with consideration of factors such as the need for antemortem and postmortem examination by a licensed veterinarian or veterinarian's designee.
(c) Field-dressed wild game animals. Field-dressed wild game animals may not be received for sale or service unless under a routine inspection program that ensures that the following occur:
(1) The animals receive a postmortem examination by a licensed veterinarian or veterinarian's designee.
(2) The animals are field-dressed and transported according to requirements specified by the Department or other regulatory agency that has animal health jurisdiction.
(3) The animals are processed according to laws governing meat and poultry as determined by the Department or other regulatory agency that has animal health jurisdiction.
(d) Endangered or threatened wildlife. A game animal may not be received for sale or service if it is a species of wildlife that is listed in 50 CFR 17 (relating to endangered and threatened wildlife and plants).
§ 46.222. Ice.
Ice for use as a food or a cooling medium shall be made from drinking water.
SPECIFICATIONS FOR RECEIVING, ORIGINAL CONTAINERS AND RECORDS § 46.241. Receiving temperature of food.
(a) Refrigerated potentially hazardous food. Except as specified in §§ 46.243(b) and 46.244(b) (relating to receiving shell eggs; and receiving eggs and milk products), refrigerated potentially hazardous food shall be at an internal temperature of 5°C (41°F) or below when received.
(b) Cooked potentially hazardous food. Potentially hazardous food that is cooked to a temperature and for a time specified in §§ 46.361--46.363 (relating to cooking raw animal-derived foods; microwave cooking; and plant food cooking for hot holding) and received hot shall be at an internal temperature of 58°C (135°F) or above.
(c) Frozen food. A food that is labeled frozen and shipped frozen by a food establishment shall be received frozen.
(d) Visible evidence of improper temperature. Upon receipt, potentially hazardous food shall be free of evidence of previous temperature abuse. This evidence might include dehydration, ice crystals, discoloration or damaged packaging.
§ 46.242. Additives.
Food may not contain unapproved food additives or additives that exceed amounts specified in 21 CFR Part 170 (relating to food additives) generally recognized as safe or prior-sanctioned substances that exceed amounts specified in 21 CFR Parts 181--186, substances that exceed amounts specified in 9 CFR 424.21 (relating to use of food ingredients and sources of radiation), or pesticide residues that exceed provisions specified in 40 CFR Part 180 (relating to food additives permitted in food or in contact with food on an interim basis pending addtional study).
§ 46.243. Receiving shell eggs.
(a) General. Shell eggs shall be received clean and sound and may not exceed the restricted egg tolerances for PA Consumer Grade B as specified in § 87.41 (relating to standards).
(b) Temperature. Shell eggs shall be received by a food facility in refrigerated equipment that maintains an ambient temperature of 7°C (45°F) or less, or as otherwise specified in section 3 of the Egg Refrigeration Law (31 P. S. § 300.3).
(c) Labeling. Shell eggs received by a food facility shall be labeled as specified in §§ 87.51 and 87.52 (relating to receptacles; and marketing) and include safe handling instructions as specified in 21 CFR 101.17(h) (relating to food labeling warning, notice, and safe handling statements).
(d) Repackaging. Cartons of shell eggs not in sound condition, such as those containing cracked eggs, leaking eggs or frozen eggs, shall be removed from retail sale. The food facility may not rework, repack or transfer shell eggs from their original cartons or containers. Shell eggs may be sold as an incomplete dozen or container provided that the quantity labeling on the carton or container is changed to reflect the actual number of shell eggs within.
§ 46.244. Receiving eggs and milk products.
(a) Liquid, frozen and dry eggs and egg products. Liquid, frozen and dry eggs and egg products shall be obtained pasteurized.
(b) Milk and milk products. Milk and milk products shall be obtained pasteurized and received at a temperature of 7°C (45°F) or less, or as otherwise permitted under the Milk Sanitation Law.
(c) Frozen milk products. Frozen milk products shall be obtained pasteurized or as otherwise permitted under the Milk Sanitation Law.
(d) Cheese. Cheese shall be obtained pasteurized unless alternative procedures to pasteurization are specified and published in the CFR. An example of acceptable alternative standards for curing certain cheese varieties is in 21 CFR 133 (relating to cheeses and related cheese products).
§ 46.245. Package integrity of food upon receipt.
Food packages shall be in good condition and protect the integrity of the contents so that the food is not exposed to adulteration or potential contaminants.
§ 46.246. Receiving shucked shellfish: packaging and identification.
(a) Label requirement. Raw shucked shellfish shall be obtained in nonreturnable packages which bear a legible label that identifies the following:
(1) The name, address and certification number of the shucker-packer or repacker of the molluscan shellfish.
(2) For packages with a capacity of less than 1.87 L (1/2 gallon): the ''sell by'' or ''best if used by'' date.
(3) For packages with a capacity of 1.87 L (1/2 gallon) or more: the date shucked.
(b) No label or inadequate label. A package of raw shucked shellfish that does not bear a label or which bears a label which does not contain all the information as specified in subsection (a) shall be subject to a detention, in accordance with section 6 of the Food Act (31 P. S. § 20.6).
§ 46.247. Shellstock identification.
(a) Harvester's and dealer's source identification tags or labels. Shellstock shall be obtained in containers bearing legible source identification tags or labels that are affixed by the harvester and each dealer that depurates, ships or reships the shellstock, as specified in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.
(1) Contents of harvester's tag or label. A harvester's tag or label shall list the following information, in the following order:
(i) The harvester's identification number as described in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, and that is assigned by the Department or other shellfish control authority having jurisdiction.
(ii) The date of harvesting.
(iii) The most precise identification of the harvest location or aquaculture site that is practicable based on the system of harvest area designations that is in use by the Department or other shellfish control authority having jurisdiction, and including the abbreviation of the name of the state or country in which the shellfish are harvested.
(iv) The type and quantity of shellfish.
(v) The following statement in bold, capitalized type: THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR RETAGGED AND THEREAFTER KEPT ON FILE FOR 90 DAYS.
(2) Contents of dealer's tag or label. A dealer's tag or label shall list the following information, in the following order:
(i) The dealer's name and address, and the certification number assigned by the Department or other shellfish control authority having jurisdiction.
(ii) The original shipper's certification number including the abbreviation of the name of the state or country in which the shellfish are harvested.
(iii) The same information as specified for a harvester's tag under paragraph (1)(ii)--(iv).
(iv) The following statement in bold, capitalized type: THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY AND THEREAFTER KEPT ON FILE FOR 90 DAYS.
(b) Missing or incomplete tag or label. A container of shellstock that does not bear a tag or label or that bears a tag or label that does not contain all the information as specified in subsection (a) shall be subject to a detention, in accordance with section 6 of the Food Act (31 P. S. § 20.6).
(c) Harvester's tag or label shall include dealer information. If a place is provided on the harvester's tag or label for a dealer's name, address and certification number, the dealer's information shall be listed first, notwithstanding subsection (a)(1).
(d) Exception to requirement of separate dealer's tag or label. If the harvester's tag or label is designed to accommodate each dealer's identification as specified in subsection (a)(2)(i) and (ii), individual dealer tags or labels need not be provided.
§ 46.248. Shellstock: condition upon receipt.
Shellstock shall be reasonably free of mud, dead shellfish and shellfish with broken shells when received by a food facility. Dead shellfish or shellstock with badly broken shells shall be discarded.
§ 46.249. Molluscan shellfish: original container.
(a) General requirement. Molluscan shellfish may not be removed from the container in which they are received other than immediately before sale or preparation for service. The two exceptions to this requirement are set forth in subsections (b) and (c).
(b) Exception: shellstock. Shellstock may be removed from the container in which they are received, displayed on drained ice or held in a display container, and a quantity specified by a consumer may be removed from the display or display container and provided to the consumer if both of the following occur:
(1) The source of the shellstock on display is identified as specified in § 46.247 (relating to shellstock identification) and recorded as specified in § 46.250 (relating to shellstock: maintaining identification)
(2) The shellstock are protected from contamination.
(c) Exception: shucked shellfish. Shucked shellfish may be removed from the container in which they were received and held in a display container from which individual servings are dispensed upon a consumer's request if both of the following apply:
(1) The labeling information for the shellfish on display as specified in § 46.246 (relating to receiving shucked shellfish: packaging and identification) is retained and correlated to the date when, or dates during which, the shellfish are sold or served.
(2) The shellfish are protected from contamination.
§ 46.250. Shellstock: maintaining identification.
(a) General requirement. Shellstock tags shall remain attached to the container in which the shellstock are received until the container is empty. The exception to this requirement is set forth in subsection (b)(2).
(b) Records of identification. The identity of the source of shellstock that are sold or served shall be maintained by retaining shellstock tags or labels for 90-calendar days from the date the container is emptied by the following methods:
(1) Using an approved recordkeeping system that keeps the tags or labels in chronological order correlated to the date when, or dates during which, the shellstock are sold or served.
(2) When shellstock are removed from their tagged or labeled container, preserving source identification by using a recordkeeping system as specified in paragraph (1), and ensuring that shellstock from one tagged or labeled container are not commingled with shellstock from another container before being ordered by the consumer.
§ 46.251. Juice.
Prepackaged juice shall be obtained from a processor with an HACCP system as specified in 21 CFR 120 (relating to hazard analysis and critical control point HACCP systems) and be one of the following:
(1) Obtained pasteurized or otherwise treated to attain a 5-log reduction (a 99.999% reduction) of the most resistant microorganism of public health significance as specified in 21 CFR 120.24 (relating to process controls).
(2) Bear a warning label as specified in 21 CFR 101.17(g) (relating to food labeling warning, notice, and safe handling statements).
PREVENTING CONTAMINATION BY EMPLOYEES § 46.261. Preventing contamination from food employees' hands.
(a) Hand washing required. Food employees shall wash their hands as specified in § 46.131 (relating to cleanliness of hands and exposed portions of arms).
(b) Hand contact with ready-to-eat food. Except when washing fruits and vegetables as specified in § 46.285 (relating to washing raw fruits and vegetables) or when approved in accordance with subsection (d), food employees may not contact exposed, ready-to-eat food with their bare hands, and shall use suitable utensils such as deli tissue, spatulas, tongs, single-use gloves or dispensing equipment.
(c) Hand contact with food that is not ready-to-eat food. Food employees shall minimize bare hand and arm contact with exposed food that is not in a ready-to-eat form.
(d) Approval of bare-hand contact. Food employees may contact ready-to-eat foods with their bare hands if the food facility operator submits a written plan to the Department and the Department provides the food facility operator written approval of the plan. The written plan and related documentation, and the Department's written approval shall be available at the food facility for use by the person in charge and review by the Department upon request. The written plan shall contain the following:
(1) The reason the person-in-charge of the food facility is unable to comply with subsection (b).
(2) A provision identifying the public health hazards associated with bare-hand contact specific to the food facility, demonstrating that these hazards are understood by the food facility operator.
(3) Verification that the food facility has implemented and is in compliance with all applicable supervision, employee health, personal cleanliness and hygienic practices provisions required under Subchapter B (relating to management and personnel).
(4) A provision identifying exposed ready-to-eat foods that will be contacted with bare hands and the procedures and practices which are in place to assure that food employees wash their hands before returning to their work station and that cross-contamination from touching raw foods and ready-to-eat foods is precluded.
(5) An effective training plan for food employees.
(i) The plan shall emphasize the following subjects addressed in this chapter:
(A) Not working when ill.
(B) Good hygienic practices and personal cleanliness.
(C) Proper handwashing procedures.
(D) Safe food preparation procedures.
(ii) The training plan shall acknowledge management responsibility for training, specify the program content and training frequency (including refresher training).
(6) Documentation demonstrating that paragraph (5)(i) and (ii) are implemented, and are verified by management.
(7) An action plan identifying corrective actions to be taken in situations in which the practices and procedures in the written plan are not complied with.
§ 46.262. Preventing contamination when tasting.
A food employee may not use a utensil more than once to taste food that is to be sold or served.
PREVENTING FOOD AND INGREDIENT CONTAMINATION § 46.281. Preventing contamination of packaged and unpackaged food: separation, packaging and segregation.
(a) Required protective measures. Food shall be protected from cross contamination by the following procedures, as applicable:
(1) Separating raw animal-derived foods during storage, preparation, holding and display from:
(i) Raw ready-to-eat food including other raw animal-derived food such as fish for sushi or molluscan shellfish, or other raw ready-to-eat food such as vegetables.
(ii) Cooked ready-to-eat food.
(2) Separating types of raw animal-derived foods (such as beef, fish, lamb, pork and poultry) from each other during storage, preparation, holding and display, except when these raw animal-derived foods are combined as ingredients, by doing the following:
(i) Using separate equipment for each type or arranging each type of food in equipment so that cross contamination of one type with another is prevented.
(ii) Preparing each type of food at different times or in separate areas.
(3) Cleaning equipment and utensils as specified in § 46.712(a) (relating to frequency of cleaning equipment food-contact surfaces and utensils) and sanitizing as specified in § 46.731(c) (relating to sanitization: requirement, frequency and methods).
(4) Storing the food in packages, covered containers or wrappings. The exception to this requirement is in subsection (b).
(5) Cleaning hermetically sealed containers of food of visible soil before opening.
(6) Protecting food containers that are received packaged together in a case or overwrap from cuts when the case or overwrap is opened.
(7) Storing damaged, spoiled or recalled food being held in the food facility as specified in § 46.964 (relating to distressed merchandise: segregated).
(8) Separating fruits and vegetables from ready-to-eat food before the fruits and vegetables are washed as specified in § 46.285 (relating to washing raw fruits and vegetables).
(b) Exception to the requirement of storing foods in packages, covered containers or wrappings. Subsection (a)(4) does not apply to the following:
(1) Whole, uncut, raw fruits and vegetables and nuts in the shell that require peeling or hulling before consumption.
(2) Primal cuts, quarters or sides of raw meat or slab bacon that are hung on clean, sanitized hooks or placed on clean, sanitized racks.
(3) Whole, uncut, processed meats such as country hams and smoked or cured sausages that are placed on clean, sanitized racks.
(4) Food being cooled as specified in § 46.384(d)(2) (relating to potentially hazardous food: cooling).
(5) Shellstock.
§ 46.282. Identification of content on food storage containers.
Working containers holding food or food ingredients (such as cooking oils, flour, herbs, potato flakes, salt, spices and sugar) that are removed from their original packages for use in the food facility shall be identified with the common name of the food they contain. However, containers holding food that can be readily and unmistakably recognized (such as dry pasta) need not be identified.
§ 46.283. Substituting pasteurized eggs for raw shell eggs in certain recipes.
Pasteurized eggs or egg products shall be substituted for raw shell eggs in the preparation of foods such as Caesar salad, hollandaise or béarnaise sauce, mayonnaise, eggnog, ice cream and egg-fortified beverages that are not either of the following:
(1) Cooked as specified in § 46.361(a)(1) or (2) (relating to cooking raw animal-derived foods).
(2) Included in § 46.361(d).
§ 46.284. Protection from unapproved additives.
(a) Unapproved additives or unsafe levels of approved additives. Food or food ingredients shall be protected from contamination that may result from the addition of unsafe or unapproved food or color additives, and from unsafe or unapproved levels of approved food and color additives, as described in § 46.242 (relating to additives).
(b) Sulfiting agents. A food employee may not do the following:
(1) Apply sulfiting agents to fresh fruits and vegetables intended for raw consumption or to a food considered to be a good source of vitamin B1, as that term is defined in 21 CFR 101.54(c) (relating to nutrient content claims for ''good source,'' ''high,'' ''more,'' and ''high potency'').
(2) Serve or sell a food specified in paragraph (1), other than grapes, that is treated with sulfiting agents before receipt by the food facility.
§ 46.285. Washing raw fruits and vegetables.
(a) General. Raw fruits and vegetables shall be thoroughly washed in water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served or offered for human consumption in ready-to-eat form.
(b) Exception. Whole, raw fruits and vegetables which are intended for washing by the consumer before consumption need not be washed before they are sold.
(c) Chemical washing. Fruits and vegetables may be washed by using chemicals as specified in § 46.1024(b) (relating to chemicals: use criteria).
§ 46.286. Preventing contamination from ice used as a coolant.
(a) Ice used as exterior coolant is prohibited as ingredient. Ice may not be used as food after it has been used as a medium for cooling the exterior surfaces of food such as melons or fish, packaged foods such as canned beverages or cooling coils and tubes of equipment.
(b) Storage or display of food in contact with water or ice.
(1) Packaged food. Packaged food may not be stored in direct contact with ice or water if the food is subject to the entry of water because of the nature of its packaging, wrapping or container or its positioning in the ice or water.
(2) General prohibition. Unpackaged foods other than those described in paragraphs (3) and (4) may not be stored in direct contact with undrained ice.
(3) Certain raw fruits and vegetables. Whole, raw fruits or vegetables; cut, raw vegetables such as celery or carrot sticks or cut potatoes; and tofu may be immersed in ice or water.
(4) Raw chicken and raw fish. Raw chicken and raw fish that are received immersed in ice in shipping containers may remain in that condition while in storage awaiting preparation, display, service or sale.
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