FDA 1997 Food Code - Chapter 2: Management and Personnel
U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
1997 Food Code
The permit holder 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 establishment during all hours of operation.
Based on the risks of foodborne illness inherent to the food operation, during inspections and upon request the person in charge shall demonstrate to the regulatory authority knowledge of foodborne disease prevention, application of the Hazard Analysis Critical Control Point principles, and the requirements of this Code. The person in charge shall demonstrate this knowledge by compliance with this Code, by being a certified food protection manager who has shown proficiency of required information through passing a test that is part of an accredited program, or by responding correctly to the inspector's questions as they relate to the specific food operation. The areas of knowledge include:
(A) Describing the relationship between the prevention of foodborne disease and the personal hygiene of a food employee;
(B) Explaining the responsibility of the person in charge for preventing the transmission of foodborne disease by a food employee who has a disease or medical condition that may cause foodborne disease;
(C) Describing the symptoms associated with the diseases that are transmissible through food;
(D) Explaining the significance of the relationship between maintaining the time and temperature of potentially hazardous food and the prevention of foodborne illness;
(E) Explaining the hazards involved in the consumption of raw or undercooked meat, poultry, eggs, and fish.
(F) Stating the required food temperatures and times for safe cooking of potentially hazardous food including meat, poultry, eggs, and fish.
(G) Stating the required temperatures and times for the safe refrigerated storage, hot holding, cooling, and reheating of potentially hazardous food;
(H) Describing the relationship between the prevention of foodborne illness and the management and control of the following:
(1) Cross contamination,
(2) Hand contact with ready-to-eat foods,
(3) Handwashing, and
(4) Maintaining the food establishment in a clean condition and in good repair;
(I) Explaining the relationship between food safety and providing equipment that is:
(1) Sufficient in number and capacity, and
(2) Properly designed, constructed, located, installed, operated, maintained, and cleaned;
(J) Explaining correct procedures for cleaning and sanitizing utensils and food-contact surfaces of equipment;
(K) Identifying the source of water used and measures taken to ensure that it remains protected from contamination such as providing protection from backflow and precluding the creation of cross connections;
(L) Identifying poisonous or toxic materials in the food establishment and the procedures necessary to ensure that they are safely stored, dispensed, used, and disposed of according to law;
(M) Identifying critical control points in the operation from purchasing through sale or service that when not controlled may contribute to the transmission of foodborne illness and explaining steps taken to ensure that the points are controlled in accordance with the requirements of this Code;
(N) Explaining the details of how the person in charge and food employees comply with the haccp plan if a plan is required by the law, this Code, or an agreement between the regulatory authority and the establishment; and
(O) Explaining the responsibilities, rights, and authorities assigned by this Code to the:
(1) Food employee,
(2) Person in charge, and
(3) Regulatory authority.
2-103.11 Person in Charge.
The person in charge shall ensure that:
(A) Food establishment operations are not conducted in a private home or in a room used as living or sleeping quarters as specified under § 6-202.111;
(B) Persons unnecessary to the food establishment 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, and linens; and unwrapped single-service and single-use articles are protected from contamination;
(C) 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 Code;
(D) Employees are effectively cleaning their hands, by routinely monitoring the employees' handwashing;
(E) Employees are visibly observing 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, by routinely monitoring the employees' observations and periodically evaluating foods upon their receipt;
(F) Employees are properly cooking potentially hazardous food, being particularly careful in cooking those foods known to cause severe foodborne illness and death, such as eggs and comminuted meats, through daily oversight of the employees' routine monitoring of the cooking temperatures;
(G) Employees are using proper methods to rapidly cool potentially hazardous foods that are not held hot or are not for consumption within 4 hours, through daily oversight of the employees' routine monitoring of food temperatures during cooling;
(H) Consumers who order raw or partially cooked ready-to-eat foods of animal origin are informed as specified under § 3-603.11 that the food is not cooked sufficiently to ensure its safety;
(I) Employees are properly sanitizing cleaned multiuse equipment and utensils before they are reused, through routine monitoring of solution temperature and exposure time for hot water sanitizing, and chemical concentration, pH, temperature, and exposure time for chemical sanitizing; and
(J) Consumers are notified that clean tableware is to be used when they return to self-service areas such as salad bars and buffets as specified under § 3-304.16.
Disease or Medical Condition
2-201.11 Responsibility of the Person in Charge to Require Reporting by Food Employees and Applicants.*
|employer requires employee reporting of:||The permit holder shall require food employee applicants to whom a conditional offer of employment is made and food employees to report to the person in charge, information about their health and activities as they relate to diseases that are transmissible through food. A food employee or applicant shall report the information in a manner that allows the person in charge to prevent the likelihood of foodborne disease transmission, including the date of onset of jaundice or of an illness specified under ¶ (C) of this section, if the food employee or applicant:|
|employee is ill|
(A) Is diagnosed with an illness due to:
(1) Salmonella typhi,
(2) Shigella spp.,
(3) Escherichia coli O157:H7, or
(4) Hepatitis A virus;
|employee has symptom of:||(B) Has a symptom caused by illness, infection, or other source that is:|
(1) Associated with an acute gastrointestinal illness such as:
(d) Jaundice, or
(e) Sore throat with fever, or
|Boil or infected wound|
(2) A lesion containing pus such as a boil or infected wound that is open or draining and is:
(a) 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,
(b) On exposed portions of the arms, unless the lesion is protected by an impermeable cover, or
(c) On other parts of the body, unless the lesion is covered by a dry, durable, tight-fitting bandage;
|employee previously ill||(C) Had a past illness from an infectious agent specified under ¶ (A) of this section; or|
employee at high risk of becoming ill:
|(D) Meets one or more of the following high-risk conditions:|
|prepared or consumed food that caused disease|
(1) Is suspected of causing, or 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:
(a) Prepared food implicated in the outbreak,
(b) Consumed food implicated in the outbreak, or
(c) 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,
|lives with ill person||(2) 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,|
|lives with person involved in disease outbreak||(3) 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, or|
|traveled outside United States or to U.S. territory||(4) Traveled out of the United States or to a United States' territory within the last 50 calendar days to an area that is identified as having epidemic or endemic disease caused by S. typhi, Shigella spp., E. coli O157:H7, or hepatitis A virus based on information published by the Centers for Disease Control and Prevention, such as the document titled Health Information for International Travel.|
2-201.12 Exclusions and Restrictions.*
|The person in charge shall:|
|excluding ill employees||(A) Exclude a food employee from a food establishment if the food employee is diagnosed with an infectious agent specified under ¶ 2-201.11(A);|
|restricting employees: (serving general population)||(B) Except as specified under ¶ (C) or (D) of this section, restrict a food employee from working with exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles, in a food establishment if the food employee is:|
|with symptom of illness or|| (1) Suffering from a symptom specified under ¶ 2-201.11(B),|
|of past illness||(2) Not experiencing a symptom of acute gastroenteritis specified under Subparagraph 2-201.11(B)(1) but has a stool that yields a specimen culture that is positive for Salmonella typhi, Shigella spp., or Escherichia coli O157:H7;|
|excluding employees: (serving high-risk population)||(C) If the population served is a highly susceptible population, exclude a food employee who:|
|with symptom of illness or||(1) Is experiencing a symptom of acute gastrointestinal illness specified under Subparagraph 2-201.11(B)(1) and meets a high-risk condition specified under Subparagraphs 2-201.11(D)(1)-(4),|
|of past illness|
(2) Is not experiencing a symptom of acute gastroenteritis specified under Subparagraph 2-201.11(B)(1) 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, or
(4) Had a past illness from Shigella spp. or E. coli O157:H7 within the last month; and
|excluding and restricting jaundiced employees|
(D) For a food employee who is jaundiced:
(1) If the onset of jaundice occurred within the last 7 calendar days, exclude the food employee from the food establishment, or
(2) If the onset of jaundice occurred more than 7 calendar days before:
(a) Exclude the food employee from a food establishment that serves a highly susceptible population, or
(b) Restrict the food employee from activities specified under ¶ 2-201.12(B), if the food establishment does not serve a highly susceptible population.
2-201.13 Removal of Exclusions and Restrictions.
|reinstating an excluded employee who is:|
(A) The person in charge may remove an exclusion specified under ¶ 2-201.12(A) if:
(1) The person in charge obtains approval from the regulatory authority; and
|no longer ill|
free of jaundice
|(2) The person excluded as specified under ¶ 2-201.12(A) provides to the person in charge written medical documentation from a physician licensed to practice medicine that specifies that the excluded person may work in an unrestricted capacity in a food establishment, including an establishment that serves a highly susceptible population, because the person is free of the infectious agent of concern as specified in § 8-501.40.|
|reinstating a restricted employee who is|
(B) The person in charge may remove a restriction specified under:
(1) Subparagraph 2-201.12(B)(1) if the restricted person:
|free of symptoms|
(a) Is free of the symptoms specified under ¶ 2-201.11(B) and no foodborne illness occurs that may have been caused by the restricted person,
(b) Is suspected of causing foodborne illness but:
(i) Is free of the symptoms specified under ¶ 2-201.11(B), and
|free of suspected infectious agent||(ii) Provides written medical documentation from a physician licensed to practice medicine stating that the restricted person is free of the infectious agent that is suspected of causing the person's symptoms or causing foodborne illness, as specified in § 8-501.40, or|
|has symptoms that are not caused by an infectious agent||(c) Provides written medical documentation from a physician licensed to practice medicine stating that the symptoms experienced result from a chronic noninfectious condition such as Crohn's disease, irritable bowel syndrome, or ulcerative colitis; or|
|no longer a shedder||(2) Subparagraph 2-201.12(B)(2) if the restricted person provides written medical documentation from a physician, licensed to practice medicine, according to the criteria specified in § 8-501.40 that indicates the stools are free of Salmonella typhi, Shigella spp., or E. coli O157:H7, whichever is the infectious agent of concern.|
|reinstating an excluded employee serving: high-risk population|
(C) The person in charge may remove an exclusion specified under ¶ 2-201.12(C) if the excluded person provides written medical documentation from a physician licensed to practice medicine:
(1) That specifies that the person is free of:
(a) The infectious agent of concern as specified in § 8-501.40, or
(b) Jaundice as specified under ¶ 2-201.13(D) if hepatitis A virus is the infectious agent of concern; or
(2) If the person is excluded under Subparagraph 2-201.12(C)(1), stating that the symptoms experienced result from a chronic noninfectious condition such as Crohn's disease, irritable bowel syndrome, or ulcerative colitis.
|reinstating an employee who is:||(D) The person in charge may remove an exclusion specified under Subparagraph 2-201.12(D)(1) and Subparagraph 2-201.12(D)(2)(a) and a restriction specified under Subparagraph 2-201.12(D)(2)(b) if:|
|not suspect source of illness||(1) No foodborne illness occurs that may have been caused by the excluded or restricted person and the person provides written medical documentation from a physician licensed to practice medicine that specifies that the person is free of hepatitis A virus as specified in Subparagraph 8-501.40(D)(1); or|
|suspect source of illness||(2) The excluded or restricted person is suspected of causing foodborne illness and complies with the requirements in Subparagraphs 8-501.40(D)(1) and (D)(2).|
2-201.14 Responsibility of a Food Employee or an Applicant to Report to the Person in Charge.*
A food employee or a person who applies for a job as a food employee shall:
(A) In a manner specified under § 2-201.11, report to the person in charge the information specified under ¶¶ 2-201.11(A)-(D); and
(B) Comply with exclusions and restrictions that are specified under ¶¶ 2-201.12(A)-(D).
2-201.15 Reporting by the Person in Charge.*
The person in charge shall notify the regulatory authority of a food employee or a person who applies for a job as a food employee who is diagnosed with, or is suspected of having an illness due to, Salmonella typhi, Shigella spp., Escherichia coli O157:H7, or hepatitis A virus.
Hands and Arms
2-301.11 Clean Condition.*
Food employees shall keep their hands and exposed portions of their arms clean.
2-301.12 Cleaning Procedure.*
Food employees shall clean their hands and exposed portions of their arms with a cleaning compound in a lavatory that is equipped as specified under ¶ 5-202.12(A) 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.
2-301.13 Special Handwash Procedures.*
2-301.14 When to Wash.*
Food employees shall clean their hands and exposed portions of their arms as specified under § 2-301.12 immediately before engaging in food preparation including working with exposed food, clean equipment and utensils, and unwrapped single-service and single-use articles and:
(A) After touching bare human body parts other than clean hands and clean, exposed portions of arms;
(B) After using the toilet room;
(C) After caring for or handling support animals or aquatic animals as specified in ¶ 2-403.11(B);
(D) After coughing, sneezing, using a handkerchief or disposable tissue, using tobacco, eating, or drinking;
(E) After handling soiled equipment or utensils;
(F) During food preparation, as often as necessary to remove soil and contamination and to prevent cross contamination when changing tasks;
(G) When switching between working with raw food and working with ready-to-eat food; and
(H) After engaging in other activities that contaminate the hands.
2-301.15 Where to Wash.
Food employees shall clean their hands in a handwashing lavatory and may not clean their hands in a sink used for food preparation, or in a service sink or a curbed cleaning facility used for the disposal of mop water and similar liquid waste.
2-301.16 Hand Sanitizers.
(A) A hand sanitizer and a chemical hand sanitizing solution used as a hand dip shall:
(1) Have active antimicrobial ingredients that are:
(a) Listed as safe and effective for application to human skin as an Antiseptic Handwash in a monograph for OTC (over-the-counter) Health-Care Antiseptic Drug Products, or
(b) Previously authorized, and listed for such use in the USDA List of Proprietary Substances and Nonfood Compounds, Miscellaneous Publication No. 1419;
(2) Have components that are:
(a) Regulated for the intended use as food additives as specified in 21 CFR 178 - Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers, or
(b) Generally recognized as safe (GRAS) for the intended use in contact with food within the meaning of the Federal Food, Drug, and Cosmetic Act § 201(s), or
(c) Exempted from the requirement of being listed in the federal food additive regulations as specified in 21 CFR 170.39 Threshold of regulation for substances used in food-contact articles; and
(3) Be applied only to hands that are cleaned as specified under § 2-301.12.
(B) If a hand sanitizer or a chemical hand sanitizing solution used as a hand dip does not meet the criteria specified under Subparagraph (A)(2) of this section, use shall be:
(1) Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves; or
(2) Limited to situations that involve no direct contact with food by the bare hands.
(C) 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 chlorine.
Food employees shall keep their fingernails trimmed, filed, and maintained so the edges and surfaces are cleanable and not rough.
While preparing food, food employees may not wear jewelry on their arms and hands. This section does not apply to a plain ring such as a wedding band.
2-304.11 Clean Condition.
Food employees shall wear clean outer clothing to prevent contamination of food, equipment, utensils, linens, and single-service and single-use articles.
Food Contamination Prevention
2-401.11 Eating, Drinking, or Using Tobacco.*
(A) Except as specified in ¶ (B) of this section, an employee shall eat, drink, or use any form of tobacco only 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.
(B) A food employee may drink from a closed beverage container if the container is handled to prevent contamination of:
(1) The employee's hands;
(2) The container; and
(3) Exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles.
2-401.12 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.
(A) Except as provided in ¶ (B) of this section, food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles.
(B) This section does not apply to food employees such as counter staff who only serve beverages and wrapped or packaged foods, hostesses, and wait staff if they present a minimal risk of contaminating exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles.
2-403.11 Handling Prohibition.*
(A) Except as specified in ¶ (B) of this section, food employees may not care for or handle animals that may be present such as patrol dogs, support animals, or pets that are allowed as specified in Subparagraphs 6-501.115(B)(2)-(4).
(B) Food employees with support animals may handle or care for their support 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 under §§ 2-301.12 and ¶ 2-301.14(C).