2001 Food Code - Hand Hygiene Version

Intent
1-102.10 Food Safety, Illness Prevention, and Honest Presentation.

The purpose of this Code is to safeguard public health and provide to consumers food that is safe, unadulterated, and honestly presented.

Scope
1-103.10 Statement.

This Code establishes definitions; sets standards for management and personnel, food operations, and equipment and facilities; and provides for food establishment plan review, permit issuance, inspection, employee restriction, and permit suspension.

Responsibility
2-101.11 Assignment.*

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.

Knowledge
2-102.11 Demonstration.*

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:

(A) Complying with this Code;

(B) 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

(C) Responding correctly to the inspector’s questions as they relate to the specific food operation. The areas of knowledge include:

(1) Describing the relationship between the prevention of foodborne disease and the personal hygiene of a food employee;

(2) 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;

(3) Describing the symptoms associated with the diseases that are transmissible through food;

(8) Describing the relationship between the prevention of foodborne illness and the management and control of the following:

(a) Cross contamination,
(b) Hand contact with ready-to-eat foods,
(c) Handwashing, and
(d) Maintaining the food establishment in a clean condition and in good repair;
(9) Explaining the relationship between food safety and providing equipment that is:

(a) Sufficient in number and capacity, and
(b) Properly designed, constructed, located, installed, operated, maintained, and cleaned;
(10) Explaining correct procedures for cleaning and sanitizing utensils and food-contact surfaces of equipment;

(13) 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;

(14) 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

(15) Explaining the responsibilities, rights, and authorities assigned by this Code to the:

(a) food employee,
(b) person in charge, and
(c) Regulatory authority.
Duties
2-103.11 Person in Charge.

The person in charge shall ensure that:

(D) Employees are effectively cleaning their hands, by routinely monitoring the Employees’ handwashing;

(K) Except when otherwise approved as specified in 3-301.11(B), Employees are preventing cross-contamination of ready-to-eat food with bare hands by properly using suitable utensils such as deli tissue, spatulas, tongs, single-use gloves, or dispensing equipment; and

(L) Employees are properly trained in food safety as it relates to their assigned duties.

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:

Health Status

Employee is ill (A) Is diagnosed with an illness due to:

(1) Salmonella Typhi ,

(2) Shigella spp.,

(3) Shiga toxin-producing Escherichia coli , or

(4) Hepatitis A virus;

Employee has symptom of: (B) Has a symptom caused by illness, infection, or other source that is:

*intestinal illness

(1) Associated with an acute gastrointestinal illness such as:

(a) Diarrhea,

(b) Fever,

(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

Employee previously ill (C) Had a past illness from:

(1) S . Typhi within the past three months,

(2) Shigella spp. within the past month,

(3) Shiga toxin-producing Escherichia coli , within the past month; or

(4) Hepatitis A virus;

Activities (D) Meets one or more of the following high-risk conditions:

Employee at high risk of becoming ill:

*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., Shiga toxin-producingEscherichia 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:

(a) 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, and has knowledge about, a person who is diagnosed with a disease caused by S . Typhi, Shigella spp., Shiga toxin-producing Escherichia coli , or hepatitis A virus, or

*lives with person involved in disease outbreak

(3) Lives in the same household as, and has knowledge about, 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.

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 of past illness

(1)Suffering from a symptom specified under 2-201.11(B)(1)(a), (b), (c), and (e), or

(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 SalmonellaTyphi, Shigella spp., or Shiga toxin-producing Escherichia coli ;

excluding employees:

(serving high-risk population)

*with symptom of illness or of past illness (C) If the population served is a highly susceptible population, Exclude a food employee who:

(1) Is experiencing a symptom of acute gastrointestinal illness specified under Subparagraph 2-201.11(B)(1)(a), (b), (c), or (e) and meets a high-risk condition specified under Subparagraphs 2-201.11(D)(1)-(3),

(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 Shiga toxin-producing Escherichia coli,

(3) Had a past illness from S . Typhi within the last 3 months, or

(4) Had a past illness from Shigella spp. or Shiga toxin-producing Escherichia coli 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:

*no longer ill

*free of jaundice (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

(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 or, if allowed by law, a nurse practitioner or physician assistant, that specifies that the excluded person may work as a food employee 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

*free of symptoms (B) The person in charge may remove a restriction specified under:

(1) Subparagraph 2-201.12(B)(1) if the restricted person:

(a) Is free of the symptoms specified under 2-201.11(B)(1)(a), (b), (c), or (e) or (2) 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)(1)(a), (b), (c), or (e) or (2), and

*ree of suspected infectious agent

(ii) Provides written medical documentation from a physician licensed to practice medicine or, if allowed by law, a nurse practitioner or 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, 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 or, if allowed by law, a nurse practitioner or physician assistant, 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, or, if allowed by law, a nurse practitioner or physician assistant, according to the criteria specified in 8-501.40 that indicates the stools are free of Salmonella Typhi, Shigella spp., or Shiga toxin-producingEscherichia coli , 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 or, if allowed by law, a nurse practitioner or physician assistant:

(1) That specifies that the person is free of the infectious agent of concern as specified in 8-501.40, 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:

*not suspect source of illness
(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:

(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 or, if allowed by law, a nurse practitioner or physician assistant, 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 that a food employee is diagnosed with an illness due to Salmonella Typhi, Shigella spp., Shiga toxin-producing Escherichia coli , 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.*

(A) Except as specified in (B) of this section, 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 lavatory that is equipped as specified under 5-202.12.

(B) Food employees shall use the following cleaning procedure:

(1) 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 or arms) for at least 10 to 15 seconds, followed by;

(2) Thorough rinsing under clean, running warm water; and

(3) Immediately follow the cleaning procedure with thorough drying of cleaned hands and arms (or surrogate prosthetic devices) using a method as specified under 6-301.12.

(D) If approved and capable of removing the types of soils encountered in the food operations involved, an automatic handwashing facility may be used by food employees to clean their hands.

2-301.13 Special Handwash Procedures.*

Reserved.
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;

(D) Except as specified in 2-401.11(B), 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;

(H) Before donning gloves for working with food; and

(I) 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 or approved automatic handwashing facility and may not clean their hands in a sink used for food preparation or warewashing, 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) Comply with one of the following:

(a) Be an approved drug that is listed in the FDA publicationApproved Drug Products with Therapeutic Equivalence Evaluations as an approved drug based on safety and effectiveness; or

(b) Have active antimicrobial ingredients that are listed in the FDA monograph for OTC Health-Care Antiseptic Drug Products as an antiseptic handwash, or

(2) Comply with one of the following:

(a) Have components that are exempted from the requirement of being listed in federal food additive regulations as specified in 21 CFR 170.39 – Threshold of regulation for substances used in food-contact articles; or

(b) Comply with and be listed in:

(i) 21 CFR 178 – Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers as regulated for use as a food additive with conditions of safe use, or

(ii) 21 CFR 182 – Substances Generally Recognized as Safe, 21 CFR 184 – Direct Food Substances Affirmed as Generally Recognized as Safe, or 21 CFR 186 – Indirect Food Substances Affirmed as Generally Recognized as Safe for use in contact with food; 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.

Fingernails
2-302.11 Maintenance.

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

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

Jewelry
2-303.11 Prohibition.

While preparing food, food employees may not wear jewelry including medical information jewelry on their arms and hands. This section does not apply to a plain ring such as a wedding band.

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.

Condition
3-101.11 Safe, Unadulterated, and Honestly Presented.*

Food shall be safe, unadulterated, and, as specified under 3-601.12, honestly presented.

Clarification of 3-301.11(B) of the Food Code

with respect to the phrase ” Except…when otherwise Approved”..

The following information is not part of Chapter 3 and is not intended to be included in the codified portion of the Food Code. In cases where the Food Code is adopted through incorporation by reference, this page may be removed.

In response to a 1996 Conference for Food Protection (CFP) Recommendation that 3-301.11(B) be modified to include the phrase “or when otherwise approved,” the 1997 Code was amended accordingly. A 1998 CFP Recommendation further suggested clarification of that added language.

This insert page is provided to alert the reader that FDA has issued, with this Code, clarification of that phrase and its application. Included in Annex 3 is a full discussion of both the Public Health Reasons associated with 3-301.11 and Administrative Guidelines regarding the criteria under which bare hand contact with ready-to-eat food may be deemed acceptable in meeting the intent of 3-301.11.

A ®). Hazard Analysis Critical Control Point. A food quality assurance system that identifies, evaluates and controls potentially hazardous foods and handling practices in the food industry. A HACCP plan is a written document based on HACCP principles to insure the safe delivery of food.”>HACCP-based approach is applied in the clarification in order to establish a system to control the principal hazard (i.e., fecal-oral transmission of foodborne pathogens) that is the target of the Code provision.

A second 1998 CFP Recommendation was made to consult the National Advisory Committee for the Microbiological Criteria for Foods (NACMCF) for its scientific recommendations surrounding the transmission of pathogens from food workers to consumers via ready-to-eat foods.

In November, 1999, the National Advisory Committee for Microbiological Critera for Foods reported that bare hand contact with ready-to-eat foods can contrigute to the transmission of foodborne illness and they agreed that the transmission of could be interrupted. The NACMCF found that science does not support an absolute ban at this time on bare hand contact of ready-to-eat food, and it is the Agency’s position that NACMCF’s recommendation is in harmony with the Food Code.

The Food Code does not provide a blanket prohibition to “Bare Hand Contact with Ready-to-Eat Foods.”
The guidance for “when otherwise approved” is provided in the Annex for situations where bare hand contact with ready-to-eat foods is deemed necessary by the retail food establishment ( Annex 3, 2001 Food Code, p. 289-292 ).

Preventing Contamination by Employees
3-301.11 Preventing Contamination from Hands.*

(A) Food employees shall wash their hands as specified under 2-301.12.

(B) Except when washing fruits and vegetables as specified under 3-302.15 or when otherwise approved, 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.

3-304.15 Gloves, Use Limitation.

If used, single-use gloves shall be used for only one task such as working with ready-to-eat food or with raw animal food, used for no other purpose, and discarded when damaged or soiled, or when interruptions occur in the operation.

Specialized Processing Methods
3-502.11 Variance Requirement.*

A food establishment shall obtain a variance from the regulatory authority as specified in 8-103.10 and under 8-103.11 before:

(G) Preparing food by another method that is determined by the regulatory authority to require a variance.

Disposition3-701.11 Discarding or Reconditioning Unsafe, Adulterated, or Contaminated Food.*

(D) Food that is contaminated by food employees, consumers, or other persons through contact with their hands, bodily discharges, such as nasal or oral discharges, or other means shall be discarded.

3-8 SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS
3-801.11 Pasteurized Foods, Prohibited Reservice, and Prohibited Food.*

In a food establishment that serves a highly susceptible population:

The following criteria apply to juice:

For the purposes of this paragraph only, children who are age 9 or less and receive food in a school, day care setting or similar facility that provides custodial care are included as highly susceptible populations;

Water Quantity and Availability
5-103.11 Capacity.*

(A) The water source and system shall be of sufficient capacity to meet the peak water demands of the food establishment.

(B) Hot water generation and distribution systems shall be sufficient to meet the peak hot water demands throughout the food establishment.

Design, Construction, and Installation
5-202.11 Approved System and Cleanable Fixtures.*

(A) A plumbing system shall be designed, constructed, and installed according to law.

(B) A plumbing fixture such as a handwashing facility, toilet, or urinal shall be easily cleanable. N

5-202.12 Handwashing Facility, Installation.

(A) A handwashing lavatory shall be equipped to provide water at a temperature of at least 38°C (100°F) through a mixing valve or combination faucet.

(B) A steam mixing valve may not be used at a handwashing lavatory.

(C) A self-closing, slow-closing, or metering faucet shall provide a flow of water for at least 15 seconds without the need to reactivate the faucet.

(D) An automatic handwashing facility shall be installed in accordance with manufacturer’s instructions.

Numbers and Capacities
5-203.11 Handwashing Facilities.*

(A) Except as specified in (B) and (C) of this section, at least 1 handwashing lavatory, a number of handwashing lavatories necessary for their convenient use by Employees in areas specified under 5-204.11, and not fewer than the number of handwashing lavatories required by law shall be provided.

(B) If approved and capable of removing the types of soils encountered in thefood operations involved, automatic handwashing facilities may be substituted for handwashing lavatories in a food establishment that has at least one handwashing lavatory.

(C) If approved , when food exposure is limited and handwashing lavatories are not conveniently available, such as in some mobile or temporary food establishments or at some vending machine locations , Employees may use chemically treated towelettes for handwashing.

Location and Placement
5-204.11 Handwashing Facilities.*

A handwashing facility shall be located:

(A) To allow convenient use by Employees in food preparation, food dispensing, and warewashing areas; and

(B) In, or immediately adjacent to, toilet rooms.

Operation and Maintenance
5-205.11 Using a Handwashing Facility.

(A) A handwashing facility shall be maintained so that it is accessible at all times for employee use.

(B) A handwashing facility may not be used for purposes other than handwashing.

5-501.13 Receptacles.

(A) Except as specified in (B) of this section, receptacles and waste handling units for refuse, recyclables, and returnables and for use with materials containing food residue shall be durable, cleanable, insect- and rodent-resistant, leakproof, and nonabsorbent.

(B) Plastic bags and wet strength paper bags may be used to line receptacles for storage inside the food establishment , or within closed outside receptacles.

Handwashing Facilities
6-301.10 Minimum Number.

Handwashing facilities shall be provided as specified under 5-203.11.

6-301.11 Handwashing Cleanser, Availability.

Each handwashing lavatory or group of 2 adjacent lavatories shall be provided with a supply of hand cleaning liquid, powder, or bar soap.

6-301.12 Hand Drying Provision.

Each handwashing lavatory or group of adjacent lavatories shall be provided with:

(A) Individual, disposable towels;

(B) A continuous towel system that supplies the user with a clean towel; or

6-301.13 Handwashing Aids and Devices, Use restrictions.

A sink used for food preparation or utensil washing, or a service sink or curbed cleaning facility used for the disposal of mop water or similar wastes, may not be provided with the handwashing aids and devices required for a handwashing lavatory as specified under 6-301.11 and 6-301.12 and 5-501.16(C).

6-301.14 Handwashing Signage.

A sign or poster that notifies food employees to wash their hands shall be provided at all handwashing lavatories used by food employees and shall be clearly visible to food employees.

6-301.20 Disposable Towels, Waste Receptacle.

A handwashing lavatory or group of adjacent lavatories that is provided with disposable towels shall be provided with a waste receptacle as specified under 5-501.16(C).

Lighting
6-303.11 Intensity.

The light intensity shall be:

(B) At least 220 lux (20 foot candles):

At a distance of 75 cm (30 inches) above the floor in areas used for handwashing, warewashing, and equipment and utensil storage, and in toilet rooms;

Handwashing Facilities
6-401.10 Conveniently Located.

Handwashing facilities shall be conveniently located as specified under 5-204.11.

6-501.15 Cleaning Maintenance Tools, Preventing Contamination.*

Food preparation sinks, handwashing lavatories, and warewashing equipment may not be used for the cleaning of maintenance tools, the preparation or holding of maintenance materials, or the disposal of mop water and similar liquid wastes.

6-501.18 Maintaining and Using Handwashing Facilities.

Handwashing facilities shall be kept clean, and maintained and used as specified under 5-205.11.

Variances
8-103.10 Modifications and Waivers.

The regulatory authority may grant a variance by modifying or waiving the requirements of this Code if in the opinion of the regulatory authority a health hazard or nuisance will not result from the variance. If a variance is granted, the regulatory authority shall retain the information specified under Â§ 8-103.11 in its records for the food establishment.

8-103.11 Documentation of Proposed Variance and Justification.

Before a variance from a requirement of this Code is approved, the information that shall be provided by the person requesting the variance and retained in the regulatory authority’s file on the food establishment includes:

(A) A statement of the proposed variance of the Code requirement citing relevant Code section numbers;

(B) An analysis of the rationale for how the potential public health hazards and nuisances addressed by the relevant Code sections will be alternatively addressed by the proposal; and

(C) A HACCP plan if required as specified under 8-201.13(A) that includes the information specified under 8-201.14 as it is relevant to the variance requested.

Facility and Operating Plans8-201.11 When Plans Are Required.

A permit applicant or permit holder shall submit to the regulatory authority properly prepared plans and specifications for review and approval before:

(A) The construction of a food establishment;

(B) The conversion of an existing structure for use as a food establishment; or

(C) The remodeling of a food establishment or a change of type of food establishment or food operation as specified under 8-302.14(C) if the regulatory authority determines that plans and specifications are necessary to ensure compliance with this Code.

8-201.12 Contents of the Plans and Specifications.

The plans and specifications for a food establishment, including a food establishment specified under Â§ 8-201.13, shall include, as required by the Regulatory authority based on the type of operation, type of food preparation, and foods prepared, the following information to demonstrate conformance with Code provisions:

(A) Intended menu;

(B) Anticipated volume of food to be stored, prepared, and sold or served;

(D) Proposed equipment types, manufacturers, model numbers, locations, dimensions, performance capacities, and installation specifications;

(E) Evidence that standard procedures that ensure compliance with the requirements of this Code are developed or are being developed; and

(F) Other information that may be required by the regulatory authority for the proper review of the proposed construction, conversion or modification, and procedures for operating a food establishment.

8-201.14 Contents of a HACCP Plan.

For a food establishment that is required under Â§ 8-201.13 to have a HACCP plan, the plan and specifications shall indicate:

(A) A categorization of the types of potentially hazardous foods that are specified in the menu such as soups and sauces, salads, and bulk, solid foods such as meat roasts, or of other foods that are specified by the regulatory authority;

(B) A flow diagram by specific food or category type identifying critical control points and providing information on the following:

(1) Ingredients, materials, and equipment used in the preparation of that food, and

(2) Formulations or recipes that delineate methods and procedural control measures that address the food safety concerns involved;

(D) A statement of standard operating procedures for the plan under consideration including clearly identifying:

(1) Each critical control point,

(2) The critical limits for each critical control point,

(3) The method and frequency for monitoring and controlling each critical control point by the food employee designated by the person in charge,

(4) The method and frequency for the person in charge to routinely verify that the food employee is following standard operating procedures and monitoring critical control points,

(5) Action to be taken by the person in charge if the critical limits for each critical control point are not met, and

(6) Records to be maintained by the person in charge to demonstrate that the HACCP plan is properly operated and managed; and

(E) Additional scientific data or other information, as required by the regulatory authority, supporting the determination that food safety is not compromised by the proposal.

Construction Inspection and Approval
8-203.10 Preoperational Inspections.

The regulatory authority shall conduct one or more preoperational inspections to verify that the food establishment is constructed and equipped in accordance with the approved plans and approved modifications of those plans, has established standard operating procedures as specified under 8-201.12(E), and is in compliance with law and this Code.

8-401.20 Performance- and Risk-Based.

Within the parameters specified in Â§ 8-401.10, the regulatory authority shall prioritize, and conduct more frequent inspections based upon its assessment of a food establishment’s history of compliance with this Code and the establishment’s potential as a vector of foodborne illness by evaluating:

(A) Past performance, for nonconformance with Code or HACCP plan requirements that are critical;

(B) Past performance, for numerous or repeat violations of Code or HACCP plan requirements that are noncritical;

(D) The hazards associated with the particular foods that are prepared, stored, or served;

(E) The type of operation including the methods and extent of food storage, preparation, and service;

(F) The number of people served; and

(G) Whether the population served is a highly susceptible population.

Report of Findings
8-403.10 Documenting Information and Observations.

The regulatory authority shall document on an inspection report form:

(A) Administrative information about the food establishment’s legal identity, street and mailing addresses, type of establishment and operation as specified under Â¶ 8-302.14(C), inspection date, and other information such as type of water supply and sewage disposal, status of the permit, and personnel certificates that may be required; and

(B) Specific factual observations of violative conditions or other deviations from this Code that require correction by the permit holder including:

(1) Failure of the person in charge to demonstrate the knowledge of foodborne illness prevention, application of HACCP principles, and the requirements of this Code specified under Â§ 2-102.11,

(2) Failure of food employees and the person in charge to demonstrate their knowledge of their responsibility to report a disease or medical condition as specified under Â§Â§Â 2-201.14 and 2-201.15,

(3) Nonconformance with critical items of this Code,

(4) Failure of the appropriate food employees to demonstrate their knowledge of, and ability to perform in accordance with, the procedural, monitoring, verification, and corrective action practices required by the regulatory authority as specified under Â§ 8-103.12,

(5) Failure of the person in charge to provide records required by the regulatory authority for determining conformance with a HACCP plan as specified under Subparagraph 8-201.14(D)(6), and

(6) Nonconformance with critical limits of a HACCP plan.

2-301.12 Cleaning Procedure. (Handwashing)*

Ansari, S. A., Springthorpe, V. S., Sattar, S. A., Tostowaryk, W., and Wells, G. A.,1991. Comparison of cloth, paper, and warm air drying in eliminating viruses and bacteria from washed hands. Am. J. Infect. Cont., Vol.19. No. 5. pp. 243-249.
Ansari, S. A, Sattar, S. A., S., V. S., Wells, G. A. and Tostowaryk, W., 1989. In Vivo Protocol for Testing Efficacy of Hand-Washing Agents against Viruses and Bacteria: Experiments with Rotavirus and Escherichia coli . Appl. Environ. Microbiol., Vol. 55, No. 12. pp. 3113-3118.
Ansari, S. A., Sattar, S. A., Springthorpe, V. S., Wells, G. A., and Tostowaryk, W., 1988. Rotavirus Survival on Human Hands and Transfer of Infectious Virus to Animate and Nonpourous Inanimate Surfaces, J. Clin. Microbiol., Vol. 26, No. 8. pp.1513-1518.
Ayliffe, G.A.J., Babb, J.R., Davies, J.G., and Lilly, H.A., 1988. Hand disinfection: a comparison of various agents in laboratory and ward studies. J. Hosp. Infect., Vol. 11,

pp. 226-243.

Ayliffe, G.A.J., Babb, J.R., and Quoraishi, A.H., 1978. A test for ‘hygienic’ hand disinfection. J. Clin. Path., Vol. 31, pp. 923-928.
Bellamy, K., Alcock, R., Babb, J.R., Davies, J.G., and Ayliffe, G.A.J. 1993. A test for the assessment of Ã¢â‚¬Ëœhygienic’ hand disinfection using rotavirus. J. Hosp. Infect., Vol. 24,

pp. 201-210.

Casewell, M., Phillips, I., 1977. Hands as route of transmission for Klebsiella species. Brit. Med. J. Vol. 2, No.19. pp.1315-1317.
Cliver, D. O., and Kostenbader, K. D., 1984. Disinfection of virus on hands for prevention of food-borne disease. Intern. J. Food Microbiol., Vol. 1, pp. 75-87.
De Witt, J.C. 1985. The importance of hand hygiene in contamination of foods. Netherlands Society for Microbiology, section for food microbiology meeting at Ede on 24 May, 1984. Antonie von Leeuwenhoek, Vol. 51, pp. 523-527.
Eckert, D.G., Ehrenkranz, N.J., Alfonso, B.C. 1989. Indications for alcohol or bland soap in removal of aerobic gram-negative skin bacteria: assessment by a novel method. Infect. Control Hosp. Epidemiol., Vol. 10, pp. 306-311.
Educational Foundation of the National Restaurant Association, 1992. The Safe Foodhandler, in Applied Foodservice Sanitation, 4th Ed. John Wiley & Sons, New York. ppÂ 60-76.
Eggers, H. J. 1990. Experiments on Antiviral Activity of Hand Disinfectants. Some Theoretical and Practical Considerations. Zbl. Bakt. Vol.273, pp.36-51.
Ehrenkranz, N.J., 1992. Bland soap handwash or hand antisepsis? The pressing need for clarity. Infect. Control Hosp. Epidemiol., Vol. 13, No. 5, pp. 299-301.
Ehrenkranz, N.J., Alfonso, B., 1991. Failure of bland soap handwash to prevent hand transfer of patient bacteria to urethral catheters. Infect. Control Hosp. Epidemiol. Vol. 12, No. 11, pp. 654-662.
Garner, J.S. and M.S. Favero, 1985. Guidelines for Handwashing and Hospital Environmental Control. Hospital Infections Program, Center for Infectious Diseases, CDC, Atlanta, GA. pp. 7-9.
Kjolen H., and Andersen, B. M., 1992. Handwashing and disinfection of heavily contaminated hands — effective or ineffective? J. Hosp. Infect., Vol. 21, pp. 61-71.
Lane, C.G., and Blank, I.H., 1942. Cutaneous Detergents. J.A.M.A. 118 (10): 804-816.
Larson, E.L., 1995. APIC Guideline for handwashing and hand antisepsis in health care settings, American J. Infect. Control, Vol. 23, No. 4, pp. 251-269.
Lilly, H.A, Lowbury, E.J.L. 1978. Transient skin flora. Their removal by cleansing or disinfection in relation to their mode of deposition. J. Clin. Path. Vol. 31, pp. 919-922.
Mbithi, J.N., Springthorpe, S., and Sattar, S., 1993. Comparative in vivo efficiencies of hand-washing agents against Hepatitis A virus (HM-175) and Poliovirus Type 1 (Sabin). Applied Environ Microbiol. Vol.59, No.10, pp. 3463-3469.
McGinley, K.J., Larson, E.L., and Leyden, J.J. 1988. Composition and Density of Microflora in the Subungual Space of the Hand. J. of Clin. Micro. 26(5): 950-953.
Minnesota Department of Health, 1990. Guidelines for the Prevention of the Transmission of Viral Hepatitis, Type A in the Food Service Area. Minnesota Department of Health, Div. Environ. Health, Minneapolis, MN. 2 pp.
Paulson, D.S., 1992. Evaluation of three handwashing modalities commonly

employed in the food processing industry. Dairy Food Environ. Sanit. 12(10):615-618.

Pether, J.V.S., and Gilbert, R.J., 1971. The survival of salmonellas on finger-tips and transfer of the organism to foods. J. Hyg. Vol. 69, pp. 673-681.
Price, P.B., 1938. The Bacteriology of Normal Skin; A New Quantitative Test Applied to a Study of the Bacterial Flora and the Disinfectant Action of Mechanical Cleansing, J. Infect. Dis. 63: 301-318.
Restaino, L. and Wind, C.E., 1990. Antimicrobial effectiveness of hand washing for food establishments. Dairy, Food and Environ. San. Vol.10, No. 3, pp.136-141.
Reybrouck, G., 1986. Handwashing and hand disinfection. J. Hosp. Infect. 8: 5-23.
Rotter, M.L., G.A.J. Ayliffe, 1991. Practical Guide on Rationale and Testing Procedures for Disinfection of Hands. World Health Organization. 57 pp.
Rotter, M.L., Koller, W., 1991. An European test for the evaluation of the efficacy of procedures for the antiseptic handwash? Hyg. Med., Vol. 16, pp.4-12.
Rose, J.B., and Slifko, T.R., 1999. Giardia, Cryptosporidium, and Cyclospora and their impact on foods: a review. J. Food Protect. Vol. 62., No. 9, pp. 1059-1070.
Sattar, S.A., and Springthorpe, V.S. 1996. Environmental spread and germicide control of viruses in hospitals. Infect Control & Steril.Tech, Vol. 2, no.7, pp. 30-36.
Schurmann, W., and Eggers, H.J. 1985. An experimental study on the epidemiology of enteroviruses: water and soap washing of poliovirus 1 — contaminated hands, its effectiveness and kinetics. Med. Microbiol. Immunol. Vol. 174, pp. 221-236.
Smith, G.A., Jr, 1991. Handwashing et cetera, Lexington Board of Health, Personal Hygiene Sanitation Programs, Lexington, KY. 2 pp.
Stiles, M.E., and Sheena, A.Z. 1987. Efficacy of Germicidal Hand Wash Agents in Use in a Meat Processing Plant. J. Food Protect. 50 (4):289-295.
Sprunt, Katherine, Redman, Winifred, and Leidy, Grace, 1973. Antibacterial Effectiveness of Routine Hand Washing. Pediatrics, Vol. 52, No. 2, pp. 264-271.
Williams, R.E.O., 1963. Healthy carriage of Staphylococcus aureus : Its prevalence and importance. Bacteriol. Rev. 27:56-71.

2-301.13 Special Handwashing Procedures.*

Reserved.

2-301.14 When to Wash.*

Ojajarvi, J., 1980. Effectiveness of handwashing and disinfection methods in removing transient bacteria after patient nursing. J. Hyg. Camb. 85:193-203.

2-301.16 Hand Sanitizers.

Code of Federal Regulations, Title 21, Part 178.1010 Sanitizing Solutions.
Food and Drug Administration, January, 1999. Investigations Operations Manual, ChapterÂ 5, Establishment Inspection, Subchapter 530, Food Section 534, Equipment and Utensils.
Stiles, M.E. and A.Z. Sheena, 1987. Efficacy of germicidal hand wash agents in use in a meat processing plant. J. Food Prot. 50(4): 289-294.

2-302.11 Maintenance. (Fingernails)

Pether, J.V.S. and R.J. Gilbert, 1971. The survival of salmonellas on finger-tips and transfer of the organisms to foods. J. Hyg. Camb. 69:673-681.
Pottinger, J., S. Burns, and C. Manake, 1989. Bacterial carriage by artificial versus natural nails. Am. J. Infect. Control, 17(6):340-344.