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FDA 1999 Food Code - Annex 7: Model Forms, Guides, and Other Aids

Return to 1999 Food Code Table of Contents

 

U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
1999 Food Code

 

Annex
7

Model Forms, Guides, and Other Aids

 

  1. Form 1 APPLICANT AND FOOD EMPLOYEE INTERVIEW
  2. Form 2 FOOD EMPLOYEE REPORTING AGREEMENT
  3. Form 3 APPLICANT AND FOOD EMPLOYEE MEDICAL REFERRAL
  4. Form 4 ADOPTION BY REFERENCE
  5. Form 5 ADOPTION BY SECTION-BY-SECTION REFERENCE
  6. Form 6 HACCP INSPECTION DATA
  7. Form 7 FOOD ESTABLISHMENT INSPECTION REPORT
  8. Guide 1 EXCLUSIONS AND RESTRICTIONS
  9. Guide 2 REMOVAL OF EXCLUSIONS AND RESTRICTIONS
  10. Guide 3 INSPECTIONAL GUIDE
  11. List WORLDWIDE STATUS OF SALMONELLA TYPHI, SHIGELLA SPP., ESCHERICHIA COLI O157:H7, AND HEPATITIS A VIRUS BY GEOGRAPHICAL AREA
  12. Chart 1 SUMMARY CHART FOR MINIMUM COOKING FOOD TEMPERATURES AND HOLDING TIMES REQUIRED BY CHAPTER 3
  13. Chart 2 SUMMARY CHART FOR MINIMUM FOOD TEMPERATURES AND HOLDING TIMES REQUIRED BY CHAPTER 3 FOR REHEATING FOODS FOR HOT HOLDING
  14. Chart 3 SUMMARY CHART - DATE MARKING AND DISPOSING READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD
  15. Chart 4 FDA FOOD CODE MOBILE FOOD ESTABLISHMENT MATRIX
  16. Summary SUMMARY OF CHANGES IN THE FDA FOOD CODE


The documents provided in this Annex are intended to facilitate adoption of the Food Code and the application of its provisions as they relate to applicants' and food employees' health and to food establishment inspections.

Forms 1-3, Guides 1 and 2, and the List are designed to assist those responsible for preventing foodborne disease. The Food Code specifies that the permit holder is responsible for requiring applicants and food employees to report certain symptoms, diagnoses, past illnesses, high-risk conditions, and foreign travel as they relate to diseases transmitted through food by infected workers. The food employee is personally responsible for reporting this information to the person in charge.

Forms 4 and 5 can be used for the Code adoption process and Forms 6 and 7 are provided for use in recording HACCP information and inspectional observations. Guide 3 is a compressed outline of the Code to use as a tool in locating and citing Code provisions.

 

 Form
    1

Applicant and Food Employee Interview

 

Preventing Transmission of Diseases through Food by Infected Food Employees with Emphasis on illness due to Salmonella Typhi, Shigella spp., Escherichia coli O157:H7, and Hepatitis A Virus

 

The purpose of this form is to ensure that Applicants to whom a conditional offer of employment has been made and Food Employees advise the Person in Charge of past and current conditions described so that the Person in Charge can take appropriate steps to preclude the transmission of foodborne illness.

 

Applicant or Employee name (print) _______________________________________________________
Address __________________________________________________________________________________
__________________________________________________________________________________________
 
  Telephone  Daytime:____________________________  Evening:_______________________________

 

TODAY:

Are you suffering from any of the following:

 
1. Symptoms
Diarrhea?
Fever?
Vomiting?
Jaundice?
Sore throat with fever?
YES/NO
YES/NO
YES/NO
YES/NO
YES/NO

2. Lesions containing pus on the hand, wrist or an exposed body part? 
(such as boils and infected wounds, however small)

 

YES/NO

PAST:

 

Have you ever been diagnosed as being ill with typhoid fever (Salmonella Typhi), shigellosis (Shigella spp.), Escherichia coli O157:H7 infection (E. coli O157:H7), or hepatitis A (hepatitis A virus)?

If you have, what was the date of the diagnosis? ______________________

 

YES/NO

HIGH-RISK CONDITIONS

1. Have you been exposed to or suspected of causing a confirmed outbreak of typhoid fever, shigellosis, E. coli O157:H7 infection, or hepatitis A? YES/NO
2. Do you live in the same household as a person diagnosed with typhoid fever, shigellosis, hepatitis A, or illness due to E. coli O157:H7? YES/NO
3. Do you have a household member attending or working in a setting where there is a confirmed outbreak of typhoid fever, shigellosis, E. coli O157:H7 infection, or hepatitis A?YES/NO

 

    Name, Address, and Telephone Number of your Doctor:

    Name    _________________________________________________________________
    Address _________________________________________________________________
    _________________________________________________________________________
    Telephone  Daytime:_____________________  Evening:_______________________
 
 
 Signature of Applicant or Food Employee __________________________________ Date ________
 
 Signature of Permit Holder's Representative ______________________________ Date ________

 

Form
    2
Food Employee Reporting Agreement

Preventing Transmission of Diseases through Food by Infected Food Employees with Emphasis on illness due to Salmonella Typhi, Shigella spp., Esherichia coli O157:H7, and Hepatitis A Virus


The purpose of this agreement is to ensure that Food Employees notify the Person in Charge when they experience any of the conditions listed so that the Person in Charge can take appropriate steps to preclude the transmission of foodborne illness.

I AGREE TO REPORT TO THE PERSON IN CHARGE:

 

FUTURE SYMPTOMS and PUSTULAR LESIONS:

  1. Diarrhea
  2. Fever
  3. Vomiting
  4. Jaundice
  5. Sore throat with fever
  6. Lesions containing pus on the hand, wrist, or an exposed body part
    (such as boils and infected wounds, however small)

 

FUTURE MEDICAL DIAGNOSIS

Whenever diagnosed as being ill with typhoid fever (Salmonella Typhi), shigellosis (Shigella spp.), Escherichia coli O157:H7 infection (E. coli O157:H7), or hepatitis A (hepatitis A virus)

 

FUTURE HIGH-RISK CONDITIONS: 

  1. Exposure to or suspicion of causing any confirmed outbreak of typhoid fever, shigellosis, E. coli O157:H7 infection, or hepatitis A
  2. A household member diagnosed with typhoid fever, shigellosis, illness due to E. coli O157:H7, or hepatitis A
  3. A household member attending or working in a setting experiencing a confirmed outbreak of typhoid fever, shigellosis, E. coli O157:H7 infection, or hepatitis A

 

I have read (or had explained to me) and understand the requirements concerning my responsibilities under the Food Code and this agreement to comply with:

  1. Reporting requirements specified above involving symptoms, diagnoses, and high-risk conditions specified;
  2. Work restrictions or exclusions that are imposed upon me; and
  3. Good hygienic practices.

I understand that failure to comply with the terms of this agreement could lead to action by the food establishment or the food regulatory authority that may jeopardize my employment and may involve legal action against me.

 Applicant or Food Employee Name (please print) _________________________________________
 
 Signature of Applicant or Food Employee __________________________________ Date ________
 
 Signature of Permit Holder's Representative ______________________________ Date ________

 

Form
    3
Applicant and Food Employee Medical Referral

 

Preventing Transmission of Diseases through Food by Infected Food Employees with Emphasis on illness due to Salmonella Typhi, Shigella spp., Escherichia coli O157:H7, and Hepatitis A Virus


The Food Code specifies, under Part 2-2 Employee Health Subpart 2-201 Disease or Medical Condition, that Applicants to whom a conditional offer of employment has been made and Food Employees obtain medical clearance from a physician licensed to practice medicine whenever the individual:

  1. Is chronically suffering from a symptom such as diarrhea; or
  2. Meets one of the high-risk conditions specified under Paragraph 2-201.11(D) and is suffering from any symptom specified under Subparagraph 2-201.11(B)(1).
  3. Has a current illness involving Salmonella Typhi (typhoid fever), Shigella spp. (shigellosis), Escherichia coli O157:H7 (E. coli O157:H7 infection), or hepatitis A virus (hepatitis A), or
  4. Reports past illness involving S. Typhi (typhoid fever), Shigella spp. (shigellosis), E. coli O157:H7, or hepatitis A virus (hepatitis A), if the establishment is a facility serving a highly susceptible population such as preschool age children, immunocompromised persons, or older adults.

Applicant or Food Employee being referred: (___________________ (Name, please print)___________________ )
Serving a highly susceptible population YES /_/ NO /_/

REASON FOR MEDICAL REFERRAL: The reason for this referral is checked below:
/_/ Chronic diarrhea or other chronic symptom ______________(specify)_______________ .
/_/ Meets a high-risk condition specified under Paragraph 2-201.11(D) ______________(specify)_______________ and suffers from a symptom specified under Subparagraph 2-201.11(B)(1). ______________(specify)_______________ .
/_/ Diagnosed or suspected typhoid fever, shigellosis, E. coli O157:H7 infection, or hepatitis A.
/_/ Reported past illness from typhoid fever, shigellosis, E. coli O157:H7 infection, or hepatitis A.
/_/ Other medical condition of concern per the following description: _________________________________

PHYSICIAN'S CONCLUSION:
/_/ Applicant or food employee is free of S. Typhi, Shigella spp., E. coli O157:H7, or hepatitis A virus and may work as a food employee without restrictions.
/_/ Applicant or food employee is an asymptomatic shedder of ____(pathogen)____ and is restricted from working with exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles in establishments that do not serve highly susceptible populations.
/_/ Applicant or food employee is not ill but continues as an asymptomatic shedder of ____(pathogen)____ and should be excluded from working with exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles in food establishments that serve highly susceptible populations such as those who are preschool age, immunocompromised, or older adults and in a facility that provides preschool custodial care, health care, or assisted living.
/_/ Applicant or food employee is suffering from typhoid fever, Shigellosis, E. coli O157:H7 infection, or hepatitis A and should be excluded from working with exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles.

COMMENTS: (In accordance with Title I of the Americans with Disabilities Act (ADA) and to provide only the information necessary to assist the food establishment operator in preventing foodborne disease transmission, please confine comments to explaining your conclusion and estimating when the employee may be reinstated.)

___________________________________________________________________________________

 
 Signature of Physician ___________________________________________________ Date ________

Paraphrased from the FDA Food Code for Physician's Reference

From §2-201.11(A) Organisms of Concern:

Any foodborne pathogen, with special emphasis on these 4 organisms:

S. Typhi Shigella spp. E. coli O157:H7 Hepatitis A virus

 

From §2-201.11(B)(1) Symptoms:

Symptoms associated with an acute gastrointestinal illness such as:

DiarrheaFever Vomiting Jaundice Sore throat with fever

 

From §2-201.11(D) High-Risk Conditions Related to a Person's Activities:

  1. Suspected of causing a foodborne outbreak or being exposed to an outbreak caused by 1 of the 4 organisms above, at an event such as a family meal, church supper, or festival because the person:
    Prepared or consumed an implicated food; or
    Consumed food prepared by a person who is infected or ill with the organism that caused the outbreak or who is suspected of being a carrier;
  2. Lives with a person who is diagnosed with illness caused by 1 of the 4 organisms; or
  3. Lives with a person who works where there is an outbreak caused by 1 of the 4 organisms.

 

From §2-201.12 Exclusion and Restriction:

Decisions to exclude or restrict a food employee are made considering the available evidence about the person's role in actual or potential foodborne illness transmission. Evidence includes:

SymptomsDiagnosis High-risk conditions Past illnesses Stool/blood tests

  • In facilities serving highly susceptible populations such as day care centers and health care facilities, a person for whom there is evidence of foodborne illness is almost always excluded from the food establishment.
  • In other establishments that offer food to typically healthy consumers, a person might only be restricted from certain duties, based on the evidence of foodborne illness.
  • Exclusion from any food establishment is required when the person is:
  • Diagnosed with illness caused by 1 of the 4 organisms of concern; or
    Jaundiced within the last 7 days.

 

From §8-501.40 Release of Employee from Exclusion or Restriction:

In addition to local law, these requirements must be met in the situations specified:

  • For infection with S. Typhi, the person's stools must be negative for 3 consecutive cultures taken at least 1 month after onset, no earlier than 48 hours after antibiotics are discontinued, and at least 24 hours apart.
  • For Shigella spp. or E. coli O157:H7 infections, the person's stools must be negative for 2 consecutive cultures taken no earlier than 48 hours after antibiotics are discontinued and at least 24 hours apart.
  • For hepatitis A virus infection, the symptoms must cease or at least 2 blood tests must show falling liver enzymes.

 

Form
    4

Adoption by Reference


This "short form" may be used by governmental bodies adopting the Food Code where authorized by law. Use of the adoption by reference form may substantially reduce the cost of publishing and printing.

The description of the Food Code, below, includes Chapter 8 and the Chapter 8 annex (Annex 1). Modifications to the description may be necessary, based on what provisions are being adopted and whether they are being adopted as law or regulation.

Section 2 lists provisions that may require modifications to be consistent with existing law or that require insertion of dollar amounts.

 

(JURISDICTION)FOOD CODE

(statute/regulation/ordinance)_____ Number __________

ADOPTING THE 1999 EDITION OF THE "FOOD CODE" REGULATING THE RETAIL SALE, COMMERCIAL AND INSTITUTIONAL SERVICE, AND VENDING OF FOOD; DEFINING PERMIT HOLDER, PERSON IN CHARGE, EMPLOYEE, FOOD, POTENTIALLY HAZARDOUS FOOD, FOOD ESTABLISHMENT, SAFE MATERIAL, SANITIZATION, AND OTHER TERMS; AND PROVIDING STANDARDS FOR EMPLOYEE FOOD SAFETY KNOWLEDGE, HEALTH, AND PRACTICES; FOOD SOURCES, PREPARATION, HOLDING TEMPERATURES, AND PROTECTION; EQUIPMENT DESIGN, CONSTRUCTION, INSTALLATION, CLEANING, AND SANITIZATION; WATER, AND LIQUID AND SOLID WASTES; FACILITIES CONSTRUCTION AND MAINTENANCE, AND STORAGE AND USE OF POISONOUS AND TOXIC MATERIALS; REQUIRING A PERMIT TO OPERATE A FOOD ESTABLISHMENT; AND PROVIDING FOR THE RESTRICTION OR EXCLUSION OF EMPLOYEES, THE EXAMINATION AND CONDEMNATION OF FOOD, AND THE ENFORCEMENT OF THIS CODE INCLUDING THE SETTING OF PENALTIES.

The __(governing body)__ of the __(jurisdiction)__ does ordain as follows:

SECTION 1. ADOPTION OF FOOD CODE

That a certain document, three copies of which are on file in the office of the __(jurisdiction's keeper of records)__ of the __(type of jurisdiction)__ of __(name of jurisdiction)__ being marked and designated as the Food Code, 1999 Recommendations of the United States Public Health Service/Food and Drug Administration as published by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration be, and is hereby adopted as, the Food Code of __(type of jurisdiction)__ of __(name of jurisdiction)__ in the State of __(state name)__; for regulating the design, construction, management and operation of food establishments, and providing for plans submission and approval and the issuance of permits and collection of fees therefore.

SECTION 2. INSERTIONS AND CHANGES

That the following provisions are hereby revised as follows:

Paragraph 8-811.10(B) Insert (Dollar Amount)
Paragraph 8-813.10(B) Insert (Dollar Amounts)
Subparagraph 8-811.10(B)(2) Insert (Number of Year(s))

 

SECTION 3. INCONSISTENT CODES REPEALED

That __(statute/regulation/ordinance)__ number __(present code number)__ of the __(jurisdiction)__ titled, __(complete title of the food code(s) in effect at the present time so they will be repealed by definite mention)__ and all other codes or portions of codes in conflict herewith are hereby repealed in that respect only.

SECTION 4. CERTIFICATION OF ADOPTION AND PUBLISHING

That the __(jurisdiction's keeper of records)__ shall certify the adoption of this __(statute/regulation/ordinance__ and cause the same to be published as required by law.

SECTION 5. EFFECTIVE DATE

That this Code and the rules, regulations, provisions, requirements, orders, and matters established and adopted hereby shall take effect and be in full force and effect __(time period)__ from and after the date of its final passage and approval.

PASSED AND APPROVED BY __(name of adopting authority)__ on this __(day)__ of __(month, year)__.

BY:____________________________________

 


Examples of how some jurisdictions have set fines, sentences, and penalties:

California law provides:

  1. For Food Manufacturing Violations:

    Criminal fines and sentence for violations of up to $10,000 and one year imprisonment if there is shown an intent to defraud or mislead, and

    Civil penalties of up to $5,000 per day for certain violations.

  2. For Food Retail Violations:

    Criminal fines and sentence for violations of not less than twenty-five dollars ($25) or more than one thousand dollars ($1000) for each offense, or by imprisonment in the county jail for a term not exceeding six months, or by both such fine and imprisonment.

Maryland law provides:

  1. Criminal fines and sentence for certain violations of up to $10,000 and one year imprisonment, and in the case of repeat code violation convictions, up to $25,000 and three years imprisonment; and

    Civil penalties of up to $5,000 for each violation and for each day the violation continues.

Texas law provides:

    Criminal fines and sentence for certain violations of up to $10,000 and two years imprisonment; and

  1. Assessment of five "severity" levels of administrative or civil penalties with base amounts ranging from $1,250 through $10,000. Base amounts can be decreased or increased by as much as 50% considering factors such as past performance, good faith, direct impact on health and safety, high-risk populations involved, etc.

Federal law provides under the Criminal Fine Enforcement Act of 1984 for a fine up to $100,000 for a misdemeanor by a corporation or individual not resulting in death and, for misdemeanors resulting in death, a fine of up to $250,000 for individuals and $500,000 for corporations.

 

Form
    5

Adoption by Section-by-Section Reference


This "long form" may be used by governmental bodies adopting the Food Code section-by-section.

The description of the "Food Code," below, includes Chapter 8 and the Chapter 8 annex (Annex 1). Modifications to the description may be necessary, based on what provisions are being adopted and whether they are being adopted as law or regulation.

Section 2 lists provisions that may require modifications to be consistent with existing law or that require insertion of dollar amounts.

 

__(JURISDICTION)__ FOOD CODE

__(statute/regulation/ordinance)__ Number _________

ADOPTING A CODE REGULATING THE RETAIL SALE, COMMERCIAL AND INSTITUTIONAL SERVICE, AND VENDING OF FOOD; DEFINING PERMIT HOLDER, PERSON IN CHARGE, EMPLOYEE, FOOD, POTENTIALLY HAZARDOUS FOOD, FOOD ESTABLISHMENT, SAFE MATERIAL, SANITIZATION, AND OTHER TERMS; AND PROVIDING STANDARDS FOR EMPLOYEE FOOD SAFETY KNOWLEDGE, HEALTH, AND PRACTICES; FOOD SOURCES, PREPARATION, HOLDING TEMPERATURES, AND PROTECTION; EQUIPMENT DESIGN, CONSTRUCTION, INSTALLATION, CLEANING AND SANITIZATION; WATER, AND LIQUID AND SOLID WASTES; FACILITIES CONSTRUCTION AND MAINTENANCE, AND STORAGE AND USE OF POISONOUS AND TOXIC MATERIALS; REQUIRING A PERMIT TO OPERATE A FOOD ESTABLISHMENT; AND PROVIDING FOR THE RESTRICTION OR EXCLUSION OF EMPLOYEES, THE EXAMINATION AND CONDEMNATION OF FOOD, AND THE ENFORCEMENT OF THIS CODE INCLUDING THE SETTING OF PENALTIES.

The __(governing body)__ of the __(jurisdiction)__ does ordain as follows:

(REPRINT THE FOOD CODE, 1999 RECOMMENDATIONS OF THE UNITED STATES PUBLIC HEALTH SERVICE/FOOD AND DRUG ADMINISTRATION, SECTION-BY-SECTION)

 

SECTION 2. INSERTIONS AND CHANGES

That the following provisions may need to be completed as follows:

Paragraph 8-811.10(B) Insert (Dollar Amount)
Paragraph 8-813.10(B) Insert (Dollar Amounts)
Subparagraph 8-811.10(B)(2) Insert (Number of Year(s))

 

SECTION 3. INCONSISTENT CODES REPEALED

That __(statute/regulation/ordinance)__ number __(present code number)__ of the __(jurisdiction)__ titled, __(complete title of the food code›s| in effect at the present time so they will be repealed by definite mention)__and all other codes or portions of codes in conflict herewith are hereby repealed in that respect only.

 

SECTION 4. CERTIFICATION OF ADOPTION AND PUBLISHING

That the __(jurisdiction's keeper of records)__ shall certify the adoption of this __(statute/regulation/ordinance__ and cause the same to be published as required by law.

 

SECTION 5. EFFECTIVE DATE

That this Code and the rules, regulations, provisions, requirements, orders, and matters established and adopted hereby shall take effect and be in full force and effect __(time period)__from and after the date of its final passage and approval.

PASSED AND APPROVED BY __(name of adopting authority)__ on this __(day)__ of __(month, year)__.

BY:____________________________________


Examples of how some jurisdictions have set fines, sentences, and penalties:

 

California law provides:

  1. For Food Manufacturing Violations:

    Criminal fines and sentence for violations of up to $10,000 and one year imprisonment if there is shown an intent to defraud or mislead, and

    Civil penalties of up to $5,000 per day for certain violations.

  2. For Food Retail Violations:

Maryland law provides:

  1. Criminal fines and sentence for certain violations of up to $10,000 and one year imprisonment, and in the case of repeat code violation convictions, up to $25,000 and three years imprisonment; and

    Civil penalties of up to $5,000 for each violation and for each day the violation continues.

Texas law provides:

  1. Criminal fines and sentence for certain violations of up to $10,000 and two years imprisonment; and

    Assessment of five "severity" levels of administrative or civil penalties with base amounts ranging from $1,250 through $10,000. Base amounts can be decreased or increased by as much as 50% considering factors such as past performance, good faith, direct impact on health and safety, high-risk populations involved, etc.

Federal law provides under the Criminal Fine Enforcement Act of 1984 for a fine up to $100,000 for a misdemeanor by a corporation or individual not resulting in death and, for misdemeanors resulting in death, a fine of up to $250,000 for individuals and $500,000 for corporations.

 

Form
    6

HACCP Inspection Data

 

The HACCP Inspection Data form is designed to accommodate the recording of observations during an inspection. The design of the form focuses on information related to the flow of potentially hazardous foods being prepared, displayed, sold, and served within the establishment. The form is intended as a worksheet for use in noting food temperatures/times at each step and other pertinent data as they compare to the established critical limits. This juxtaposition of the observations and the critical limits highlights the violative steps. The information then is transferred to the Establishment Inspection Report form.

Refer to Annex 4, Food Establishment Inspection, Sections 5 and 10, for further discussion regarding the use of the form.

 


 

FDA logoDEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION

 

HACCP INSPECTION DATA


EST. NAME:PERMIT NO.INSPECTOR:
DATE:TIME IN: :AM / PM TIME OUT: :AM/ PM

 

Record all observations below - transfer violations to Inspection Report

FOOD TEMPERATURES / TIMES / OTHER CRITICAL LIMITS
Use Additional Forms If Necessary

FOOD

STEP

1.

 

CRITICAL
LIMIT

2.

 

CRITICAL
LIMIT

3.

 

CRITICAL
LIMIT

4.

 

CRITICAL
LIMIT

A. SOURCE

 

        

B. STORAGE

 

        
C. PREP
BEFORE
COOK
        

D. COOK

 

        
E. PREP
AFTER
COOK
        

F. HOT/COLD
HOLD

 

        

G. DISPLAY/
SERVICE

 

        

H. COOL

 

        

I. REHEAT

 

        

 

OTHER FOOD TEMPERATURES OBSERVED          Use steps from above for location
FOODTEMP.
°C/°F
STEPFOODTEMP.
°C/°F
STEPFOODTEMP.
°C/°F
STEP
         
         
         

 

MANAGEMENT / PERSONNEL OBSERVATIONS

  
  
  
  
  

OTHER FOOD OBSERVATIONS

  
  
  
  
  

EQUIPMENT, UTENSILS, AND LINEN OBSERVATIONS

  
  
  
  
  

WATER, PLUMBING, AND WASTE OBSERVATIONS

  
  
  
  
  

PHYSICAL FACILITIES

  
  
  
  
  

POISONOUS OR TOXIC MATERIALS OBSERVATIONS

  
  
  
  
  

 

Form
    7

Food Establishment Inspection Report

 

The food establishment inspection report is the official agency document regarding compliance of the establishment with agency requirements. The goal of the report is to clearly, concisely, and fairly present the compliance status of the establishment and to convey compliance information to the permit holder or person in charge at the conclusion of the inspection. The Food Establishment Inspection Report form is provided as a model for use during routine, follow-up, and investigative inspections.

Refer to Annex 4, Food Establishment Inspection, Sections 6, 11, and 12, for further discussion.


FDA logoDEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION

 

FOOD ESTABLISHMENT INSPECTION REPORT

Violations cited in this report shall be corrected within the time frames specified below, but within a period not to exceed 10 calendar days for critical items (§ 8-405.11) or 90 days for noncritical items (§ 8-406.11).

VIOLATIONS:CRITICAL _____NONCRITICAL_____

 

 ESTABLISHMENT:                               PERMIT NUMBER:                DATE:
 ADDRESS:                                   CITY:                    STATE:     ZIP:
 PERSON IN CHARGE / TITLE:                                               TELEPHONE:
 INSPECTOR / TITLE:
 INSPECTION TYPE:     ROUTINE    FOLLOW-UP    COMPLAINT    OTHER:               TIME:
Critical (X)Repeat (X)Code ReferenceViolation Description / Remarks / Corrections
    
    
    
    
    
    
    
    
    
    
    
    
    
Food Establishment Inspection Report Page ___ of ___

 

FOOD ESTABLISHMENT INSPECTION REPORT

 

 ESTABLISHMENT:                               PERMIT NUMBER:                DATE:
Critical(X)Repeat (X)Code ReferenceViolation Description / Remarks / Corrections
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
Food Establishment Inspection Report Page ___ of ___


Guide
    1

Exclusions and Restrictions for Food Employees and Applicants

 

Health StatusFacilities Serving Highly Susceptible PopulationFacilities Not Serving Highly Susceptible Population
1. Diagnosed with illness due to Salmonella Typhi, Shigella spp., Escherichia coli O157:H7, or hepatitis A virusExclude
2-201.12(A)
Exclude
2-201.12(A)
2. Experiencing a symptom listed in 2-201.11(B)Restrict
2-201.12(B)
Restrict
2-201.12(B)
3. Experiencing a symptom listed in 2-201.11(B)(1) and meets a high-risk condition* of 2-201.11(D)(1)-(3)Exclude
2-201.12(C)(1)*
Restrict
2-201.12(B)(1)
4. Asymptomatic but stools positive for S. Typhi, Shigella spp., or E. coli O157:H7Exclude
2-201.12(C)(2)
Restrict
2-201.12(B)(2)
5. Past illness from Salmonella Typhi within the last 3 monthsExclude
2-201.12(C)(3)
No Restrictions
6. Past illness from Shigella spp. or E. coli O157:H7 within the last monthExclude
2-201.12(C)(4)
No Restrictions
7. Onset of jaundice within the last 7 daysExclude
2-201.12(D)(1)
Exclude
2-201.12(D)(1)
8. Onset of jaundice more than 7 days agoExclude
2-201.12(D)(2)(a)
Restrict
2-201.12(D)(2)(b)

* High-risk conditions apply only to exclusions under this Subparagraph.


Guide
    2

Removal of Exclusions and Restrictions for Food Employees and Applicants

 

Health Status
2-201.11 and .12
Facilities Serving Highly Susceptible Population
2-201.13
Facilities Not Serving Highly Susceptible Population
2-201.13
1. Diagnosed with illness due to Salmonella Typhi, Shigella spp., Escherichia coli O157:H7, or hepatitis A virus 2-201.11(A)1. RA Approval +
2. Doctor*:
    Stool free or
    Blood free or symptom-free
  (A)(1)
1. RA Approval +
2. Doctor*:
    Stool free or
    Blood free or symptom-free
  (A)(2)
2. Experiencing a symptom listed in 2-201.11(B)1. No illness results + no symptoms or
2. Suspect cause of illness + no symptoms
    + Doctor*: stool or blood free or
3. Doctor*: Noninfectious condition
  (B)(1)
1. No illness results + no symptoms or
2. Suspect cause of illness + no symptoms
    + Doctor*: stool or blood free or
3. Doctor*: Noninfectious condition   (B)(1)
3. Experiencing a symptom listed in
2-201.11(B)(1) and meets a high-risk condition
2-201.11(D)(1)-(3)
2-201.12(C)(1)
Doctor*:
1. Stools or blood free or
2. No jaundice per .13(D)
3..12 (C)(1) Noninfectious condition   (C)
1. No illness results + no symptoms or
2. Suspect cause of illness + no symptoms
    + Doctor*: stool or blood free or
3. Doctor*: Noninfectious condition
  (B)(1)
4. Asymptomatic but stools positive for S. Typhi, Shigella spp., or E. coli O157:H7 2-201.12(B)(2) &
(C)(2)
Doctor* - stools free
  (C)
Doctor* - stools free
  (B)(2)
5. Past illness from Salmonella Typhi within the last 3 months 2-201.11(C)Doctor* - stools free
  (C)
NA
6. Past illness from Shigella spp., or E. coli O157:H7 within last month 2-201.11(C)Doctor* - stools free
  (C)
NA
7. Onset of jaundice within last 7 days 2-201.12(D)(1)1. No illness results +
   Doctor* - blood free or
   Doctor* - no jaundice or
2. Suspect cause of illness + both satisfied
  (D)
1. No illness results +
   Doctor* - blood free or
   Doctor* - no jaundice or
2. Suspect cause of illness + both satisfied
  (D)
8. Onset of jaundice more than 7 days ago 2-201.12(D)(1)1. No illness results +
   Doctor* - blood free or
   Doctor* - no jaundice or
2. Suspect cause of illness + both satisfied
  (D)
1. No illness results +
   Doctor* - blood free or
   Doctor* - no jaundice or
2. Suspect cause of illness + both satisfied
  (D)

*Where "doctor" is indicated, nurse practitioner or physician assistant, if allowed by law, may provide documentation.


Guid
    3

Inspectional Guide

 

The major headings from each of the Code chapters have been extracted and condensed in this Guide to key word phrases to assist the person conducting inspections in locating the Code citation that corresponds to a given violation. The Guide is intended to be used during inspections as an aid in referencing Code provisions, ensuring that provisions of the Code are not overlooked during the inspection, and accurately completing the Food Establishment Inspection Report form.

INSPECTIONAL GUIDE

Management and Personnel
SUPERVISION
2-101.11 Assignment of Responsibility*
2-102.11 Demonstration of Knowledge*
2-103.11 Duties of Person in Charge

EMPLOYEE HEALTH
Disease or Medical Condition
2-201.11 Responsibility of Person in Charge*
2-201.12 Exclusions and Restrictions*
2-201.13 Removal of Exclusions/Restrictions
2-201.14 Reporting by Employee/Applicant*
2-201.15 Reporting by Person In Charge*

PERSONAL CLEANLINESS
Hands and Arms 
2-301.11 Clean Condition*
2-301.12 Cleaning Procedure*
2-301.13 Special Handwash Procedures*
2-301.14 When to Wash*
2-301.15 Where to Wash
2-301.16 Hand Sanitizers
2-302.11 Fingernail Maintenance
2-303.11 Jewelry Prohibitions
2-304.11 Outer Clothing Cleanliness/

HYGIENIC PRACTICES
2-401.11 Eating, Drinking, or Using Tobacco*
2-401.12 Discharges-Eye, Nose, Mouth*
2-402.11 Hair Restraint Effectiveness
2-403.11 Animal Handling Prohibition*

Food
CHARACTERISTICS
3-101.11 Safe/Unadult./Honestly Presented*

SOURCES/SPECIFICATIONS/ORIGINAL
CONTAINER/RECORDS
Sources
3-201.11 Compliance with Food Law*
3-201.12 Hermetically Sealed Food*
3-201.13 Fluid Milk and Milk Products*
3-201.14 Fish*
3-201.15 Molluscan Shellfish*
3-201.16 Wild Mushrooms*
3-201.17 Game Animals*
Specifications for Receiving
3-202.11 Temperature*
3-202.12 Additives*
3-202.13 Shell Eggs*
3-202.14 Pasteurized Eggs and Milk*
3-202.15 Package Integrity*
3-202.16 Ice*
3-202.17 Shucked Shellfish, Packaging/ID
3-202.18 Shellstock Identification*
3-202.19 Shellstock, Condition
Original Containers and Record of Source
3-203.11 Shellfish
3-203.12 Shellstock, Record Keeping*

PROTECT. FROM CONTAMINATION AFTER RECEIVING
3-301.11 Contamination from Employees' Hands*
3-301.12 Contamination When Tasting*
Contamination from Other Foods/Ingredients
3-302.11 Separation/Packaging/Segregation*
3-302.12 Containers Identified/Common Name
3-302.13 Pasteurized Eggs, Certain Recipes.*
3-302.14 Unapproved Additives*
3-302.15 Washing Fruits and Vegetables
Contamination from Ice Used as a Coolant
3-303.11 Exterior Ice Prohibited Ingredient
3-303.12 Food in Contact with Water or Ice
Contamination from Equip./Utensils/Linens 
3-304.11 Food Contact with Soiled Items*
3-304.12 In-Use Utensils/Between-Use Storage
3.304.13 Linens and Napkins, Use Limitation
3-304.14 Wiping Cloths, Use Limitation
3-304.15 Gloves, Use Limitation
3-304.16 Clean Tableware for Second Portions
3-304.17 Refilling Returnables
Contamination from the Premises
3-305.11 Food Storage
3-305.12 Food Storage, Prohibited Areas
3-305.13 Vended Food, Original Container
3-305.14 Food Preparation
Contamination from Consumers 
3-306.11 Food Display
3-306.12 Condiments, Protection
3-306.13 Consumer Self-Service Operations*
3-306.14 Returned Food and Reservice of Food*
Contamination from Other Sources
3-307.11 Miscellaneous Sources

DESTROYING ORGANISMS OF PUB. HLTH . CONCERN
Cooking
3-401.11 Raw Animal Foods*
3-401.12 Microwave Cooking*
3-401.13 Plant Foods for Hot Hold
Freezing 
3-402.11 Parasite Destruction*
3-402.12 Records, Creation and Retention
Reheating
3-403.10 Preparation for Immediate Service
3-403.11 Hot Holding*

LIMITING ORGANISMS OF PUBLIC HEALTH CONCERN
Temperature and Time Control
3-501.11 Frozen Food
3-501.12 Slacking
3-501.13 Thawing
3-501.14 Cooling*
3-501.15 Cooling Methods
3-501.16 Hot and Cold Holding*
3-501.17 Ready-to-Eat Food, Dating*
3-501.18 Ready-to-Eat Food, Disposition*
3-501.19 Time as a Public Health Control*
Special Processing Methods
3-502.11 Variance Requirement*
3-502.12 Reduced Oxygen Packaging, Criteria*

FOOD ID./PRESENTATION/ ON-PREMISES LABELING
Accurate Representation
3-601.11 Standards of Identity
3-601.12 Honestly Presented
Labeling
3-602.11 Food Labels
3-602.12 Other Forms of Information
Consumer Advisory
3-603.11 Consumption of Raw Animal Foods*

CONTAMINATED FOOD
Disposition
3-701.11 Discarding Contaminated Food*

HIGHLY SUSCEPTIBLE POPULATIONS
3-801.11 Special Requirements*

Equipment, Utensils, and Linens
MATERIALS FOR CONSTRUCTION AND REPAIR
Multiuse
4-101.11 Characteristics*
4-101.12 Cast Iron
4-101.13 Lead in Ceramic, China, Crystal Utensils
4-101.14 Copper*
4-101.15 Galvanized Metal*
4-101.16 Sponges
4-101.17 Lead in Pewter
4-101.18 Lead in Solder and Flux
4-101.19 Wood
4-101.110 Nonstick Coatings
4-101,111 Nonfood-Contact Surfaces
Single-Service and Single-Use
4-102.11 Characteristics*

DESIGN AND CONSTRUCTION
Durability and Strength
4-201.11 Equipment and Utensils
4-201.12 Food Temperature Measuring Devices*
Cleanabilty
4-202.11 Food-Contact Surfaces*
4-202.12 CIP Equipment 
4-202.13 "V" Threads
4-202.14 Hot Oil Filtering Equipment
4-202.15 Can Openers
4-202.16 Nonfood-Contact Surfaces
4-202.17 Kick Plates, Removable
4-202.18 Ventilation Hood, Filters
Accuracy
4-203.11 Food Temperature Measuring Devices
4-203.12 Ambient Temp. Measuring Devices
4-203.13 Pres. Meas. Dev., Mech. Ware. Equip.
Functionality
4-204.11 Ventilation Hoods, Drip Prevention
4-204.12 Equip. Openings, Closures/Deflectors
4-204.13 Dispensing Equipment, Barriers
4-204.14 Vending Machine, Stage Closure
4-204.15 Bearings and Gear Boxes, Leakproof
4-204.16 Beverage Tubing, Separation
4-204.17 Ice Units, Separation of Drains
4-204.18 Condenser Unit, Separation
4-204.19 Can Openers on Vending Machines
4-204.110 Molluscan Shellfish Tanks
4-204.111 Vending Machines, Automatic Shutoff*
4-204.112 Temperature Measuring Devices 
4-204.113 Warewasher, Data Plate Operat.Spec.
4-204.114 Warewasher, Internal Baffles
4-204.115 Warewasher, Temp. Measuring Devices
4-204.116 Manual Warewashing, Heaters/Baskets
4-204.117 Warewasher, Sanitizer Indicator
4-204.118 Warewasher, Flow Pressure Device
4-204.119 Sinks and Drainboards/Self-Draining
4-204.120 Equipment Compartments, Drainage
4-204.121 Vending Mach./Liquid Waste Products
4-204.122 Case Lot Handling Equip/Moveability
4-204.123 Vending Machine Doors and Openings

NUMBERS AND CAPACITIES
Equipment
4-301.11 Cooling/Heating/Holding Capacities
4-301.12 Warewashing, Sink Requirements
4-301.13 Drainboards
4-301.14 Ventilation Hood Systems, Adequacy
4-301.15 Clothes Washers and Dryers
Utensils and Measuring/Testing Devices
4-302.11 Utensils for Consumer Self-Service
4-302.12 Food Temperature Measuring Devices
4-302.13 Wash/San. Temp. Measuring Devices
4-302.14 Sanitizing Solution Testing Devices

LOCATION AND INSTALLATION
4-401.11 Equip. Location/Preventing Contam.
Installation
4-402.11 Fixed Equipment, Spacing/Sealing
4-402.12 Fixed Equipment, Elevation/Sealing

MAINTENANCE AND OPERATION
Equipment
4-501.11 Good Repair and Proper Adjustment
4-501.12 Cutting Surfaces
4-501.13 Microwave Ovens
4-501.14 Equipment, Cleaning Frequency
4-501.15 Warewasher, Operating Instructions
4-501.16 Warewashing Sinks, Use Limitation
4-501.17 Warewashing, Cleaning Agents
4-501.18 Warewashing, Clean Solutions
4-501.19 Warewashing, Wash Sol. Temperature
4-501.110 Warewasher, Wash Sol. Temperature
4-501.111 Warewashing, San. Water Temp.*
4-501.112 Warewasher, San. Water Temp.
4-501.113 Warewasher, Sanitization Pressure
4-501.114 Chem.San., Temp./pH/Concentr./Hard.*
4-501.115 Chem.San., Detergent-Sanitizers
4-501.116 Determining Chem.San. Concentration
Utensil/Temperature/Pressure Measuring Device
4-502.11 Good Repair and Calibration
4-502.12 Single-Ser./Use Art., Required Use
4-502.13 Single-Ser./Use Art., Use Limitation
4-502.14 Shells, Use Limitation

CLEANING OF EQUIPMENT AND UTENSILS
Objective
4-601.11 Clean Sight/Touch-No Accum/Encrust.*
Frequency
4-602.11 Food-Contact Surfaces and Utensils*
4-602.12 Cooking and Baking Equipment
4-602.13 Nonfood-Contact Surfaces
Methods
4-603.11 Dry Cleaning
4-603.12 Precleaning
4-603.13 Loading of Soiled Items, Warewasher
4-603.14 Wet Cleaning
4-603.15 Washing, Alternative Manual Equipment
4-603.16 Rinsing Procedures
4-603.17 Returnables, Cleaning for Refilling*

SANITIZATION OF EQUIPMENT AND UTENSILS
Objective
4-702.11 Frequency-Before Use After Cleaning*
4-703.11 Methods-Hot Water and Chemical*

LAUNDERING
4-801.11 Objective, Clean Linens
4-802.11 Frequency, Specifications
Methods
4-803.11 Storage of Soiled Linens
4-803.12 Mechanical Washing
4-803.13 Use of Laundry Facilities

PROTECTION OF CLEAN ITEMS
Drying
4-901.11 Equipment and Utensils, Air-Drying
4-901.12 Wiping Cloths, Air-Drying
Lubricating and Reassembling
4-902.11 Food-Contact Surfaces
4-902.12 Equipment
Storing
4-903.11 Equip./Uten./Lin./Sing.-Ser/Use Art.
4-903.12 Prohibitions
Handling
4-904.11 Kitchenware and Tableware
4-904.12 Soiled and Clean Tableware
4-904.13 Preset Tableware

Water, Plumbing, and Waste
WATER
Source
5-101.11 Approved System*
5-101.12 System Flushing and Disinfection*
5-101.13 Bottled Drinking Water.*
Quality
5-102.11 Standards*
5-102.12 Nondrinking Water*
5-102.13 Sampling
5-102.14 Sample Report
Quantity and Availability
5-103.11 Capacity*
5-103.12 Pressure
Distribution, Delivery, and Retention
5-104.11 System
5-104.12 Alternative Water Supply

PLUMBING SYSTEM
5-201.11 Materials, Approved*
Design, Construction, and Installation
5-202.11 Approved System/Cleanable Fixtures*
5-202.12 Handwashing Facility, Installation
5-202.13 Backflow Prevention, Air Gap*
5-202.14 Backflow Prevention Device, Design
5-202.15 Conditioning Device, Design
Numbers and Capacities
5-203.11 Handwashing Facilities*
5-203.12 Toilets and Urinals*
5-203.13 Service Sink
5-203.14 Backflow Prevention Device/Required*
5-203.15 Backflow Prevention Dev./Carbonator*
Location and Placement
5-204.11 Handwashing Facilities*
5-204.12 Backflow Prevention Device/Location
5-204.13 Conditioning Device, Location
Operation and Maintenance
5-205.11 Handwashing Facility
5-205.12 Prohibiting a Cross Connection*
5-205.13 Scheduling Device Inspect./Service
5-205.14 Fogging Device Reservoir/Cleaning*
5-205.15 System Maintained/Repair*

MOBILE WATER TANK/MOBILE ESTAB. WATER TANK
5-301.11 Materials, Approved
Design and Construction
5-302.11 Enclosed System, Sloped to Drain
5-302.12 Inspection Port, Protected/Secured
5-302.13 "V" Type Threads, Use Limitation
5-302.14 Tank Vent, Protected
5-302.15 Inlet and Outlet, Sloped to Drain
5-302.16 Hose, Construction/Identification
Numbers and Capacities
5-303.11 Filter, Compressed Air
5-303.12 Protective Equipment or Device
5-303.13 Mobile Food Est. Water Tank Inlet
Operation and Maintenance
5-304.11 Flushing and Disinfecting System*
5-304.12 Using Pump and Hoses/Backflow Prev.
5-304.13 Protect. Inlet/Outlet/Hose Fitting
5-304.14 Dedicating Tank, Pump, and Hoses

SEWAGE, OTHER LIQUID WASTES, AND RAINWATER 
Mobile Holding Tank
5-401.11 Capacity and Drainage
Retention, Drainage, and Delivery
5-402.11 Backflow Prevention*
5-402.12 Grease Trap
5-402.13 Conveying Sewage*
5-402.14 Removing Mobile Food Est. Wastes
5-402.15 Flushing a Waste Retention Tank
Disposal Facility
5-403.11 Approved Sewage Disposal System*
5-403.12 Other Liquid Wastes and Rainwater

REFUSE, RECYCLABLES, AND RETURNABLES
Facilities on the Premises
5-501.11 Outdoor Storage Surface
5-501.12 Outdoor Enclosure
5-501.13 Receptacles
5-501.14 Receptacles in Vending Machines
5-501.15 Outside Receptacles
5-501.16 Areas-Receptacles, Capacity/Avail.
5-501.17 Toilet Room Receptacle, Covered
5-501.18 Cleaning Implements and Supplies
5-501.19 Storage Areas and Units/Location
5-501.110 Storing Refuse/Recyclables/Return.
5-501.111 Areas/Enclosures/Receptacles, Repair
5-501.112 Outside Storage Prohibitions
5-501.113 Covering Receptacles
5-501.114 Using Drain Plugs
5-501.115 Maintaining Refuse Areas/Enclosures
5-501.116 Cleaning Receptacles
Removal
5-502.11 Frequency
5-502.12 Receptacles or Vehicles
Facilities for Disposal/Recycling/Refilling
5-503.11 Community or Individual Facility

Physical Facilities
MATERIALS FOR CONSTRUCTION AND REPAIR
6-101.11  Indoors, Surface Characteristics
6-102.11 Outdoors, Surface Characteristics

DESIGN, CONSTRUCTION, AND INSTALLATION
Cleanability
6-201.11 Floors, Walls, and Ceilings
6-201.12 Floors/Walls/Ceilings,Utility Lines
6-201.13 Junctures, Coved/Enclosed/Sealed
6-201.14 Carpeting,Restriction/Installation
6-201.15 Floor Covering, Mats and Duckboards
6-201.16 Wall, Ceiling, Coverings/Coatings
6-201.17 Walls and Ceilings, Attachments
6-201.18 Wall, Ceiling, Studs/Joists/Rafters
Functionality
6-202.11 Light Bulbs, Protective Shielding
6-202.12 Ventilation System, Exhaust Vents
6-202.13 Insect Contr. Dev., Design/Install.
6-202.14 Toilet Rooms, Enclosed
6-202.15 Outer Openings, Protected
6-202.16 Exterior Walls/Roofs, Barriers
6-202.17 Outdoor Vending Areas, Protection
6-202.18 Outdoor Servicing Areas, Protection
6-202.19 Outdoor Walk/Drive Surfaces, Drained
6-202.110 Outdoor Refuse Areas, Curbed/Drained
6-202.111 Homes/Living/Sleeping Qtrs., Prohib.
6-202.112 Living/Sleeping Quarters, Separation

NUMBERS AND CAPACITIES
Handwashing Facilities
6-301.11 Hand Cleanser, Available
6-301.12 Hand Drying Provision
6-301.13 Handwash Aids and Devices, Use Restrictions
6-301.14 Handwashing Signage
Toilets and Urinals
6-302.11 Toilet Tissue, Availability
6-303.11 Lighting, Intensity
6-304.11 Ventilation, Mechanical
6-305.11 Dressing Areas/Lockers, Designation

LOCATION AND PLACEMENT
6-402.11 Toilet Rooms, Convenient/Accessible
6-403.11 Employee Accommodations, Designated
6-404.11 Distressed Merchandise, Segregated


MAINTENANCE AND OPERATION
Premises/Fixtures - Methods
6-501.11 Repairing
6-501.12 Cleaning, Frequency/Restrictions
6-501.13 Cleaning Floors, Dustless Methods
6-501.14 Clean. Vent. Sys., Prev. Discharge
6-501.15 Clean. Maint. Tools, Prev. Contam.*
6-501.16 Drying Mops
6-501.17 Floors - Absorbent Materials
6-501.18 Maintaining/Using Handwashing Facilities
6-501.19 Closing Toilet Room Doors
6-501.110 Using Dressing Rooms and Lockers
6-501.111 Controlling Pests*
6-501.112 Removing Dead or Trapped Pests
6-501.113 Storing Maintenance Tools
6-501.114 Unnecessary Items and Litter
6-501.115 Prohibiting Animals*

Poisonous or Toxic Materials
LABELING AND IDENTIFICATION
Original Containers
7-101.11 Identifying Information, Prominence*
7-102.11 Working Containers, Common Name*

OPERATIONAL SUPPLIES AND APPLICATIONS
7-201.11 Storage, Separation*
Presence and Use
7-202.11 Restriction*
7-202.12 Conditions of Use*
Container Prohibitions
7-203.11 Poisonous/Toxic Material Containers*
Chemicals
7-204.11 Sanitizers*
7-204.12 Washing Fruits and Vegetables*
7-204.13 Boiler Water Additives*
7-204.14 Drying Agents*
7-205.11 Lubricants, Incidental Food Contact*
Pesticides
7-206.11 Restricted-Use, Criteria*
7-206.12 Bait Stations*
7-206.13 Tracking Powders*
Medicines
7-207.11 Restriction and Storage*
7-207.12 Medicines, Refrigerated Storage*
7-208.11 First Aid Supplies, Storage*
7-209.11 Other Personal Care Items, Storage

STOCK AND RETAIL SALE
7-301.11 Storage and Display, Separation*

Compliance and Enforcement
CODE APPLICABILITY
Variances
8-103.11 Documentation and Justification
8-103.12 Conformance with Procedures*

PLAN SUBMISSION AND APPROVAL
Facility and Operating Plans
8-201.11 When Plans Are Required
8-201.12 Contents of Plans/Specifications
8-201.13 HACCP Plan/When Required
8-201.14 Contents of a HACCP Plan

PERMIT TO OPERATE
8-301.11 Requirement, for Operation
Application Procedure
8-302.11 Submit 30 Days Before Opening
8-302.12 Form of Submission
8-302.13 Applicant Qualification/Responsibility
8-302.14 Contents of the Application
Conditions of Retention
8-304.11 Permit Holder Responsibility

INSPECTION AND CORRECTION OF VIOLATIONS
Access
8-402.11 After Due Notice at Reasonable Time
Imminent Health Hazard
8-404.11 Ceasing Operations and Reporting
8-404.21 Resumption of Operations
Critical Violation
8-405.11 Timely Correction
Noncritical Violation
8-406.11 Time Frame for Correction

 

 

List

Worldwide Status of Salmonella Typhi, Shigella, Escherichia coli O157:H7, and Hepatitis A Virus by Geographical Area.

 

Preventing Transmission of Diseases through Food by Infected Food Employees with Emphasis on Salmonella Typhi, Shigella spp., Escherichia coli O157:H7, and Hepatitis A Virus.

 

The following list of countries shows where typhoid fever, hepatitis A, and various diarrheal diseases commonly occur or are epidemic as reported to the Centers for Disease Control and Prevention (CDC) by the World Health Organization (WHO). CDC publishes this information annually in what is referred to as the "Yellow Book," Health Information for International Travel. Statistics cited were adapted from CDC's 1996-97 edition in the section entitled "Geographical Distribution of Potential Health Hazards to Travelers." The list is not comprehensive. Reporting to WHO is voluntary and is based on mortality, not morbidity. Where the Yellow Book refers to nonspecific "diarrheal disease," E. coli O157:H7 has been denoted as a possible cause.

This list is intended to be used as an aid to increase awareness of the person in charge that travel to some points outside the U.S. may increase the risk of acquiring foodborne illness. The person in charge can use the list to educate food employees about the need to be vigilant in the protection of their health during travel and the importance of informing the person in charge if symptoms occur or if there is a diagnosis of an illness (due to one of the four pathogens listed above) during or following travel.

 

AFRICA


Northern Africa checkboxes- Typhoid, Shigellosis, E. coli O157:H7, Hepatitis A checked
Algeria, Egypt, Libyan Arab Jamahiriya, Morocco, and Tunisia


Sub-Saharan Africa checkboxes- Typhoid, Shigellosis, E. coli O157:H7, Hepatitis A checked
Angola, Benin, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Côte D'Ivoire, Djiouti, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Niger, Nigeria, Réunion, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, Sudan, Togo, Uganda, United Republic of Tanzania, Zaire, Zambia, and Zimbabwe.


Southern Africa checkboxes- Typhoid, Shigellosis, E. coli O157:H7, Hepatitis A checked
Botswana, Lesotho, Namibia, St. Helena, South Africa, and Swaziland.

 

The AMERICAS


North America checkboxes- Typhoid, Shigellosis, E. coli O157:H7, Hepatitis A not checked
Bermuda, Canada, Greenland, St. Pierre and Miquelon and the United States of America.


Mainland Middle America checkboxes- Typhoid, Shigellosis, E. coli O157:H7, Hepatitis A checked
Belize, Costa Rica, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, and Panama.


Caribbean Middle America checkboxes- Typhoid not checked; Shigellosis, E. coli O157:H7, Hepatitis A checked
Antigua and Barbuda, Aruba, Bahamas, Barbados, British Virgin Islands, Cayman Islands, Cuba, Dominica, Dominican Republic, Grenada, Guadeloupe, Haiti, Jamaica, Martinique, Montserrat, Netherlands Antilles, Puerto Rico, St. Christopher and Nevis, Saint Lucia, Saint Vincent, and the Grenadines, Trinidad and Tobago, Turks and Caicos Islands, and the Virgin Islands (USA).


Tropical South America checkboxes- Typhoid not checked; Shigellosis, E. coli O157:H7, Hepatitis A checked
Bolivia, Brazil, Colombia, Ecuador, French Guiana, Guyana, Paraguay, Peru, Suriname, and Venezuela.


Temperate South America checkboxes- Typhoid, Shigellosis, E. coli O157:H7, Hepatitis A checked
Argentina, Chile, Falkland Islands (Malvinas), and Uruguay.

 

ASIA


East Asia checkboxes- Typhoid not checked; Shigellosis, E. coli O157:H7, Hepatitis A checked
China, the Democratic People's Republic of Korea, Hong Kong, Japan, Macao, Mongolia, and the Republic of Korea.


Eastern South Asia checkboxes- Typhoid, Shigellosis, E. coli O157:H7, Hepatitis A checked
Brunei Darussalam, Cambodia, Indonesia, Lao People's Democratic Republic, Malaysia, Myanmar (formerly Burma), the Philippines, Singapore, Thailand, and Viet Nam.


Middle South Asia checkboxes- Typhoid, Shigellosis, E. coli O157:H7, Hepatitis A checked
Afghanistan, Armenia, Azerbaijan, Bangladesh, Bhutan, India, Islamic Republic of Iran, Kazakhstan, Kyrgyzstan, Maldives, Nepal, Pakistan, Sri Lanka, Tajikistan, Turkmenistan, and Uzbekistan.


Western South Asia checkboxes- Typhoid, Shigellosis, E. coli O157:H7, Hepatitis A checked
Bahrain, Cyprus, Iraq, Israel, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Syrian Arab Republic, Turkey, the United Arab Emirates, and Yemen.

 

EUROPE


Northern Europe checkboxes- Typhoid, Shigellosis, E. coli O157:H7, Hepatitis A not checked
Belarus, Belgium, Czech Republic, Denmark (with the Faroe Islands), Estonia, Finland, Germany, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Republic of Moldova, Russian Federation, Slovakia, Sweden, Ukraine, and the United Kingdom (with the Channel Islands and the Isle of Man).


Southern Europe checkboxes- Typhoid, Shigellosis, E. coli O157:H7 checked; Hepatitis A not checked
Albania, Andorra, Austria, Bosnia, and Herzegovina, Bulgaria, Croatia, France, Gibraltar, Greece, Hungary, Italy, Liechtenstein, Malta, Monaco, Portugal (with the Azores and Madeira), Romania, San Marino, Slovenia, Spain (with the Canary Islands), Switzerland, and the former Yugoslav Republic of Macedonia, and Yugoslavia.

 

OCEANIA


Australia, New Zealand & Antarctic checkboxes- Typhoid, Shigellosis, E. coli O157:H7, Hepatitis A not checked


Melanesia & Micronesia (Polynesia) checkboxes- Typhoid, Shigellosis, E. coli O157:H7 checked; Hepatitis A not checked
American Samoa, Cook Islands, Easter Island, Federated States of Micronesia, Fiji, French Polynesia, Guam, Kiribati, Marshall Islands, Nauru, New Caledonia, Niue, Palau, Papua New Guinea, Pitcairn, Samoa, Solomon Islands, Tokelau, Tonga, Trust Territory of the Pacific Islands, Tuvalu, Vanuata, Wake Island (U.S.) and the Wallis and Futuna Islands.

 

 

Chart
    1

Summary Chart for Minimum Cooking Food Temperatures and Holding Times Required by Chapter 3

 

FoodMinimum TemperatureMinimum Holding Time at the Specified Temperature
Unpasteurized Shell Eggs prepared for immediate service
Commercially Raised Game Animals
Fish, Pork, and Meat Not Otherwise Specified in this Chart or in in ¶ 3-401.11(B)
63°C (145°F)15 seconds
Unpasteurized Shell Eggs not prepared for immediate service
Exotic Species of Game Animals
Comminuted Fish and Meats
Injected Meats
70°C (158°F)
68°C (155°F)
66°C (150°F)
63°C (145°F)
<1 second
15 seconds
1 minute
3 minutes
Poultry
Stuffed Fish; Stuffed Meat; Stuffed Pasta; Stuffed Poultry
Stuffing Containing Fish, Meat, or Poultry
Wild Game Animals
74°C (165°F)15 seconds
Food Cooked in a Microwave Oven74°C (165°F)and hold for 2 minutes after removing from microwave oven

 

Chart
    2

Summary Chart for Minimum Food Temperatures and Holding Times Required by Chapter 3 for Reheating Foods for Hot Holding

 

FoodMinimum TemperatureMinimum Holding Time at the Specified TemperatureMaximum Time to Reach Minimum Temperature
¶ 3-403.11(A)
Food that is cooked, cooled, and reheated
74°C (165°F)15 seconds2 hours
¶ 3-403.11(B)
Food that is reheated in a microwave oven
74°C (165°F)and hold for 2 minutes after removing from microwave oven2 hours
¶ 3-403.11(C)
Food that is taken from a commercially processed, hermetically sealed container or intact package
60°C (140°F)No time specified2 hours
¶ 3-403.11(E)
Unsliced portions of roasts of beef and roasts of pork cooked as specified under Subparagraph 3-401.11(B)
Same oven parameters and minimum time and temperature conditions as specified under Subparagraph 3-401.11(B)Not applicable
OR
Minimum time and temperature conditions listed in this chart for ¶ 3-403.11(A) or ¶ 3-403.11(B).

 

Chart
    3

Summary Chart Ready-to-Eat, Potentially Hazardous Food, Date Marking § 3-501.17 and Disposition § 3-501.18

flow diagram of permissible times

 

Formula for Consume- or Dispose-by Date
C = T - F

C = consume- or dispose-by date
T = days allowed based on storage temperature
F = days before freezing

Example:    The morning of October 1, a chicken was cooked, then cooled, refrigerated for 2 days at 41°F and then frozen. If the chicken is thawed October 10, the food must be consumed or discarded no later than midnight of October 15.

 

Chart 4

 

FDA Food Code Mobile Food Establishment Matrix

This table is a plan review and inspectional guide for mobile food establishments based on the mobile unit's menu and operation. Mobile units range in type from push carts to food preparation catering vehicles.

 

To use the table, read down the columns based on the menu and operation in use. For example, if only prepackaged potentially hazardous food is served, then requirements listed in the Potentially Hazardous Menu - Prepackaged column apply. Likewise, if only food that is not potentially hazardous is prepared on board, then requirements listed in the Not Potentially Hazardous Menu - Food Preparation column apply. Note that if a mobile food establishment has available for sale to the consumer both prepackaged potentially hazardous food and potentially hazardous food prepared on board, then the more stringent requirements of the Potentially Hazardous Menu - Food Preparation column apply.

It is important to remember that mobile units may also be subject to all Food Code provisions that apply to food establishments. Consult the local regulatory authority for specific local requirements.

The local regulatory authority's decision to require auxiliary support services such as a commissary or servicing area should be based on the menu, type of operation and availability of on-board or on-site equipment.

NOTE: The Food Code definition of "Food Establishment" does not include an establishment that offers only prepackaged foods that are not potentially hazardous.

 

FDA FOOD CODE MOBILE FOOD ESTABLISHMENT MATRIX

Food CodePotentially Hazardous MenuNot Potentially Hazardous Menu
Areas/Chapter

Food Preparation

Prepackaged

Food Preparation

PersonnelApplicable Sections of Parts 2-2 - 2-4
5-203.11 (B)
Applicable Sections of Parts 2-2 - 2-4
5-203.11 (B)
Applicable Sections of Parts 2-2 - 2-4
5-203.11 (B)
Food3-101.11
3-201.11-.16
3-202.16;
Applicable Sections of Part 3-3;
3-501.16
3-501.18(A) &(C)
3-101.11
3-201.11-.16
3-303.12(A)
3-305.11;
3-305.12
(Applicable to Service Area or Commissary)
3-101.11;
3-201.11 3-202.16;
Applicable Sections of Part 3-3
Temperature Requirements3-202.11;
Applicable Sections of Parts 3-4 & 3-5
3-202.11
3-501.16
NONE
Equipment RequirementsApplicable Sections of Parts 4-1 - 4-9 and 5-5Applicable Sections of Parts 4-1 - 4-2; 4-6 and 5-5Applicable Sections of Parts 4-1 - 4-2; 4-5 - 4-6 and 5-5
Water & Sewage5-104.12
5-203.11(A) & (B) Part 5-3; 5-401.11 5-402.13-.15
5-203.11(B)5-104.12
5-203.11(A) & (B)
Part 5-3; 5-401.11
5-402.13-.15
Physical Facility6-101.11;
6-201.11
6-102.11(A) & (B)
6-202.15;
6-501.11
6-501.12;
6-501.111
6-101.11
6-102.11(A) & (B)
6-202.15
6-501.111
6-101.11;
6-201.11
6-102.11(A) & (B)
6-202.15;
6-501.11
6-501.12;
6-501.111
Toxic MaterialsApplicable Sections of Chapter 7Applicable Sections of Chapter 7Applicable Sections of Chapter 7
Servicing6-202.18 / As necessary to comply with the Food Code6-202.18 / As necessary to comply with the Food Code6-202.18 / As necessary to comply with the Food Code
Compliance and Enforcement Applicable Sections of Chapter 8 and Annex 1Applicable Sections of Chapter 8 and Annex 1Applicable Sections of Chapter 8 and Annex 1