U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
2001 Food Code
(Updated April 2004*)
Supplement to the 2001 Food Code

 
 
Chapter
 3
 
    Food
Parts
  3-1   CHARACTERISTICS
  3-2   SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND RECORDS
  3-3   PROTECTION FROM CONTAMINATION AFTER RECEIVING
  3-4   DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN
  3-5   LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN
  3-6   FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING
  3-7   CONTAMINATED FOOD
  3-8   SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS
3-1    CHARACTERISTICS
 
Subparts
 
3-101     Condition

Condition

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

Food shall be safe, unadulterated, and, as specified under § 3-601.12, honestly presented.
 
 
3-2     SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND RECORDS
 
Subparts
 
3-201     Sources
3-202     Specifications for Receiving
3-203     Original Containers and Records

Sources

   3-201.11 Compliance with Food Law.*

   3-201.12 Food in a Hermetically Sealed Container.*

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

   3-201.13 Fluid Milk and Milk Products.*

Fluid milk and milk products shall be obtained from sources that comply with grade a standards as specified in law.

   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.*

(See Supplement)

   3-202.12 Additives.*

Food may not contain unapproved food additives or additives that exceed amounts specified in 21 CFR 170-180 relating to food additives, generally recognized as safe or prior sanctioned substances that exceed amounts specified in 21 CFR 181-186, substances that exceed amounts specified in 9 CFR Subpart C Section 424.21(b) Food ingredients and sources of radiation, or pesticide residues that exceed provisions specified in 40 CFR 185 Tolerances for Pesticides in Food.

   3-202.13 Shell Eggs.*

Shell eggs shall be received clean and sound and may not exceed the restricted egg tolerances for U.S. Consumer Grade B as specified in 7 CFR Part 56 " Voluntary Grading of Shell Eggs and United States Standards, Grades, and Weight Classes for Shell Eggs, and 9 CFR Part 590 " Inspection of Eggs and Egg Products.

   3-202.14 Eggs and Milk Products, Pasteurized.*

   3-202.15 Package Integrity.*

Food packages shall be in good condition and protect the integrity of the contents so that the food is not exposed to adulteration or potential contaminants.

   3-202.16 Ice.*

Ice for use as a food or a cooling medium shall be made from drinking water.

   3-202.17 Shucked Shellfish, Packaging and Identification.

   3-202.18 Shellstock Identification.*

   3-202.19 Shellstock, Condition.

When received by a food establishment, shellstock shall be reasonably free of mud, dead shellfish, and shellfish with broken shells. Dead shellfish or shellstock with badly broken shells shall be discarded.

   3-202.110 Juice Treated.

Pre-packaged juice shall:

Original Containers and Records

   3-203.11 Molluscan Shellfish, Original Container.

   3-203.12 Shellstock, Maintaining Identification.*


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 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.

 
 
3-3     PROTECTION FROM CONTAMINATION AFTER RECEIVING
 
Subparts
 
3-301     Preventing Contamination by Employees
3-302     Preventing Food and Ingredient Contamination Contamination
3-303     Preventing Contamination from Ice Used as a Coolant
3-304     Preventing Contamination from Equipment, Utensils, and Linens
3-305     Preventing Contamination from the Premises
3-306     Preventing Contamination by Consumers
3-307     Preventing Contamination from Other Sources

Preventing Contamination by Employees

   3-301.11 Preventing Contamination from Hands.*

(See Supplement)

   3-301.12 Preventing Contamination when Tasting.*

A food employee may not use a utensil more than once to taste food that is to be sold or served.

Preventing Food and Ingredient Contamination

   3-302.11 Packaged and Unpackaged Food - Separation, Packaging, and Segregation.*

   3-302.12 Food Storage Containers, Identified with Common Name of Food.

Working containers holding food or food ingredients that are removed from their original packages for use in the food establishment, such as cooking oils, flour, herbs, potato flakes, salt, spices, and sugar shall be identified with the common name of the food except that containers holding food that can be readily and unmistakably recognized such as dry pasta need not be identified.

   3-302.13 Pasteurized Eggs, Substitute for Raw Shell Eggs for Certain Recipes.*

Pasteurized eggs or egg products shall be substituted for raw shell eggs in the preparation of foods such as Caesar salad, hollandaise or Béarnaise sauce, mayonnaise, eggnog, ice cream, and egg-fortified beverages that are not:

   3-302.14 Protection from Unapproved Additives.*

   3-302.15 Washing Fruits and Vegetables.

Preventing Contamination from Ice Used as a Coolant

   3-303.11 Ice Used as Exterior Coolant, Prohibited as Ingredient.

After use as a medium for cooling the exterior surfaces of food such as melons or fish, packaged foods such as canned beverages, or cooling coils and tubes of equipment, ice may not be used as food.

   3-303.12 Storage or Display of Food in Contact with Water or Ice.

Preventing Contamination from Equipment, Utensils, and Linens

   3-304.11 Food Contact with Equipment and Utensils.*

Food shall only contact surfaces of equipment and utensils that are cleaned as specified under Part 4-6 of this Code and sanitized as specified under Part 4-7 of this Code.

   3-304.12 In-Use Utensils, Between-Use Storage.

(See Supplement)

During pauses in food preparation or dispensing, food preparation and dispensing utensils shall be stored:

   3-304.13 Linens and Napkins, Use Limitation.

Linens and napkins may not be used in contact with food unless they are used to line a container for the service of foods and the linens and napkins are replaced each time the container is refilled for a new consumer.

   3-304.14 Wiping Cloths, Use Limitation.

(See Supplement)

   3-304.15 Gloves, Use Limitation.

   3-304.16 Using Clean Tableware for Second Portions and Refills.

   3-304.17 Refilling Returnables.

Preventing Contamination from the Premises

   3-305.11 Food Storage.

   3-305.12 Food Storage, Prohibited Areas.

Food may not be stored:

   3-305.13 Vended Potentially Hazardous Food, Original Container.

Potentially hazardous food dispensed through a vending machine shall be in the package in which it was placed at the food establishment or food processing plant at which it was prepared.

   3-305.14 Food Preparation.

During preparation, unPACKAGED FOOD shall be protected from environmental sources of contamination.

Preventing Contamination by Consumers

   3-306.11 Food Display.

Except for nuts in the shell and whole, raw fruits and vegetables that are intended for hulling, peeling, or washing by the consumer before consumption, food on display shall be protected from contamination by the use of packaging; counter, service line, or salad bar food guards; display cases; or other effective means.

   3-306.12 Condiments, Protection.

   3-306.13 Consumer Self-Service Operations.*

(See Supplement)

   3-306.14 Returned Food and Reservice of Food.*

Preventing Contamination from Other Sources

   3-307.11 Miscellaneous Sources of Contamination.

Food shall be protected from contamination that may result from a factor or source not specified under Subparts 3-301 - 3-306.
 
 
3-4     DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN
 
Subparts
 
3-401     Cooking
3-402     Freezing
3-403     Reheating
3-404     Other Methods

Cooking

   3-401.11 Raw Animal Foods.*

(See Supplement)

   3-401.12 Microwave Cooking.*

Raw animal foods cooked in a microwave oven shall be:

   3-401.13 Plant Food Cooking for Hot Holding.

(See Supplement)

Fruits and vegetables that are cooked for hot holding shall be cooked to a temperature of 60°C (140°F).

Freezing

   3-402.11 Parasite Destruction.*

   3-402.12 Records, Creation and Retention.

Reheating

   3-403.10 Preparation for Immediate Service.

Cooked and refrigerated food that is prepared for immediate service in response to an individual consumer order, such as a roast beef sandwich au jus, may be served at any temperature.

   3-403.11 Reheating for Hot Holding.*

(See Supplement)

Other Methods

   3-404.11 Treating Juice

Juice packaged in a food establishment shall be:
 
 
3-5     LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN
 
Subparts
 
3-501     Temperature and Time Control
3-502     Specialized Processing Methods

Temperature and Time Control

   3-501.11 Frozen Food.

Stored frozen foods shall be maintained frozen.

   3-501.12 Potentially Hazardous Food, Slacking.

Frozen potentially hazardous food that is slacked to moderate the temperature shall be held:

   3-501.13 Thawing.

Except as specified in ¶ (D) of this section, potentially hazardous food shall be thawed:

   3-501.14 Cooling.*

(See Supplement)

   3-501.15 Cooling Methods.

   3-501.16 Potentially Hazardous Food, Hot and Cold Holding.*

(See Supplement)

   3-501.17 Ready-to-Eat, Potentially Hazardous Food, Date Marking.*

on-premises preparation
  • prepare and hold cold
  • (A) Except as specified in ¶ (D) of this section, refrigerated, ready-to-eat, potentially hazardous food prepared and held in a food establishment for more than 24 hours shall be clearly marked to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded, based on the temperature and time combinations specified below:
     
    • (1) 5°C (41°F) or less for a maximum of 7 days; or
       
    • (2) 7°C (45°F) or between 5°C (41°F) and 7°C (45°F) for a maximum of 4 days in existing refrigeration equipment that is not capable of maintaining the food at 5°C (41°F) or less if:
       
      • (a) The equipment is in place and in use in the food establishment, and
         
      • (b) Within 5 years of the regulatory authority's adoption of this code, the equipment is upgraded or replaced to maintain food at a temperature of 5°C (41°F) or less.
         
    The day of preparation shall be counted as Day 1.
commercially processed food
  • open and hold cold
     
  • (B) Except as specified in ¶¶ (D) and (E) of this section, refrigerated, ready-to-eat, potentially hazardous food prepared and packaged by a food processing plant shall be clearly marked, at the time the original container is opened in a food establishment and if the food is held for more than 24 hours, to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded, based on the temperature and time combinations specified in ¶ (A) of this section; and:
     
    • (1) The day the original container is opened in the food establishment shall be counted as Day 1; and
       
    • (2) The day or date marked by the food establishment may not exceed a manufacturer's use-by date if the manufacturer determined the use-by date based on food safety.
       
  • (C) A refrigerated, ready-to-eat potentially hazardous food that is frequently rewrapped, such as lunchmeat or a roast, or for which date marking is impractical, such as soft serve mix or milk in a dispensing machine, may be marked as specified in ¶ (A) or (B) of this section, or by an alternative method acceptable to the regulatory authority.
     
  • (D) Paragraphs (A) and (B) of this section do not apply to individual meal portions served or repackaged for sale from a bulk container upon a consumer's request.
     
  • (E) Paragraph (B) of this section does not apply to the following when the face has been cut, but the remaining portion is whole and intact:
     
    • (1) Fermented sausages produced in a federally inspected food processing plant that are not labeled "Keep Refrigerated" and which retain the original casing on the product;
       
    • (2) Shelf stable, dry, fermented sausages; and
       
    • (3) Shelf stable salt-cured products such as prosciutto and Parma (ham) produced in a federally inspected food processing plant that are not labeled "Keep Refrigerated".
       
  • (F) A refrigerated, ready-to-eat, potentially hazardous food ingredient or a portion of a refrigerated, ready-to-eat, potentially hazardous food that is subsequently combined with additional ingredients or portions of food shall retain the date marking of the earliest-prepared or first-prepared ingredient.

   3-501.18 Ready-to-Eat, Potentially Hazardous Food, Disposition.*

   3-501.19 Time as a Public Health Control.*

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:

Clostridium botulinum Controls

   3-502.12 Reduced Oxygen Packaging, Criteria.*

(See Supplement)

3-6     FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING
 
Subparts
 
3-601     Accurate Representation
3-602     Labeling
3-603     Consumer Advisory

Accurate Representation

   3-601.11 Standards of Identity.

Packaged food shall comply with standard of identity requirements in 21 CFR 131-169 and 9 CFR 319 Definitions and Standards of Identity or Composition, and the general requirements in 21 CFR 130 - Food Standards: General and 9 CFR 319 Subpart A - General.

   3-601.12 Honestly Presented.

Labeling

   3-602.11 Food Labels.

   3-602.12 Other Forms of Information.


Current Status of Consumer Advisory Language Regarding § 3-603.11

The following information is not part of Chapter 3 and is not intended to be included in the codified portion of the Food Code. It is inserted here to provide a summary of recent events surrounding the matter of a consumer advisory, addressed in § 3-603.11 of the Code. In cases where the Food Code is adopted through incorporation by reference, this page may be removed.

A consensus as to what constitutes satisfactory compliance with § 3-603.11 was reached at the 1998 Conference for Food Protection (CFP) meeting. A third option for the consumer "reminder" was added later. This insert page is to alert the reader to the options available to food establishments in advising consumers of the increased possibility of foodborne illness when animal-derived foods are eaten raw or undercooked.

Included in Annex 3 is a full discussion of the evolution of the 1998 CFP consensus, satisfactory compliance, applicability of the Code provision, and the meaning and application of the phrase that appears in § 3-603.11, i.e., "or otherwise processed to eliminate pathogens."

There are two components to satisfactory compliance: Disclosure and Reminder.

Disclosure is satisfied when: Reminder is satisfied when the items requiring disclosure are asterisked to a footnote that states: ________________________________
  1 Essential criteria for such written information are being developed and will be made available, with a downloadable model brochure, on the CFSAN Web Page at http://www.cfsan.fda.gov. All brochures must meet these essential criteria.
 

Consumer Advisory

   3-603.11 Consumption of Animal Foods that are Raw, Undercooked, or Not Otherwise Processed to Eliminate Pathogens.*

(See Supplement)

Except as specified in ¶ 3-401.11(C) and Subparagraph 3-401.11(D)(3) and under ¶ 3-801.11(D), if an animal food such as beef, eggs, fish, lamb, milk, pork, poultry, or shellfish that is raw, undercooked, or not otherwise processed to eliminate pathogens is offered in a ready-to-eat form as a deli, menu, vended, or other item; or as a raw ingredient in another ready-to-eat food, the permit holder shall inform consumers by brochures, deli case or menu advisories, label statements, table tents, placards, or other effective written means of the significantly increased risk associated with certain especially vulnerable consumers eating such foods in raw or undercooked form.
 
 
3-7     CONTAMINATED FOOD
 
Subpart
 
3-701     Disposition

Disposition

   3-701.11 Discarding or Reconditioning Unsafe, Adulterated, or Contaminated Food.*


 
3-8     SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS
 
Subpart
 
3-801     Additional Safeguards

Additional Safeguards

(See Supplement)

   3-801.11 Pasteurized Foods, Prohibited Reservice, and Prohibited Food.*

(See Supplement)

In a food establishment that serves a highly susceptible population:

* April 2004 Update: Editorial edits were made to the 2001 Food Code to incorporate the Errata Sheet, corrections since original posting date, and for content accuracy. Links were also added where references exist to other parts/sections of the Food Code, the Code of Federal Regulations, the United States Code, and the Supplement to the 2001 Food Code.

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