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U. S. Department of Health and Human Services Public Health Service Food and Drug Administration 1999 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
Subpart
3-101 Condition
(D) Fish, other than molluscan shellfish, that are intended for consumption in their raw form and allowed as specified in Subparagraph 3-401.11(C)(1) may be offered for sale or service if they are obtained from a supplier that freezes the fish as specified under § 3-402.11; or frozen on the premises as specified under § 3-402.11 and records are retained as specified under §3-402.12.
(3-201.14 Fish.* (A) Fish that are received for sale or service shall be:
(1) Commercially and legally caught or harvested; or
(2) Approved for sale or service.
(B) Molluscan shellfish that are recreationally caught may not be received for sale or service.
Specifications for Receiving
3-202.11 Temperature.* (A) Except as specified in ¶ (B) of this section, refrigerated, potentially hazardous food shall be at a temperature of 5°C (41°F) or below when received.
(B) If a temperature other than 5°C (41°F) for a potentially hazardous food is specified in law governing its distribution, such as laws governing milk, molluscan shellfish, and shell eggs, the food may be received at the specified temperature.
(C) Potentially hazardous food that is cooked to a temperature and for a time specified under §§ 3-401.11 - 3-401.13 and received hot shall be at a temperature of 60°C (140°F) or above.
(D) A food that is labeled frozen and shipped frozen by a food processing plant shall be received frozen.
(E) Upon receipt, potentially hazardous food shall be free of evidence of previous temperature abuse.
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 - Regulations Governing the Grading of Shell Eggs and U.S. Standards, Grades, and Weight classes for Shell Eggs, and 7 CFR Part 59 - Regulations Governing the Inspection of Eggs and Egg Products.
(B) Fruits and vegetables may be washed by using chemicals as specified under § 7-204.12.
3-4 DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN
Subparts
3-401 Cooking 3-402 Freezing 3-403 Reheating
Freezing
3-402.11 Parasite Destruction.* (A) Except as specified in ¶ (B) of this section, before service or sale in ready-to-eat form, raw, raw-marinated, partially cooked, or marinated-partially cooked fish other than molluscan shellfish shall be frozen throughout to a temperature of:
(1) -20°C (-4°F) or below for 168 hours (7 days) in a freezer; or
(2) -35°C (-31°F) or below for 15 hours in a blast freezer.
(B) If the fish are tuna of the species Thunnus alalunga, Thunnus albacares (Yellowfin tuna), Thunnus atlanticus, Thunnus maccoyii (Bluefin tuna, Southern), Thunnus obesus (Bigeye tuna), or Thunnus thynnus (Bluefin tuna, Northern), the fish may be served or sold in a raw, raw-marinated, or partially cooked ready-to-eat form without freezing as specified under ¶ (A) of this section.
3-402.12 Records, Creation and Retention. (A) Except as specified in ¶ 3-402.11(B) and ¶ (B) of this section, if raw, raw-marinated, partially cooked, or marinated-partially cooked fish are served or sold in ready-to-eat form, the person in charge shall record the freezing temperature and time to which the fish are subjected and shall retain the records at the food establishment for 90 calendar days beyond the time of service or sale of the fish.
(B) If the fish are frozen by a supplier, a written agreement or statement from the supplier stipulating that the fish supplied are frozen to a temperature and for a time specified under § 3-402.11 may substitute for the records specified under ¶ (A) of this section.
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:
(A) Under refrigeration that maintains the food temperature at 5°C (41°F) or less, or at 7°C (45°F) or less as specified under ¶ 3-501.16(C); or
(B) At any temperature if the food remains frozen.
3-501.13 Thawing. Except as specified in ¶ (D) of this section, potentially hazardous Food shall be thawed:
(A) Under refrigeration that maintains the food temperature at 5°C (41°F) or less, or at 7°C (45°F) or less as specified under ¶ 3-501.16(C); or
(B) Completely submerged under running water:
(1) At a water temperature of 21°C (70°F) or below,
(2) With sufficient water velocity to agitate and float off loose particles in an overflow, and
(3) For a period of time that does not allow thawed portions of ready-to-eat food to rise above 5°C (41°F), or 7°C (45°F) as specified under¶ 3-501.16(C), or
(4) For a period of time that does not allow thawed portions of a raw animal food requiring cooking as specified under ¶ 3-401.11(A) or (B) to be above 5°C (41°F), or 7°C (45°F) as specified under ¶ 3-501.16(C), for more than 4 hours including:
(a) The time the food is exposed to the running water and the time needed for preparation for cooking, or
(b) The time it takes under refrigeration to lower the food temperature to 5°C (41°F), or 7°C (45°F) as specified under ¶ 3-501.16(C); (c) Delineate cleaning and sanitization procedures for food-contact surfaces; and
(7) Describes the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the:
(a) Concepts required for a safe operation,
(b) Equipment and facilities, and
(c) Procedures specified under Subparagraph (B)(6) of this section and ¶ 8-201.14(D).
(C) Except for fish that is frozen before, during, and after packaging, a food establishment may not package fish using a reduced oxygen packaging method.
There are two components to satisfactory compliance: Disclosure and Reminder.
Disclosure is satisfied when:
(1) Items are described, such as: (a) Oysters on the half-shell (raw oysters), (b) Raw-egg Caesar salad, and (c) Hamburgers (can be cooked to order); or
(2) Items are asterisked to a footnote that states that the items: (a) Are served raw or undercooked, or (b) Contain (or may contain) raw or undercooked ingredients.
Reminder is satisfied when the items requiring disclosure are asterisked to a footnote that states:
(1) Regarding the safety of these items, written information is available upon request;1
(2) Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness; or
(3) Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness, especially if you have certain medical conditions.
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Consumer Advisory
3-603.11 Consumption of Animal Foods that are Raw, Undercooked, or Not Otherwise Processed to Eliminate Pathogens.* Except as specified in ¶ 3-401.11(C) and Subparagraph 3-401.11(D)(3) And under ¶ 3-801.11(D), if 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.
3-8 SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS
Subpart
3-801 Additional Safeguards
3-801.11 Pasteurized Foods, Prohibited Reservice, and Prohibited Food.* In a food establishment that serves a highly susceptible population:
(A) Prepackaged juice or a prepackaged beverage containing juice, that bears a warning label as specified in 21 CFR, Section 101.17(g) Food Labeling, may not be served or offered for sale;
(B) Pasteurized shell eggs or pasteurized liquid, frozen, or dry eggs or egg products shall be substituted for raw shell eggs in the preparation of:
(1) Foods such as Caesar salad, hollandaise or Béarnaise sauce, mayonnaise, egg nog, ice cream, and egg-fortified beverages, and
(2) Except as specified in ¶ (E) of this section, recipes in which more than one egg is broken and the eggs are combined;
(C) Food in an unopened original package may not be re-served; and
(D) The following foods may not be served or offered for sale in a ready-to-eat form:
(1) Raw animal foods such as raw fish, raw-marinated fish, raw molluscan shellfish, and steak tartare,
(2) A partially cooked animal food such as lightly cooked fish, rare meat, soft-cooked eggs that are made from raw shell eggs, and meringue, and
(3) Raw seed sprouts.
(E) Subparagraph (B)(2) of this section does not apply if:
(1) The raw eggs are combined immediately before cooking for one consumer"s serving at a single meal, cooked as specified under Subparagraph 3-401.11(A)(1), and served immediately, such as an omelet, soufflé, or scrambled eggs;
(2) The raw eggs are combined as an ingredient immediately before baking and the eggs are thoroughly cooked to a ready-to-eat form, such as a cake, muffin, or bread; or
(3) The preparation of the food is conducted under a HACCP plan that:
(a) Identifies the food to be prepared,
(b) Prohibits contacting ready-to-eat food with bare hands,
(c) Includes specifications and practices that ensure:
(i) Salmonella Enteritidis growth is controlled before and after cooking, and
(ii) Salmonella Enteritidis is destroyed by cooking the eggs according to the temperature and time specified in subparagraph 3-401.11(A)(2),
(d) Contains the information specified under ¶ 8-201.14(D) including procedures that:
(i) Control cross contamination of ready-to-eat food with raw eggs, and
(ii) Delineate cleaning and sanitization procedures for food-contact surfaces, and
(e) Describes the training program that ensures that the food employee responsible for the preparation of the food understands the procedures to be used.
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