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U.S. Department of Health and Human Services

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FDA Food Code 2009: Annex 3 - Public Health Reasons / Administrative Guidelines - Chapter 1, Purpose and Definitions

 

Public Health Reasons / Administrative Guidelines for:


Chapter 1 Purpose and Definitions

Applicability and Terms Defined

1-201.10 Statement of Application and Listing of Terms.

(B) Terms Defined

The individual definitions in Chapter 1 are not numbered, consistent with current conventions regarding the use of plain language in drafting rules, and with use in national and international standards and some Federal regulations. This facilitates making changes to the definitions as they become necessary in subsequent editions of the Food Code. The intent of the definitions to be binding in terms of the application and interpretation of the Code is clearly stated in Chapter 1.

Accredited Program.

Refer to the definition for Accredited Program in ¶ 1-201.10 (B)(3).

Food protection manager certification occurs when individuals demonstrate through a certification program that they have met specified food safety knowledge standards.

Food protection certification program accreditation occurs when certification organizations demonstrate through an accreditation program that they have met specified program standards.

Accreditation is a conformity assessment process through which organizations that certify individuals may voluntarily seek independent evaluation and listing by an accrediting agency based upon the certifying organization=s meeting program accreditation standards. Such accreditation standards typically relate to such factors as the certifying organization's structure, mission, policies, procedures, and the defensibility of its examination processes. These standards are intended to affirm or enhance the quality and credibility of the certification process, minimize the potential for conflicts of interest, ensure fairness to candidates for certification and others, and thereby increase public health protection.

Program accreditation standards known to be relevant to food protection manager certification programs include those contained in the Standards for Accreditation of Food Protection Manager Certification Programs available from the Conference for Food Protection, 2792 Miramar Lane, Lincoln, CA 95648 and found at Standards for Accreditation of Food Protection Manager Certification Programs

Allowing food protection managers to demonstrate their required food safety knowledge "through passing a test that is part of an accredited program" is predicated on the fact that their credentials have been issued by certifying organizations that have demonstrated conformance with rigorous and nationally recognized program standards.

Egg.

The definition of egg includes avian species' shell eggs known to be commercially marketed in the United States. Also included are the eggs of quail and ratites such as ostrich.

Not included are baluts. Baluts are considered a delicacy among Philippine and Vietnamese populations. They are derived from fertile eggs, typically duck eggs, subjected to incubation temperatures for a period of time less than necessary for the embryo to hatch resulting in a partially formed embryo within the shell. Under the Egg Products Inspection Act (EPIA), an egg is typically considered adulterated if it has been subjected to incubation. However, in 9 CFR 590.5, baluts are specifically exempted from inspection as eggs under the EPIA.

In producing baluts, fertile duck eggs are incubated for approximately 18 days at a temperature of 42.5°C (108.5°F) in incubators with a relatively high humidity. (Complete development and hatching would take place in 28 days.) Under these conditions, the potential for growth of transovarian Salmonella organisms such as S. Enteritidis within the shell, and the potential for an increase in pathogenic microflora on the shell itself, are increased. Where chicken eggs are used in preparing baluts, the incubation period may only be 14 days at an incubation temperature of 37°C (99°F). A balut is a potentially hazardous food (time/temperature control for safety food) subject to time/temperature management including proper cooking and hot and cold holding. Baluts are typically boiled and packed in salt before sale or service.

Also, not included in this definition are the eggs of reptile species such as alligators and turtles. Alligator eggs are available for sale in some parts of the southern United States. In restaurants, the menu item "Alligator Eggs" is sometimes made of alligator egg, but other times is simply a fanciful name for a menu item that may include seafood items such as shrimp, but contains no alligator egg.

Sea turtle eggs have been consumed in Asian and Latin American Countries. However, turtle eggs are not mentioned in the definitions section because sea turtles (Loggerhead, East Pacific Green, Leatherback, Hawksbill, Kemp's Ridley, and Olive Ridley) are protected by The Endangered Species Act of 1973 and therefore may not be sold or consumed. This Act, with respect to turtle eggs, is enforced by the United States Department of Interior, U.S. Fish and Wildlife Service, Washington, DC.

Food establishment and food processing plant.

Food Establishment and a food processing plant located within the same premises of a food establishment

Some food businesses perform operations that provide food directly to consumers as a "Food Establishment," and also supply food to other business entities as a "Food Processing Plant." Within such a business, those operations that provide food directly to consumers only should be considered part of a "Food Establishment" for the purposes of applying the Food Code while those operations that supply food to other business entities may be subject to other rules and regulations that apply to "Food Processing Plants". It is essential that the permit holder and persons in charge be aware that regulatory requirements and the appropriate operational practices for "Food Establishments" may differ from those for "Food Processing Plants."

Some facilities and functions may be subject to different regulatory requirements depending on whether that facility or function is regulated as a "Food Establishment" or as a "Food Processing Plant", or both. Those facilities and functions within a business that are shared by both the "Food Establishment" and "Food Processing Plant" operations, e.g., refrigeration units, dressing room and toilet facilities, food equipment, water and waste systems, pest control, might be subject to similar regulatory requirements. The Food Code is intended to apply to "food establishments".

Potentially Hazardous Food (Time/Temperature Control for Safety Food)

Potentially hazardous food (PHF/TCS food) is defined in terms of whether or not it requires time/temperature control for safety to limit pathogen growth or toxin formation. The term does not include foods that do not support growth but may contain a pathogenic microorganism or chemical or physical food safety hazard at a level sufficient to cause foodborne illness or injury. The progressive growth of all foodborne pathogens is considered whether slow or rapid.

The definition of PHF/TCS food takes into consideration pH, aw, pH and aw interaction, heat treatment, and packaging for a relatively simple determination of whether the food requires time/temperature control for safety. If the food is heat-treated to eliminate vegetative cells, it needs to be addressed differently than a raw product with no, or inadequate, heat treatment. In addition, if the food is packaged after heat treatment to destroy vegetative cells and subsequently packaged to prevent re-contamination, higher ranges of pH and/or aw can be tolerated because remaining spore-forming bacteria are the only microbial hazards of concern. While foods will need to be cooled slightly to prevent condensation inside the package, they must be protected from contamination in an area with limited access and packaged before temperatures drop below 57°C (135°F). In some foods, it is possible that neither the pH value nor the aw value is low enough by itself to control or eliminate pathogen growth; however, the interaction of pH and aw may be able to accomplish it. This is an example of a hurdle technology. Hurdle technology involves several inhibitory factors being used together to control or eliminate pathogen growth, when they would otherwise be ineffective if used alone. When no other inhibitory factors are present and the pH and/or aw values are unable to control or eliminate bacterial pathogens which may be present, growth may occur and foodborne outbreaks result. Cut melons, cut tomatoes, and cut leafy greens are examples where intrinsic factors are unable to control bacterial growth once pathogens are exposed to the cellular fluids and nutrients after cutting.

In determining if time/temperature control is required, combination products present their own challenge. A combination product is one in which there are two or more distinct food components and an interface between the two components may have a different property than either of the individual components. A determination must be made about whether the food has distinct components such as pie with meringue topping, focaccia bread, meat salads, or fettuccine alfredo with chicken or whether it has a uniform consistency such as gravies, puddings, or sauces. In these products, the pH at the interface is important in determining if the item is a PHF/TCS food.

A well designed inoculation study or other published scientific research should be used to determine whether a food can be held without time/temperature control when:

  • process technologies other than heat are applied to destroy foodborne pathogens (e.g., irradiation, high pressure processing, pulsed light, ozonation);
  • combination products are prepared; or
  • other extrinsic factors (e.g., packaging/atmospheres) or intrinsic factors (e.g., redox potential, salt content, antimicrobials) are used to control or eliminate pathogen growth.

Before using Tables A and B in paragraph 1-201.10(B) of the definition for "potentially hazardous food (time/temperature control for safety food)" in determining whether a food requires time/temperature control for safety (TCS), answers to the following questions should be considered:

  • Is the intent to hold the food without using time or temperature control?
    • If the answer is No, no further action is required. The decision tree later in this Annex is not needed to determine if the item is a PHF/TCS food.
  • Is the food raw, or is the food heat-treated?
  • Does the food already require time/temperature control for safety by definition in paragraph 1-201.10(B)?
  • Does a product history with sound scientific rationale exist indicating a safe history of use?
  • Is the food processed and packaged so that it no longer requires TCS such as ultra high temperature (UHT) creamers or shelf-stable canned goods?
  • What is the pH and aw of the food in question using an independent laboratory and Association of Official Analytical Chemists (AOAC) methods of analysis?

A food designated as product assessment required (PA), in either table should be considered PHF/TCS Food until further study proves otherwise. The PA means that based on the food's pH and aw and whether it was raw or heat-treated or packaged, it has to be considered PHF until inoculation studies or some other acceptable evidence shows that the food is a PHF/TCS food or not. The Food Code requires a variance request to the regulatory authority with the evidence that the food does not require time/temperature control for safety.

The Food Code definition designates certain raw plant foods as PHF/TCS food because they have been shown to support the growth of foodborne pathogens in the absence of temperature control and to lack intrinsic factors that would inhibit pathogen growth. Unless product assessment shows otherwise, these designations are supported by Tables A and B. For example:

For cut cantaloupe (pH 6.2-7.1, aw > 0.99, not heat-treated), fresh sprouts (pH > 6.5, aw > 0.99, not heat-treated), and cut tomatoes (pH 4.23 - 5.04, aw > 0.99, not heat-treated), Table B indicates that they are considered PHF/TCS Foods unless a product assessment shows otherwise. Maintaining these products under the temperature control requirements prescribed in this code for PHF/TCS food will limit the growth of pathogens that may be present in or on the food and may help prevent foodborne illness.

If a facility adjusts the pH of a food using vinegar, lemon juice, or citric acid for purposes other than flavor enhancement, a variance is required under ¶ 3-502.11(C). A HACCP plan is required whether the food is a PHF/TCS food as in subparagraph 3-502.11 (C)(1) or not a PHF/TCS food, as in subparagraph 3-502.11(C)(2). A standardized recipe validated by lab testing for pH and aw would be an appropriate part of the variance request with annual (or other frequency as specified by the regulatory authority) samples tested to verify compliance with the conditions of the variance.

More information can be found in the Institute of Food Technologists (IFT) Report, "Evaluation and Definition of Potentially Hazardous Foods".

Instructions for using the following Decision Tree and Table A and Table B:

  1. Does the operator want to hold the food without using time or temperature control?
    1. No - Continue holding the food at ≤5°C(41°F) or ≥57°C(135°F) for safety and/or quality.
    2. Yes - Continue using the decision tree to identify which table to use to determine whether time/temperature control for safety (TCS) is required.
  2. Is the food heat-treated?
    1. No - The food is either raw, partially cooked (not cooked to the temperature specified in section 3-401.11 of the Food Code) or treated with some other method other than heat. Proceed to step #3.
    2. Yes - If the food is heat-treated to the required temperature for that food as specified under section 3-401.11 of the Food Code, vegetative cells will be destroyed although spores will survive. Proceed to step #4.
  3. Is the food treated using some other method?
    1. No - The food is raw or has only received a partial cook allowing vegetative cells and spores to survive. Proceed to step #6.
    2. Yes - If a method other than heat is used to destroy pathogens such as irradiation, high pressure processing, pulsed light, ultrasound, inductive heating, or ozonation, the effectiveness of the process needs to be validated by inoculation studies or other means. Proceed to step #5.
  4. Is it packaged to prevent re-contamination?
    1. No - Re-contamination of the product can occur after heat treatment because it is not packaged. Proceed to step #6.
    2. Yes - If the food is packaged immediately after heat treatment to prevent re-contamination, higher ranges of pH and/or aw can be tolerated because spore-forming bacteria are the only microbial hazard. Proceed to step #7.
  5. Further product assessment or vendor documentation required.
    1. The vendor of this product may be able to supply documentation that inoculation studies indicate the food can be safely held without time/temperature control for safety.
    2. Food prepared or processed using new technologies may be held without time/temperature control provided the effectiveness of the use of such technologies is based on a validated inoculation study.
  6. Using the food's known pH and/or aw values, position the food in the appropriate table.
    1. Choose the column under "pH values" that contains the pH value of the food in question.
    2. Choose the row under "aw values" that contains the aw value of the food in question.
    3. Note where the row and column intersect to identify whether the food is "non-PHF/non-TCS food" and therefore does not require time/temperature control, or whether further product assessment (PA) is required. Other factors such as redox potential, competitive microorganisms, salt content, or processing methods may allow the product to be held without time/temperature control but an inoculation study is required.
  7. Use Table A for foods that are heat-treated and packaged OR use Table B for foods that are not heat-treated or heat-treated but not packaged.
  8. Determine if the item is non-PHF/non-TCS or needs further product assessment (PA).

1-201.10(B) Decision Tree #1 - Using pH, aw, or the Interaction of pH and aw to Determine if a Food Requires Time/Temperature Control for Safety

Link to description of 1-201.10(B) Decision Tree #1.

1-201.10(B) - Table A and Table B

Table A. Interaction of pH and aw for control of spores in food
heat-treated to destroy vegetative cells and subsequently packaged
aw valuespH values
4.6 or less> 4.6 - 5.6> 5.6
≤ 0.92non-PHF*/non-TCS food**non-PHF/non-TCS foodnon-PHF/non-TCS food
> 0.92 - .95non-PHF/non-TCS foodnon-PHF/non-TCS foodPA***
> 0.95non-PHF/non-TCS foodPAPA

* PHF means Potentially Hazardous Food
** TCS food means Time/Temperature Control for Safety food
*** PA means Product Assessment required

 Table B. Interaction of pH and aw for control of vegetative cells
and spores in food not heat-treated or heat-treated but not packaged
aw valuespH values
< 4.24.2 - 4.6> 4.6 - 5.0> 5.0
< 0.88non-PHF*/ non-TCS food**non-PHF/ non-TCS foodnon-PHF/ non-TCS foodnon-PHF/ non-TCS food
0.88 - 0.90non-PHF/ non-TCS foodnon-PHF/ non-TCS foodnon-PHF/ non-TCS foodPA***
> 0.90 - 0.92non-PHF/ non-TCS foodnon-PHF/ non-TCS foodPAPA
> 0.92non-PHF/ non-TCS foodPAPAPA

* PHF means Potentially Hazardous Food
** TCS food means Time/Temperature Control for Safety food
*** PA means Product Assessment required