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Issue Number: Council III 005

Title

TPHC 2 - Foods Starting at Room Temperature and Held Using TPHC

Issue you would like the Conference to consider

FDA Model Food Code (hereafter Food Code) Section 3-501.19 requires ready-to-eat, time/temperature control for safety food (TCS) to be at 5°C (41°F) or less before it is removed from temperature control for the purpose of using time alone as a public health control to hold or display the food. Food Code does not exclude cut tomatoes, cut cantaloupe, chopped leafy greens, opened canned tuna, and opened canned product used as a sole item when originating from ambient air temperature from the requirement of cooling to 5°C (41°F) prior to using Time As A Public Health Control (TPHC), although these foods commonly originate from ambient temperatures. As a result, this requires the aforesaid ambient temperature foods that become TCS during preparation (i.e. via cutting, chopping, or opening a hermetically sealed container) to undergo cooling to 5°C (41°F) or less before TPHC is allowed. Expanding the Food Code provision would allow for use of TPHC immediately after preparation of these foods at ambient temperature.

Public Health Significance

Tomatoes, cantaloupe, leafy greens, canned tuna, and other canned products used as a sole item are commonly held at room temperature prior to food preparation that renders them TCS. Broadening the TPHC provision in Food Code to incorporate a starting temperature of room temperature for these foods would eliminate the requirement to first cool the food items to 5°C (41°F) or below. In the absence of cooling to 5°C (41°F) or below, the bacterial lag phase may be affected as the food items would no longer require warming to reach equilibrium with room temperature.

In June 2010, FDA issued a guidance document regarding TPHC for cut tomatoes. The document referenced FDA's in-house studies wherein data suggested that the product temperature at the time of cutting did not significantly affect the growth of representative bacteria in the cut, inoculated tomatoes when they are subsequently displayed or held at room temperature. Furthermore, laboratory data and available growth models suggested that the lag time combined with the likely rate of growth would result in only limited concern about pathogen growth during a 4-hour period of room temperature storage immediately after slicing. The guidance document concluded that TPHC can be used to sufficiently limit the growth of pathogens in cut tomatoes, even if the tomatoes have been stored at room temperature prior to being sliced or cut.

When ComBase pathogen growth modeling is used to evaluate growth of pathogens of concern during a 4-hour period at room temperature for cut cantaloupe, chopped leafy greens, and opened canned tuna, the predicted growth rates suggest that TPHC can be used for these foods, similar to cut tomatoes.

References:

See TPHC Committee Final Report (attached to Issue titled: "Report-Time as a Public Health Control (TPHC) Committee") for documents and references reviewed by the committee.

Recommended Solution: The Conference recommends...

that a letter be sent to the FDA requesting that the 2013 Food Code be amended as follows (new language in underline format):

Section 3-501.19 (B)

(1) The FOOD shall have an initial temperature of 5°C (41°F) or less when removed from cold holding temperature control, or 57°C (135°F) or greater when removed from hot holding temperature control.P Tomatoes, cantaloupe, leafy greens, canned tuna, and shelf-stable canned product used as a sole item shall have an initial temperature of 22°C (72°F) or less when rendered time/temperature control for safety by way of cutting, chopping, or opening of a hermetically sealed container.

(2) The FOOD shall be marked or otherwise identified to indicate the time that is 4 hours past the point in time when the FOOD is removed from temperature control Pf, or rendered time/temperature control for safety food by way of cutting, chopping, or opening of a hermetically sealed container;

(3) The FOOD shall be cooked and served, served at any temperature if READY-TO-EAT, or discarded, within 4 hours from the point in time when the FOOD is removed from temperature controlP or rendered time/temperature control for safety food by way of cutting, chopping, or opening of a hermetically sealed container; and

Submitter Information

Name CAPT Charles S. Otto, III, RS, USPHS, Co-Chair
Organization Time as a Public Health Control Committee
Address USPHS / CDC / Vessel Sanitation Program
4770 Buford Highway NE - MS-58
Atlanta, GA 30341
Telephone (770) 488-3524
Fax (770) 488-7310
Email cotto@cdc.gov
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