[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.23]

[Page 270-271]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
 
                           Subpart A--General
 
Sec. 318.23  Heat-processing and stabilization requirements for uncured meat patties.

    (a) Definitions. For purposes of this section, the following 
definitions shall apply:
    (1) Patty. A shaped and formed, comminuted, flattened cake of meat 
food product.
    (2) Comminuted. A processing term describing the reduction in size 
of pieces of meat, including chopping, flaking, grinding, or mincing, 
but not including chunking or sectioning.
    (3) Partially-cooked patties. Meat patties that have been heat 
processed for less time or using lower internal temperatures than are 
prescribed by paragraph (b)(1) of this section.
    (4) Char-marked patties. Meat patties that have been marked by a 
heat source and that have been heat processed for less time or using 
lower internal temperatures than are prescribed by paragraph (b)(1) of 
this section.
    (b) Heat-processing procedures for fully-cooked patties. (1) 
Official establishments which manufacture fully-cooked patties shall use 
one of the following heat-processing procedures:

Permitted Heat-Processing Temperature/Time Combinations for Fully-Cooked
                                 Patties
------------------------------------------------------------------------
Minimum internal temperature at the center of each  Minimum holding time
                 patty  (Degrees)                      after required
--------------------------------------------------- internal temperature
                                                     is reached  (Time)
                                                   ---------------------
           Fahrenheit              Or centigrade                   Or
                                                     Minutes    seconds
------------------------------------------------------------------------
151............................  66.1.............        .68         41
152............................  66.7.............        .54         32
153............................  67.2.............        .43         26
154............................  67.8.............        .34         20
155............................  68.3.............        .27         16
156............................  68.9.............        .22         13
157 (and up)...................  69.4 (and up)....        .17         10
------------------------------------------------------------------------

    (2) The official establishment shall measure the holding time and 
temperature of at least one fully-cooked patty from each production line 
each hour of production to assure control of the heat process. The 
temperature measuring device shall be accurate within 1 degree F.
    (3) Requirements for handling heating deviations. (i) If for any 
reason a heating deviation has occurred, the official establishment 
shall investigate and identify the cause; take steps to assure that the 
deviation will not recur; and place on file in the official 
establishment, available to any duly authorized FSIS program employee, a 
report of the investigation, the cause of the deviation, and the steps 
taken to prevent recurrence.
    (ii) In addition, in the case of a heating deviation, the official 
establishment may reprocess the affected product, using one of the 
methods in paragraph (b)(1) in this section; use the affected product as 
an ingredient in another product processed to one of the temperature and 
time combinations in paragraph (b)(1) in this section, provided this 
does not violate the final product's standard of composition, upset the 
order of predominance of ingredients, or perceptibly affect the normal 
product characteristics; or relabel the affected product as a partially-
cooked patty product, if it meets the stabilization requirements in 
paragraph (c) of this section.
    (c) Stabilization. (1) Fully cooked, partially cooked, and char-
marked meat patties must be produced using processes ensuring no 
multiplication of toxigenic microorganisms such as Clostridium 
botulinum, and no more than a 1 log10 multiplication of 
Clostridium perfringens, within the product.
    (2) For each meat patty product produced using a stabilization 
process other than one conducted in accordance with the Hazard Analysis 
and Critical Control Point (HACCP) system requirements in part 417 of 
this chapter, an establishment must develop and have on file, available 
to FSIS, a process schedule, as defined in Sec. 301.2 of this chapter. 
Each process schedule must be approved in writing by a process authority 
for safety and efficacy in meeting the performance standards established 
for the product in question. A process authority must have access to an 
establishment in order to evaluate and approve the safety and efficacy 
of each process schedule.

[[Page 271]]

    (3) Under the auspices of a processing authority, an establishment 
must validate new or altered process schedules by scientifically 
supportable means, such as information gleaned from the literature or by 
challenge studies conducted outside the plant.
    (4) Partially cooked patties must bear the labeling statement 
``Partially cooked: For Safety Cook Until Well Done (Internal Meat 
Temperature 160 degrees F.).'' The labeling statement must be adjacent 
to the product name, and prominently placed with such conspicuousness 
(as compared with other words, statements, designs or devices in the 
labeling) as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use.
    (5) Char-marked patties must bear the labeling statement ``Uncooked, 
Char-marked: For Safety, Cook Until Well Done (Internal Meat Temperature 
160 degrees F.).'' The labeling statement shall be adjacent to the 
product name, at least one-half the size of the largest letter in the 
product name, and prominently placed with such conspicuousness (as 
compared with other words, statements, designs or devices in the 
labeling) as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use.

[64 FR 744, Jan. 6, 1999]