[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.300]

[Page 282-283]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
                  Subpart G_Canning and Canned Products
 
Sec. 318.300  Definitions.

    Source: 51 FR 45619, Dec. 19, 1986, unless otherwise noted.


    (a) Abnormal container. A container with any sign of swelling or 
product leakage or any evidence that the contents of the unopened 
container may be spoiled.
    (b) Acidified low acid product. A canned product which has been 
formulated or treated so that every component of the finished product 
has a pH of 4.6 or lower within 24 hours after the completion of the 
thermal process unless data are available from the establishment's 
processing authority demonstrating that a longer time period is safe.
    (c) Bleeders. Small orifices on a retort through which steam, other 
gasses, and condensate are emitted from the retort throughout the entire 
thermal process.
    (d) Canned product. A meat food product with a water activity above 
0.85 which receives a thermal process either before or after being 
packed in a hermetically sealed container. Unless otherwise specified, 
the term ``product'' as used in this subpart G shall mean ``canned 
product.''
    (e) Closure technician. The individual(s) identified by the 
establishment as being trained to perform specific container integrity 
examinations as required by this subpart and designated by the 
establishment to perform such examinations.
    (f) Code lot. All production of a particular product in a specific 
size container marked with a specific container code.
    (g) Come-up time. The elapsed time, including venting time (if 
applicable), between the introduction of the heating medium into a 
closed retort and the start of process timing.
    (h) Critical factor. Any characteristic, condition or aspect of a 
product, container, or procedure that affects the adequacy of the 
process schedule. Critical factors are established by processing 
authorities.
    (i) Headspace. That portion of a container not occupied by the 
product.
    (1) Gross headspace. The vertical distance between the level of the 
product (generally the liquid surface) in an upright rigid container and 
the top edge of the container (i.e., the flange of an unsealed can, the 
top of the double seam on a sealed can, or the top edge of an unsealed 
jar).
    (2) Net headspace. The vertical distance between the level of the 
product (generally the liquid surface) in an upright rigid container and 
the inside surface of the lid.
    (j) Hermetically sealed containers. Air-tight containers which are 
designed and intended to protect the contents against the entry of 
microorganisms during and after thermal processing.
    (1) Rigid container. A container, the shape or contour of which, 
when filled and sealed, is neither affected by the enclosed product nor 
deformed by external mechanical pressure of up to 10 pounds per square 
inch gauge (0.7 kg/cm\2\) (i.e., normal firm finger pressure).
    (2) Semirigid container. A container, the shape or contour of which, 
when filled and sealed, is not significantly affected by the enclosed 
product under normal atmospheric temperature and pressure, but can be 
deformed by external mechanical pressure of less than 10 pounds per 
square inch gauge (0.7 kg/cm\2\) (i.e., normal firm finger pressure).
    (3) Flexible container. A container, the shape or contour of which, 
when filled and sealed, is significantly affected by the enclosed 
product.
    (k) Incubation tests. Tests in which the thermally processed product 
is kept at a specific temperature for a specified period of time in 
order to determine if outgrowth of microorganisms occurs.
    (l) Initial temperature. The temperature, determined at the 
initiation of a thermal process cycle, of the contents of the coldest 
container to be processed.
    (m) Low acid product. A canned product in which any component has a 
pH value above 4.6.
    (n) Process schedule. The thermal process and any specified critical 
factors for a given canned product required to achieve shelf stability.

[[Page 283]]

    (o) Process temperature. The minimum temperature(s) of the heating 
medium to be maintained as specified in the process schedule.
    (p) Process time. The intended time(s) a container is to be exposed 
to the heating medium while the heating medium is at or above the 
process temperature(s).
    (q) Processing authority. The person(s) or organization(s) having 
expert knowledge of thermal processing requirements for foods in 
hermetically sealed containers, having access to facilities for making 
such determinations, and designated by the establishment to perform 
certain functions as indicated in this subpart.
    (r) Program employee. Any inspector or other individual employed by 
the Department or any cooperating agency who is authorized by the 
Secretary to do any work or perform any duty in connection with the 
Program (see Sec. 301.2(f)).
    (s) Retort. A pressure vessel designed for thermal processing of 
product packed in hermetically sealed containers.
    (t) Seals. Those parts of a semirigid container and lid or of a 
flexible container that are fused together in order to hermetically 
close the container.
    (u) Shelf stability. The condition achieved by application of heat, 
sufficient, alone or in combination with other ingredients and/or 
treatments, to render the product free of microorganisms capable of 
growing in the product at nonrefrigerated conditions (over 50 [deg]F or 
10 [deg]C) at which the product is intended to be held during 
distribution and storage. Shelf stability and shelf stable are 
synonymous with commercial sterility and commercially sterile, 
respectively.
    (v) Thermal process. The heat treatment necessary to achieve shelf 
stability as determined by the establishment's processing authority. It 
is quantified in terms of:
    (1) Time(s) and temperature(s); or
    (2) Minimum product temperature.
    (w) Venting. The removal of air from a retort before the start of 
process timing.
    (x) Water activity. The ratio of the water vapor pressure of the 
product to the vapor pressure of pure water at the same temperature.