[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.3]
[Page 225-227]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart A--General Provisions
Sec. 113.3 Definitions.
For the purposes of this part, the following definitions apply:
(a) Aseptic processing and packaging means the filling of a
commercially sterilized cooled product into presterilized containers,
followed by aseptic hermetical sealing, with a presterilized closure, in
an atmosphere free of microorganisms.
(b) Bleeders means openings used to remove air that enters with
steam from retorts and steam chambers and to promote circulation of
steam in such retorts and steam chambers. Bleeders may serve as a means
of removing condensate.
(c) Come-up-time means the time which elapses between the
introduction of steam into the closed retort and the time when the
retort reaches the required processing temperature.
(d) Commercial processor includes any person engaged in commercial,
custom, or institutional (church, school, penal, or other organization)
processing of food, including pet food. Persons engaged in the
production of foods that are to be used in market or consumer tests are
also included.
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(e) Commercial sterility: (1) ``Commercial sterility'' of thermally
processed food means the condition achieved--
(i) By the application of heat which renders the food free of--
(a) Microorganisms capable of reproducing in the food under normal
nonrefrigerated conditions of storage and distribution; and
(b) Viable microorganisms (including spores) of public health
significance; or
(ii) By the control of water activity and the application of heat,
which renders the food free of microorganisms capable of reproducing in
the food under normal nonrefrigerated conditions of storage and
distribution.
(2) ``Commercial sterility'' of equipment and containers used for
aseptic processing and packaging of food means the condition achieved by
application of heat, chemical sterilant(s), or other appropriate
treatment that renders the equipment and containers free of viable
microorganisms having public health significance, as well as
microorganisms of nonhealth significance, capable of reproducing in the
food under normal nonrefrigerated conditions of storage and
distribution.
(f) Critical factor means any property, characteristic, condition,
aspect, or other parameter, variation of which may affect the scheduled
process and the attainment of commercial sterility.
(g) Flame sterilizer means an apparatus in which hermetically sealed
containers are agitated at atmospheric pressure, by either continuous,
discontinuous, or reciprocating movement, with impinging gas flames to
achieve sterilization temperatures. A holding period in a heated section
may follow the initial heating period.
(h) Headspace, gross is 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 (the top of the double seam of a can
or the top edge of a glass jar).
(i) Headspace, net of a container is the vertical distance between
the level of the product (generally the liquid surface) in the upright
rigid container and the inside surface of the lid.
(j) Hermetically sealed container means a container that is designed
and intended to be secure against the entry of microorganisms and
thereby to maintain the commercial sterility of its contents after
processing.
(k) Incubation means the holding of a sample(s) at a specified
temperature for a specified period of time for the purpose of permitting
or stimulating the growth of microorganisms.
(l) Initial temperature means the average temperature of the
contents of the coldest container to be processed at the time the
thermal processing cycle begins, as determined after thorough stirring
or shaking of the filled and sealed container.
(m) Lot means that amount of a product produced during a period of
time indicated by a specific code.
(n) Low-acid foods means any foods, other than alcoholic beverages,
with a finished equilibrium pH greater than 4.6 and a water activity
(aw) greater than 0.85. Tomatoes and tomato products having a
finished equilibrium pH less than 4.7 are not classed as low-acid foods.
(o) Minimum thermal process means the application of heat to food,
either before or after sealing in a hermetically sealed container, for a
period of time and at a temperature scientifically determined to be
adequate to ensure destruction of microorganisms of public health
significance.
(p) Operating process means the process selected by the processor
that equals or exceeds the minimum requirements set forth in the
scheduled process.
(q) Retort means any closed vessel or other equipment used for the
thermal processing of foods.
(r) Scheduled process means the process selected by the processor as
adequate under the conditions of manufacture for a given product to
achieve commercial sterility. This process may be in excess of that
necessary to ensure destruction of microorganisms of public health
significance, and shall be at least equivalent to the process
established by a competent processing authority to achieve commercial
sterility.
(s) Shall is used to state mandatory requirements.
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(t) Should is used to state recommended or advisory procedures or to
identify recommended equipment.
(u) Vacuum-packed products means those products that are sealed in a
container under the vacuum specified in the scheduled process, the
maintenance of which vacuum is critical to the adequacy of the scheduled
process.
(v) Vents means openings through the retort shell, controlled by
gate, plug cock, or other adequate valves used for the elimination of
air during the venting period.
(w) Water activity (aw) is a measure of the free moisture
in a product and is the quotient of the water vapor pressure of the
substance divided by the vapor pressure of pure water at the same
temperature.