[Code of Federal Regulations]

[Title 21, Volume 2]

[Revised as of April 1, 2020]
[CITE: 21CFR113]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
PART 113 THERMALLY PROCESSED LOW-ACID FOODS
  PACKAGED IN HERMETICALLY SEALED  
CONTAINERS

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.
(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.
(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.

Sec. 113.5 Current good manufacturing practice.

The criteria in §§ 113.10, 113.40, 113.60, 113.81, 113.83, 113.87, 113.89,

and 113.100 shall apply in determining whether the facilities, methods,
practices, and controls used by the commercial processor in the
manufacture, processing, or packing of low-acid foods in hermetically
sealed containers are operated or administered in a manner adequate to
protect the public health.

Sec. 113.10 Personnel.

The operators of processing systems, retorts, aseptic processing and

packaging systems and product formulating systems (including systems
wherein water activity is used in conjunction with thermal processing) and
container closure inspectors shall be under the operating supervision of a
person who has attended a school approved by the Commissioner for giving
instruction appropriate to the preservation technology involved and who has
been identified by that school as having satisfactorily completed the
prescribed course of instruction. This person shall supervise only in those
areas for which a school approved by the Commissioner identifies the person
as having satisfactorily completed training.

Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.

Source: 44 FR 16215, Mar. 16, 1979, unless otherwise noted.