Current through August 26, 2024
(1) Except as provided under sub. (2), every
dairy product shall be pasteurized at the dairy plant where that dairy product
is manufactured.
(2) Subsection (1)
does not apply to any of the following:
(a) A
dairy product shipped in bulk to another dairy plant for use in manufacturing
dairy products, provided that the shipment is accompanied by a bill of lading
that identifies the dairy product as unpasteurized.
(b) A dairy product made entirely from dairy
products that have been pasteurized at the same dairy plant.
(c) Ice cream or frozen dessert made from
pasteurized ice cream mix or pasteurized frozen-dessert mix, provided that no
unpasteurized dairy product is added to the pasteurized mix.
(d) A dairy product for which the standard of
identity provides that the dairy product and its ingredients need not be
pasteurized.
(e) A dairy product
that is sterilized and packaged in a hermetically sealed package.
(f) Cream, skim milk, or low-fat milk that
have been treated with heat to an extent less than pasteurization, and then
shipped in bulk to another dairy plant for use in manufacturing dairy products,
provided that the bulk shipment is accompanied by a bill of lading that
identifies the contents of the bulk shipment as being unpasteurized and
heat-treated. The heat-treated cream, skim milk, or low-fat milk may be heated
not more than once for separation purposes, to a temperature that is not less
than 125º F. (52º C.) nor more than 161º F. (72º C.).
Heat-treated cream may be heated to a greater extent, up to a temperature of
166º F. (75º C.) in a continuing heating process, if further heating
is necessary to deactivate enzymes for functional reasons. Cream, skim milk,
and low-fat milk, after being heated to an extent less than pasteurization,
shall immediately be cooled to a temperature of 45º F. (7º C.) or
less.
(g) Dried condensed whey
produced by drying condensed whey that was previously pasteurized at another
dairy plant, provided that all of the following apply:
1. The pasteurized condensed whey received
for drying contained at least 40% total solids, and was partially crystallized
by cooling at the dairy plant where it was pasteurized.
2. The partially crystallized condensed whey
was kept at a temperature of 45º F. (7º C.) or less prior to
drying.
3. The bulk milk tanker
used to transport the partially crystallized condensed whey was washed and
sanitized immediately before filling, was sealed immediately after filling, and
remained sealed until it was unloaded at the receiving dairy plant.
4. The receiving dairy plant unloaded the
partially crystallized condensed whey using unloading pumps and pipelines that
are used only for that purpose and have been cleaned and sanitized as a
separate C-I-P circuit before use in unloading.
(h) Grade B dairy products produced by adding
previously pasteurized and dried dairy products with a water activity not
greater than 0.85 to previously pasteurized grade B dairy products, if approved
in writing by the division.
(i)
Grade B dairy products produced by adding previously pasteurized packaged dairy
products to previously pasteurized grade B dairy products, if approved in
writing by the division.
(3) A dairy product, required to be
pasteurized under sub. (1), shall be pasteurized by, or under the direct
supervision of, a pasteurizer operator who has successfully completed any of
the following:
(a) A pasteurization training
course, of at least 8 hours duration, provided by the University of Wisconsin
or an equivalent course approved by the division.
(b) A competency examination approved by the
division.
(4) If a dairy
product standard of identity requires that any ingredient of that product be
pasteurized, the ingredient shall be pasteurized according to s.
ATCP 65.58.
(5)
Except as provided in subs. (6) to (8), a dairy product that is required to be
pasteurized under sub. (1) or (4) shall be pasteurized before it is introduced
into any membrane or condensing processing system.
(6) Subsection (5) does not apply to grade B
whey or whey product if at least one of the following applies:
(a) The whey or whey product is derived from
milk pasteurized in the same dairy plant.
(b) The whey is acid whey, which has a pH
less than 4.7 when drawn from the curd.
(c) The whey or whey product is processed in
a membrane processing system that complies with sub. (9) and is designed and
maintained to keep the whey or whey product at a temperature of 65º F.
(18.3º C.) or below during processing. If the whey or whey product
temperature exceeds 65º F. (18.3º C.) for more than 15 minutes during
processing, or exceeds 70º F. (21.1º C.) at any time during
processing, the whey or whey product shall be immediately diverted from moving
beyond the membrane processing system by means of automatic controls. The
diverted product shall be treated in one of the following ways:
1. Recycled through the membrane processing
system and subjected to cooling. The diverted product may proceed beyond the
membrane processing system when the product temperature falls to 65º F.
(18.3º C.) or below.
2. Cooled
in a system other than the membrane processing system until the temperature
falls to 45º F. (7º C.) or below, and may then be reintroduced into
the membrane processing system.
3.
Pasteurized in a pasteurization system, and may then be reintroduced into the
membrane processing system.
4.
Discarded.
(7) Subsection (5) does not apply to grade A
whey or whey product that is pasteurized in a membrane processing system that
complies with sub. (9) if at least one of the following apply:
(a) The whey is acid whey, which has a pH
less than 4.7 when drawn from the curd.
(b) The membrane processing system is
designed and maintained to keep the whey or whey product at a temperature of
45º F. (7º C.) or below during processing.
(8) Subsection (5) does not apply to
unpasteurized milk that is processed, before pasteurization, in a membrane
processing system that complies with sub. (9) and is designed and maintained to
keep the milk at a temperature of 65º F. (18.3º C.) or below during
processing. If the milk temperature exceeds 65º F. (18.3 º C.) for
more than 15 minutes during processing, or exceeds 70º F. (21.1º C.)
at any time during processing, the milk shall be immediately diverted from
moving beyond the membrane processing system by means of automatic controls.
The diverted milk shall be treated in any of the following ways:
(a) Recycled through the membrane processing
system and subjected to cooling. The diverted product may proceed beyond the
membrane processing system when the product temperature falls to 65º F.
(18.3º C.) or below.
(b)
Cooled in a system other than the membrane processing system until the
temperature falls to 45º F. (7º C.) or below, and may then be
reintroduced into the membrane processing system.
(c) Pasteurized in a pasteurization system,
and may then be reintroduced into the membrane processing system.
(d) Discarded.
(9) A membrane processing system under sub.
(6) (c), (7), or (8) shall be equipped with temperature monitoring and
recording devices that comply with Appendix H, Subsection IV of the PMO. At a
minimum, the system shall monitor and record product temperature at all of the
following points during processing:
(a) The
point at which the dairy product enters the system.
(b) A point immediately preceding each
intermediate cooling.
(c) A point
immediately preceding final cooling.
(d) The point at which the product exits the
system.
PMO Appendix H, Subsection IV is on file with the
division and the legislative reference bureau. Copies may be obtained from the
division at cost or online at
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Milk.
