Current through Register Vol. 49, No. 13, September 23, 2024
A. Except for a
food establishment that obtains a variance as specified in part 4626.0415, a
food establishment that packages TCS food using a reduced oxygen packaging
method must control the growth and toxin formation of Clostridium
botulinum and the growth of Listeria
monocytogenes.P1
B. Except as specified in item F, a food
establishment that packages TCS food using a reduced oxygen packaging method
must have a HACCP plan that contains the information in part 4626.1735 and
that:P2
(1) identifies
the food to be packaged;P2
(2) except as specified in items C to E,
requires that the packaged food must be maintained at 41 degrees F (5 degrees
C) or less and meet at least 1 of the following
criteria:P2
(a) has an
aw of 0.91 or less;P2
(b) has a pH of 4.6 or
less;P2
(c)
is a meat or poultry product cured at a food processing plant regulated by the
USDA using substances specified in Code of Federal Regulations, title 9,
subpart C, section
424.21, and is received
in an intact package;P2 or
(d) is a food with a high level of competing
organisms such as raw meat, raw poultry, or raw
vegetables;P2
(3) describes how the package must be
prominently and conspicuously labeled on the principal display panel in bold
type on a contrasting background, with instructions
to;P2
(a) maintain the
food at 41 degrees F (5 degrees C) or below;P2
and
(b) discard the food if within
30 calendar days of its packaging it is not served for on-premises consumption,
or consumed if served or sold for off-premises
consumption;P2
(4) limits the refrigerated shelf life to no
more than 30 calendar days from packaging to consumption, except the time the
product is maintained frozen, or the original manufacturers "sell by" or "use
by" date, whichever occurs first;P1
(5) includes operational procedures that:
(a) prohibit contacting ready-to-eat food
with bare hands as specified in part 4626.0225, item
A;P2
(b)
identify a designated work area and the method by
which:P2
i. physical
barriers or methods of separation of raw foods and ready-to-eat foods minimize
cross-contamination;P2 and
ii. access to the processing equipment is
limited to responsible trained personnel familiar with the potential hazards of
the operation;P2
(c) delineate cleaning and sanitization
procedures for food-contact surfaces;P2
(6) describes the training program
that ensures that the individual responsible for the reduced oxygen packaging
operation understands the;P2
(a) concepts required for a safe
operation;P2
(b) equipment and
facilities;P2 and
(c) procedures in subitem (5) and part
4626.1735, items C and D;P2 and
(7) is provided to the regulatory authority
prior to implementation as required by part 4626.1730, item B.
C. Except for fish that is frozen
before, during, and after packaging, a food establishment must not package fish
using a reduced oxygen packaging method. Reduced oxygen packaged fish must be
held frozen until used or removed from reduced oxygen packaging prior to the
thawing process.P1
D. Except as specified in items C and F, a
food establishment that packages TCS food using a cook-chill or sous-vide
process must:
(1) provide to the regulatory
authority prior to implementation a HACCP plan that contains the information in
part 4626.1735, items C and D;P2
(2) ensure the food is:
(a) prepared and consumed on the premises, or
prepared and consumed off the premises but within the same business entity with
no distribution or sale of the packaged product to another business entity or
the consumer;P2
(b) cooked to heat all parts of the food to a
temperature and for a time as specified in part 4626.0340, items A to
C;P1
(c)
protected from contamination before and after cooking as specified in parts
4626.0225 to 4626.0337 and 4626.0340 to
4626.0367;P1
(d) placed in a package with an oxygen
barrier and sealed before cooking, or placed in a package and sealed
immediately after cooking and before reaching a temperature below 135 degrees F
(57 degrees C);P1
(e) cooled to 41 degrees F (5 degrees C) in
the sealed package or bag as specified in part 4626.0385 and
subsequently;P1
i.
cooled to 34 degrees F (1 degree C) within 48 hours of reaching 41 degrees F (5
degrees C) and held at that temperature until consumed or discarded within 30
days after the date of packaging;P1
ii. held at 41 degrees F (5 degrees C) or
less for no more than 7 days, at which time the food must be consumed or
discarded;P1 or
iii. held frozen with no shelf life
restriction while frozen until consumed or
used;P1
(f) held in a refrigeration unit that is
equipped with an electronic system that continuously monitors time and
temperature and is visually examined for proper operation twice
daily;P2
(g)
if transported off-site to a satellite location of the same business entity,
equipped with verifiable electronic monitoring devices to ensure that times and
temperatures are monitored during transportation;P2
and
(h) labeled with the product
name and the date packaged;P2
(3) maintain the records required to confirm
that cooling and cold holding refrigeration time/temperature parameters are
required as part of the HACCP plan and:
(a)
make records available to the regulatory authority upon
request;P2 and
(b) hold records for at least 6
months;P2 and
(4) implement written operational procedures
as specified in item B, subitem (5), and a training program as specified in
item B, subitem (6).P2
E. Except as specified in item F, a food
establishment that packages cheese using a reduced oxygen packaging method
must:
(1) limit the cheeses packaged to those
that are commercially manufactured in a food processing plant with no
ingredients added in the food establishment and that meet the standards of
identity as specified in Code of Federal Regulations, title 21, section
133.150; 133.169; or 133.187;P1
(2) have a HACCP plan that contains the
information in part 4626.1735, items C and
D;P2
(3)
label the package on the principal display panel with a "use by" date that does
not exceed 30 days from its packaging or the original manufacturers "sell by"
or "use by" date, whichever occurs first;P2
and
(4) discard the reduced oxygen
packaged cheese if it is not sold for off-premises consumption or consumed
within 30 calendar days of its packaging.P2
F. A HACCP plan is not required
when a food establishment uses a reduced oxygen packaging method to package TCS
food that is always:
(1) labeled with the
production time and date;
(2) held
at 41 degrees F (5 degrees C) or less during refrigerated storage;
and
(3) removed from its package in
the food establishment within 48 hours after packaging.
Statutory Authority: MS s
31.101;
31.11;
144.05;
144.08;
144.12;
157.011