| (13) Filling, assembling, packaging, and other operations
must be performed in such a way that the food is protected against
allergen cross-contact, contamination, and the growth of undesirable
microorganisms.
(14) Food such as, dry mixes, nuts, intermediate moisture
food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable
microorganisms must be processed to and maintained at a safe moisture
level.
(15) Food such as acid and acidified food, that relies
principally on the control of pH for preventing the growth of undesirable
microorganisms, must be monitored and maintained at a pH of 4.6 or
below. Acid or acidified foods must be heat treated to destroy mesophilic
microorganisms when those foods are to be held in hermetically sealed
containers at ambient temperatures.
(16) Modified Atmosphere Packaging. Manufacturers using
Modified Atmosphere Packaging:
(A) Except for a facility that is subject to 21 Code
of Federal Regulations Part 117, Subchapter C Hazard Analysis and
Risk-Based Preventive Controls or the product being produced is subject
to 21 Code of Federal Regulations Part 123, Fish and Fishery Products,
a facility that packages a Time/Temperature Control for Safety (TCS)
food using a modified atmosphere packaging method shall control the
growth and toxin formation of Clostridium
botulinum and the growth of Listeria
monocytogenes.
(B) a facility that packages TCS food using a modified
atmosphere packaging method must implement a food safety plan that
contains the information specified under 21 Code of Federal Regulations §117.135
a(1)-c(3) and that:
(i) identifies the food to be packaged;
(ii) except as specified under subparagraphs (C) and
(D) of this paragraph, requires that the packaged food shall be maintained
at 5 degrees Celsius (41 degrees Fahrenheit) or less and meet at least
one of the following criteria:
(I) has an aw of 0.91
or less;
(II) has a pH of 4.6 or less;
(III) is a meat or poultry product cured at a food
processing plant regulated by the USDA or the department using substances
specified in 9 Code of Federal Regulations §424.21, use of food
ingredients and sources of radiation, and is received in an intact
package; or
(IV) is a food with a high level of competing organisms
such as raw meat, raw poultry, or raw vegetables;
(iii) describes how the packages shall be prominently
and conspicuously labeled on the principal display panel in bold type
on a contrasting background, with instructions to:
(I) maintain the food at 5 degrees Celsius (41 degrees
Fahrenheit) or below; and
(II) 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;
(iv) 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 manufacturer's "sell
by" or "use by" date, whichever occurs first;
(C) a facility that packages TCS food using a modified
atmosphere packaging method must ensure individuals performing modified
atmosphere packaging have the appropriate training and documentation
as required by §229.212 of this title (relating to Qualifications
of Individuals Who Manufacture, Process, Pack, or Hold Food).
(D) Except for fish that is frozen before, during,
and after packaging, a facility may not package fish using a modified
atmosphere packaging method unless the product is subject to 21 Code
of Federal Regulations Part 123, Fish and Fishery Products;
(E) Cheese. A facility that packages cheese using a
Modified Atmosphere Packaging method must:
(i) limit the cheeses packaged to those that are commercially
manufactured in a food processing plant with no ingredients added
in a facility other than the original food processing plant and that
meet the Standards of Identity as specified in 21 Code of Federal
Regulations §133.150, Hard cheeses, 21 Code of Federal Regulations §133.169
Pasteurized process cheese or 21 Code of Federal Regulations §133.187
Semisoft cheeses;
(ii) have a food safety plan that contains the information
specified under 21 Code of Federal Regulations §117.135 a(1)-c(3);
and
(iii) 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 manufacturer's sell by date, or "use by" date, whichever
occurs first.
(F) A facility using a Modified Atmosphere Packaging
method for TCS Foods, intended to be frozen after packaging other
than those specified in subparagraph (B)(ii)(I)-(IV) of this paragraph
must:
(i) implement a food safety plan that contains the
information specified under 21 Code of Federal Regulations §117.135
a(1)-c(3);
(ii) immediately freeze the product following packaging:
(iii) label the product Keep Frozen; and
(iv) provide instructions for safe handling after thawing.
(G) Foods other than those specified in subparagraphs
(B)(ii), (D), (E) (F) of this paragraph may be packaged utilizing
modified atmosphere packaging if the facility complies with 21 Code
of Federal Regulations Part 117, Subchapter C, Hazard Analysis and
Risk Based Preventive Controls.
(17) Unshelled pecans intended to be consumed raw must
be thoroughly cleaned to remove foreign matter before cracking. After
cleaning, unshelled pecans must be sanitized.
(18) When ice is used in contact with food, it must
be made from water that is safe and of adequate sanitary quality in
accordance with §229.220 of this title (relating to Sanitary
Facilities and Controls) and must be used only if it has been manufactured
in accordance with current good manufacturing practice as outlined
in this subchapter.
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