Reduced oxygen packaging criteria.
  (1) Except for a food establishment that obtains a
variance as specified in §228.76 of this title, a food establishment
that packages time/temperature controlled for safety (TCS) food using
a reduced oxygen packaging method shall control the growth and toxin
formation of Clostridium botulinum and the growth of Listeria monocytogenes.P   (2) Except as specified in paragraph (6) of this section,
a food establishment that packages TCS food using a reduced oxygen
packaging method shall implement a HACCP plan that contains the information
specified in §228.244(d)(2) and (4) of this title and that:Pf     (A) identifies the food to be packaged;Pf     (B) except as specified in paragraphs (3) - (6) of
this section, 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:Pf       (i) has an aw of 0.91
or less;Pf       (ii) has a pH of 4.6 or less;Pf       (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 CFR §424.21, use of food ingredients and sources
of radiation, and is received in an intact package;
Pf or
      (iv) is a food with a high level of competing organisms
such as raw meat, raw poultry, or raw vegetables;Pf
    (C) 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:
Pf       (i) maintain the food at 5 degrees Celsius (41 degrees
Fahrenheit) or below;Pf 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;Pf     (D) 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;P     (E) includes operational procedures that:
      (i) prohibit contacting ready-to-eat food with bare
hands as specified in §228.65(a)(2) of this title;Pf       (ii) identify a designated area and the method by which:Pf         (I) physical barriers or methods of separation of raw
foods and ready-to-eat foods minimize cross contamination;Pf and
        (II) access to the processing equipment is limited
to responsible trained personnel familiar with the potential hazards
of the operation;Pf and
      (iii) delineate cleaning and sanitization procedures
for food-contact surfaces;Pf and
    (F) describes the training program that ensures that
the individual responsible for the reduced oxygen packaging operation
understands the:Pf       (i) concepts required for a safe operation;Pf       (ii) equipment and facilities;Pf and

      (iii) procedures specified in paragraph (2)(E) of this
subsection and §228.244(d)(2) and (4) of this title.Pf     (G) is provided to the regulatory authority prior to
implementation as specified in §228.244(c)(3) of this title.Pf   (3) Except for fish that is frozen before, during,
and after packaging, a food establishment may not package fish using
a reduced oxygen packaging method.P   (4) Cook-Chill or Sous Vide. Except as specified in
paragraphs (3) and (6) of this subsection, a food establishment that
packages TCS food using cook-chill or sous vide process shall:
    (A) provide to the regulatory authority prior to implementation,
a HACCP plan that contains the information specified in §228.244(d)(2)
and (4) of this title;Pf     (B) ensure the food is:
      (i) 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;Pf       (ii) cooked and heat all parts of the food to a temperature
and time as specified in §228.71(a)(1), (2) and (3) of this title;P       (iii) protected from contamination before and after
cooking as specified in §§228.65 - 228.74 of the this title;P       (iv) placed in package with oxygen barrier and sealed
before cooking, or placed in package and sealed immediately after
cooking and before reaching an internal temperature below 57 degrees
Celsius (135 degrees Fahrenheit);P       (v) cooled to 5 degrees Celsius (41 degrees Fahrenheit)
in the sealed package or bag as specified in §228.75(d) of this
title:P         (I) cooled to 1°C (34°F) within 48 hours of
reaching 5°C (41°F) and held at that temperature until consumed
or discarded within 30 days after the date of packaging; P         (II) held at 5°C (41°F) or less for no more
than 7 days, at which time the food must be consumed or discarded;P or
        (III) held frozen with no shelf life restriction while
frozen until consumed or used.P       (vi) 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;Pf       (vii) 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;Pf and
      (viii) labeled with the product name and the date packaged;Pf and
    (C) Maintain the records required to confirm that cooling
and cold holding refrigeration time/temperature parameters are required
as part of the HACCP plan and:
      (i) make such records available to the regulatory authority
upon request;Pf and
      (ii) hold such records for at least 6 months;Pf and
    (D) Implement written operational procedures as specified
in paragraph (2)(E) of this section and a training program as specified
in paragraph (2)(F) of this section.Pf   (5) Cheese. Except as specified in paragraph (6) of
this section, a food establishment that packages cheese using a ROP
method shall:
    (A) 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 21 CFR 133.150 Hard cheeses, 21 CFR 133.169 Pasteurized
process cheese or 21 CFR 133.187 Semisoft cheeses;P
    (B) have a HACCP plan that contains the information
specified in §228.244(d)(2) and (4) of this title and as specified
in paragraph (2)(A), (2)(C)(i), (2)(E) and (2)(F) of this section;Pf     (C) labels 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" or "use by" date, whichever
occurs first;Pf and
    (D) discards the reduced oxygen packaging cheese if
it is not sold for off-premises consumption or consumed within 30
calendar days of its packaging.Pf   (6) A HACCP Plan is not required when a food establishment
uses a reduce oxygen packaging method to package TCS food that is
always:
    (A) labeled with the production time and date;
    (B) held at 5°C (41°F) or less during refrigerated
storage; and
    (C) removed from its package in the food establishment
within 48 hours after packaging.


Source Note: The provisions of this §228.77 adopted to be effective October 11, 2015, 40 TexReg 6901