(A) Except for a FOOD ESTABLISHMENT that
obtains a VARIANCE as specified under § 3-502.11, a FOOD ESTABLISHMENT
that PACKAGES TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a REDUCED OXYGEN
PACKAGING method shall control the growth and toxin formation of
Clostridium botulinum and the growth of
Listeria monocytogenes.
P
(B) Except as specified under ¶ (F) of
this section, a FOOD ESTABLISHMENT that PACKAGES TIME/TEMPERATURE CONTROL FOR
SAFETY FOOD using a REDUCED OXYGEN PACKAGING method shall implement a HACCP
PLAN that contains the information specified by the DEPARTMENT under
§§ 1-106.11 and 1-106.12 and that:
Pf
(1) Identifies the FOOD to be PACKAGED;
Pf
(2) Except as specified under ¶¶
(C)- (E) of this section, requires that the PACKAGED FOOD shall be maintained
at 5°C (41 °F) or less and meet at least one of the following criteria:
Pf
(a) Has a Aw of 0.91
or less,
Pf
(b) Has a pH of 4.6 or less,
Pf
(c) Is a MEAT or POULTRY product cured at a
FOOD PROCESSING PLANT regulated by the USDA or 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
(d) Is a FOOD with a high level of competing
organisms such as raw MEAT raw POULTRY or raw vegetables;
Pf
(3) Describes how the PACKAGE shall be
prominently and conspicuously labeled on the principal display panel in bold
type on a contrasting background, with instructions to:
Pf
(a) Maintain the FOOD at 5°C (41 °F)
or below,
Pf and
(b) Discard the FOOD if within 30 calendar
days of its PACKAGING if it is not served for on-PREMISES consumption, or
consumed if served or sold for off-PREMISES consumption;
Pf
(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 manufacturer's "sell by" or "use
by" date, whichever occurs first;P
(5) Includes operational procedures that:
(a) Prohibit contacting READY-TO-EAT FOOD
with bare hands as specified under ¶ 3-301.11 (B),
Pf
(b) Identify a designated work 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
(c) Delineate cleaning and SANITIZATION
procedures for FOOD-CONTACT SURFACES;
Pf and
(6) Describes the training program that
ensures that the individual responsible for the REDUCED OXYGEN PACKAGING
operation understands the:
Pf
(a) Concepts required for a safe operation,
Pf
(b) EQUIPMENT and facilities,
Pf and
(c) Procedures specified under Subparagraph
(B) (5) of this section and ¶ 1-106.12.
Pf
(7) Is provided to the DEPARTMENT prior to
implementation as specified under ¶¶ 1-106.11 and 1-106.13.
(C)
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
(D) Except as specified under ¶ (C) and
¶ (F) of this section, a FOOD ESTABLISHMENT that PACKAGES TIME/TEMPERATURE
CONTROL FOR SAFETY FOOD using a cook-chill or sous vide process shall:
(1) Provide to the DEPARTMENT prior to
implementation, a HACCP PLAN that contains the information as specified by the
DEPARTMENT under §§ 1-106.11 and 1-106.12;
Pf
(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,
Pf
(b) Cooked to heat all parts of the FOOD to a
temperature and for a time as specified under §§ 3-401.11 (A), (B),
and (C),
P
(c) Protected from contamination before and
after cooking as specified under Parts 3-3 and 3-4,
P
(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 57°C
(135°F),
P
(e) Cooled to 5°C (41 °F) in the
sealed PACKAGE or bag as specified under § 3-501.14 and:
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
(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,
Pf
(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,
Pf and
(h) Labeled with the product name and the
date PACKAGED;
Pf and
(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 such records available to the REGULATORY AUTHORITY upon request,
Pf and
(b) Hold such records for at least 6 months;
Pf and
(4) Implement written operational procedures
as specified under Subparagraph (B)(5) of this section and a training program
as specified under Subparagraph (B)(6) of this section.
Pf
(E) Except as specified under ¶ (F) of
this section, a FOOD ESTABLISHMENT that PACKAGES cheese using a REDUCED OXYGEN
PACKAGING method shall:
(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
21
CFR 133.150 - Hard cheeses,
21 CFR
133.169 - Pasteurized process cheese or
21 CFR 133.187 -
Semi-soft cheeses;
P
(2) Have a HACCP PLAN that contains the
information specified by the DEPARTMENT under § 1-106.12 and as specified
under ¶¶ (B)(1), (B)(3)(a), (B)(5), and (B)(6) of this section;
Pf
(3) 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
(4) Discards the REDUCED OXYGEN PACKAGED
cheese if it is not sold for off-PREMISES consumption or consumed within 30
calendar days of its PACKAGING.
Pf
(F)
A HACCP PLAN is not required when
a FOOD ESTABLISHMENT uses a REDUCED OXYGEN PACKAGING method to PACKAGE
TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is always:
(1)
Labeled with the production time
and date,
(2)
Held
at 5°C (41 °F) or less during refrigerated storage,
and
(3)
Removed
from its PACKAGE in the FOOD ESTABLISHMENT within 48 hours after
PACKAGING.