(1)
Frozen
Food. Stored frozen FOODS shall be maintained frozen.
(2)
Time/Temperature Control for Safety
Food, Slacking. Frozen TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is
SLACKED to moderate the temperature shall be held:
(a) Under refrigeration that maintains the
FOOD temperature at 5°C (41°F) or less; or
(b) At any temperature if the FOOD remains
frozen.
(3)
Thawing. Except as specified in (d) of this section,
TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall be thawed:
(a) Under refrigeration that maintains the
FOOD temperature at 5°C (41°F) or less; or
(b) Completely submerged under running water:
1. At a water temperature of 21°C
(70°F) or below,
2. With
sufficient water velocity to agitate and float off loose particles in an
overflow, and
3. For a period of
time that does not allow thawed portions of READY-TO-EAT FOOD to rise above
5°C (41°F), or
4. For a
period of time that does not allow thawed portions of a raw animal FOOD
requiring cooking as specified under
40-7-1-.11(1)(a) or
(b) to be above 5°C (41°F) for more
than four (4) hours including:
(i) The time
the FOOD is exposed to the running water and the time needed for preparation
for cooking, or
(ii) The time it
takes under refrigeration to lower the FOOD temperature to 5°C
(41°F);
(c) As part of a cooking process if the FOOD
that is frozen is:
1. Cooked as specified
under 40-7-1-.11(1)(a) or
(b) or
40-7-1-.11(2),
or
2. Thawed in a microwave oven
and immediately transferred to conventional cooking EQUIPMENT, with no
interruption in the process; or
(d)
Using any procedure if a portion
of frozen READY-TO-EAT FOOD is thawed and prepared for immediate service in
response to an individual CONSUMER'S order.
(e) REDUCED OXYGEN PACKAGED FISH that bears a
label indicating that it is to be kept frozen until time of use shall be
removed from the reduced oxygen environment:
1. Prior to its thawing under refrigeration
as specified in (a) of this section; or
2. Prior to, or immediately upon completion
of, its thawing using procedures specified in (b) of this section.
(4)
Cooling.
(a) Cooked
TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall be cooled:
1. Within two (2) hours from 57°C
(135°F) to 21°C (70°F);P and
2. Within a total of six (6) hours from
57°C (135°F) to 5°C (41°F) or
less.P
(b) TIME/TEMPERATURE CONTROL FOR SAFETY FOOD
shall be cooled within four (4) hours to 5°C (41°F) or less if prepared
from ingredients at ambient temperature, such as reconstituted FOODS and canned
tuna.P
(c) Except as specified under (d) of this
section, a TIME/TEMPERATURE CONTROL FOR SAFETY FOOD received in compliance with
LAWS allowing a temperature above 5°C (41°F) during shipment from the
supplier as specified in
40-7-1-.09(8)(b),
shall be cooled within four (4) hours to 5°C (41°F) or
less.P
(d) Raw EGGS shall be received as specified
under 40-7-1-.09(8)(c) and
immediately placed in refrigerated EQUIPMENT that maintains an ambient air
temperature of 7°C (45°F) or
less.P
(5)
Cooling Methods.
(a) Cooling shall be accomplished in
accordance with the time and temperature criteria specified under
40-7-1-.12(4) by
using one or more of the following methods based on the type of FOOD being
cooled:
1. Placing the FOOD in shallow
pans;Pf
2. Separating the FOOD into smaller or
thinner portions;Pf
3. Using rapid cooling
EQUIPMENT;Pf
4. Stirring the FOOD in a container placed in
an ice water bath;Pf
5. Using containers that facilitate heat
transfer;Pf
6. Adding ice as an
ingredient;Pf or
7. Other effective
methods.Pf
(b) When placed in cooling or cold holding
EQUIPMENT, FOOD containers in which FOOD is being cooled shall be:
1. Arranged in the EQUIPMENT to provide
maximum heat transfer through the container walls; and
2. Loosely covered, or uncovered if protected
from overhead contamination as specified under Subparagraph
40-7-1-.10(17)(a)2,
during the cooling period to facilitate heat transfer from the surface of the
FOOD.
(6)
Time/Temperature Control for Safety Food, Hot and Cold Holding.
(a)
Except during preparation,
cooking, or cooling, or when time is used as the public health control as
specified under
40-7-1-.12(9)
, and except as specified under (b) and in (c) of this section,
TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall be maintained:
1. At 57°C (135°F) or above,
except that roasts cooked to a temperature and for a time specified in
40-7-1-.11(1)(b) or
reheated as specified in
40-7-1-.11(8)(e) may
be held at a temperature of 54°C (130°F) or
above;P or
2. At 5°C (41°F) or
less.P
(b) EGGS that have not been treated to
destroy all viable Salmonellae
shall be stored
in refrigerated EQUIPMENT that maintains an ambient air temperature of 7°C
(45°F) or less.P
(c) TIME/TEMPERATURE CONTROL FOR SAFETY FOOD
in a homogenous liquid form may be maintained outside of the
temperature control requirements, as specified under (a) of this section, while
contained within specially designed EQUIPMENT that complies with the design and
construction requirements as specified under
40-7-1-.17(16)(e)
.
(7)
Ready-to-Eat, Time/Temperature Control for Safety Food, Date
Marking.
(a) Except when PACKAGING
FOOD using a REDUCED OXYGEN PACKAGING method as specified under
40-7-1-.12(11), and
except as specified in (e) and (f) of this section, refrigerated, READY-TO-EAT,
TIME/TEMPERATURE CONTROL FOR SAFETY FOOD prepared and held in a FOOD
ESTABLISHMENT for more than twenty-four (24) hours shall be clearly marked to
indicate the date or day by which the FOOD shall be consumed on the PREMISES,
sold, or discarded when held at a temperature of 5°C (41°F) or less for
a maximum of seven (7) days. The day of preparation shall be counted as Day
1.Pf
(b)
Except as specified in (e) - (g) of this section, refrigerated, READY-TO-EAT
TIME/TEMPERATURE CONTROL FOR SAFETY FOOD prepared and PACKAGED by a FOOD
PROCESSING PLANT shall be clearly marked, at the time the original container is
opened in a FOOD ESTABLISHMENT and if the FOOD is held for more than
twenty-four (24) hours, to indicate the date or day by which the FOOD shall be
consumed on the PREMISES, sold, or discarded based on the temperature and time
combinations specified in (a) of this section and:Pf
1. The day the original container is opened
in the FOOD ESTABLISHMENT shall be counted as Day
1;Pf and
2. The day or date marked by the FOOD
ESTABLISHMENT may not exceed a manufacturer's use-by date if the manufacturer
determined the use-by date based on FOOD
safety.Pf
(c) A refrigerated, READY-TO-EAT
TIME/TEMPERATURE CONTROL FOR SAFETY FOOD ingredient or a portion of a
refrigerated, READY-TO-EAT, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is
subsequently combined with additional ingredients or portions of FOOD shall
retain the date marking of the earliest-prepared or first-prepared
ingredient.Pf
(d)
A date marking system that meets
the criteria stated in (a) and (b) of this section may include:
1.
Using a method APPROVED by the
DEPARTMENT for refrigerated, READY-TO-EAT TIME/TEMPERATURE CONTROL FOR SAFETY
FOOD that is frequently rewrapped, such as lunchmeat or a roast, or for which
date marking is impractical, such as soft serve mix or milk in a dispensing
machine;
2.
Marking the date or day of preparation, with a procedure to discard the
FOOD on or before the last date or day by which the FOOD must be consumed on
the premises, sold, or discarded as specified under (a) of this
section;
3.
Marking the date or day the original container is opened in a FOOD
ESTABLISHMENT, with a procedure to discard the FOOD on or before the last date
or day by which the FOOD must be consumed on the premises, sold, or discarded
as specified under (b) of this section; or
4.
Using calendar dates, days of the
week, color-coded marks, or other effective marking methods, provided that the
marking system is disclosed to the DEPARTMENT upon request.
(e)
Paragraphs (a) and (b)
of this section do not apply to individual meal portions served or rePACKAGED
for sale from a bulk container upon a CONSUMER'S request.
(f)
Paragraphs (a) and (b) of this
section do not apply to SHELLSTOCK.
(g)
Paragraph (b) of this section
does not apply to the following FOODS prepared and PACKAGED by a FOOD
PROCESSING PLANT inspected by a REGULATORY AUTHORITY:
1.
Deli salads, such as ham salad,
seafood salad, chicken salad, egg salad, pasta salad, potato salad, and
macaroni salad, manufactured in accordance with 21 CFR 110 Current good
manufacturing practice in manufacturing, packing, or holding human
food;
2.
Hard
cheeses containing not more than 39% moisture as defined in 21 CFR 133 Cheeses
and related cheese products, such as cheddar, gruyere, parmesan, and reggiano,
and romano;
3.
Semi-soft cheeses containing more than 39% moisture, but not more than
50% moisture, as defined in 21 CFR 133 Cheeses and related cheese products,
such as blue, edam, gorgonzola, gouda, and monterey jack;
4.
Cultured dairy products as defined
in 21 CFR 131 Milk and cream, such as yogurt, sour cream, and
buttermilk;
5.
Preserved FISH products, such as pickled herring and dried or salted
cod, and other acidified FISH products defined in 21 CFR 114 Acidified
foods;
6.
Shelf
stable, dry fermented sausages, such as pepperoni and Genoa; and
7.
Shelf stable salt-cured
products such as prosciutto and Parma (ham).
(8)
Ready-to-Eat,
Time/Temperature Control for Safety Food, Disposition.
(a) A FOOD specified in
40-7-1-.12(7)(a) or
(b) shall be discarded if it:
1. Exceeds the temperature and time
combination specified in
40-7-1-.12(7)(a),
except time that the product is frozen;P
2. Is in a container or PACKAGE that does not
bear a date or day;P or
3. Is inappropriately marked with a date or
day that exceeds a temperature and time combination as specified in
40-7-1-.12(7)(a).P
(b) Refrigerated, READY-TO-EAT,
TIME/TEMPERATURE CONTROL FOR SAFETY FOOD prepared in a FOOD ESTABLISHMENT and
dispensed through a VENDING MACHINE with an automatic shutoff control shall be
discarded if it exceeds a temperature and time combination as specified in
40-7-1-.12(7)(a).P
(9)
Time as a Public Health
Control.
(a) Except as specified under
(d) of this section, if time without temperature control is used as the public
health control for a working supply of TIME/TEMPERATURE CONTROL FOR SAFETY FOOD
before cooking, or for READY-TO-EAT TIME/TEMPERATURE CONTROL FOR SAFETY FOOD
that is displayed or held for sale or service:
1. Written procedures shall be prepared in
advance, maintained in the FOOD ESTABLISHMENT and made available to the
DEPARTMENT upon request that specify:Pf
(i) Methods of compliance with Subparagraphs
(b)1 - 4 or (c)1 - 5 of this section;Pf
and
(ii) Methods of compliance with
40-7-1-.12(4) for
FOOD that is prepared, cooked, and refrigerated before time is used as a public
health control.Pf
(b) If time without temperature control is
used as the public health control up to a maximum of four (4) hours:
1. The FOOD shall have an initial temperature
of 5°C (41°F) or less when removed from cold holding temperature
control, or 57°C (135°F) or greater when removed from hot holding
temperature control;P
2. The FOOD shall be marked or otherwise
identified to indicate the time that is four (4) hours past the point in time
when the FOOD is removed from temperature
control;Pf
3. The FOOD shall be cooked and served,
served at any temperature if READY-TO-EAT, or discarded, within four (4) hours
from the point in time when the FOOD is removed from temperature
control;P and
4. The FOOD in unmarked containers or
PACKAGES, or marked to exceed a four (4) hour limit shall be
discarded.P
(c) If time without temperature control is
used as the public health control up to maximum of six (6) hours:
1. The FOOD shall have an initial temperature
of 5°C (41°F) or less when removed from temperature control and the
FOOD temperature may not exceed 21°C (70°F) within a maximum time
period of six (6) hours;P
2. The FOOD shall be monitored to ensure the
warmest portion of the FOOD does not exceed 21°C (70°F) during the six
(6) hour period, unless an ambient air temperature is maintained that
ensures the FOOD does not exceed 21°C (70°F) during the six (6) hour
holding period;Pf
3. The FOOD shall be marked or otherwise
identified to indicate:Pf
(i) The time when the FOOD is removed from
5°C (41°F) or less cold holding temperature
control,Pf and
(ii) The time that is six (6) hours past the
point in time when the FOOD is removed from cold holding temperature
control;Pf
4. The FOOD shall be:
(i) Discarded if the temperature of the FOOD
exceeds 21°C (70°F),P or
(ii) Cooked and served, served at any
temperature if READY-TO-EAT, or discarded within a maximum of six (6) hours
from the point in time when the FOOD is removed from 5°C (41°F) or less
cold holding temperature control;P and
5. The FOOD in unmarked containers
or PACKAGES, or marked with a time that exceeds the six (6) hour limit shall be
discarded.P
(d) A FOOD ESTABLISHMENT that serves a HIGHLY
SUSCEPTIBLE POPULATION may not use time as specified under (a), (b) or (c) of
this section as the public health control for raw EGGS.
(10)
Variance Requirement. A
FOOD ESTABLISHMENT shall obtain a VARIANCE from the DEPARTMENT as specified in
40-7-1-.38(3) and
under 40-7-1-.38(4)
before:Pf
(a)
Smoking FOOD as a method of FOOD preservation rather than as a method of flavor
enhancement;Pf
(b) Curing
FOOD;Pf
(c) Using FOOD ADDITIVES or adding components
such as vinegar:Pf
1. As a method of FOOD preservation rather
than as a method of flavor enhancement,Pf
or
2. To render a FOOD so that it
is not TIME/TEMPERATURE CONTROL FOR SAFETY
FOOD;Pf
(d) Packaging TIME/TEMPERATURE CONTROL FOR
SAFETY FOOD using a REDUCED OXYGEN PACKAGING method except where the
growth of and toxin formation by Clostridium botulinum and the
growth of Listeria monocytogenes are controlled as specified under
40-7-1-.12(11)
;Pf
(e) Operating a MOLLUSCAN SHELLFISH
life-support system display tank used to store or display shellfish that are
offered for human consumption;Pf
(f) Custom processing animals that are for
personal use as FOOD and not for sale or service in a FOOD
ESTABLISHMENT;Pf
(g) Preparing FOOD by another method that is
determined by the DEPARTMENT to require a
VARIANCE;Pf or
(h) Sprouting seeds or
beans.Pf
(11)
Reduced Oxygen Packaging Without a
Variance, Criteria.
(a) Except for a
FOOD ESTABLISHMENT that obtains a VARIANCE as specified under
40-7-1-.12(10), 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 under
40-7-1-.39(4)(c) and
(d) 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
(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 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
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
(i) Maintain
the FOOD at 5°C (41°F) or below,Pf
and
(ii) Discard the FOOD if within
thirty (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 thirty (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:
(i) Prohibit contacting READY-TO-EAT FOOD
with bare hands as specified under
40-7-1-.10(1)(b),
Pf
(ii) 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
(iii) 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
(i) Concepts required for a safe
operation,Pf
(ii) EQUIPMENT and
facilities,Pf and
(iii) Procedures specified under Subparagraph
(b)5 of this section and
40-7-1-.39(4)(c) and
(d).Pf
7. Is provided to the DEPARTMENT
prior to implementation as specified under
40-7-1-.39(3)(b).
(c)
Except for FISH that
is frozen before, during, and after PACKAGING and bears a label indicating it
is to be kept frozen until time of use, 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 under
40-7-1-.39(4)(c) and
(d);Pf
2. 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 to heat all parts of the FOOD to
a temperature and for a time as specified under
40-7-1-.11(1)(a), (b), and
(c),
P
(iii) Protected from contamination before and
after cooking as specified under
40-7-1-.10(1) - (25)
and 40-7-1-.11(1) -
(9),
P
(iv) 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
(v) Cooled to 5°C (41°F) in the
sealed PACKAGE or bag as specified under
40-7-1-.12(4)
and:P
(I) Cooled to
1°C (34°F) within forty-eight (48) hours of reaching 5°C (41°F)
and held at that temperature until consumed or discarded within thirty (30)
days after the date of PACKAGING;P
(II) Held at 5°C (41°F) or less for
no more than seven (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
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:
(i)
Make such records available to the DEPARTMENT upon
request,Pf and
(ii) Hold such records for at least six (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 Semisoft
cheeses;P
2. Have a HACCP PLAN that contains the
information specified under
40-7-1-.39(4)(c) and
(d) and as specified under (b)1, (b)3(i),
(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 thirty (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 thirty
(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 forty-eight (48) hours after
PACKAGING.