§81.12. Reduced oxygen packaging; cook chill and sous vide processing.

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Scope and applicability. A food service establishment may package and process food using

reduced oxygen packaging ("ROP"), as defined in §81.03 of this Code, in accordance with this

section, provided that the food being processed shall have at least two controls in place, including

but not limited to time, temperature, Aw or pH, to prevent the growth and formation of C.

botulinum or Listeria monocytogenes.

Approved Hazard Analysis and Critical Control Point (HACCP) plan required. A food

service establishment shall not utilize ROP processes without obtaining prior Department

approval of a Hazard Analysis and Critical Control Point (HACCP) plan. The establishment shall

submit to the Department its HACCP plan that conforms to §81.06(c) of this Article for each food

item or food category it intends to prepare using a ROP processing technique.

On-site preparation, consumption, sale and distribution. Foods processed by ROP shall be

prepared and consumed on the premises of the food service establishment, or off premises if the

preparation site is properly permitted and wholly owned and operated by the same business entity

as the food service establishment, and no ROP food products shall be sold or distributed to any

other business entities or consumers.

Specific requirements. Foods shall be:

(1) Placed in an ROP package or ROP bag before cooking, or placed in a package or bag

immediately after cooking and before reaching an internal temperature below 140 degrees

Fahrenheit (60 degrees Celsius).

(2) Cooked immediately to require minimum internal temperatures specified in §81.09 of this

Article or held at a specified temperature and time approved by the Department in the HACCP

Plan. However, if such food has an Aw of 0.91 or less; has a pH of 4.6 or less; is a meat or poultry

product cured at a food processing plant regulated by the United States Department of Agriculture

using substances specified in 9 CFR 424.21, or successor regulation, and is received in an intact

package; or is a food with high level of competing organisms such as raw meat or raw poultry, it

may be held at 38 degrees Fahrenheit (2.2 degrees Celsius) without being cooked for no more

than 14 calendar days, and shall be discarded thereafter.

(3) Protected from contamination after cooking as specified in §81.07 of this Article.

(4) Cooled so that every part of the ROP package is reduced from 140 degrees Fahrenheit (60

degrees Celsius) to 70 degrees Fahrenheit (21.1 degrees Celsius) within two (2) hours and to 41

degrees Fahrenheit (5 degrees Celsius) or below within four (4) additional hours and

subsequently:

Cooled to 34 degrees Fahrenheit (1 degree Celsius) within 48 hours of reaching 41

degrees Fahrenheit (5 degrees Celsius) and held at that temperature until consumed or discarded

within 30 days after the date of packaging;

(ii) Cooled to 34 degrees Fahrenheit (1degree Celsius) within 48 hours of reaching 41

degrees Fahrenheit (5 degrees Celsius), removed from refrigeration equipment that maintains a 34

degree Fahrenheit (1 degree Celsius) food temperature and then held at 41 degrees Fahrenheit (5

degrees Celsius) or less for no more than 72 hours, at which time the food shall be consumed or

discarded;

(iii) Cooled to 38 degrees Fahrenheit (3 degrees Celsius) or less within 24 hours of reaching

41 degrees Fahrenheit (5 degrees Celsius) and held there for no more than 72 hours from

packaging, at which time the food shall be consumed or discarded; or

(iv) Held frozen with no shelf life restriction while frozen until consumed or used.

(5) 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.

(6) Labeled with the product name, date packed, and dates to be discarded, and stored in

accordance with a "First-in" "First out" storage rotation procedure, in accordance with the

HACCP plan.

Aquatic animals. Except for aquatic animals that are frozen before, during, and after

packaging, a food establishment may not package aquatic animals using an ROP method.

Cheese. A food service establishment may package cheese using an ROP method provided

that it limits the cheeses packaged to those commercially manufactured in a food processing plant

with no ingredients added by the food establishment, and provided the cheese meets the United

States Food and Drug Administration standards of identity specified in 21 CFR §133.150 ("Hard

cheeses"); 21 CFR §133.169 ("Pasteurized process cheese"); and 21 CFR §133.187 ("Semisoft

cheeses"), or successor regulations. The "use by" date of cheese shall not exceed 30 days after

packaging, or the original manufacturer's "sell by" or "use by" date, whichever occurs first.

Equipment. All equipment used in ROP processing shall be approved by the Department

and shall comply with all specifications for equipment in this Article, and the following

additional criteria:

(1) Thermometers used in cook chill or sous vide cooking methods shall be food grade

thermocouple type, equipped with probe, with a temperature range of -40 degrees Fahrenheit (-40

degrees Celsius) to 212 degrees Fahrenheit (100 degrees Celsius), and shall not contain glass or

any parts that can easily fall into food. Thermometers shall be calibrated before each batch

process, and at other times in accordance with manufacturers' instructions and whenever

calibration could have been compromised by extreme temperatures or after being accidentally

dropped.

(2) ROP products that are transported off site to a satellite location of the same business entity

shall be kept in containers equipped with verifiable monitoring devices enabling monitoring of

time and temperature and kept at temperatures no higher than 38 degrees Fahrenheit (3.3 Celsius)

during transportation. Such products or containers shall be labeled with the product name, date

packaged, and discard date.

(3) Sous vide processed foods shall be cooked in an approved water immersion unit or

combination oven (an oven combining convection and added moisture) that can be equipped with

an electronic system that continuously monitors time and temperature, and is visually examined

for proper operation twice daily. At least one item of each type of food of similar size cooked in a

water immersion or combination oven shall have its internal temperature monitored to determine

if the food is being cooked to the temperatures required by §81.09 of this Article.

(4) Sous vide cooking equipment shall include a thermal bath and immersion circulator or a

combination oven. The thermal bath and immersion circulator shall be a commercial type able to

heat water to precise temperatures. The immersion circulator or combination oven shall be

equipped with a temperature controller, temperature sensor, heater, and circulating element, and

continuous temperature recorder and display accurate to one tenth of a degrees, capable of

recording temperatures between 32 degrees Fahrenheit (0 degrees Celsius) and 212 degrees

Fahrenheit (100 degrees Celsius), and large enough to enable complete immersion of the largest

piece of food.

(5) ROP processors shall utilize a chamber type vacuum packaging machine with a pump able

to achieve a flow rate of 10m3

per hour and capable of heat sealing the food storage bag to

maintain the vacuum, or other commercial grade vacuum packaging equipment as approved by

the Department in the establishment's HACCP plan or as determined on inspection.

(6) Cook chill processors shall utilize an ice bath or a NSF approved blast or tumble chiller that

can lower temperatures of food from 185 degrees Fahrenheit (85 degrees Celsius) to 32-38

degrees Fahrenheit (0-3.3 degrees Celsius) within two hours, and is equipped with a factory

installed temperature monitoring device and alarm system. If a tumble chiller is used, the

associated ice builder must meet the sanitary requirements of this Article.

(7) Cook chill processors shall utilize a commercial type stainless steel NSF approved cook

tank or steam kettle with an agitation mechanism, and factory installed temperature monitoring

devices, or other cooking equipment approved by the Department in the establishment's HACCP

plan or as determined on inspection.

(8) All cook chill bags (casings) shall be made of food grade plastic, able to withstand

temperatures of 212 degrees Fahrenheit (100 degrees Celsius) to -20 degrees Fahrenheit (-28.8

degrees Celsius) and rapid temperature change from 185 degrees Fahrenheit (85 degrees Celsius)

to 34 degrees Fahrenheit or below (1 degree Celsius).