Article 5. Limitation of Growth of Organisms of Public Health Concern
12VAC5-421-765. Treating juice.
Article 5
Limitation of Growth of Organisms of Public Health Concern
Juice packaged in a food establishment shall be:
1. Treated under a HACCP plan as specified in 12VAC5-421-3630 to attain a five-log reduction, which is equal to a 99.999% reduction, of the most resistant microorganism of public health significance;P or
2. Labeled, if not treated to yield a five-log reduction of the most resistant microorganism of public health significance:Pf
a. As specified under 12VAC5-421-900;Pf and
b. As specified in 21 CFR 101.17(g) with the following, "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems."Pf
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.
12VAC5-421-770. Frozen food.
Stored frozen foods shall be maintained frozen.
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.
12VAC5-421-780. Time/temperature control for safety food, slacking.
Frozen time/temperature control for safety food that is slacked to moderate the temperature shall be held:
1. Under refrigeration that maintains the food temperature at 41°F (5°C) or less; or
2. At any temperature if the food remains frozen.
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.
12VAC5-421-790. Thawing.
A. Except as specified in subdivision 4 of this subsection, time/temperature control for safety food shall be thawed:
1. Under refrigeration that maintains the food temperature at 41°F (5°C) or less;
2. Completely submerged under running water:
a. At a water temperature of 70°F (21°C) or below;
b. With sufficient water velocity to agitate and float off loose particles in an overflow; and
c. For a period of time that does not allow thawed portions of ready-to-eat food to rise above 41°F (5°C); or
d. For a period of time that does not allow thawed portions of a raw animal food requiring cooking as specified under 12VAC5-421-700 A or B to be above 41°F (5°C) for more than four hours including:
(1) The time the food is exposed to the running water and the time needed for preparation for cooking; or
(2) The time it takes under refrigeration to lower the food temperature to 41°F (5°C);
3. As part of a cooking process if the food that is frozen is:
a. Cooked as specified under 12VAC5-421-700 A or B or 12VAC5-421-710; or
b. Thawed in a microwave oven and immediately transferred to conventional cooking equipment, with no interruption in the process; or
4. 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.
B. 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 subdivision A 1 of this section.
2. Prior to, or immediately upon completion of, its thawing using procedures specified in subdivision A 2 of this section.
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.
12VAC5-421-800. Cooling.
A. Cooked time/temperature control for safety food shall be cooled:
1. Within two hours, from 135°F (57°C) to 70°F (21°C);P and
2. Within a total of six hours from 135°F (57°C) to 41°F (5°C) or less.P
B. Time/temperature control for safety food shall be cooled within four hours to 41°F (5°C) or less if prepared from ingredients at ambient temperature, such as reconstituted foods and canned tuna.P
C. Except as specified in subsection D of this section, a time/temperature control for safety food received in compliance with laws allowing a temperature above 41°F (5°C) during shipment from the supplier as specified in 12VAC5-421-340 B, shall be cooled within four hours to 41°F (5°C) or less.P
D. Raw eggs shall be received as specified under 12VAC5-421-340 C and immediately placed in refrigerated equipment that maintains an ambient air temperature of 45°F (7°C) or less.P
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.
12VAC5-421-810. Cooling methods.
A. Cooling shall be accomplished in accordance with the time and temperature criteria specified under 12VAC5-421-800 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 12VAC5-421-610 A 2, during the cooling period to facilitate heat transfer from the surface of the food.
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.
12VAC5-421-820. 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 12VAC5-421-850 and except as specified in subsections B and C of this section, time/temperature control for safety food shall be maintained:
1. At 135°F (57°C) or above, except that roasts cooked to a temperature and for a time specified under 12VAC5-421-700 B or reheated as specified in 12VAC5-421-760 E may be held at a temperature of 130°F (54°C) or above;P or
2. At 41°F (5°C) 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 45°F (7°C) or less.P
C. Time/temperature control for safety food in a homogenous liquid form may be maintained outside the temperature control requirements, as specified in subsection A of this section, while contained within specially designed equipment that complies with the design and construction requirements as specified under subdivision 5 of 12VAC5-421-1230.P
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.
12VAC5-421-830. 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 12VAC5-421-870, and except as specified in subsections 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 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 41°F (5°C) or less for a maximum of seven days. The day of preparation shall be counted as day 1.Pf
B. Except as specified in subsections E, F, and 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 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 subsection 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 shall 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 specified in subsections 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 in subsection 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 subsection 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. Subsections 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. Subsections A and B of this section do not apply to shellstock.
G. Subsection 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 Part 110;
2. Hard cheeses containing not more than 39% moisture as defined in 21 CFR Part 133, such as cheddar, gruyere, parmesan and reggiano, and romano;
3. Semi-soft cheese containing more than 39% moisture, but not more than 50% moisture, as defined in 21 CFR Part 133, such as blue, edam, gorgonzola, gouda, and monterey jack;
4. Cultured dairy products as defined in 21 CFR Part 131, 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 as defined in 21 CFR Part 114;
6. Shelf stable, dry fermented sausages, such as pepperoni and Genoa salami; and
7. Shelf stable salt-cured products such as prosciutto and Parma (ham).
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.
12VAC5-421-840. Ready-to-eat, time/temperature control for safety food; disposition.
A. A food specified under 12VAC5-421-830 A or B shall be discarded if it:
1. Exceeds either of the temperature and time combination specified in 12VAC5-421-830 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 12VAC5-421-830 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 12VAC5-421-830 A.P
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.
12VAC5-421-850. Time as a public health control.
A. Except as specified under subsection 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, written procedures shall be prepared in advance, maintained in the food establishment, and made available to the department upon request that specify:Pf
1. Methods of compliance with subsection B or C of this section;Pf and
2. Methods of compliance with 12VAC5-421-800 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 hours:
1. The food shall have an initial temperature of 41°F (5°C) or less when removed from cold holding temperature control or 135°F (57°C) 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 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 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-hour limit shall be discarded.P
C. If time without temperature control is used as the public health control up to a maximum of six hours:
1. The food shall have an initial temperature of 41ºF (5ºC) or less when removed from temperature control and the food temperature may not exceed 70ºF (21ºC) within a maximum time period of six hours;P
2. The food shall be monitored to ensure the warmest portion of the food does not exceed 70ºF (21ºC) during the six-hour period, unless an ambient air temperature is maintained that ensures the food does not exceed 70ºF (21ºC) during the six-hour holding period;Pf
3. The food shall be marked or otherwise identified to indicate:Pf
a. The time when the food is removed from 41ºF (5ºC) or less cold-holding temperature control,Pf and
b. The time that is six hours past the point in time when the food is removed from 41ºF (5ºC) or less cold-holding temperature control;Pf
4. The food shall be:
a. Discarded if the temperature of the foods exceeds 70ºF (21ºC);P or
b. Cooked and served, served at any temperature if ready-to-eat, or discarded within a maximum of six hours from the point in time when the food is removed from 41ºF (5ºC) 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-hour limit shall be discarded.P
D. A food establishment that serves a highly susceptible population may not use time as specified under subsection A, B, or C of this section as the public health control for raw eggs.
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.
12VAC5-421-860. Variance requirement.
A food establishment shall obtain a variance from the department as specified in 12VAC5-421-3570 and 12VAC5-421-3580 before:Pf
1. Smoking food as a method of food preservation rather than as a method of flavor enhancement; Pf
2. Curing food;Pf
3. Using food additives or adding components such as vinegar:Pf
a. As a method of food preservation rather than as a method of flavor enhancement;Pf or
b. To render a food so that it is not a time/temperature control for safety food; Pf
4. 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 12VAC5-421-870;Pf
5. Operating a molluscan shellfish life-support system display tank used to store or display shellfish that are offered for human consumption;Pf
6. Custom processing animals that are for personal use as food and not for sale or service in a food establishment;Pf
7. Sprouting seeds or beans;Pf or
8. Preparing food by another method that is determined by the department to require a variance.Pf
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.
12VAC5-421-870. Reduced oxygen packaging without a variance, criteria.
A. Except for a food establishment that obtains a variance as specified under 12VAC5-421-860, 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 subsection F of this section, a food establishment that packages time/temperature control for safety food using a reduced oxygen method shall implement a HACCP plan that contains the information specified under subdivisions 3 and 4 of 12VAC5-421-3630 and that:Pf
1. Identifies food to be packaged;Pf
2. Except as specified in subsections C, D, and E of this section , requires that the packaged food shall be maintained at 41°F (5°C) or less and meet at least one of the following criteria:Pf
a. Has an 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 using substances specified in 9 CFR 424.21 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 food at 41°F (5°C) or below;Pf and
b. 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
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 in 12VAC5-421-450 B;Pf
b. Identify a designated work area and the method by which:Pf
(1) Physical barriers or methods of separation of raw foods and ready-to-eat foods minimize cross contamination;Pf and
(2) 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
6. Describes the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the:Pf
a. Concepts required for safe operation;Pf
b. Equipment and facilities;Pf and
c. Procedures specified under subdivision B 5 of this section and subdivisions 3 and 4 of 12VAC5-421-3630; Pf and
7. Is provided to the department prior to implementation as specified under 12VAC5-421-3620 B.
C. Except for fish that is frozen before, during, and after packaging and bears a label indicating that 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 in subsections 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 subdivisions 3 and 4 of 12VAC5-421-3630;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 bagged 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 subsections A, B, and C of 12VAC5-421-700;P
c. Protected from contamination before and after cooking as specified in 12VAC5-421-450 through 12VAC5-421-765;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 135°F (57°C);P
e. Cooled to 41°F (5°C) in the sealed package as specified under 12VAC5-421-800; and:P
(1) Cooled to 34°F (1°C) within 48 hours of reaching 41°F (5°C) and held at that temperature until consumed or discarded within 30 days after the date of packaging;P
(2) Held at 41°F (5°C) or less for no more than seven days, at which time the food must be consumed or discarded;P or
(3) 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, maintained and:
a. Made available to the department upon request;Pf and
b. Held for six months;Pf and
4. Implement written operational procedures as specified under subdivision B 5 of this section and a training program as specified under subdivision B 6 of this section.Pf
E. Except as specified under subsection 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, 21 CFR 133.169, or 21 CFR 133.187;P
2. Have a HACCP plan that contains the information specified in subdivisions 3 and 4 of 12VAC5-421-3630 and as specified under subdivisions B 1, B 3 a, B 5, and B 6 of this section;Pf
3. 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" or "use by" date, whichever occurs first;Pf and
4. Discard 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 41°F (5°C) or less during refrigerated storage; and
3. Removed from its packaging in the food establishment within 48 hours after packaging.
Statutory Authority
§§ 35.1-11 and 35.1-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.