10-144-200 Me. Code R. § 3-5

Current through 2024-51, December 18, 2024

Section 144-200-3-5 - LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN

3-501 Temperature and Time Control

3-501.11 Frozen Food.

Stored frozen Foods shall be maintained frozen.

3-501.12 Potentially Hazardous Food, (Time/Temperature Control for Safety Food), Slacking.

Frozen Potentially Hazardous Food (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 5ºC (41ºF) or less; or

(B) At any temperature if the Food remains frozen.

3-501.13 Thawing.

Except as specified in ¶ (D) of this section, Potentially Hazardous Food (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 ¶ 3-401.11(A) or (B) to be above 5°C (41°F), or 7°C (45°F) as specified under ¶ 3-501.16(C), for more than 4 hours including:

(a)The time the Food is exposed to the running water and the time needed for preparation for cooking, or

(b) The time it takes under refrigeration to lower the Food temperature to 5ºC (41ºF),;

(C) As part of a cooking process if the Food that is frozen is:

(1) Cooked as specified under ¶ 3-401.11(A) or (B) or §3-401.12, 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.

3-501.14 Cooling.*

(A) Cooked Potentially Hazardous Food (Time/Temperature Control for Safety Food)shall be cooled:

(1) Within 2 hours, from 57°C (135 °F) to 21°C (70°F); and

(2) Within a total of 6 hours, from 57°C (135 °F) to 5°C (41°F) or less.

(B)Potentially Hazardous Food (Time/Temperature Control for Safety Food) shall be cooled within 4 hours to 5°C (41°F) or less, if prepared from ingredients at ambient temperature, such as reconstituted Foods and canned tuna.

(C) Except as specified in ¶ (D) of this section, a Potentially Hazardous Food (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 ¶ 3-202.11(B),

shall be cooled within 4 hours to 5°C (41°F) or less.

(D)Raw Eggs shall be received as specified under ¶ 3-202.11(C) and immediately placed in refrigerated Equipment that maintains an ambient air temperature of 7°C (45°F) or less. Eggs need not comply with ¶ (C) of this section if the Eggs are placed immediately upon their receipt in refrigerated Equipment that is capable of maintaining Food at 5°C (41°F) or less, or 7ºC (45°F) or less as specified under ¶ 3-501.16(C).

3-501.15 Cooling Methods.

(A) Cooling shall be accomplished in accordance with the time and temperature criteria specified under §3-501.14 by using one or more of the following methods based on the type of Food being cooled:

(1) Placing the Food in shallow pans;

(2) Separating the Food into smaller or thinner portions;

(3) Using rapid cooling Equipment;

(4) Stirring the Food in a container placed in an ice water bath;

(5) Using containers that facilitate heat transfer;

(6) Adding ice as an ingredient; or

(7) Other effective methods.

(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 3-305.11(A)(2), during the cooling period to facilitate heat transfer from the surface of the food.

3-501.16Potentially Hazardous Food, (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 §3-501.19, and except as specified under ¶ (B) and in ¶ (C) of this section, Potentially Hazardous Food (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 under ¶ 3-401.11(B) or reheated as specified in ¶ 3-403.11(E) may be held at a temperature of 54°C (130°F); or

(2)At 5°C (41°F) or less.

(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.

(C)Potentially Hazardous Food (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 complieswith the design and construction requirements as specified under ¶ 4-204.13(E).

3-501.17Ready-to-Eat, Potentially Hazardous Food, (Time/Temperature Control for Safety Food) Date Marking.*

(A)Except when Packaging Food using a Reduced Oxygen Packaging method as specified under § 3-502.12, and except as specified in ¶¶ (D) and (E) of this section, refrigerated, Ready-to-EatPotentially Hazardous Food (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 5ºC (41ºF) or less for a maximum of 7 days. The day of preparation shall be counted as Day 1.

(B)Except as specified in ¶¶ (D) - (F) of this section, refrigerated, Ready-to-Eat, Potentially Hazardous Food (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. If the Food is held for more than 24 hours, it shall 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:

(1) The day the original container is opened in the Food or Eating Establishment shall be counted as Day 1; and

(2) The day or date marked by the Food or Eating Establishment may not exceed a manufacturer's use-by date if the manufacturer determined the use-by date based on Food safety.

(C) A refrigerated, Ready-to-Eat, Potentially Hazardous Food (Time/Temperature Control for Safety Food) ingredient or a portion of a refrigerated, Ready-to-Eat, Potentially Hazardous Food (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.

(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 Regulatory Authority for refrigerated, Ready-to-Eat, Potentially Hazardous Food (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 or Eating 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 Regulatory Authority 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)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)(2012 ed.);

(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)(2012 ed.);

(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)(2012 ed.), such as blue, edam, gorgonzola, gouda, and monterey jack;

(4)

Cultured dairy products as defined in 21 CFR 131 (Milk and cream)(2012 ed.), 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)(2012 ed.);

(6)

Shelf stable, dry fermentedsausages, such as pepperoni and Genoa salami that are not labeled "Keep Refrigerated" as specified in 9 CFR 317 (Labeling, marking devices, and containers)(2012 ed.), and which retain the original casing on the product;

(7)

Shelf stable salt-cured products such as prosciutto and Parma (ham) that are not labeled "Keep Refrigerated" as specified in 9 CFR 317 (Labeling, marking devices, and containers)(2012 ed.); and

(8)

Raw, Live In-Shell Shellstock.

3-501.18 Ready-to-Eat, Potentially Hazardous Food(Time/Temperature Control for Safety Food), Disposition.*

(A)A Food specified in ¶ 3-501.17(A) or (B) shall be discarded if it:

(1)Exceeds the temperature and time combination specified in ¶ 3-501.17(A), except time that the product is frozen

(2)Is in a container or Package that does not bear a date or day; or

(3)Is appropriately marked with a date or day that exceeds a temperature and time combination as specified in ¶ 3-501.17(A).

(B)Refrigerated, Ready-to-Eat, Potentially Hazardous Food (Time/Temperature Control for Safety Food) prepared in a Food or Eating 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 ¶ 3-501.17(A).

3-501.19 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 Ready-to-Eat, Potentially Hazardous Food (Time/Temperature Control for Safety Food) before cooking, or for Ready-to-Eat, Potentially Hazardous Food (Time/Temperature Control for Safety Food) that is displayed or held for service for sale or service:

(1)Written procedures shall be prepared in advance, maintained in the Food or Eating Establishment, and made available to the Regulatory Authority upon request that specify:

(a)Methods of compliance with Subparagraphs (B)(1) -(3) or C)(1)-(5) of this section;

(b)Methods of compliance with § 3-501.14 for food that is prepared, cooked, and refrigerated before time is used as a public health control.

(B) If time without temperature control is used as the public health control up to a maximum of 4 hours:

(1) The Food shall have an initial temperature of 5ºC (41ºF) or less when removed from cold holding temperature control, or 57°C (135°F) or greater when removed from hot holding temperature control; *

(2) The Food shall be marked or otherwise identified to indicate the time that is 4 hours past the point in time when the Food is removed from temperature control;

(3) The Food shall be cooked and served, served at any temperature if Ready-to-Eat, or discarded, within 4 hours from the point in time when the Food is removed from temperature control; * and

(4) The Food in unmarked containers or Packages, or marked to exceed a 4-hour limit shall be discarded. *

(C) If time without temperature control is used as the public health control up to a maximum of 6 hours:

(1) The Food shall have an initial temperature of 5ºC (41ºF) or less when removed from temperature control and the Food temperature may not exceed 21ºC (70ºF) within a maximum time period of 6 hours; *

(2) The Food shall be monitored to ensure the warmest portion of the Food does not exceed 21ºC (70ºF) during the 6-hour period, unless an ambient air temperature is maintained that ensures the Food does not exceed 21ºC (70ºF) during the 6-hour holding period;

(3) The Food shall be marked or otherwise identified to indicate:

(a) The time when the Food is removed from 5ºC (41ºF) or less cold holding temperature control, and

(b) The time that is 6 hours past the point in time when the Food is removed from cold holding temperature control;

(4) The Food shall be:

(a) Discarded if the temperature of the Food exceeds 21°C (70°F), * or

(b) Cooked and served, served at any temperature if Ready-to-Eat, or discarded within a maximum of 6 hours from the point in time when the Food is removed from 5ºC (41ºF) or less cold holding temperature control; * and

(5) The Food in unmarked containers or Packages, or marked with a time that exceeds the 6-hour limit shall be discarded. *

(D) A Food or Eating 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.

3-502 Specialized Processing Methods

3-502.11Variance Requirement.*

A Food or Eating Establishment shall obtain a Variance from the Regulatory Authority, as specified in § 8-103.1 0 and under § 8-103.1 1 before:

(A)Smoking Food as a method of Food preservation rather than as a method of flavor enhancement;

(B)Curing Food;

(C)Using Food Additives or adding components such as vinegar:

(1) As a method of Food preservation rather than as a method of flavor enhancement ,or

(2) To render a Food so that it is not Potentially Hazardous Food (Time/Temperature Control for Safety Food);

(D)Packaging 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 §3-502.12;

(E)

Operating a Molluscan Shellfish life-support system display tank used to store or display shellfish that are offered for human consumption;

(F)Custom processing animals that are for personal use as Food and not for sale or service in a Food or Eating Establishment;

(G)Preparing Food by another method that is determined by the Regulatory Authority to require a Variance; or

(H)Sprouting seeds or beans.

3-502.12 Reduced Oxygen Packaging, Criteria.*

(A) Except for a Food or Eating Establishment that obtains a Variance as specified under §3-502.11, a Food or Eating Establishment that packages Potentially Hazardous Food (Time/Temperature Control for Safety Food)using a Reduced Oxygen Packaging method shall control the growth and toxin formation of Clostridium botulinumand the growth of Listeria monocytogenes.

(B) A Food or Eating Establishment that packages Potentially Hazardous Food (Time/Temperature Control for Safety Food)using a Reduced Oxygen Packaging method shall have a HACCP Plan that contains the information specified under ¶ 8-201.14(D) and that:

(1) Identifies the Food to be Packaged;

(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:

(a)Has an AW of 0.91 or less,

(b) Has a PH of 4.6 or less,

(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, (Use of food ingredients and sources of radiation)(2012 ed.), and is received in an intact Package,or

(d) Is afood with a high level of competing organisms such as raw meat, raw poultry, or raw vegetables;

(3)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:

(a) Maintain the Food at 5ºC (41ºF) or below, and

(b) Discard the Food if within 14 calendar days of its packaging it is not served for on-premises consumption, or consumed if served or sold for off-premises consumption;

(4)Limits the shelf life to no more than 14 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;

(5) Includes operational procedures that:

(a) Prohibit contacting Ready-to-Eat Food with bare hands, as specified under ¶ 3-301.11(B),

(b) Identify a designated area and the method by which:

(i)

Physical barriers or methods of separation of raw Foods and Ready-to-Eat Foods minimize cross contamination, and

(ii)Access to the processing Equipment is restricted to responsible trained personnel familiar with the potential Hazards of the operation, and

(c) Delineate cleaning and Sanitization procedures for Food-Contact Surfaces; and

(6) Describes the training program that ensures that the individual responsible for the Reduced Oxygen Packaging operation understands the:

(a) Concepts required for a safe operation,

(b)Equipment and facilities, and

(c) Procedures specified under Subparagraph (B)(5) of this section and ¶ 8-201.14(D).

(C)

Except for Fish that is frozen before, during, and after packaging, a Food or Eating Establishment may not package Fish using a Reduced Oxygen Packaging method.

(D)

Except as specified under ¶ (C) of this section, a Food or Eating Establishment that packages Food using a cook-chill or sous vide process shall:

(1)Implement a HACCP Plan that contains the information as specified under ¶ 8-201.14(D);

(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,

(b) Cooked to heat all parts of the Food to a temperature and for a time as specified under § 3-401.11,

(c) Protected from contamination before and after cooking as specified under Parts 3-3 and 3-4,

(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 atemperature below 57°C (135°F),

(e) Cooled to 5°C (41°F) in the sealed package or bag, as specified under § 3-501.14, and subsequently:

(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;

(ii)Cooled to 1°C (34°F) within 48 hours of reaching 5°C (41°F), removed from refrigeration equipment that maintains a 1°C (34°F) food temperature and then held at 5°C (41°F) or less for no more than 72 hours, at which time the Food must be consumed or discarded;

(iii)Cooled to 3°C (38°F) or less within 24 hours of reaching 5°C (41°F) and held there for no more than 72 hours from Packaging, at which time the Food must be consumed or discarded; or

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

(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,

(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, and

(h) Labeled with the product name and the date packaged; and

(3) Maintain the records required to confirm that cooling and cold holding refrigerationtime/temperature parameters are required as part of the HACCP Plan and:

(a)Make such records available to the Regulatory Authority upon request, and

(b) Hold such records for at least 6 months; 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.

(E) A Food Establishment that packages cheese using a Reduced Oxygen Packaging method shall:

(1) Limit the cheeses packaged to those that are (1) commercially manufactured in a Food Processing Plant; (2) with no ingredients added in the Food Establishment; and (3)

that meet the Standards of Identity as specified in 21 CFR 133.150 (Hard cheeses)(2012 ed.), 21 CFR 133.169 (Pasteurized process cheese)(2012 ed.) or 21 CFR 133.187 (Semisoft cheeses)(2012 ed.); *

(2) Have a HACCP Plan that contains the information specified under ¶ 8-201.14(D) and as specified under ¶¶ (B)(1), (B)(3)(a), (B)(5) and (B)(6) of this section;

(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; 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.

10-144 C.M.R. ch. 200, § 3-5