Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-3-16 - PRODUCTION, PROCESSING, HANDLING OR DISTRIBUTION OF MILK, MILK PRODUCTS AND FROZEN DESSERTS › APPENDICES › Appendix R - DETERMINATION OF TIME/TEMPERATURE CONTROL FOR SAFETY MILK AND/OR MILK PRODUCTS

Current through Register Vol. 42, No. 9, June 28, 2024
The Institute of Food Technologists (IFT) prepared and
				  submitted a report as part of a contract with the FDA that contains responses
				  to various questions posed by the FDA about potentially hazardous food (PHF).
				  IFT reviewed the evolution of the term PHF and recommended a change to
				  time/temperature control for safety (TCS) food, as well as a science-based
				  framework for determining the effectiveness of processing technologies that
				  formulate a food.
The report examines intrinsic factors such as aw, pH, redox
				  potential, natural, and added antimicrobial and competitive microorganisms; and
				  extrinsic factors such as packaging, atmospheres, storage conditions,
				  processing steps, and new preservation technologies that influence microbial
				  growth. The report also analyzes microbial hazards related to time/temperature
				  control of foods for safety.
IFT developed a framework that could be used to determine
				  whether a food is a TCS or not. Part of the framework, applicable to Grade "A"
				  milk and milk products includes two tables that consider the interaction of pH
				  and aw in milk and milk products, whether the milk or milk product is
				  pasteurized and subsequently packaged (Table A), or not pasteurized or
				  pasteurized but not packaged (Table B). When further product assessment (PA) is
				  required, the application of microbiological challenge testing (inoculation
				  studies) is discussed along with pathogen modeling programs and reformulation
				  of the milk and/or milk product. An extensive reference list is included in the
				  report.
TCS food is defined in terms of whether or not it requires
				  time/temperature control for safety to limit pathogen growth or toxin
				  formation. The definition does not address foods that do not support growth but
				  may contain a pathogenic microorganism or chemical or physical food safety
				  hazard at a level sufficient to cause foodborne illness or injury. The
				  progressive growth of all foodborne pathogens is considered whether slow or
				  rapid.
The definition of TCS takes into consideration aw, pH, aw and
				  pH interaction, pasteurization, and subsequent packaging for a relatively
				  simple determination of whether the food requires time/temperature control for
				  safety. If a milk or milk product is pasteurized to eliminate pathogenic
				  vegetative cells, it needs to be addressed differently than a raw product or a
				  raw product subjected to inadequate heating. In addition, if a milk or milk
				  product is packaged after pasteurization to prevent re-contamination, higher
				  ranges of pH and/or aw can be tolerated because
				  spore-forming bacteria are the only microbial hazards of concern. Milk and milk
				  products shall be protected from contamination in an area with limited access
				  and packaged at a temperature in compliance with the
Grade "A"
				  PMO
requirements. In some milk or milk products, it is possible that
				  neither the pH value nor the aw value is low enough by
				  itself to control or eliminate pathogen growth; however, the interaction of pH
				  and aw may be able to accomplish it. This is an example
				  of a hurdle technology. Hurdle technology is utilized when several inhibitory
				  factors are used together to control or eliminate pathogen growth that would
				  otherwise be ineffective when used alone.
Another important factor to consider is combination products.
				  A combination product is one (1) in which there are two (2) or more distinct
				  food components, and an interface between the two (2) components may have a
				  different property than either of the components present. Determine whether the
				  food has distinct components such as cottage cheese curd with fruits and/or
				  vegetables to be added and the creaming mixture, or does it have a uniform
				  consistency such as the cottage cheese creaming mixture or plain yogurt. In
				  these products, the pH at the interface is important in determining if the item
				  is a TCS milk or milk product.
Appropriate evidence acceptable to FDA such as other
				  published scientific research and/or an inoculation study should be used to
				  determine whether a food can be held without time/temperature control
				  when:
1. Combination products are prepared; or
2. Other extrinsic factors (packaging/atmospheres) or
				  intrinsic factors (redox potential, salt content, antimicrobials, etc.) found
				  in the food are used to control or eliminate pathogen growth.
Before using Tables A and B, which are included in the
				  definition of Time/Temperature Control for Safety of Milk and/or Milk Products
				  of these rules, in determining whether a milk or milk product requires TCS,
				  answers to the following questions should be considered:
1. Is the intent to hold the milk or milk product without
				  using time or temperature control? If the answer is "No", no further action is
				  required. The decision tree is not needed to determine if the item is a TCS
				  milk or milk product.
2. Is the milk or milk product raw or heat-treated, or is the
				  milk or milk product pasteurized?
3. Does the
Grade "A" PMO
already require
				  TCS for the milk or milk product?
4. Does a product history with good scientific rationale
				  exist indicating a safe history of use?
5. Is the milk and/or milk product processed and packaged so
				  that it does not require TCS; such as aseptically processed and packaged Grade
				  "A" low-acid milk and/or milk products and/or retort processed after packaged
				  Grade "A" low-acid milk and/or milk products?
6. What is the aw and pH of the milk
				  or milk product in question using laboratory results accepted by FDA.
A milk or milk product designated PA (further product
				  assessment required) in either Table A or B should be considered TCS until
				  sufficient information is provided to demonstrate the safety of the product.
				  The PA shall be an evaluation of the milk or milk product group's ability to
				  not support pathogenic growth. Means to evaluate this assessment include (but
				  are not limited to) : literature review of similar milk products, inoculation
				  studies, expert risk assessment, and/or Health Officer assessment.
A milk or milk product designated PA (further product
				  assessment required) in either Table A or B should be considered TCS until
				  sufficient information is provided to demonstrate the safety of the product.
				  The PA will be an evaluation of the product or product group's ability to not
				  support pathogenic growth. Means to evaluate this assessment include (but are
				  not limited to): literature review of similar products, inoculation studies,
				  expert risk assessment, and/or state regulatory assessment.
INSTRUCTIONS FOR USING TABLES A AND B
1. Does the operator want to hold the milk or milk product
				  without using time or temperature control?
a. No: Continue holding the milk or milk product at 7°C
				  (45°F) or less as required in the Grade "A" PMO.
b. Yes: Continue using the decision tree to identify which
				  table to use to determine whether TCS is required.
2. Is the milk or milk product pasteurized?
a. No: The milk or milk product is either raw or
				  heat-treated. Proceed to Step 3.
b. Yes: The milk or milk product is pasteurized to the
				  required minimum time and temperature for the milk or milk product as specified
				  in the definition of pasteurization of these rules. Proceed to Step 4.
3. Is the milk or milk product treated using some other
				  method equivalent to pasteurization?
a. No: The milk or milk product is raw or heat-treated which
				  may allow vegetative cells and spores to survive. Proceed to Step 6.
b. Yes: If another method equivalent to pasteurization is
				  used to destroy pathogens such as irradiation, high pressure processing, pulsed
				  light, ultrasound, inductive heating, etc., the new technology shall have been
				  recognized by the FDA as providing milk or milk product safety equal to
				  pasteurization, and the effectiveness of the process shall be demonstrated by
				  sufficient evidence or other means proceed to Step 5.
4. Is it packaged to prevent re-contamination?
a. No: Re-contamination of the product can occur after
				  pasteurization because it is not immediately packaged. Proceed to Step 6 and
				  use Table B.
b. Yes: If the milk or milk product is packaged immediately
				  after pasteurization to prevent re-contamination, higher ranges of
				  aw and/or pH can be tolerated because spore-forming
				  bacteria are the only microbial hazard. Proceed to Step 6 and use Table
				  A.
5. Further PA or plant documentation required.
a. The manufacturer of this product may be able to supply
				  evidence acceptable to the FDA that indicate the milk or milk product can be
				  safely held without TCS.
b. Milk and milk products prepared or processed using new
				  technologies may be held without time/temperature control provided the new
				  technology has been recognized by the FDA as providing milk or milk product
				  safety equal to pasteurization and provided the effectiveness of the use of
				  such technologies is based on evidence accepted by the FDA.
6. Using the milk or milk product's processing parameters,
				  known aw and/or pH values, position the milk or milk
				  product in the appropriate table.
a. Choose the column under "pH Values" that contains the pH
				  value of the milk or milk product in question.
b. Choose the row under "aw Values"
				  that contains the aw value of the milk or milk product
				  in question.
c. Note where the row and column intersect to identify
				  whether the milk or milk product is Non-TCS and therefore does not require
				  time/temperature control, or whether further PA is required. Other factors such
				  as redox potential, competitive microorganisms, salt content, or processing
				  methods may allow the product to be held without time/temperature control;
				  however, evidence acceptable to the FDA is required.
7. Use Table B for milk or milk products that are not
				  pasteurized or pasteurized but not immediately packaged, where both pathogenic
				  spores and vegetative cells may be a concern, or use Table A for milk and milk
				  products that are pasteurized and immediately packaged, where only pathogenic
				  spores are of concern.
8. Determine if the milk or milk product is Non-TCS or needs
				  further PA.
Click to view
				  image
Figure 59. Decision Tree for Using pH,
				  aw, or the Interaction of pH and aw to Determine if a
				  Milk or Milk Product Requires Time/Temperature for Safety
Source Document: Evaluation and Definition of Potentially
				  Hazardous Foods, IFT, 2001 available at
				  http://www.fda.gov/-comm/ift4exec.html.
Author:
G. M. Gallaspy, Jr.
Statutory Authority:
Code of Ala. 1975,
					 §§
											22-2-2,
					 22-20-7.