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Web Content Viewer (JSR 286)

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2018-2020 Subcommittee: Microbiological Testing by Industry of Ready-To-Eat Foods Under FDA's Jurisdiction for Pathogens (or Appropriate Indicator Organisms): Verification of Preventive Controls

Subcommittee Members

Dr. Kathleen Glass and Dr. Laurie Post:  Working Group Chairs

  • Dr. De Ann Davis
  • Dr. Francisco Diez-Gonzalez
  • Dr. Joseph Eifert
  • Dr. Philip Elliott
  • Dr. Patty Lewandowski
  • Ms. Wendy McMahon
  • Dr. Angela Melton-Celsa
  • Dr. Haley Oliver
  • Dr. Angela Ruple
  • Dr. Jenny Scott
  • Dr. Valentina Trinetta
  • Dr. Alisa Wilma

Executive Summary

FDA’s final rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (the CGMP & PC rule) requires a facility that has identified hazards requiring preventive controls to verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazard. Verification activities for preventive controls for microbial hazards include, as appropriate to the facility, the food, and the nature of the preventive control and its role in the facility's food safety system, product testing for a pathogen (or appropriate indicator organism).  FDA is seeking advice from NACMCF on 1) the utility and necessity of industry testing ready-to-eat (RTE) foods for pathogens and 2) criteria industry could apply in determining what, if any, microbiological testing is appropriate for verifying pathogen control for the RTE foods produced in a facility.

Background

In 2015, FDA published its final rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (the CGMP & PC rule) in title 21 of the Code of Federal Regulations (CFR) part 117.  A facility that has identified hazards requiring preventive controls must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazard. As specified in 21 CFR 117.165, verification activities for preventive controls for microbial hazards include, as appropriate to the facility, the food, and the nature of the preventive control and its role in the facility's food safety system, product testing for a pathogen (or appropriate indicator organism).  FDA has indicated that such product testing is a verification activity to help assess and verify the effectiveness of a food safety plan and the facility’s capability to consistently deliver against it, not to establish the acceptability of every lot or batch.  

Because of the flexibility FDA provided in the rule, advice from NACMCF on 1) the utility and necessity of industry testing ready-to-eat (RTE) foods for pathogens and 2) criteria industry could apply in determining what, if any, microbiological testing is appropriate for verifying pathogen control for the RTE foods produced in a facility, would be highly beneficial for industry. Such advice should include the test microorganism(s), the sampling plan that should be used, the type of test (e.g., presence/absence or enumeration), the frequency of such testing, interpretation of results, and actions to take when such testing indicates a loss of control. Advice from NACMCF on the use by industry of enzymatic indicators of application of heat-based processes (e.g., alkaline phosphatase for pasteurization of milk) and whether there are situations where verification testing of products by industry would not be necessary if there is evidence that the appropriate treatment was applied would be useful as well.

Note that a 2013-2015 NACMCF Subcommittee addressed a charge from the Department of Defense (DoD) on Microbiological Criteria as Indicators of Process Control or Insanitary Conditions.  That charge was to develop microbiological and other possible criteria for DoD auditors to better evaluate process control and insanitary conditions at the point of production.   Some of the information developed in the final report of that Subcommittee (see NACMCF, 2018, Response to Questions Posed by the Department of Defense Regarding Microbiological Criteria as Indicators of Process Control or Insanitary Conditions, Journal of Food Protection: 81(1): 115–141) may be useful in addressing this charge.  However, the focus here is on practical advice for manufacturers/processors subject to the preventive control requirements in 21 CFR part 117 about when they should use microbiological testing for pathogens (or appropriate indicator organisms) to verify process control for pathogens in RTE foods under FDA’s jurisdiction.

Food categories of concern include:

Dairy Products:

  • Butter, margarine
  • Cheese, hard (e.g., Cheddars), extra hard, grating (e.g., Parmesan, Romano)
  • Cheese, fresh (Queso fresco), soft, soft-ripened (Camembert), semi-soft (Edam, Gouda), veined cheeses (Roquefort, Gorgonzola)
  • Cultured, pH < 4.8
  • Cultured, pH > 4.8 and <5.4
  • Dried products (including dairy ingredients used to make infant formula)
  • Frozen desserts
  • Milk and milk products (fluid)

Grain-Based Products:

  • RTE baked items, refrigerated or time-temperature controlled for safety (TCS)
  • RTE baked items, shelf stable or non-TCS
  • RTE cereals
  • RTE cold-pressed bars

Meals and Entrees:

  • RTE deli salads
  • RTE sandwiches
  • “Heat and eat” meals/entrees

Nuts (including tree nuts and peanuts) and Nut/Seed Products:

  • RTE nuts not processed for lethality (e.g., chopped untreated tree nuts)
  • RTE nuts processed for lethality (e.g., roasted tree nuts, almond milk, coconut milk)
  • RTE nut/seed butters processed for lethality (e.g., peanut butter, sunflower butter)

Fruits and Vegetables:

  • RTE fresh-cut fruits (e.g., cut melon, sectioned grapefruit, sliced pineapple)
  • RTE fresh-cut vegetables (e.g., cut celery stalks, peeled baby carrots, sliced mushrooms, shredded cabbage, chopped lettuce)
  • RTE dried/dehydrated fruits (e.g., dried cranberries, raisins, dried apricots)
  • Packaged uncut leafy greens (e.g., spinach leaves, baby greens leaves)

Spices and Herbs:
(Include consideration for intrinsic properties in certain spices and herbs (e.g., cinnamon, cloves, oregano) that can interfere with test methodology and risk from added components in spice blends.)

  • RTE spices and spice blends, not processed for lethality
  • RTE spices and spice blends, processed for lethality
  • Dried, chopped herbs

Charge Questions for the Subcommittee

  1. For the food categories listed above, what principles and criteria should a company apply in determining the need for and in designing an effective microbial testing program to verify that processes are effectively controlling microbial pathogens? 
     
  2. Are there situations in which testing other than for pathogens or indicator organisms, e.g., enzymes, would be an appropriate verification activity for a company?
     
  3. Are there situations where verification testing by a company would not be necessary if there is evidence that the appropriate treatment was, in fact, applied?
     
  4. When microbial testing is an appropriate verification activity, what considerations should a company apply in selecting the test microorganism (e.g., specific pathogen or specific indicator organism) and type of test (e.g., presence/absence or enumeration)? What are appropriate indicator microorganisms for verifying processes that adequately control pathogens?
     
  5. What principles and criteria should a company apply in determining the frequency of testing finished product to determine if the company’s food safety system for that product is effective?
     
  6. Generally microbial testing by a company to verify process control is conducted on “finished product.” Are there situations in which testing at sites other than at the end of the process can achieve the goal of verifying the adequacy of control of microbial hazards?  Describe the situations and the testing that would be appropriate. 
     
  7. The CGMP & PC rule requires environmental monitoring for an environmental pathogen (e.g., Listeria monocytogenes, Salmonella) or for an appropriate indicator organism as a verification activity if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (such as sanitation controls).   What impact should environmental monitoring have on frequency and extent of product testing verification activities by companies?
     
  8. What criteria should a company apply in determining that microbial testing results indicate a loss of process control? What actions should a company take if test results indicate a loss of process control? When verification testing indicates loss of process control, to what extent should verification testing be increased, how far upstream and downstream should it go, and when and how should it be scaled back?

 

Last Modified Sep 26, 2018