L. mono draft guidance provides specifications for RTE foods

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L. mono

The FDA recently updated its draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods,” in an effort to provide new, detailed information for ready-to-eat food (RTE) facilities subject to FSMA’s Preventive Controls rule.

While the draft guidance is long and comprehensive, it makes some clear recommendations that the Acheson Group outlines and provides as key takeaways from the document.

As a reminder, RTE facilities are defined as those which manufacture, process, pack, or hold foods. Although many different types of facilities fall into this category, the guidance is providing a uniform federal approach for the control of Listeria monocytogenes (L. mono) by integrating a “seek and destroy” approach. The FDA believes this approach will provide a more effective effort to control L. mono in RTE products.

Below is a list of the areas the FDA recommends RTE facilities take proper precautions in to avoid L. mono contamination.

  • Personnel
    An individual’s actions can transfer mono from the processing environment to a RTE food. The guidance includes recommendations for hands, gloves and footwear, as well as foamers, footbaths for personnel associated with specific areas in the plant.
  • Plant Design and Construction
    The guidance includes general design and construction of a plant to facilitate maintenance and sanitary operations, along with those for water systems and proper air flow.
  • Plant Operations
    Includes recommendations for traffic flow patterns for personnel, food products, food packaging materials, and equipment and management of pallets and other containers.
  • Equipment Design and Construction
    The guidance recommends that the RTE production equipment be designed and constructed to minimize sites where microbial harborage and multiplication can occur, with specifications for food-contact surfaces.
  • Equipment Maintenance
    A preventive maintenance program should be designed to minimize breakdowns and prevent contamination that could occur during repair of equipment. Also included are recommendations for use of dedicated tools, filter changing, and record maintenance.
  • Sanitation
    Food facilities are to establish and use a sanitation program that includes written sanitation procedures and a schedule for areas where RTE foods or food contact surfaces are processed or exposed. Includes recommendations for CIP systems, wet cleaning and sanitizing, production line cleaning, sanitation monitoring, recordkeeping and more.
  • Raw materials and Ingredients
    Facilities should assess which raw materials and other ingredients are more likely to be contaminated with mono and focus control efforts here. Additionally: Verify that any suppliers with listericidal control measures have validated the process and have ongoing monitoring and verification programs.
  • Storage Practices and Time/Temperature Controls
    The guidance recommends the establishment and implementation of procedures to minimize the potential for any mono that could be present.
  • Transportation
    Trailers and tankers should be inspected and include time/temperature controls; tankers/repeat-use bulk containers should be dedicated to the RTE product or preventative control procedures must be established.

To read the full list and the rest of the guidance document, click here.

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