Skip to content
DWT logo
People Expertise Insights
About Locations Careers
Search
People
Expertise
Insights
About
Locations
Careers
Search
Advisories
Food + Beverage

Controlling L. mono in RTE Foods: FDA Publishes Draft Guidance

By  Allison B. Condra
01.17.17
Share
Print this page

Quick Bite:
The FDA is seeking comment until July 17, 2017, on draft guidance about recommended practices to control Listeria monocytogenes in food facilities.

The Details:
The Food and Drug Administration (“FDA”) recently published draft guidance articulating recommended practices to control Listeria monocytogenes (“L. mono”) in Ready-to-Eat Foods (“RTE Foods”) manufactured in food facilities. The guidance applies to food facilities that are subject to current good manufacturing practices requirements (“CGMP”) and/or the hazard analysis and risk-based preventive controls requirements (“PCHF”) finalized in part 117 of the Code of Federal Regulations as part of FDA’s implementation of the Food Safety Modernization Act.

FDA intends the guidance to assist food facilities in “complying with the CGMP and the PCHF requirements … with respect to L. mono whenever a RTE Food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. mono) that would significantly minimize L. mono.” The guidance addresses a range of topics, including:

  • personnel practices;
  • the design, construction, and operation of a food facility;
  • the design, construction and maintenance of equipment;
  • sanitation practices;
  • raw materials and other ingredients;
  • storage practices;
  • transportation;
  • environmental monitoring;
  • sampling and testing of RTE Foods;
  • training; and
  • recordkeeping.

FDA is seeking comment from the food industry on the draft guidance. For example, what did the FDA get right on this? Did the FDA forget to include practices that would help control L. mono in food facilities?

Although FDA guidance is not binding on the food industry, it does provide a guide to how the agency thinks about and will enforce the regulations under part 117. It is important, then, for FDA to hear from the food industry about the draft guidance. Food facilities that are subject to CGMP and/or PCHF requirements can submit their comments starting today, January 17, 2017; the comment period closes on July 17, 2017.

Related Articles

DWT logo
©1996-2022 Davis Wright Tremaine LLP. ALL RIGHTS RESERVED. Attorney Advertising. Prior results do not guarantee a similar outcome.
NAVIGATE
Home People Expertise Insights
About Locations Careers Events Blogs
STAY CONNECTED

Subscribe to stay informed.

Subscribe
Employees
DWT Collaborate
EEO
Affiliations
Legal notices
Privacy policy
©1996-2022 Davis Wright Tremaine LLP. ALL RIGHTS RESERVED. Attorney Advertising. Prior results do not guarantee a similar outcome.
Close
Close

CAUTION - Before you proceed, please note: By clicking “accept” you agree that our review of the information contained in your e-mail and any attachments will not create an attorney-client relationship, and will not prevent any lawyer in our firm from representing a party in any matter where that information is relevant, even if you submitted the information in good faith to retain us.