Alliance: Change listeria draft guidance for fresh produce

The docket on the draft guidance for control of listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods provoked a comment from an industry alliance Oct. 9. Here is a letter that seeks to recenter the FDA's focus:




October 9, 2008
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No. 2007-D-0494: Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods; Availability
Dear Sir or Madam:
On behalf of the Alliance for Listeriosis Prevention (listed at the end of this letter), we are submitting the attached copy of FDA’s “Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods” with suggested changes marked with “track changes.” Our suggestions incorporate the concepts that have made industry control of L. monocytogenes so successful in many operations and better delineate controls based on product risk (e.g., foods that support growth versus those that do not).
We note in submitting these comments that fresh and fresh-cut produce present a unique set of risks and consequences for controls, compared with other ready-to-eat foods, as noted in the April 7, 2008 comments submitted to FDA by United Fresh Produce Association. Thus, many of the recommendations in the guidance are not appropriate for these products. FDA has already noted the special circumstances of fresh produce in the recommendation for fresh produce companies to refer to the Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables for Listeria controls. The Alliance therefore respectfully suggests that FDA’s guidance also refer fresh-cut operations to the February 2008 Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables as the most appropriate approach for control of pathogens in these products. We welcome the opportunity to have additional discussions on control of pathogens, including Listeria monocytogenes, in fresh and fresh-cut produce. We urge FDA to revise the guidance as outlined in the document to better align it with current industry practices that have been developed and enhanced over many years. If we can provide more information, please do not hesitate to call.
Respectfully submitted,
Craig W. Henry, Ph.D.
Senior Vice President and Chief Operating Officer
Grocery Manufacturers Association