Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods

The Northwest Horticultural Council submits the following comments regarding FDA's "Control of Listeria monocytogenes (Lm) in Ready-To-Eat Foods: Guidance for Industry" draft guidance. A full copy of our comments is enclosed. The NHC represents apple, pear, and cherry growers, packers, and shippers in Idaho, Oregon, and Washington on federal and international policy and regulatory issues. Our growers and packers are dedicated to food safety. They take efforts to control Lm very seriously and are continually looking for more and better information on how to control this pathogen within the packinghouse. An overarching theme regarding our concerns with this guidance document is that it does not adequately reflect the realities of the production of fresh, whole produce, which is grown in the outside environment where transient Lm is known to persist at low levels without known preventive controls to reduce Lm at the farm level or "kill" step (listeriacidal treatment) at the packinghouse level. Additional flexibility, and in some cases guidance, is needed in certain areas to reflect the reality of growing and packing fresh produce and assist packinghouses in prioritizing resources to address the highest risks for Lm cross-contamination, therefore allowing for the maximum protection of public health. Environmental Monitoring: We appreciate FDA's adoption of the USDA Food Safety and Inspection Service's approach to environmental monitoring that encourages operators to seek out transient Lm within their facilities so it can be eradicated before becoming resident. Cleaning and Sanitation: We appreciate the guidance provided by FDA on cleaning and sanitation procedures. Sanitary Equipment/Facility Design: We believe FDA must acknowledge in the guidance document that (a) some industries are still in the process of developing designs for sanitary equipment; (b) the standards in this document should be considered guidelines when constructing new facilities and/or equipment; (c) sanitary equipment and facility design is a long-term goal that some facilities may not be able to achieve in the short-term; and that (d) it should only be considered part of the picture, along with a robust cleaning/sanitation and environmental monitoring program, for an appropriate food safety plan to control Lm. Product Testing: We are concerned with references to product testing as both raw ingredients and final product. As recognized by FDA in two FSMA rules, product testing for produce is of limited value because we know Lm is a naturally-occurring pathogen that enters the packinghouse, and product testing only identifies an issue with one product at one point-of-time without identifying causes or contributing factors. The NHC believes that (a) environmental monitoring is a more valuable verification activity; (b) product testing is redundant of a robust environmental monitoring program; and (c) FDA must clarify in this guidance document that product sampling is not expected for fresh produce because it is of limited value. RTE Versus Non-RTE Zones: FDA repeatedly references separation and/or different requirements for RTE and non-RTE areas. The separation of raw product from RTE areas simply does not exist within our industry. The NHC requests FDA clarify that there is no separation between RTE and non-RTE areas within packinghouses for produce, and that facilities should rely on their hazard analyses to determine how to apply the various provisions of this document that reference this differentiation. Controls on Personnel: We are concerned that the costs of some of the recommendations in this section far exceed any potential benefit to the protection of human health for facilities like tree-fruit packinghouses. We are concerned that the lack of flexibility or references to a facility's hazard analysis in this section could force facilities to expend unnecessary resources complying with these recommendations that could be better used on cleani…