News & Resources

Dairy Plant Audits to Increase as FDA Releases Guidance on Supply Chain Program

February 9, 2018

The U.S. Food and Drug Administration (FDA) issued materials on Jan. 24 to help importers and food producers comply with the food safety rules mandated by the Food Safety Modernization Act (FSMA). One of the documents, “Chapter 15: Supply Chain Program for Human Food Products,” covers the supply-chain program, required by the Preventive Controls Rule for Human Food. NMPF is reviewing the complex document and will work with FDA to prevent the imposition of burdensome audits across the dairy processing chain related to FSMA compliance.

At issue for the dairy industry is a ready-to-eat (RTE) food manufacturer’s use of milk powder or cheese in a RTE food. FDA says that because L. monocytogenes (Lm) can cause serious health issues, there must be an annual on-site audit to ensure the dairy manufacturing facility is controlling the pathogen. The guidance describes how to approve suppliers, determine supplier verification activities and determine the frequency of conducting verification.

In addition, FDA discusses how an environmental monitoring program is used to verify that the supplier’s sanitation controls are working, and described situations where an immediate supplier may not be the only one performing a preventive control. For example, if a RTE food manufacturer’s immediate supplier does not make the cheese, but cuts and wraps it, then the RTE food manufacturer will need information from its immediate supplier about its environmental monitoring program. The RTE manufacturer will also need from the cheese manufacturer (or the supplier’s supplier) information regarding milk pasteurization and its environmental monitoring program.

NMPF envisions that most cut-and-wrap operations will secure the appropriate verification from the cheese manufacturers and pass it along to the RTE food manufacturers, thereby cutting down on an endless stream of on-site audits. NMPF has told FDA in the past that too many audits detract from food safety.

While the draft guidance does not specify a due date for comments, NMPF plans to file and address this issue.