Dive Brief:
- The FDA is going to pause its testing program for non-toxigenic E. coli in cheese after raw milk cheese producers raised concerns about the requirement. The agency said it would review the testing requirement in the context of FSMA rules, particularly for preventive controls.
- Producers said that this testing could "limit the production of raw milk cheese without demonstrably benefitting public health," according to the FDA.
- The FDA has long used testing for non-toxigenic E. coli to detect the contamination of fecal matter, which would suggest unsanitary conditions at a processing facility. Concerns about this safety criteria include how FDA applies test results and the criteria's scientific basis.
Dive Insight:
As FSMA rules take effect, manufacturers of other foods and beverages could begin questioning certain testing requirements, so the FDA may make similar considerations for other categories. One argument regards the necessity of such testing, especially when it can needlessly limit production. The new FSMA rules require producers to put in place preventive controls and reporting systems. That could negate the need for some of these safety testing criteria if companies can already demonstrate that they have adequate preventive protocols.
These tests may seem an unnecessary hindrance to production, but the FDA does have cause for concern about raw milk products, as companies have enacted dozens of recalls for raw cheese over the years for contaminations of campylobacter, salmonella, E. coli, and listeria. However, with companies adjusting operations and safety protocols to meet FSMA requirements, particularly preventive controls, manufacturers will be watching to see what other categories and testing requirements the FDA will reconsider.
As for the FDA's raw cheese testing requirement in question, "The compliance guide issued by the FDA in 2010 reduced the amount of non-toxigenic E. coli that can be in a product to 10 most probable number (MPN) per gram, from 100 MPN per gram in two of five samples, a 90% reduction. This standard does limit production of raw milk cheeses," according to Food Poisoning Bulletin.