FDA pauses non-toxigenic E. coli testing in cheese

10-Feb-2016 - Last updated on 09-Feb-2016 at 21:44 GMT

FDA to re-look at non-toxigenic E. coli testing in cheese

The US Food and Drug Administration (FDA) is to pause its testing program for non-toxigenic E. coli in cheese while it re-evaluates the issue.

It will continue to inspect cheese-making facilities and test for pathogens in domestic and imported items.

A re-evaluation will include the Food Safety Modernization Act (FSMA) and the Preventive Controls for Human Food rule, which requires food producers identify hazards in their product and operations and put controls in place to prevent or minimize them.

The agency said cheesemakers have raised concerns suggesting it is applying safety criteria that may limit the production of raw milk cheese without benefitting public health.

This type of testing has been used by FDA, public health agencies in the US and other countries to indicate fecal contamination.

The FDA said the reason for testing cheese samples for non-toxigenic E. coli is that bacteria above a certain level could indicate unsanitary conditions in a processing plant.

It added surveillance sampling shows that the vast majority of domestic and imported raw milk cheeses are meeting the criteria.

The FDA will also consider and update, the 2010 Compliance Policy Guide, which outlines safety criteria.

Reaction to FDA move

Keller and Heckman said the FDA announcement pledges a re-evaluation of its safety criteria under the framework in FSMA and references the relevance of hazard analysis and risk-based preventive controls (HARPC).

It is not clear when FDA’s revisions to the 2010 CPG will be complete but the law firm said it was ‘interesting’ to see the agency expressly citing a FSMA-based and science-focused rationale among the reasons for a proactive change to enforcement policies.

The American Cheese Society (ACS) said it was ‘pleased’ that FDA expressed its respect for raw milk cheesemaking and artisan producers in the statement.

“This action comes on the heels of collaborative efforts by industry members, including ongoing regulatory advocacy by ACS, to address changes in permissible levels of non-toxigenic E. coli in raw milk cheese,” said the group.

“This also shows FDA's continued effort to adhere to science-based regulatory changes, something ACS has championed. As FDA recently sampled and collected data on 1,200 imported and 400 domestic raw milk cheeses, we hope the overall safe profile of legally-made raw milk cheeses from licensed facilities will inform any future changes to existing standards.

“We are proud that our advocacy efforts, in conjunction with those of so many allied industry groups that share our interests, have made a real impact on the regulatory landscape. Of course, our work is not over. We continue to maintain a keen focus on preserving traditional cheesemaking for generations to come.”

Previous work

An FDA call for information on cheese made from raw milk received more than 70 comments last year.

Also in 2015, Peter Welch, Patrick Leahy and Bernie Sanders challenged a FDA standard that could ban age-old recipes for raw milk cheese and harm artisan producers in Vermont.

The FDA standard specifically seeks to limit the level of non-toxigenic E. coli in raw milk cheeses from 10,000 most probable number (MPN)/gram in 2009 to 10 MPN/gram.

“Artisan cheese plays a powerful role in rural economies through job creation and conservation of working landscapes. Every industry needs good regulation in order to thrive,” said Mateo Kehler, Co-Founder, Jasper Hill Farm.

“As a cheesemaking community we are not asking for ‘less' regulation, we are asking for ‘good' regulation that is developed transparently and based on solid science. Getting the details right is of critical importance. The future of artisan cheesemaking in America depends on it.”