Blessed are the cheesemakers: Is non-toxigenic E. coli an indicator for food safety in raw milk cheese, US FDA is taking a ‘pause’

Recently, cheesemakers have raised concerns suggesting that the FDA is applying safety criteria that may, in effect, limit the production of raw milk cheese without demonstrably benefitting public health.

cheesemakersIn response, we want to first acknowledge our respect for the work of the artisan cheesemakers who produce a wide variety of flavorful, high-quality cheeses using raw milk and our appreciation for the great care that many take to produce raw milk cheeses safely. We understand the concerns expressed by some cheesemakers, as well as lawmakers, and intend to engage in a scientific dialogue on these issues.

The agency’s role in this area, and with respect to food safety generally, is to work with the industry, consumers, government partners, and experts to be sure the right science-based, prevention-oriented standards and safety criteria are in place and that there is widespread compliance in the interest of food safety and consumer confidence.

Some question testing raw milk cheese for the presence of non-toxigenic E. coli, which has long been used by FDA and other public health agencies in the U.S. and other countries to indicate fecal contamination.  Specifically, the concerns include the application of the test results and scientific foundation of these criteria.

The FDA’s 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. Our surveillance sampling shows that the vast majority of domestic and imported raw milk cheeses are meeting the established criteria.

The agency will re-evaluate its criteria in the context of the overarching framework for the oversight of food production provided by the 2011 FDA Food Safety Modernization Act (FSMA). The Preventive Controls for Human Food rule mandated by FSMA, which became final in September, requires that food producers identify hazards in their product and operations and put controls in place to prevent or minimize those hazards.

Looking ahead, with the FSMA preventive controls rule now final, we will be taking another look at what role non-toxigenic E. coli should have in identifying and preventing insanitary conditions and food safety hazards for both domestic and foreign cheese producers.

The FDA will also consider and update, as appropriate, the 2010 Compliance Policy Guide, which outlines safety criteria. Any changes will be informed by our engagement with stakeholders and experts on such issues as the use of a single bacterial criterion for both pasteurized and raw milk cheese, and the use of non-toxigenic E. coli as an indicator organism.

The agency will continue to inspect cheese-making facilities and test for pathogens in domestic and imported cheese but, in the meantime, FDA is in the process of pausing its testing program for non-toxigenic E. coli in cheese. We will also continue working with all stakeholders to benefit from their expertise about safe cheese-making practices and achieve the mutual goal of food safety.

Blessed are the cheesemakers who don’t include listeria

A Washington state cheese processor and distributor has agreed to keep its products off the market until they are proven safe for consumption as part of a consent decree of permanent injunction with the U.S. Food and Drug Administration.

Del Bueno, of Grandview, Wash., which processes a variety of cheeses and distributes them to specialty grocery stores and restaurants, and owner Jesus Rodriguez, agreed to terms of the consent decree entered by U.S. District Judge Lonny R. Suko of the Eastern District of Washington, on April 3.

Under the consent decree, Del Bueno cannot process or distribute food until it demonstrates that it has developed a control program to eliminate Listeria monocytogenes from its production facility and products.

Del Bueno must, among other actions, hire an independent laboratory to collect and analyze samples for the presence of Listeria, retain an independent sanitation expert, develop a program to control Listeria for all employees in both English and Spanish, and destroy all food items currently in the facility. Once the company is permitted to resume operations, the FDA may still require the company to recall products or cease production if future violations occur.

“When a company continues to produce food that presents a risk for consumers, the FDA will take action,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “We will not hesitate to protect the public’s health.”

FDA and Washington State Department of Agriculture (WSDA) inspections since 2009 have documented numerous deficiencies in Del Bueno’s processing facility. In addition, FDA laboratory testing since 2010 also found Listeria monocytogenes in Del Bueno’s finished cheese products and in the Del Bueno facility. Both the FDA and the WSDA repeatedly advised Del Bueno and its owner of the unsanitary conditions at the facility.

In 2010, Del Bueno cheese was linked to a case of listeriosis in Washington state. Although no illnesses have been reported in 2012 from Del Bueno products, individuals who have eaten these products and experience any of the symptoms of listeriosis listed above should contact their health care professional.