ACS has received an industry update from FDA regarding non-toxigenic E. coli in raw milk cheese.

We are pleased that our outreach to, and collaboration with, FDA has resulted in this modification to testing and regulatory action for non-toxigenic E. coli. We will continue to seek further clarity on the data that led to the limits being lowered initially -- and you can assist us in our efforts to provide comments and further industry information to FDA. Please see the bottom of this message to learn more about what you can do, now, around this issue.

We will keep members posted with additional updates if and when we have new information to share.

Thank you,

Nora Weiser
Executive Director
 

MESSAGE TO INDUSTRY STAKEHOLDERS FROM FDA:

Industry Partners,

The FDA began a food sampling pilot aimed at aligning with the goals of FSMA, which mandates a risk-informed and preventive approach to food safety.  Through one portion of this pilot, the FDA is seeking information on the rates of microbial contamination in raw milk cheese aged for 60 days.  Upon completion, the FDA will have a statistically significant data set to help inform the agency's decision making process.  During this pilot process, the agency has been closely monitoring the product collections and analysis and stakeholder feedback in an effort to gather lessons learned and make course corrections, if necessary, to meet the goals of the pilot. 

At this time, we want to inform our industry partners about one such course correction that we are making with regard to non-toxigenic Escherichia coli (E. coli) policy in raw milk, aged cheese.  One industry partner asked that we re-examine non-toxigenic E. coli policy and subsequent action taken by the agency on imported cheeses during the pilot.  Upon re-examining the basis for the non-toxigenic E. coli in cheese compliance policy, FDA determined that adjustments to testing and regulatory action information were necessary.  Specifically, the agency has updated instructions to its field laboratories to limit testing for non-toxigenic E. coli in raw milk cheese to five (5) subsamples.  Subsequent regulatory information was also modified to indicate that only lots with non-toxigenic E.coli levels in three or more subsamples of the five examined exceeding 10 MPN/g but less than 100 MPN/g would be considered violative.  A single result above 100 MPN/g remains a violation.  Adjustments were made to facilities subject to import alert based on the policy changes.  It is important to note that ten (10) subsamples will continue to be collected and analyzed for the Salmonella spp., Listeria monocytogenes and E. coli O157:H7.  The regulatory information applied to these microbial findings will remain unchanged.

At this time, the FDA has collected and analyzed approximately 55% of the 1600 raw milk, aged cheese samples requested as part of this pilot.  These samples comprise raw milk cheeses coming from Austria, Belgium, Bulgaria, Canada, Cyprus, Denmark, France, Germany, Ireland, Italy, Mexico, Netherlands, Nicaragua, Poland, Portugal, Spain, Swaziland, Switzerland, United Kingdom, and the U.S. We are considering ways to share more interim data with you and hope to provide more information in the next few months.  We also, plan to issue a report at the completion of the pilot to share our findings and key lessons learned with industry.  In the meantime, we want to thank you for your patience and cooperation with this pilot. 

Amy Barringer

Director, Division of Field Programs and Guidance

FDA/CFSAN/OC

STAY CONNECTED WITH US