With so many questions swirling around the regulation of non-toxigenic E. coli in cheese, ACS is posting below with the latest information we have, and a call to action for industry members.
Since meeting with FDA reps in Sacramento, we have been engaging with FDA around issues that impact our members – one of which is acceptable limits for non-toxigenic E. coli in cheese. At issue is a 2010 Compliance Program Guideline (CPG) that calls for all milk products to have <10 MPN/g (Most Probable Number/g) of non-toxigenic E. coli in at least 3 of 5 subsamples – with no samples greater than 100 MPN/g. This is lower than the amount allowed in the existing compliance program (<10,000 MPN/g), and it also lowers the amount proposed in the 2009 Draft version of the CPG, which specified a higher limit for raw milk cheeses (<100 MPN/g in at least 3 of 5 subsamples, with no samples greater than 1,000 MPN/g).
ACS reached out to FDA for an explanation of the reasoning behind lowering the permissible levels in the 2010 CPG, as well as for removing language that specifically addressed raw milk cheese. In its response to ACS, FDA made a correction to its testing protocol, increasing the number of subsamples allowed to exceed the 10 MPN/g limit from 1-of-10 to 2-of-5, as long as no sample exceeds 100 MPN/g. FDA claims that 95% of raw milk cheeses would meet these guidelines, based on the results of their raw milk pilot testing program.
The CPG has been in place since 2010, so it isn’t new. However, it is only recently that we have been made aware of enforcement of this guideline. We have requested additional clarification from FDA as to what data led to the change in the compliance policy, and to gain an understanding of any public health risks stemming from non-toxigenic E. coli that are of concern to FDA. In FDA’s pilot testing program, 885 raw milk cheeses have been sampled thus far. Of those, 2 tested positive for Salmonella spp., 3 for Listeria monocytogenes, and none for E. Coli O157:H7. The positive samples came from imported, not domestically-produced, cheeses. This indicates a pathogen contamination rate of less than 1% for raw milk cheeses.
You can see FDA’s latest public update, which also includes information about internationally-produced cheeses that have been placed on Import Alert, here: http://www.fda.gov/Food/NewsEvents/ucm413309.htm
So, where do members of this group come in? FDA has asked for stakeholder comments to the 2010 CPG, and thus far, only 3 comments have been submitted! We need more cheese professionals to provide comments at http://www.regulations.gov/#!documentDetail;D=FDA-2009-D-0466-0008. If you need some guidance or suggestions, please see below:
Comment on how this issue may impact your business, such as:
- Consumer demand for cheeses to which you now have limited access.
- Financial losses due to lack of inventory and/or delayed shipments leading to waste.
- Other challenges you face due to enforcement of the <10 MPN/g guideline.
- Ask why the allowable limits were lowered, and what foodborne illness outbreaks have been linked to non-toxigenic E. coli levels over 10 MPN/g.
- Request that FDA included language/limits in the Compliance Policy Guideline allowing for differences between cheeses made from pasteurized and non-pasteurized milk.
- State that limits should be based on science, consider public health risks, and be realistic and consistently attainable for producers.
Thanks in advance for your support! We will continue to share updates as we receive them via our CheeseBytes newsletter, our Facebook page, and from time to time through this group.
Marketing & Communications Director
American Cheese Society