Next month, FDA will launch a pilot program to sample and test domestic and imported raw milk cheese aged at least 60 days for salmonella, L. monocytogenes, and E. coli O157:H7. On December 19, members of the ACS Regulatory & Academic Committee attended a conference call held by FDA to share information about the program. Critical details are summarized below.
ACS advises all members to carefully review the information below. If you have questions about this pilot program that are not addressed in this Member Alert, please contact our office at 720-328-2788 or info@cheesesociety.org and our staff will work to assist you.
What is the purpose of the pilot program?
This program will test a new microbiological sampling surveillance model, which should help to fill knowledge gaps on the prevalence of microbiological hazards in commodities and increase FDA's understanding of risks, contamination rates, and mitigation strategies. Samples of raw milk cheese aged at least 60 days (both domestic and imported) will be analyzed for contamination from salmonella, L. monocytogenes and E. coli O157:H7. Along with raw milk cheese, the pilot program will include domestic and imported sprouts and raw almonds.
Which cheeses may be affected by this program?
This program will focus on raw milk cheeses aged at least 60 days, including both hard and soft cheese styles. In total, it will include approximately 1,600 samples: 70% of cheeses sampled will be imported, and 30% will be produced domestically. Please note that this pilot program will take place in addition to, rather than in place of, current FDA sampling programs.
Where/when will sampling take place?
Sampling will begin in January 2014 (an exact date has not been provided) and will last for approximately 12 months. Sampling may take place at any point in the supply chain for domestic cheeses, including at the cheesemaking plant. For imported cheeses, sampling will occur at locations where the cheese normally enters the U.S.
If cheeses that I produce or import are tested, how can I get test results?
FDA is unlikely to provide results directly to you, so please be proactive in contacting FDA's District Compliance Officer with your sample number(s) to get your results.
- If a test is negative, this information should be available as soon as 3 days after the sample is received in an FDA testing lab.
- If a test is tentatively positive, FDA will run a confirmatory test, and that final result should be available approximately 5-8 days after the sample is received in an FDA testing lab. Please remember to follow up on your tests, as you may not otherwise receive word of a positive result until an inspector arrives at your facility.
- Note: Producers will not be notified that their cheese has been tested if it is sampled outside the manufacturing facility and the test is negative.
What happens if my product tests positive?
For domestic cheese, response to positive findings will be at FDA's discretion, but will likely follow traditional FDA approaches similar to those used whenever a product is believed to be contaminated — including traceback, inspection, environmental sampling, additional product testing, and voluntary recall if necessary.
For imported cheese, FDA will likely issue an "Import Alert" to essentially block import of the cheese into the U.S. The government of the exporting country will also be notified, so that their own regulatory authority can follow up with the producer.
When will the overall results/outcomes of this program be made available?
FDA representatives have stated that general information and trending of sample results will likely not be released until the analysis is complete at the end of the pilot program, in January 2015 at the earliest.
Where can I get more information on this program?
FDA has stated that there will be no public notification about this program beyond the information shared via the December 19 conference call and subsequently via this Member Alert.
If my products are tested, should I notify ACS?
ACS would like to stay apprised of any testing of members' products that takes place via this pilot program. We encourage you to contact our office if your products are tested, or if you have questions about the program: 720-328-2788 or info@cheesesociety.org. Please note that any details related to testing at your facility will remain completely confidential.
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Source: American Cheese Society