The agency said it was taking action due to scientific data on potential health risks associated with cheese made from unpasteurized milk.
The FDA said it recognizes there is broad diversity in cheese manufacturing operations and approaches.
“Many types of raw milk cheeses are made using traditional methods that require a successful balance involving the quality of the milk, the equipment, and the environment, including ensuring the presence of bacteria critical to the nature of the cheese while preventing the introduction or growth of pathogens,” said the agency.
It wants to learn more about the standards and practices in use by producers, including the growing artisanal cheese manufacturing community.
The notice can be found in the Federal Register and the comment period expires on November 2.
US and Canada risk assessment
FDA is seeking comments based in part on findings from a joint FDA/Health Canada Quantitative Risk Assessment (QRA) which was just re-released after draft publication in 2013.
The agency said scientific data has shown potential health risks associated with eating cheese made from unpasteurized milk.
“The aging period for cheese manufactured from unpasteurized milk was presumed to act as a control measure to reduce the risk that pathogens would be present when the cheese was consumed,” it said.
“However, the available data and information raise questions about the safety of cheese manufactured from unpasteurized milk, even when aged.”
Comments are wanted to assist in identifying and evaluating intervention measures for bacterial pathogens in cheeses manufactured in this way.
The QRA is to evaluate the effect of the microbiological status of milk, cheese-manufacturing steps, and conditions during distribution and storage on the risk of listeriosis to consumers of soft-ripened cheese in the US or Canada.
27 of 65 cheese-associated outbreaks from 1993-2006 were attributable to products manufactured from unpasteurized milk, even though the contribution of unpasteurized dairy products to all dairy product consumption in the US during the time period was estimated at below 1%.
The 65 analyzed outbreaks resulted in 641 associated illnesses with 131 hospitalizations with pathogens including Listeria monocytogenes, E. coli O157, Salmonella and others.
In 2013, FDA made available a draft document on the subject.
It gave interested parties an opportunity to comment so the agency could consider the approach and data used, assumptions made, modeling techniques, and clarity and transparency of QRA documentation.
It received 96 comments on the draft QRA including from the EU Commission and the American Cheese Society (ACS).
Responding to the 2013 federal register notice, ACS said it was concerned the conclusions from the risk assessment may be based on an incomplete data set and may not be wholly accurate.
“We are concerned that the net impact of these misrepresentations may lead to reduced sales of safe cheese products and increased regulatory efforts beyond those justified by empirical evidence.”
The European Commission said results for one cheese cannot be easily extended to the overall soft-ripened cheese production.
“For these reasons, Commission invites FDA to take into consideration all the existing scientific studies, the production peculiarities before taking any management decision on possible risk derived by consumption of soft-ripened cheese.
“Whatever decision not in line with science and with the demonstrated safe consumer habits could lead to unjustified trade disruption.”