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Dairy Facts 2016

FDA Explains How Preventive Controls Rule Will Affect PMO

May 22, 2013

The Food and Drug Administration posted a set of frequently asked questions (FAQs) last Thursday to explain how the proposed rule for Preventive Controls relates to dairy products that are produced under the Pasteurized Milk Ordinance (PMO). The proposed rule is one of five that will establish the framework for implementing the Food Safety Modernization Act.

The Pasteurized Milk Ordinance sets standards for Grade A milk production, processing and packaging from the farm to the consumer. The Preventive Controls for Human Food rule would require food companies, including dairy food manufacturers – whether they manufacture, process, pack or store food – to have or put in place adequate controls to reduce the risk of contamination.

Under the proposed rule, food companies would need to have written plans to identify potential hazards and provide steps to address them, verify that the steps are working and outline how to correct any problems that arise. FDA would evaluate the plans and continue to inspect facilities to make sure the plans are being implemented properly.

According to the new FAQs, Grade A milk plants currently inspected under the PMO would be required to meet any additional requirements of the Preventive Controls rule. FDA is asking for comments explaining how the requirements of the PMO and the Preventive Controls rule can be implemented in a way that avoids duplication and makes sense with respect to ensuring food safety.

“IDFA does not believe the PMO-regulated dairy industry would be well served by having to follow two distinct regulatory standards, the PMO and the Preventive Controls rule,” said Clay Detlefsen, IDFA vice president of regulatory affairs. “We should follow one, and we note that the PMO is dairy specific and has been in place for decades.”

The FAQs posting also notes that the proposed rule did not include requirements for environmental monitoring or finished product testing. Instead, FDA is seeking comments regarding when or if this monitoring or testing would be appropriate for milk and dairy products. IDFA opposes finished product testing and plans to submit extensive comments before the September 16 deadline.

“The preventive controls rule is one of the most important rules under FSMA for the dairy processing industry,” said Detlefsen. "While our initial thoughts were favorable, the more we understand FDA’s position on the underlying issues, the more concerned we become. Therefore, we must continue to engage with FDA throughout the promulgation process to ensure the final outcome is reasonable as well." 

For more information, contact Detlefsen at


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