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Finished Product Pathogen Testing Is Unnecessary, Impractical

Aug 24, 2011

In comments filed Monday, IDFA responded to the Food and Drug Administration's request for information on current industry practices to help the agency develop guidance on preventive controls for food facilities, which are required by the Food Safety Modernization Act. IDFA outlined the industry's current preventive controls and urged FDA not to mandate finished product pathogen testing, saying it would impose considerable costs for companies without adding any public health benefit.

"It is the dairy product manufacturer's responsibility to determine and implement the appropriate verification activities for its preventive controls, which are in turn specific to its facility, products and processes," the comments said. "A one-size-fits-all requirement for finished product testing for pathogens is not appropriate for the dairy industry and should not be required."

Echoing earlier comments submitted jointly with the National Milk Producers Federation, IDFA said pasteurization is the key to assuring the safety of milk and other dairy products. Alkaline phosphatase testing and time and temperature checks are the best methods for verifying that dairy products have been properly pasteurized, IDFA said, not testing finished products for pathogens.

Alkaline phosphatase, an enzyme that is naturally found in milk, is denatured by pasteurization temperatures. If the enzyme is discovered in milk during testing, it can indicate that the milk wasn't properly pasteurized.

The industry also uses temperature recording devices on pasteurization equipment, storage tanks and cleaning systems as verification tools. IDFA noted that the Pasteurized Milk Ordinance (PMO) lists 15 different equipment tests that must be performed on pasteurization equipment to ensure that it's operating properly.

In addition to being unnecessary, finished product pathogen testing would be impractical for the dairy industry, IDFA said. Most fluid milk is packaged and shipped to retail within 24 hours, but product testing would require processors to hold the product for days pending the results of the tests.

"Holding milk for three or four days would require the expansion of storage capabilities by a factor of three or four. Cost aside, which would be enormous, most plants simply do not have the space to add that kind of storage capacity on site," the comments said.

This is the fifth set of comments that IDFA has submitted to FDA regarding the Food Safety Modernization Act. FDA is accepting comments on different sections of the act to gather input and encourage industry participation prior to its rulemaking process.

For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at

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