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FDA Releases Details for Determining High-Risk Facilities Under FSMA

Mar 14, 2012

The Food and Drug Administration last Friday released new information detailing how it would determine which food facilities are “high risk” and require more frequent inspections under the Food Safety Modernization Act (FSMA). The two main criteria are known safety risks of foods, such as related Class 1 recalls and illness outbreaks, and the facility's compliance history.

Of the more than 82,000 domestic facilities listed in FDA's inventory, the agency said it considers 22,325 to be high risk facilities and 60,000 to be "not high risk."

Although the act mandates inspection frequency based on risk, the inspection schedules for both high risk and not high risk facilities are still less frequent than the schedules most milk processing and dairy manufacturing plants currently follow. High-risk facilities must be inspected at least once in the first five years following the enactment of FSMA and then once every three years thereafter. Not-high-risk facilities must be inspected at least once in the first seven years following enactment and then once every five years thereafter.

"For Grade A plants, the Pasteurized Milk Ordinance requires plants to be inspected quarterly, and other plants are typically inspected at least once a year," said Clay Detlefsen, IDFA vice president of regulatory affairs. "The new details won't have much of an impact on the dairy industry."

Interim Final Rule on Records Access

FDA also recently issued an interim final rule for "Establishment, Maintenance and Availability of Records: Amendment to Record Availability Requirements," which became effective March 1. FSMA expands FDA's access to records regarding "a specific suspect article of food to records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner."

According to Detlefsen, if a company has a production line problem and FDA believes the same problem could occur at another similar production line in that facility or elsewhere, FDA now can request records relating to these other lines and facilities. In the past, FDA could only see records relating to the production line with the known problem.

Although the interim final rule is already effective, FDA is still accepting comments until May 23. It expects to issue a final rule by May 23, 2013.

For more information, contact Detlefsen at

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