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FDA Releases First Proposed Rules Under FSMA

Jan 09, 2013

Two years after President Obama signed the Food Safety Modernization Act (FSMA) into law, the Food and Drug Administration has released two proposed rules that set science-based standards for the prevention of foodborne illnesses.

The Preventive Controls for Human Food rule would require food companies, including dairy food manufacturers – whether they manufacture, process, pack or store food – to put in place better controls to reduce the risk of contamination. The Produce Safety rule would require farms that grow, harvest, pack or hold fruits and vegetables to follow standards that are aimed at preventing contamination.

“The preventive controls rule is one of the most important rules under FSMA for the dairy processing industry,” said Clay Detlefsen, IDFA’s vice president of regulatory affairs. “The good news is that our industry’s use of Hazard Analysis and Critical Control Points plans positions us well regarding the proposed requirements.”

The preventive controls rule proposes that food companies have written plans in place to identify potential hazards, put in place 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. FDA is proposing that the requirements become effective one to three years after a final rule is published in the Federal Register, depending on the size of the company.

“IDFA is pleased that FDA separated out the requirements for food defense plans, allowing the proposed rules to focus exclusively on unintentional contamination,” said Detlefsen.

FDA did not include finished product testing or environmental monitoring in the proposed rule but did give those matters considerable discussion and has requested comments on those issues.  FDA identified three areas where finished product testing would be beneficial as a verification step:

  1. raw agricultural commodities that are prepared as ready-to-eat without further preparation,
  2. manufactured nut butters (including, but not limited to peanut butter) and
  3. untreated inclusions that are added to a treated processed product. FDA specifically mentioned the addition of spices or vegetables to cottage or cream cheese.

FDA also has taken a favorable position on the warehouse petition that IDFA and other trade associations filed in 2011. Specifically, FDA concurs that warehouses that hold products not exposed to the environment (e.g., are packaged) and not requiring refrigeration for the safety of the product are exempt from the preventive controls requirements and the creation of food safety plans.

That exemption would apply to ice cream warehouses where freezing is done for quality, not food safety. For warehouses that refrigerate for safety reasons, FDA reduced the preventive controls to monitoring temperature and keeping records to show the proper temperature was maintained.

"Thus far, we believe that the preventive controls rule is well thought out and will not be overly burdensome on dairy facilities," said Detlefsen. "But it is important to note that the proposed rule is tentative. Therefore we must continue to engage with FDA throughout the promulgation process to ensure the final outcome is reasonable as well."

Comments on the proposed rule are due 120 days after the rule is published in the Federal Register, which is expected on January 16. IDFA will be commenting on the preventive controls proposed rule.

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

Members may login below to read the memo from Hogan Lovells, "FDA Proposes Extensive New Food Safety Regulations."

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