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FDA Heeds Industry Calls for Flexibility in New FSMA Updates

Sep 25, 2014

The Food and Drug Administration last Friday released proposed revisions to four proposed rules for implementing portions of the Food Safety Modernization Act (FSMA). The updates, which cover preventive controls for human food, preventive controls for animal food, foreign supplier verification programs and produce safety, reflect significant changes requested by IDFA and others in the food industry.

Perhaps the most important change for IDFA members is FDA’s flexibility with regard to environmental and finished-product testing for pathogens. The proposed update for preventive controls for human food would allow each facility to determine how best to conduct product testing and environmental monitoring to verify the implementation and effectiveness of the facility’s preventive controls.

“We’re very pleased that FDA listened to industry comments, including those from IDFA, that showed finished product testing for pathogens is not a control measure and would do nothing to ensure food safety,” said John Allan. “IDFA was very clear in comments that a broad requirement for finished product pathogen testing would be extremely costly without providing commensurate public health benefit, so we appreciate the revised thinking and flexibility demonstrated in the updates from FDA.” 

Byproducts Used as Animal Food

Also of interest to IDFA members is the revision to the proposed rule affecting the use of spent grains and byproducts that may be used as animal food.  The updated proposed rule would clarify that human food manufacturers that create byproducts used as animal food would not need to comply with the full animal food rule if they are already complying with the human food rule.

IDFA had called for this change in joint comments filed in April with the National Milk Producers Federation. The comments also noted that the increased cost of compliance could lead dairy companies to dispose of the byproducts and waste in other ways, such as sending to landfills or incineration, which could cause an increase in greenhouse gas emissions.

Foreign-Supplier Verification

Revisions to the foreign-supplier verification proposed rule give importers more flexibility to determine appropriate supplier verification measures based on risk and previous experience with their suppliers. In comments filed in January, IDFA urged the agency to allow companies to customize the regulatory requirements to their own systems in a risk-based fashion that advances food safety.

FDA will accept comments on the proposed revisions of the four proposed rules for 75 days while continuing to review comments already received on the sections of the proposed rules that are staying the same. IDFA plans to submit comments on the proposed rules, excluding the one on produce safety. The agency will consider all comments before issuing final rules in 2015.

For more information, contact Allan at

Read the proposed revisions to the FSMA proposed rules:

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