Food safetyFDA indefinitely delays enforcing 4 FSMA provisions

The Food and Drug Administration (FDA) announced that, for now, it will not enforce four rules related to the implementation of the Food Safety Modernization Act (FSMA), a law passed in 2011 that signaled the biggest overhaul in the U.S. food safety laws in seventy years.

In a press release, FDA commissioner Scott Gottlieb said that although the FDA has been working hard to implement provisions of the law, “we recognize that such a fundamental change in our food safety approach may require adjustments along the way to address issues that had not been previously anticipated.” He added that the agency values feedback on the rule changes and acknowledges challenges that farmers, manufacturers, and other stakeholders face as the new rules are implemented.

CIDRAP notes that the provisions the FDA does not intend to enforce include aspects of the “farm” definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for use as animal food within three of FSMA’s rules that relate to human and animal food safety, foreign supplier verification, and growing standards for human food.

“This action will help reduce the burdens on both industry and government and provide the agency the ability to consider the most effective and efficient way forward,” Gottlieb said. Along with the announcement, the FDA posted a constituent update and a fact sheet that detailed the scope and rationale for the new decision.

In response to the announcement, Peter Lurie, president of the Center for Science in the Public Interest (CSPI), said that by indefinitely delaying enforcement of the rules, the Trump administration is undermining the landmark food safety legislation. In a CSPI statement, he said the FSMA was intended to cover the entire food chain, and that the new guidance would create gaps, for now, by exempting some who harvest, package, or hold food produced on farms, and eliminate company-to-company assurances required to identify pathogens to be addressed by downstream processors.

Lurie’s statement:

All Americans, regardless of their political affiliation, want safe food.

That’s why the Food Safety Modernization Act passed with broad bipartisan support. Make no mistake: The Trump administration is today undermining that landmark legislation by indefinitely delaying enforcement of the rules that would put it into effect. The announcement is a rotten anniversary present, given that FSMA was signed into law on this very day seven long years ago.

FSMA was intended to cover the entire food chain, from farm to fork, and the Trump administration’s new guidance would create a gap in that safety chain by exempting, at least for now, some of those who harvest, package, and hold food produced on farms. In addition, the guidance would eliminate the written company-to-company food safety assurances required under the final FSMA rules that identify dangerous pathogens that should be addressed by downstream processors. Undoing those aspects of the rules threatens to expose consumers to hazards like Salmonella and E. coli.

Notably, when these same food safety rules were created, and then delayed for a finite period of time under the Obama administration, the rules were subject to public notice and comment before being published. During that period, industry had adequate opportunity to raise the very concerns used by FDA today to justify today’s announcement. But under the Trump Administration, these indefinite delays are being unveiled in a surprise final guidance without public input.  

— Read more 4 January FDA statement; 4 January FDA constituent update; FDA guidance for industry; FDA fact sheet; and 4 January CSPI statement