FSMA Enforcement Delay Stirs Controversy

Posted by Denis Storey on March 7, 2018 at 8:02 AM


When federal regulators ask for comments to proposed rule changes, it’s a lot like a game of Marco Polo – with 300 million swimmers. Commenters either drown the agency with a flood of conflicting opinions or they barely cause a ripple.

In the case of the Food Safety Modernization Act, the process actually worked. Just after the new year, the Food and Drug Administration decided to delay enforcement of four FSMA provisions — indefinitely.

Among other things, the broad scope of the FSMA has made compliance more time-consuming than anyone (in Washington, anyway) might have anticipated.

"While we’ve been setting in place the public health gains envisioned as part of FSMA by issuing new standards for food safety, 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,” FDA Commissioner Scott Gottlieb explained in a release announcing the delay.

As with the implementation of any new broad legislation, this latest delay has earned both praise and scorn. The major industry trade groups embraced the decision, which gives their members more time to become compliant.

But Dr. Peter G. Lurie, president of the Center for Science in the Public Interest, wasn’t very happy about the delay.

“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,” Lurie said in a statement condemning the move.

The delayed rules cover:

  • What is a farm? Because of certain exemptions and how the law is written, FSMA has managed to muddy the definition of a farm, and what exactly constitutes farm-related activities. The legislation has left many in the supply chain wondering whether they qualify as a farm or a food processing facility, while also putting produce farms under greater, and some might say unfair, scrutiny.
  • Are assurances worth the paper they’re written on? One of the more contentious areas of the law deals with customer provisions, which are meant “to provide written assurance to a manufacturer, processor, importer, or farmer that the food will be processed to control for hazards before the food reaches consumers.” Based on stakeholder feedback, the FDA determined this might be a bit more complicated than they realized when they drafted this rule.
  • Are food contact substances food? The FDA has decided to exclude food contact substances from the definition of food, as originally dictated under the Foreign Supplier Verification Program. The original rule caused some confusion among stakeholders, so for now at least, importers will get a reprieve.
  • Byproducts as animal food. Finally, the FDA determined that new rules regarding the processing of byproducts for use as animal food are simply too cumbersome to roll out right now. So certain activities related to converting human food by-products to animal, such as drying/dehydrating, evaporating, pressing, and chopping and similar activities to reduce weight, bulk or volume are exempt.

This move is the latest in a string of delays that’s plagued this sweeping legislation, but stakeholders need to be more diligent than ever in their compliance efforts. A robust digital platform, such as the supplier compliance software offered by TraceGains can ensure your operations are safe and compliant.

Tags: FSMA, FDA, supply chain, Food Safety Modernization Act