What USDA-Regulated Facilities Need to Know About FSMA

Chuck Steak

The Food Safety Modernization Act (FSMA) has introduced a set of new, and in many cases more stringent, food safety requirements to an already complex regulatory landscape.

FSMA also gives the FDA more power to enforce those requirements and broadens the FDA’s scope to include all components of the food supply chain. For example, all foreign suppliers are subject to the same standards as the domestic producers and processors they supply.

This broadening of scope has muddied the waters a bit for food facilities not traditionally under the jurisdiction of the FDA, in particular, the meat and poultry industry, which is overseen by the USDA’s Food Safety Inspection Service (FSIS). While FSMA doesn’t change that, it does bring the USDA and the FDA into closer communication.

USDA-regulated facilities can’t afford to ignore FSMA. As former top FDA official David Acheson wrote earlier this year, “FSMA compliance [is critical and should be] a major focus of your food safety practices as the deadlines loom…you need to ensure you are looking at all your products and ingredients, to ensure you know, meet, and preferably exceed, all the relevant standards and regulations.”

If you’re a USDA-regulated facility, here’s what you need to know.

Your facility may be dual-regulated

Many facilities fall under the jurisdiction of both FSMA and FSIS. If your facility produces foods that combine meats and produce (e.g., soup, pizza, RTE meals), then you need to comply with both sets of regulations.

In this case, your auditor may — or may not — hold the meat production areas of your facilities to FSMA standards.

In a webinar Q&A late last year, FDA attorney Marc Sanchez fielded a question about the BRC audit process. He said that third-party auditors are “likely” to skip over the meat processing areas of dual-regulated facilities. However, “likely” doesn’t mean “always.” First-hand reports suggest that BRC auditors will still inspect these areas, though they may be a little more lenient.

Your suppliers may be regulated by FSMA

Many USDA-regulated facilities have FDA-regulated suppliers. This means your suppliers will be subject to FSMA rules such as HARPC (Hazard Analysis and Risk-Based Preventive Controls).

In this case, you should ensure that your suppliers are in compliance with all new standards. Especially if you import foods, the onus for ensuring the safety of the products is on you.

You must still comply with FSMA’s Sanitary Food Transportation Act

The Sanitary Food Transportation Act (SFTA) aims to ensure food doesn’t become contaminated during transportation.

SFTA requires sanitary transportation practices as well as detailed recordkeeping. It applies to “shippers, receivers, loaders, and carriers who transport food in the United States by motor or rail vehicle.”

For clarification on what this act requires and who must comply, check out this article by FMI regulatory counsel Stephanie Barnes.

The future may see closer alignment between the FDA and USDA

FSMA brings the FDA and the USDA in closer cooperation than they’ve been before. For example, the two agencies worked together on the pilot programs that informed FSMA Section 204: Enhanced Tracking and Tracing of Food and Recordkeeping. They also joined forces to create the Produce Safety Alliance.

While these collaborations don’t specifically affect meat and poultry processors, they do suggest we may see closer alignment between the two major branches of the U.S. food safety system.


The take-home message is: Even if you aren’t directly subject to FSMA, don’t take chances. Follow David Acheson’s advice of exceeding all relevant standards and regulations, so you’ll be ready for whatever the inspectors throw your way.

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