© Beth Walrond

FSMA’s Preventive Controls for Human Food Rule (PC Rule) was the first to be proposed — in January 2013. Two years later in September 2015, it (along with the Animal Foods rule) was the first to be finalized with compliance dates beginning a year following finalization.

Food businesses with thorough HACCP plans were well prepared for the new rule as, in many ways, the PC Rule was FDA’s way of updating and regulating HACCP, said Sabra Senior Director of Global Quality and Safety Rob Mommsen. But a lot of small companies did not have HACCP because they weren’t required to. Now they have to have a written Food Safety Plan (FSP), so for those who didn’t have HACCP, the PC Rule is difficult, he said.


The primary difference between HACCP and the PC Rule is that HACCP is based on a hazard analysis that identifies and sets controls for activities or areas specified as critical control points. It’s not unusual for a HACCP plan to have a single CCP, he said. “That is all that is needed,” Mommsen added, explaining that other parameters are deemed as important for food safety, but don’t need to be listed as CCPs.

But, Mommsen said, “With the PC Rule, everything in the plant needs a preventive control.” And everything needs to be written out in a Food Safety Plan (FSP). “In my opinion, and many others agree, the preventive controls rule is no different than HACCP, except it has many, many more steps.”

For example, processors cannot simply base the FSP on what they know to be the inherent bacteria of their products and ingredient, they must reference FDA’s catalog for the associated hazards the agency has identified. Then, Mommsen explained, “You have to write how you control for it to not happen. And if it does happen, how you will control it.” For Sabra, Mommsen had to look up three dozen ingredients for the FDA-listed associated hazards, then justify why they weren’t a problem or how they are controlled.

“In my opinion ... the preventive controls rule is no different than HACCP, except it has many, many more steps.” Rob Mommsen, Sabra Senior Director of Global Quality and Safety

This means that while the company’s HACCP plans used to be about 10 pages — including a flow diagram, FSMA’s required FSP now needs to be 60 pages to meet the rule’s Hazard Analysis and Risk-Based Preventive Controls requirements. The problem with this, he said, is that the program required by the PC Rule does control hazards such as microbial load, but “a PC at a metal detector doesn’t prevent anything; it just tells you if anything is falling apart.”

Sabra had a thorough HACCP plan, so “forming that into a PC plan took only a couple months,” he said. “But what we weren’t prepared for was the FDA saying, ‘It’s not really what we were looking for.’ So, initially, we had to do a lot of rewrites.”

The industry began to take it in stride that FDA would come in and find something. “The lion’s share was getting over that hump; but now 99% of us are over the hump.” In fact, he said proudly, “On our last inspection, FDA found nothing, not even verbal.”


With all that, Mommsen sees FSMA and the PC Rule as having a lot of positives. “Both are risk based; they got that right,” he said. “FSMA brought with it some teeth for food safety. USDA has FSIS; FDA never had that until September of 2015.”

Other areas Mommsen sees as positives of FSMA and the PC Rule (“which I use interchangeably because you really can’t separate them,” he said) are:

  • Mandated Recalls. FDA can now force companies to recall foods. “That is a very good thing. Though they get it wrong once in a while; I get that.”
  • The Reportable Food Registry. “If I feel there is a possibility of a food safety issue with any of my suppliers, I can fill out a form anonymously that triggers an FDA investigation. No one liked that except me.”
  • Allergens. For HACCP, allergens had to be identified and labeled; for PC, they have to be controlled. “I thought HACCP was a little light on allergens; the PC Rule is a little overkill, but it’s needed.”

There are a lot of people who don’t like the PC Rule because of the tedium, and there are certainly areas in which Mommsen is in agreement. “But I think FSMA was a good thing,” he said. “It was a long time coming, but at least it’s here now.”