Is FSMA Under a Regulatory Freeze?

The answer is NO.

As the Trump Administration settles in, it is doing what all new administrations do almost as their first action: place a freeze on new or pending regulations left over from the previous occupant of the White House.

This is precisely what the Trump team did shortly after the inauguration. But, given the whirl of activities in Washington, it’s hardly surprising that companies impacted by the Food Safety Modernization Act (FSMA) might be wondering if — or whether — the new regulations may be delayed, canceled, or allowed to proceed.

Here’s a quick rundown of the situation:

  1. FSMA won’t be affected by the freeze. The food safety law was implemented nationwide last September, following five years of regulation-writing and industry comments. Since the law was published in the Federal Register (think of the Register as the official source document for all federal regulations), it is on the books and its provisions can’t be revoked or canceled without Congressional action — which no one is contemplating. (Besides which, removing existing regulations in the law requires a procedure that mirros the creation and passage of new laws, including hearings, comments, Congressional review and approval, plus White House endorsement).
  2. Pending deadlines for small and very small business compliance with FSMA also aren’t affected, since these were established in the basic food safety law. Ditto for the provisions covering the sanitary transportation of food and animal food products, foreign supplier verification and a host of others.

But — and it is a large “but,” FSMA compliance enforcement depends upon government funding for the Food and Drug Administration (as well as state health and inspection services), and this is a matter that remains very much up-in-the-air.

The FDA, many will recall, conveyed to the food industry that rather than go hard for immediate compliance with the law’s many requirements, it planned to take a more gradual approach, one that emphasized education and training. True compliance would begin a year after implementation (i.e., September, 2017). That’s when food manufacturers would have to show that they had a food safety plan up and running, among dozens of other requirements.

Still, compliance is a costly undertaking, and at this point, there is widespread uncertainty about the federal budget for the FDA (which is part of the Agriculture Department. As this space reported last year, the outgoing Obama Administration requested a modest increase in the FDA’s budget to help fund its FSMA regulatory activities. It’s unclear whether that request, in whole or in part, will make it through the Trump Administration’s budget team. If money isn’t allocated, or if enforcement budgets are slashed, then it’s fair to state that FSMA compliance will end up being a moot point.

Right now, industry observers are taking a wait-and-see attitude, while food manufacturers are moving ahead with implementation. No one wants to be caught flat-footed when FSMA compliance begins in earnest; the negative publicity could very definitely hurt a food brand’s reputation. So, cautious optimism appears to be the way to appraise FSMA’s future under the Trump Administration. Budgets could, of course, be trimmed or excised. But it is doubtful the White House or food manufacturers wants to be seen as soft on food safety.

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