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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Is the Nation’s New Food Safety Law on the Cutting Block?

Is the nation’s new food safety law on Congress’s cutting block?

The 2016 election results have the food industry and regulators scrambling to determine whether – or which – government programs may be affected once President-elect Trump and a new, Republican-controlled Congress take office in January.

The short answer is that nearly every program and agency in the federal budget likely will come under review, as is always the case each fiscal year but even more so when there’s a new Administration. Donald Trump and the GOP strongly advocate cutting government spending, so it is a safe bet that the Congressional budget and appropriations committees will be focusing renewed attention on by eliminating or trimming existing programs and regulations.

How will funding for the new Food Safety Modernization Act (FSMA) fare? Right now, an educated guess will have to suffice; much depends upon appropriations choices for the U.S. Department of Agriculture, the parent agency of the Food and Drug Administration, which oversees FSMA implementation.

What we do know is that in outgoing President Obama’s final budget submission to Congress (which was declared “dead on arrival by House Republicans), the Administration sought a $25 million increase in FDA’s food safety budget to a total of $1.195 billion FY 2017. That’s down from the FY 2016 budget in which the FDA received a $1.5 billion outlay, which was higher due to FDA’s FSMA implementation.

Beyond the bare numbers, which are sure to change, the following are for possible food safety budget reductions:

  • Food safety inspections of domestic and foreign manufacturing plants. FSMA envisions a preventive-based approach to food safety that is backed by extensive and strengthened inspection procedures carried out by the agency itself and by state agriculture or public health agencies. The food industry prefers voluntary compliance, and it is possible Congress will delay stepped-up inspection and rely on industry self-compliance.
  • Compliance deadlines. Although FSMA is now fully implemented, the agency plans to emphasize education over enforcement until August 2017. For budget reasons, as well as ongoing industry challenges in achieving compliance, it may be tempting for Congress to push back the compliance deadline even more into the future.
  • Food safety research and testing. Over the past several budget cycles, the FDA and the Centers for Disease Control (CDC) have spearheaded the use of emerging microbiological technologies to more quickly pinpoint the sources of food-borne illnesses. Yet the GOP Congress has long been skeptical about government research, preferring privately funded activities, and the new Congress could take a red pen to food safety research expenditures.

Of course, there is an alternative case to be made that Congress will leave FDA funding mostly alone. Food illness outbreaks always generate headlines and, at times, huge negative publicity when there are fatalities or indications of industry malfeasance. Food safety’s importance to consumers may thus prompt legislators to refrain from sizable budget reductions. Still, with the federal deficit at record highs and a majority political party eager to bring federal spending under control, the budget for food safety regulation may be vulnerable to cutbacks when FSMA’s full impact will be just getting underway.

 

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