FSMA compliance: What it means and how it will impact recalls

Food in the United States is about to get safer. But it also is likely to see more recalls.

The FDA’s long-awaited first Food Safety Modernization Act (FSMA) rules take effect for large manufacturers next week. On Sept. 19, the FDA will begin enforcing the preventive controls rules for human food and pet food for businesses with more than 500 employees.

The rest of the seven foundational FSMA rules, which the FDA has proposed over time since January 2013, will have their compliance deadlines in the coming years. In the meantime, the FDA will continue to focus on education, training and technical assistance to help manufacturers abide by the new requirements, an FDA spokesperson told Food Dive.

Though the deadline is upon manufacturers, what compliance looks like for these initial rules — and the other five — still challenges many of them. But what noncompliance looks like, and what the consequences might be for manufacturers with food safety plans that don’t meet the new regulations, could be more concerning.

From reactive to proactive

Katy Jones, VP at FoodLogiQ, described FSMA as “the most sweeping piece of legislation in the food industry in about 70 years.” The new rules mark a monumental change in the dynamic of food safety.

“Obviously, there’s a lot that’s changing, but I think overarching is a tremendous shift from just constantly reacting to everything from a safety perspective… this shift from reaction to preventive approaches,” Jones told Food Dive.

Part of that sea change from reactive to proactive safety measures involves more of a standardized approach to scenarios like recalls, inspections and production shutdowns. Several companies abide by many of these regulations already and won’t have to change much about their operations or safety protocols. For others, the adjustment to new FSMA rules could be significant.

“As a whole, (the FDA is) really looking to formalize food safety and then work with the industry,” said Jones. “Because for the most part, a lot of companies — because this is their livelihood — they’ve done a lot of things to make sure that they are safe. You have outliers, obviously. You’ve got folks that just really did not do the right thing, but I think (FSMA) formalizes it. I think it provides some action steps for food companies to know exactly what to do.”

Vickery Brewer, consumer safety officer at FDA and CFSAN, said on a recent FSMA webinar that the regulations require manufacturers to notify both retailers and the public about a recall, and the recall plan should include checks. The manufacturer must also disclose how it will handle the recalled products and operations going forward, such as through reprocessing, reworking or destroying the food, Brewer said.

None of these regulations are necessarily new compared to regular recall requirements. But they may cause some initial problems as manufacturers determine how to incorporate them into their processes.

Challenges for FSMA compliance

The biggest problem upfront for manufacturers will be the initial investments, including money, time, labor and potentially legal resources to develop the plan. But once a manufacturer creates its food safety plan, the main obstacles going forward will be implementing the plan and reviewing it on a periodic basis, said Brewer. That review should occur at least every three years according to the preventive controls rule, said Warren Stone, senior director of science policy at the Grocery Manufacturers Association, who also spoke on the FSMA webinar.

Documentation will likely be the most substantial change — and challenge — for manufacturers as they work toward developing their food safety plan. Not only do manufacturers have to assess all possible food safety risks and devise solutions for them, but they need to back up all of their assessments, testing and plans with meticulous records.

“If those processes aren’t documented, they don’t exist in the eyes of the FDA,” Robin Peterson, North America sales director at Micreos, told Food Dive.

How FSMA regulations could spike recall numbers

An FDA-compliant recall plan is a natural output of manufacturers’ work on FSMA, Stone said. As manufacturers dig in, they could uncover issues that could potentially lead to recalls and encourage them to put controls in place to prevent them in the future.

This is key. Triggers for recalls have not changed under FSMA — they’re still adulteration (Section 402) and misbranding (Section 403). But the FDA is likely to scrutinize products, operations and recall procedures more than ever before. And manufacturers have to remember to properly document everything.

“We’re going to see this increase in recalls, and there are always going to be pathogens in the supply chain that’s fresh food,” said Jones. “As you see more companies and more restaurants, particularly trying to get to where they’re offering fresh beef, not frozen, there are a lot of things that are going to go on — that mandatory recall.”

“And then if (the FDA) really feels like you were not good stewards of the law and didn’t take every step, they can come in and, for an FDA-registered facility, actually shut down operations while they’re conducting an audit and trying to figure that out,” Jones continued.

“Companies that once experienced collaboration and wide latitude when working with the FDA during inspections and recalls now report a greater degree of strictness in their dealings with federal regulators,” said Peterson. “More fines are being levied and plants are shut down for longer periods of time than they were during recalls of a few years ago. In addition, the Department of Justice is now more likely under FSMA to investigate how companies managed food and ingredient handling before and during a recall.”

In addition to increased scrutiny, the FDA and other food regulators have more sophisticated tools and testing methodologies that can detect pathogens more accurately and more quickly. Both factors are likely to lead to a spike — albeit, an artificial increase — in numbers of recalls. With whole genome sequencing and other DNA tests, that’s already happening even before FSMA officially takes effect.

A recent Stericycle ExpertSolutions report found that recalls jumped in Q2 2016. The FDA recalled more than 80 times more food compared in that time period compared with Q1 2016. In the same time frame, the USDA recalled more than 45 times the amount of products. However, the report also attributed that number in part to more accurate genomic testing combined with stricter regulations.

While the numbers of recalls may artificially rise, the speed and accuracy with which manufacturers and regulators can resolve them may also become drastically shorter. That’s due primarily to those same testing techniques and increased supply chain traceability.

“It’s maybe the sheer number of recalls continue to go up, but they’re much more precise,” said Jones. “Maybe the number of products is lower, and that’s much more targeted, and they know exactly which product to pull, as opposed to now. That requires a lot to be that precise with a recall. Obviously the propensity from a public health standpoint is to just get it out — as far back and as far forward as you think the affected product is between this state and this state. You want to make sure you’re communicating that.”

FSMA hasn’t even taken effect yet, but already its implications and the challenges of compliance are palpable industrywide. But manufacturers can take advantage of multiple resources available from the FDA and sources like the National Sustainable Agriculture Coalition to ensure they are on track to be FSMA-compliant before the FDA inspections begin.