Bumpy Road Ahead for Implementing FSMA

April 4, 2016
Almost six years after the landmark food safety law was signed, enforcement of FSMA will begin in September.

The fifth anniversary of the Food Safety Modernization Act (FSMA) came and went in January, and before the sixth anniversary arrives, most of the food production plants in the U.S. and offshore facilities sending food products here will be expected to comply with the law.

FSMA compliance will be expected by September at all but the smallest food and beverage producers: those with sales under $1 million and fewer than 500 employees. Regardless of whether they need to comply this year or by the 2017 and 2018 phase-ins, most processing professionals are somewhat uncertain and uneasy about their organizations’ readiness for FSMA’s rollout, and for good reason: As March was drawing to a close, food companies still were awaiting guidance documents from FDA.

Generally speaking, the largest companies are among the one-quarter that consistently report they are well prepared for FSMA. Within a year of the act’s passage and long before final rules on preventive controls and other requirements were published in the Federal Register, H.J. Heinz Co. had conducted gap analyses and reviewed HACCP plans for every product on every production line in its global network of 87 facilities, including scrutiny of the scientific basis of its practices. The initiative was headed by Kurt Deibel, who now serves as vice president of food safety & quality-Americas for Kraft Heinz Co.

Organizations that believe they have their ducks in a row are turning their attention to suppliers, increasing the angst of mid-sized companies that supply the raw materials and ingredients that make up other firms’ finished goods. Those firms often are among the two-thirds of processors who believe they are somewhat FSMA ready (fewer than one in 10 rate themselves as totally unprepared).

The largest food companies, many of whom had a seat at the table when FSMA rules were being written, are turning up the heat on their suppliers to disclose protocols and procedures for preventive controls. Pushback is unavoidable, with many companies regarding the information as proprietary. Another complication is that organizations like Kraft Heinz have thousands of suppliers, making management of that information almost impossible.

The foreign supplier verification program is another anxiety-producer, and even the biggest companies are struggling. QA professionals may know the science but not the process; production personnel know the process but not necessarily the science; and often both are answering to a corporate lawyer, “the last person on the planet who understands logistics and compliance,” suggests David Acheson, CEO of the Acheson Group and a former FDA associate commissioner. “With so many people addressing the issue, there are too many cooks in the kitchen.”

By contrast, small companies with a single point person working with one outside expert often are extremely well prepared, he adds, because they understand that FDA’s nonprescriptive approach provides some latitude in achieving FSMA’s objectives.

Varying degrees of understanding are evident north of the border. At Canada Bread in Hannon, Ontario, plant manager Chris Markwood downplayed foreign supplier rules, saying baked goods flow as needed between his distribution center and those of U.S. Grupo Bimbo facilities, and that the biggest impact would involve labeling “tweaks.”

In contrast, Brantford, Ontario-based Dure Foods Ltd., a private-label blender of cocoa mixes and functional foods, recently hired a QA manager who spends a good part of her day making sure finished goods headed south satisfy the guidelines and won’t be stopped at the border.

FSMA’s biggest black hole is facility inspection. For USDA plants, Food Safety and Inspection Service inspectors will continue to police the premises, with rules governing the sanitary transport of food one of the few real changes in food safety protocols (another is FSMA compliance by ingredient suppliers who are subject to the law). That leaves about 70,000 U.S. facilities, 150,000 foreign firms and another 100,000-plus farms in Mexico, South America and elsewhere that will have to be inspected at least every five years. “We’re probably talking 300,000-400,000 physical locations around the world” that will have to be inspected, Acheson ballparks.

State inspectors will help pick up the slack for FDA, which has fewer than 2,000 inspectors on staff. Recruiting and training qualified inspectors will be a Herculean task, made more difficult by Congress’ refusal to fund the effort. Asked how many expert inspectors it would need, an FDA spokeswoman responded by email, “We currently have FSMA work groups working on hiring plans for preventive controls, produce and foreign supplier verification.” She did not provide a target number for new hires, ballpark or otherwise.

Industry self-policing through independent, third-party audits to SQF, BRC and other Global Food Safety Initiative standards should help companies with their FDA inspections. Based on Food Processing’s 2016 Manufacturing Outlook survey, two-thirds of food processors either have been certified under a GFSI standard or are considering such a review. Those audits closely parallel FDA expectations, although they tend to be “check-listy and prescriptive,” says Acheson.

“An FDA inspector is wired to look for loose ends,” he adds. “They can go outside the box. I think it’s a tougher process.”

When the journey to FSMA implementation began in 2011, the assumption at FDA was that companies had sufficient internal expertise to meet the higher food safety standards. For most processors, that’s not proving to be the case: 23.2 percent of respondents to the Manufacturing Outlook survey already have brought in outside consultants, and almost half are considering doing so.

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