New FSMA Rules Require Agencies To Collaborate And Integrate

By John Kalkowski, editor in chief, Food Online

Implementation of FSMA’s new rules — with an emphasis on integration and collaboration — was the primary theme of the recent Food Safety Summit held April 27-30 in Baltimore.

The FDA estimates that one in six Americans is hit with food-related illnesses each year, which could largely be prevented through better handling of food.

The FDA has been mandated by federal courts to finalize the new FSMA rules in seven stages beginning this August, with actual enforcement to begin in 2016. The far-reaching FSMA was signed into law in 2011, but defining the rules, their implementation, and how they will be enforced has been a massive undertaking requiring collaboration between regulatory agencies, consultants, industry associations, and CPGs.

The Food Safety Summit had five sessions that provided updates on FSMA strategies for introducing the rules, which include preventive controls for human food (due Aug. 30, 2015), preventive controls for animal food (Aug. 30), produce safety rule (Oct. 31), foreign supplier verification program (Oct. 31), third-party audit certifications (Oct. 31), sanitary transportation (March 31, 2016), and intentional adulteration (May 31, 2016).

So far, the FDA has relied heavily on collaboration with industry to develop the regulations and develop plans for how they will be enforced, according to Roberta Wagner, FDA deputy director for regulatory affairs. She points to three major challenges to implementing the rules:

• Full federal funding  to effectively do the work
• Creating the infrastructure to handle all the inspections and enforcement
• Driving a cultural change in how the FDA does its work

Agencies Need to Explain Rules First

One major concern echoed by several speakers is how the FDA will educate the industry on the specifics of the rules and how they will be enforced. One mantra being adopted, Wagner says, is to “educate before you regulate.” She explains there is a big need for guidance in simple and plain English, especially for small- and medium-sized food businesses. In addition, she says, the FDA must develop a competent and educated inspection force to deliver consistency in food inspections.

Joseph Corby, executive director of the Association of Food and Drug Officials, calls FSMA “the most comprehensive reform of food safety in our nation’s history.” He emphasizes the need to set priorities for inspections, saying that high-risk food manufacturers should be inspected three times per year. He adds that inspectors can’t be expected to be the primary source for education on FSMA rules. Wagner agrees, saying the FDA faces challenges in educating without taking off its regulatory hat. “FDA should not cross the lines, telling companies how to run their business,” she says.

There is considerable concern within the food industry that once rules are issued that they be enforced consistently. Jennifer McEntire, VP of science operations for the Grocery Manufacturers Association,  points out that 80 percent of facility inspections are being done by the states, and these need to be harmonized. Inspections need to be consistent from inspector to inspector and from the local/state levels to the federal level, she says, adding, “Processors don’t always know if they are doing the right thing.”

In turn, she continues, this can make it difficult for a multi-facility company to operate due to differences between local rules and FDA guidelines. Eventually, this could create a disincentive to have facilities located in some states.

Record-keeping Called Key to Success

Joseph Levitt, partner at the law firm of Hogan-Lovells and former director of FDA's Center for Food Safety and Applied Nutrition, says that good record-keeping will help food companies stay on the right side of FSMA regulations. He says companies must have written plans and control systems in place and documentation that validates they are following these systems.

“You are what your records say you are. It’s not just what you are doing today, but what you did yesterday, last week, and last year,” he says. “Don’t worry that something went wrong. Recognize it, address it, and document it.” He explains that FSMA is going to be about how a company thinks about safety and the rationale for its actions. “Your success can stand or fall on your record-keeping,” he says.

FSMA Funding Falls Short Of Requirements

In a town hall presentation on the last day of the summit, several leaders of federal regulatory agencies addressed some of the major topics they are facing. These speakers included Alfred Almanza, deputy undersecretary  for Food Safety, USDA; Joseph Corby, executive director, Association of Food and Drug Officials; Christopher Braden, director of foodborne, waterborne and environmental diseases, Center for Disease Control; and Michael Taylor, deputy commissioner for foods and veterinary medicine, FDA.

Among topics they addressed were funding for implementation of FSMA and whether all food regulatory activity should be combined under a single federal agency. Since it became law, FSMA has only received about half the funding needed for full implementation. The FDA faces a daunting challenge, Taylor said, emphasizing that full funding is required to fulfill all the goals of the legislation.

Regarding assigning a single agency to administer all food safety activities, the panel members all agreed that is unlikely to happen any time soon, and that now the main focus should be on collaboration between established agencies.

“If we were starting from scratch, we wouldn’t design this system organizationally this way,” Taylor said. “We wouldn’t necessarily have it be the same statutorily.”

Corby, who leads a group  that represents officials from multiple agencies, supports an integrated food safety system of federal, state, and local agencies working together to administer inspection and enforcement programs. “To go and try to mess around with the federal government and a single agency would be too disruptive to the efforts that we have invested in to develop an integrated food safety system,” Corby said.

Braden of the CDC says that a single agency would likely experience some of the same communication and enforcement problems that exist between multiple agencies. He emphasizes the need to share information through better communication and collaboration between regulators.