Improving Food Regulation in 2019

“FDA has kicked the can down the road,” Dr. Acheson tells Food Quality & Safety. “They don’t know how to control risks in water very well through testing.” And should irrigation-related outbreaks continue after farm inspections begin, “there will be continued criticism of the regulatory agencies and effectiveness of produce inspections overall,” he says.

Traceability and Labeling

As good as WGS is at identifying specific pathogens, the traceback investigation of a contaminated commodity, such as romaine lettuce, remains complex and cumbersome.

“It’s a labor-intensive task. It requires collecting and evaluating thousands of records while also trying to accurately document how the contaminated lettuce moved through the food supply chain to grocery stores, restaurants, and other locations where it was sold or served to the consumers who became ill,” said FDA Commissioner Scott Gottlieb, MD, and Deputy Commissioner Frank Yiannas, in a recent joint statement.

While accurate records are essential for traceability, FSMA (implemented with the Bioterrorism Act of 2002) requires FDA-registered firms (not including growers, retailers, or restaurants) to be able to trace only one step forward and one step backward in the supply chain. Late last year, after CDC warned consumers not to eat romaine lettuce, the industry adopted an FDA proposal to voluntarily label produce entering the market with the growing region and harvest date. “If it does not have this information, you should not eat or use it,” FDA announced.

Consumer groups were less than enthusiastic. “[I]t relies on the shopper standing in the produce aisle to know first that there has been an outbreak, then remember which part of the country is involved, and also realize that they can check the label for the information,” Consumer Reports said.

Acknowledging that labeling alone is not a long-term solution, FDA plans to use technology “to improve our ability to track and trace products through the supply chain. We’ll be launching a comprehensive effort in early 2019 to advance our work in this area,” Dr. Gottlieb and Yiannas announced in December 2018, without offering details.

But many observers expect FDA to encourage industry to adopt blockchain and similar technologies to enhance product tracking and traceability this year. Prior to joining FDA as deputy commissioner for food policy and response, Yiannas was vice president for food safety at Walmart, where he had championed the mandatory adoption of blockchain on the part of its leafy greens suppliers, starting this year.

“We have a guy starting…the former head of food safety at Walmart who is going to be coming to the FDA to help us put in place among other things better track-and-trace using tools like blockchain maybe to even do track-and-trace on the food supply chain,” Dr. Gottlieb told CNBC in an interview.

FSMA Compliance Deadlines

A number of FSMA regulations become effective in 2019 for companies and farms, depending on the size of their business and the products they produce or handle. They include the following.

Produce Safety Rule requires domestic and foreign farms to have preventive measures in place for growing, harvesting, packing, and holding fruit and vegetables. Small and very small farms (less than $500,000 and $250,000 in annual revenues, respectively), became subject to the Produce Safety Rule (except for agricultural water) in January. Routine farm inspections for compliance with the rule are set to begin this spring.

Foreign Supplier Verification Program (FSVP) requires U.S. importers to verify that the food they import meets the same safety standards as domestically produced items. This year U.S. companies importing from “small” foreign suppliers (fewer than 500 full-time employees) and “very small” foreign suppliers (less than $1 million in average annual sales) are subject to FSVP.