FDA Weighing Risk, Traceability Rules for Leafy Greens

In response to recent multistate outbreaks of pathogenic E. coli O157:H7 infections linked to romaine lettuce and leafy greens, nine prominent consumer and food safety groups have urged FDA to designate produce, particularly leafy greens, as a high-risk food category and to implement long-overdue Food Safety Modernization Act (FSMA) traceability requirements for them by the end of this year.

But that seems unlikely to happen, as FDA is continuing to take its time. Section 204 of the FSMA, enacted in January 2011, gave the agency one year to compile a list of high-risk foods and two years to propose enhanced recordkeeping requirements for them. FDA, however, is still working on the list even as it grapples with new challenges, such as implementing the produce safety rule, particularly the inspection of farms and other facilities that grow, harvest, pack, and hold fruits and vegetables for human consumption.

The FSMA final produce safety rule (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption) went into effect in January 2016 and compliance began in January 2018 for large farms (having more than $500,000 in average annual sales). Smaller farms have until January 2019 or January 2020 to comply, depending on their annual sales. (FSMA has exemptions for very small farms, farms that only sell raw produce locally, such as at farmers markets, and those that grow crops for further processing, such as tomatoes for canned tomato sauce.)

“The FDA is committed to making sure that the standards designed to minimize the risk of contaminations are workable, and that farmers have the information and tools needed to effectively implement them,” wrote FDA Commissioner Scott Gottlieb, MD, and Deputy Commissioner Stephen Ostroff, MD, in a September blog posting.

Accordingly, FDA has delayed routine farm inspections until spring 2019 to allow more time for guidance, training, technical assistance, and planning. The agency is also methodically working through such contentious issues as agricultural water testing and the safe use of raw manure on crops.

“We urge you to designate produce, including leafy greens, as a high-risk food category and propose regulations that will enhance product tracing for produce in the event of an outbreak,” nine major consumer and food safety groups urged FDA Commissioner Gottlieb in May. Among the groups signing the six-page letter were the Center for Science in the Public Interest, Consumers Union, Food & Water Watch, The Pew Charitable Trusts, and the Consumer Federation of America.

Noting that retailers now can trace the origin of certain produce shipments in mere seconds using blockchain and other advanced technologies, “it is no longer acceptable that the FDA has no means to swiftly determine where a bag of lettuce was grown or packaged,” the groups wrote.

In 2014, FDA published a draft methodology for identifying high-risk foods and opened a docket for public comments. The methodology remains unfinalized. “Such a lengthy and resource-intensive process for identifying high-risk foods is at odds with the one- and two-year timeline that Congress set out in FSMA,” the groups wrote, noting that produce, especially leafy greens, is “clearly” high-risk. An FDA spokesperson says the agency “has spent the years since the passage of FSMA developing and implementing rules that transform our food safety system from being reactive to preventive.”

The Bioterrorism Preparedness and Response Act of 2002 requires businesses in the food supply chain to maintain rudimentary one-step-forward, one-step-back traceability records. But farms are exempt from that rule. And while the produce safety rule does impose certain recordkeeping requirements on covered farms, traceability coding is not one of them.

As required by FSMA, FDA has completed two product tracing pilot projects in conjunction with the nonprofit Institute of Food Technologists (IFT). Based on IFT’s findings and recommendations, FDA in 2016 submitted a report to Congress with its own recommendations, the implementation of which the agency said “will be resource-dependent.”