Some Worry FDA’s High-Risk Foods List May Have Unintended Consequences

Enacted in January 2011, FSMA requires a range of preventive measures to reduce foodborne hazards, including the designation of high-risk foods that are more susceptible to being a source for foodborne illness outbreaks and additional reporting requirements for them.

FSMA Section 204(d)(2) gave the agency one year to compile the list and two years to propose enhanced recordkeeping requirements. FDA has been working on the matter even while grappling 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.

FDA delayed routine farm inspections until spring 2019 to allow more time for guidance, training, technical assistance, and planning. The agency continues to methodically work through such contentious issues as agricultural water testing and the safe use of raw manure on crops, especially in light of recent E. coli O157:H7 contamination of romaine lettuce linked to untreated on-farm reservoirs and runoff from concentrated animal feeding operations.

Despite missing the two high-risk food designation deadlines, FDA in 2014 did publish a draft methodology for identifying such foods and opened a docket for public comments. And as required by FSMA, FDA completed two product tracing pilot projects in conjunction with the nonprofit Institute of Food Technologists.

Currently, the Bioterrorism 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 imposes certain recordkeeping requirements on covered farms, traceability coding is not one of them. Any new high-risk food recordkeeping rules that FDA develops will be in addition to these requirements.

Growing Burden of Illness

An estimated 48 million people in the U.S. become ill from foodborne diseases each year, according to CDC. Approximately 128,000 are hospitalized and 3,000 die every year based on exposure to pathogens present in the food supply. The annual cost to the U.S. economy in medical bills and productivity losses is more than $93 billion, according to a 2015 study.

The incidence of foodborne infections increased in 2018 compared to 2015-17, according to CDC’s Foodborne Diseases Active Surveillance Network (FoodNet) report, released in April. Surveillance from labs in 10 states confirmed that more than 25,600 infections, nearly 5,900 hospitalizations, and 120 deaths were caused by eight enteric pathogens commonly transmitted through food.

As in previous years, Campylobacter was the most prevalent, being responsible for 9,723 illnesses, 1,811 hospitalizations, and 30 deaths. This was followed by Salmonella with 9,084 illnesses, 2,416 hospitalizations, and 36 deaths. Campylobacter is commonly associated with consumption of raw or undercooked poultry and meat, while Salmonella is an issue in many types of food, including eggs, meat, poultry, fruits, vegetables, spices, and nuts.

Nationwide, the actual number of cases is much greater. This is because FoodNet collects data from public health departments in only 10 states, covering just 15 percent of the U.S. population.

Making a List

FDA’s draft methodology for designating high-risk foods lists several factors the agency might consider. These include the food’s known safety risks, including its history and severity of illnesses; its potential risk for microbial or chemical contamination given its nature or production processes; the point in manufacturing where contamination is most likely to occur, and steps needed to reduce it; and the food’s likely or known severity, including health and economic impacts.

Dr. Acheson draws particular attention to the fact that, for the high-risk designation, FDA might consider not only the food but the manufacturing process points at which contamination is most likely to occur. He urges FDA to consider feedback it received from its proposed 2014 designation of high-risk foods.