Improving Food Regulation in 2019

Both FDA and industry will come under increased pressure in 2019 to improve food safety, largely in response to last year’s widespread outbreaks of E. coli O157:H7 from romaine lettuce and other leafy greens from the growing regions of Yuma, Ariz., and California. Hundreds of people nationwide were sickened and hospitalized, and five people died after consuming contaminated romaine lettuce.

Last year also saw scores of smaller outbreaks and recalls involving Listeria in deli ham, pork, vegetable dip trays, salad mixes, and imported crab meat; Shiga toxin-producing E. coli O26 in ground beef; and Salmonella in breakfast cereal, shell eggs, ground beef and turkey products, and even boxed cake mix.

Foodborne outbreaks occur with some regularity, but recent advances in whole genome sequencing (WGS) and other technologies are allowing regulators to identify microbial pathogens with greater accuracy than ever before. Even so, tracing a contaminated food product through the supply chain remains complex and time consuming, requiring numerous regulatory and public health agencies to collect and evaluate thousands of records.

While the magnitude of food-related illnesses appears to be increasing, FDA officials suggest this may be an appearance due to improved detection capabilities. Nevertheless, FDA, USDA, and state and local agencies are finding food safety regulation to be increasingly challenging, especially in this era of constrained budgets and—for routine FDA inspections early this year—furloughs because of the federal government shutdown.

Focus on Prevention

The Food Safety Modernization Act (FSMA) is intended to reduce food-related illnesses by shifting the emphasis from inspection by government agencies to prevention by the food industry. But several key FSMA provisions are still being adopted by industry, such as the Produce Safety Rule and the Foreign Supplier Verification Program, and some major areas remain largely unaddressed.

A prime example is water used for agricultural purposes. Last year, canal water containing E. coli O157:H7 was used to irrigate romaine lettuce and other leafy green crops in the Yuma, Ariz., growing region. While a concentrated animal feeding operation (100,000-plus cattle) was located adjacent to a stretch of the implicated irrigation canal, the source or sources of the outbreak-related contamination remain unclear, according to FDA and CDC.

This year, more farms will be subject to FSMA’s Produce Safety Rule, and starting this spring, FDA will begin inspecting farms for compliance. But the agency has delayed the provision of the Produce Safety Rule pertaining to agricultural water. FDA has extended the compliance deadline for the testing and safety of water used in agriculture (other than for sprouts) by an additional two to four years to ensure the standards are “feasible for farmers to adopt in all regions of the country.” As a result, agricultural water compliance will not begin until January 2022 for the largest farms, January 2023 for small farms, and January 2024 for very small farms.

“This is unacceptable in the wake of last spring’s outbreak and the deaths and illnesses it caused,” says Sandra Eskin, food safety project director at the Pew Charitable Trusts. “FDA must end these delays and promptly finish any revisions [of the rules] guided by results from relevant environmental assessments and outbreak investigations.”

Further, federal and state agencies “should use their authority over canal water quality to require that water be treated to reduce foodborne pathogens before being used in produce fields,” Eskin says, noting that farmers in the Yuma region had already begun planting their winter romaine crops. “It is unclear whether they are being irrigated with untreated canal water,” she adds.

If FDA doesn’t shorten the compliance deadlines for agricultural water, more widespread recalls of leafy greens and other produce are likely, predicts David Acheson, MD, former FDA associate commissioner for foods and founder and CEO of The Acheson Group.