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.
“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.
Intentional Adulteration Rule is designed to protect the food supply from widespread public harm. Large businesses become subject to the rule in July. FDA is releasing draft guidance in installments throughout the year.
Voluntary Qualified Importer Program (VQIP) gives U.S. companies with a high level of control over the safety and security of their import supply chain expedited review and importation of their foods. Applications are being accepted through May, and the first VQIP starts in October.
Other Regulatory Activities
Other activities taking place in the coming year include the following.
Enhancing food recalls. This year, FDA plans to disclose the names and addresses of stores where recalled products may have been sold. Previously, the agency had felt constrained because of confidentiality agreements between suppliers and retailers. Now, FDA will disclose retailer information when the recalled product is not easily identifiable from its packaging (such as without a barcode or Universal Product Code) and when the food is likely to still be in the consumer’s possession based on shelf life or perishability.
GMO labels. Starting this year, food manufacturers may begin using USDA’s approved “Bioengineered” symbol on labels to disclose the presence of GMO ingredients. Under a final rule issued last December, food manufacturers must disclose the presence of foods or ingredients made from genetic engineering when the bioengineered portion exceeds 5 percent by weight of each ingredient. Mandatory disclosure starts Jan. 1, 2022, but companies can voluntarily begin disclosure starting Feb. 19, 2019, when the final rule takes effect.
Cell-based meat. USDA and FDA this year may hammer out draft regulations for overseeing the production and distribution of cell-based meat, or animal tissue produced without growing or slaughtering animals. FDA will oversee cell collection, cell banks, and cell growth and differentiation. USDA oversight will begin from the cell harvest stage, and will continue during the production and labeling of food products.
Inspections and Enforcement
Of wide industry interest, FDA inspectors this year will ramp up testing for pathogens. “FDA will be pressing to make sure there are no more repeats of past outbreaks,” says Shawn K. Stevens, food industry attorney with Food Industry Counsel LLC, Milwaukee, Wis. “The agency will be working very aggressively to make sure food companies are following the rules,” he tells Food Quality & Safety.
Stevens recommends manufacturers “play FDA for a day” and do their own extensive testing using WGS or other environmental sampling. “You should find out what’s there and respond to those findings aggressively and appropriately before the FDA arrives,” he suggests. Dr. Acheson agrees. “It’s better to know what’s going on in your food plant before the FDA tells you,” he says.
However, possessing that information is probably discoverable by FDA. If a manufacturer does have a resident bacterial strain in the plant and is trying to eradicate it, “the agency needs to be lenient and not penalize the company for it,” Dr. Acheson says. “We need more regulatory clarity on this point because sometimes oversight shuts down good food safety practices at the plant level out of fear of discovery.”
Failure to develop a FSVP was the single-most frequent food safety violation cited by FDA investigators last year, with 278 Form 483s issued to U.S. companies for not having verified that the food they import meets the same safety standards as domestically produced items.
FSVP requires all U.S. food importers (not just those registered with FDA) to develop plans to and actively monitor their foreign suppliers’ compliance with FSMA provisions.
Late last year, FDA’s Office of Regulatory Affairs released summaries of routine field inspections and enforcement activities conducted during fiscal 2018 (Oct. 1, 2017, through Sept. 30, 2018). The summaries identify the statutory areas under which thousands of Form 483s were issued to companies having conditions or practices that may violate FDA requirements.
As in previous years, other common food safety violations involved sanitation monitoring (188 citations); pest control (183 citations); controls for sanitary manufacturing, processing, packing, and holding (175 citations); sanitary plant maintenance (167 citations); and HACCP plan implementation (136 citations). In total, nearly 2,600 Form 483s were issued for food safety related violations last year.
U.S. importers are required to develop, maintain, and follow a foreign supplier verification plan (also called an FSVP) for each food they import, unless an exemption applies (such as for juice and seafood, which are covered by separate HACCP regulations, and certain low-acid canned foods).
While fiscal 2018 was the first full year that FSVP regulations were in effect, not all U.S. companies had been required to comply, depending on the size of their foreign suppliers (rather than the size of the U.S. firm) and the types of food products. This year (fiscal 2019, Oct. 1, 2018, through Sept. 30, 2019), more U.S. companies will come under FSVP’s purview. As such, the number of FSVP violations is likely to increase.
Furthermore, FDA’s focus last year had been on education, generally allowing companies an opportunity to come into compliance with FSVP, unless dangerous problems were uncovered. This year, FDA inspectors are more likely to issue violations than warnings. “We’ll see more FSMA enforcement in 2019 than in the past,” says David Acheson, MD, former FDA associate commissioner for foods. “FDA’s been in a mode of education, but more enforcement is likely to be coming this year.”—T.A.