A day after the FDA and industry unveiled their cooperative plan for labeling romaine lettuce with harvest dates and regions, an iconic consumer advocacy organization and the chair of the Congressional Food Safety Caucus say the voluntary program has no teeth and labels will have virtually no impact on public safety.

The commissioner of the Food and Drug Administration said Monday the labels will go far to “improve the ability of the FDA to provide more targeted information to consumers in the event of a future outbreak of illness.” His announcement came a week after the FDA urged the public to avoid all romaine from all growing regions, telling consumers to throw out any they had on hand because the vegetable had been linked to a new multi-state E. coli outbreak.

Consumer Reports says voluntary use of the labels could help consumers identify romaine in the future if it is implicated in outbreaks or recalled. The group also believes it would be a good idea for the labels to be used on all leafy greens. 

But, the consumer advocacy organization contends the labels don’t address the issues at the heart of the three romaine outbreaks that U.S. and Canadian officials have documented in the past 12 months.

“The FDA should implement the water quality standards that it put on hold a year ago to ensure irrigation water is safe and sanitary,” Consumer Reports’ Director of Food Policy Initiatives Jean Halloran said in a news release Tuesday. “Stronger industry recordkeeping requirements are also long overdue and sorely needed to help the FDA quickly identify the source of foodborne illness outbreaks.”

Irrigation water from open canals near the Yuma, AZ, romaine growing area has been determined to be the probable source, according to the FDA, of E. coli O157:H7 that sickened more than 200 people, killing five earlier this year. The current outbreak is from a different strain, but is the same strain that infected people in November 2017. 

Although Consumer Reports did not reference this spring’s outbreak, it did cite a congressional mandate requiring the FDA to implement new water testing requirements. The mandate is part of the 2011 Food Safety Modernization Act (FSMA). 

“The FDA proposed new agricultural water rules in 2013, but announced last September that it was delaying their implementation until 2022 at the earliest,” the Consumer Reports news release said.

Another key provision of FSMA involves requirements for recordkeeping fir the specific purpose of fast traceback during outbreaks and recalls. Consumer Reports said Nov. 27 the comprehensive and rapid traceability of produce, including leafy greens, is absolutely necessary for public safety.

Current federal rules require food supply chain businesses to only keep shipping and receiving records “one step forward and one step back.” Consumer Reports contends a continuous record that tracks a product from the beginning to the end of the supply chain is what Congress intended when it passed FSMA.

“Under the current system, tracing the movement of produce back through the supply chain to find the source of an foodborne illness outbreak has been arduous and time consuming. FDA investigators have been plagued by a tangled web of inconsistent and inadequate records, sometimes handwritten,” according to Consumer Reports’ news release.

“Section 204 of FSMA requires the FDA to create enhanced recordkeeping requirements for high-risk foods. Yet, more than seven years after the enactment of FSMA, the FDA has failed to carry out Congress’ mandate to create a list of high-risk foods and issue a proposed rule for enhanced recordkeeping.”

U.S. Representative chastises agency for failing to follow law
Rosa DeLauro, a Democrat representing Connecticut’s 3rd District in the U.S. House of Representatives, had even stronger words for the FDA. She described the voluntary harvest date/region labeling program is a grandstand move by federal bureaucrats and big business.

“… the announcement is nothing more than a distraction that changes the discussion away from what the FDA should be doing as a regulatory agency,” DeLauro said in a statement issued yesterday.

“The safety of our nation’s food should not be left up to big corporations. It is long past time the FDA steps up and prevent future outbreaks instead of having industry regulate itself. That means addressing structural inadequacies within the produce industry by enforcing all parts of the Food Safety Modernization Act — including agricultural water testing. Through FSMA, Congress aimed to change the nature of our food safety system from reactive to proactive. Yet, despite being signed into law more than seven years ago, major deficiencies persist. That is unacceptable.”

DeLauro chairs the Congressional Food Safety Caucus and is a senior Democrat on the Agriculture Appropriations Subcommittee. She was a member of the House when Congress approved FSMA.

“The agreement that the FDA and industry reached on voluntary — rather than required — labeling where romaine lettuce is grown and when it was harvested is not meaningful action to prevent further outbreaks,” DeLauro said. “This agreement misses the crux of the issue: What should our federal agencies be doing to keep Americans’ food safe? While such labeling may help to reduce the size and scope of future outbreaks, these labels will have no impact on ensuring contaminated food does not make it to grocery store shelves in the first place.”

The FDA commissioner was firm in his commitment to the voluntary labeling program in his Monday announcement, describing it as an effective mechanism to allow growers and other businesses in the supply chain to begin harvesting and selling romaine. 

Most of the industry participated in a voluntarily recall and put everything on hold two days before Thanksgiving, at the request of the FDA. The request came simultaneously with the announcement of the current outbreak.

“Knowing the growing origin of produce will continue to play an important role in allowing consumers to avoid contaminated products and facilitating market withdrawals and tracebacks,” Commissioner Scott Gottlieb said in his Nov. 26 announcement.

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