The FDA spent nine years “dragging its feet” on monitoring high-risk foods, watchdog says


Last week the Food and Drug Administration (FDA) proposed a rule that, if put into effect, would more effectively trace and name foods that are high-risk at being contaminated — including certain types of shellfish, freshly cut fruits and vegetables, leafy greens and nut butter.

In the process, it also settled a 2018 lawsuit by the non-profit group Center for Food Safety (CFS) over its alleged failure to abide by reporting mandates and deadlines established by the Food Safety Modernization Act (FSMA) in 2011, according to a report by Food Safety News.

“[The FSMA] was passed by Congress in 2011 after some high profile foodborne illness outbreaks in the years prior,” Ryan Talbott, a staff attorney at CFS, told Salon. “It was the first major update to our food safety laws since the late 1930s, and it was really Congress’ attempt to have that agency go from reacting to illness outbreaks to being more proactive and preventing them from happening in the first place.”

As a result, Talbott explained, the FSMA “established a series of mandates for FDA to, by certain deadlines, to be more proactive on the food safety front: Having manufacturers have food safety plans and preventive controls in place, the produce safety rule establishing new standards for how we’re handling produce, how food is transported across the country so along the food supply chain [we’re] making sure that they are improving so we are reducing the possibility for a foodborne illness outbreak.”

Talbott also told Salon that CFS has felt compelled to litigate against the FDA because the organization has spent nearly a decade avoiding meeting the requirements established by the Food Safety Modernization Act.

“They’ve really dragged their feet since FSMA was passed, and when it was passed in 2011, it set very quick deadlines for the FDA to meet,” Talbott explained. “These were usually one in the range of one to two years for the agency to issue a proposed rule and then a final rule. Congress’ thinking was that this is a major issue and the agency needs to take this seriously and follow through on it and come up with new rules and regulations. But all along the way, the FDA has dragged its feet, which has required to litigate when they’ve missed these deadlines.”

He added, “I think that’s the biggest complaint, from a food safety perspective. This is the agency that’s supposed to be ensuring that our food is safe and they have clear directors from Congress, based on what was happening in the past, to make improvements. They’ve been given these new tools by Congress, and throughout the history of the last decade, it’s been foot-dragging instead of harnessing those new tools to improve our food safety system.”

According to Food Safety News, the CFS pursued its first lawsuit against the FDA from 2012 to 2014 over the agency’s alleged failure to abide by the legal timelines for issuing seven different regulations. The CFS also pursued a third lawsuit against the FDA that was filed after the 2018 one which was settled this month. (Those lawsuits were ultimately successful.) 

Talbott told Salon that the CFS is still concerned about many of the foods that Americans commonly eat.

“I think over the last several years, you look at some of the outbreaks with leafy greens and romaine lettuce,” Talbott explained. “That’s a particular issue. And the FDA recently just lifted their initial high-risk foods list, and I think for all the foods that are on there, we think that’s a reasonable start for their compliance with this rule. And that includes various fruits and vegetables, nut butters, shellfish, and leafy greens.

Peter Cassell, press officer at the FDA, told Salon by email that “our initial priority was the issuance and implementation of the seven foundational FSMA rules. These rules, which set out requirements for industry to put measures in place throughout the supply-chain to protect the safety of food, form the core of the preventive framework envisioned by Congress. From a public health standpoint, it made sense to prioritize these rulemakings, given that we have limited resources for regulation development.”

After listing steps that he claims the FDA has undertaken to effectively implement the FSMA, he told Salon that “we thought the term ‘high-risk foods list’ could lead to an incorrect understanding of what is intended by this rule. The term ‘Food Traceability List’ helps us convey the connection between this list and the traceability recordkeeping requirements that will be created through this rulemaking process.” He also added that “the foods included on the FTL can all be part of a healthy and nutritious diet. Their inclusion on this list simply means that when compared with other foods using the risk-ranking model, they ranked higher based on the criteria considered.”

According to the Centers for Disease Control and Prevention, foodborne illnesses cause approximately 48 million people to get sick every year, with 128,000 of them being hospitalized and 3,000 of them dying. Scientists have identified more than 250 diseases that are transmitted through food, with most of them being caused by parasites, bacteria and viruses. There are also many foods that become high risk because they have contaminated by chemicals and other toxins.

To list merely two examples of recently exposed food dangers: In July, a study published in the journal Frontiers in Microbiology found that Salmonella enterica Typhimurium is able to enter plants like lettuce and spinach through their stomates, or the tiny air holes that plants can open and close to breathe and stay cool, and as a result cannot be washed off with water and chemicals. In October, a study commissioned by Healthy Babies Bright Futures (HBBF) tested 168 baby foods from American manufacturers for arsenic, cadmium, lead and mercury. They found that only nine of the baby foods tested did not contain any of those materials, while 95 percent were contaminated with at least one of the four and 25 percent had been contaminated by all four of them.

Despite these recent controversies over its handling of food safety issues, the FDA decided to temporarily loosen food rules on labeling and information requirements for food manufacturers, the fifth time that the agency has made this decision during the novel coronavirus pandemic, as the Washington Post reported. The FDA argued that this decision was meant to help companies deal with kinks in their supply chains caused by the pandemic through measures like being flexible with vending machine operators about omitting calorie information about their food and allowing food companies to switch out hard-to-find ingredients without altering their labels.

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