Washington Insider -- Tuesday

FDA's Recent Tuna Recall Decision

Here's a quick monitor of Washington farm and trade policy issues from DTN's well-placed observer.


President Donald Trump addressed the American Farm Bureau Federation annual meeting for the third year in a row, and predictably Trump spent a good portion of his time before the gathering talking about Phase One of the agreement signed with China on Jan. 15. He dubbed the accord "a bonanza for American farmers, adding he thinks the pact is "going to work out well. I think China is going to go all out. … I think they're looking to prove that it's going to be great for the farmer."

Trump also pointed to regulatory relief measures his administration had taken, including the repeal of "waters of the U.S." (WOTUS) rule that expanded federal jurisdiction over some wetlands and streams. "As long as I'm president, government will never micromanage America's farmers. You're going to micromanage your own farm and that's the way it should be," Trump said.

Trump also highlighted actions by the administration on issues like broadband access and farm labor.

"We want them *immigrants) to come in, legally, and we want them to come in so they can help the farmer, just so you understand because I want them to be able to come in to help our farmers, and we're going to give you plenty of help," Trump said.


Chinese officials continue to reiterated what Vice Premier Liu He said at the signing ceremony for the Phase One deal with the U.S. -- the purchases China has committed to making will be made based on market conditions.

The purchases will also follow WTO rules, said Li Xingqian, head of foreign trade department at Ministry of Commerce. In remarks in Beijing, he said that the increased imports from the U.S. will not affect imports from other countries.

China's Liu made the same point in this remarks at the signing ceremony.

Further, Li said that the Chinese has large potential and it welcomes high quality and competitive U.S. goods.


Food Safety News is running a guest editorial this week on the need to recall tainted tuna. The writer is Sandra Eskin who directs the Pew Charitable Trusts' work on food safety, a non-partisan, global research and public policy effort dedicated to serving the public interest.

The editorial focuses on a recently announced FDA interpretation of authority on mandatory recalls that it claims "weakens food safety."

The writer says that the Food and Drug Administration decided late last year not to order a mandatory recall of yellowfin tuna that sickened at least 50 people in 11 states—and thereby "threatens to undermine a crucial tool of last resort to protect consumers from hazardous food."

"She urges FDA leaders to reverse course and require that the companies responsible for these products remove them from the market."

In a Nov. 15 announcement, the agency said the illnesses were caused by imported tuna with high levels of scombrotoxin, a substance produced when certain fish species spoil. The company supplying most of the implicated tuna has not initiated a recall, despite an FDA request.

In fact, she asserts that "these products could still be on the market," according to the agency and neither cooking nor freezing them will make them safe to eat. A Dec. 26 FDA update on the investigation said that additional illnesses had been reported and voluntary recalls by business customers of the fish supplier "have not effectively removed" the dangerous tuna from the market. Still, the agency stopped short of mandating a recall, Eskin noted.

Congress armed the agency for exactly this kind of situation in 2011's FDA Food Safety Modernization Act. The law authorized mandatory recalls when companies do not conduct them voluntarily for products that may cause "serious adverse health consequences or death" to people or animals.

The agency's initial announcement, however, argued that "because scombrotoxin fish poisoning causes temporary or medically reversible adverse health consequences this incident did not meet the threshold for the use of FDA's mandatory recall authority."

Eskin argues that this interpretation of the law "fails to protect Americans from preventable illnesses." Scombrotoxin poisoning can cause serious adverse health consequences including nausea, headache, faintness, abdominal cramps, and diarrhea. According to the FDA, "severe cases may blur vision, and cause respiratory stress and swelling of the tongue." Patients may require medical treatment such as intravenous fluids, oxygen, and antihistamines, and people with particularly serious reactions to the toxin have experienced cardiac complications and low blood pressure.

In addition, Eskin charges that this decision by FDA could set a dangerous precedent, one that may encourage companies to disregard requests for voluntary recalls or to challenge agency-mandated recalls on the grounds that the harm likely done by their products is not serious enough.

The agency's response also runs counter to pledges by its leaders to "make more robust use of mandatory recall authority"—a power used just three times since FSMA's enactment nine years ago, Eskin says.

In November 2018 FDA released final guidance to clarify for businesses when and how it will exercise this authority for potentially contaminated food. Then-Commissioner Scott Gottlieb explained the goal: "Our aim is to expand the appropriate use of our mandatory recall authority in cases where we have to intervene quickly to help protect consumers from unsafe products."

The ongoing outbreak of scombrotoxin poisoning presents a crucial test of this commitment, Eskin says. "The agency's overly restrictive interpretation of serious adverse health consequences" undermines both the letter and the spirit of FSMA.

She calls on FDA leaders to reconsider their response in this case and, going forward, should make greater use of mandatory recall authority to protect the public from preventable foodborne infections.

Recalls of contaminated food products are an important regulatory tool of food inspection agencies, but are wielded reluctantly because of the inconvenience and cost to manufacturers. As a result, FDA has long been reluctant to impose recalls—and in cases where products have been recalled, have taken significant steps to make sure these have been as sensitive as possible to producer interests.

The new FSMA was designed to provide rules that to make clear specific actions to be taken to protect consumers from exposure to contaminated food products—and to strengthen what was seen by many as the agencies reluctance to impose tough safeguards. These rules are crucially important to the credibility of the national food safety effort and debates about how those safeguards are defined and implemented should be watched closely by producers as they emerge, Washington Insider believes.

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