I.M. Healthy Brand SoyNut Butter, a peanut-free sandwich spread, is hastily pulling its jars from store shelves. Last week, the company learned some of its product was contaminated with the bacteria E. coli — an outbreak that has, as of the Center for Disease Control and Prevention's most recent update on March 7, caused five kidney failures and eight hospitalizations.
The SoyNut Butter and a related granola were sold in stores across the country, according to the Food and Drug Administration. It was also served in an untold number of child-care centers and schools.
The FDA does not specify, however, which stores, centers or schools — because that would violate its interpretation of an obscure trade secret rule.
This interpretation differs from that of other agencies in the federal food safety system, an overlapping and often illogical network of regulatory fiefdoms. The system, which is responsible for keeping food free of bacteria and other pathogens, frequently has to weigh the very real interests of private food companies against potential risks to the public. In the case of releasing retailer lists during major outbreaks, the FDA has historically sided with business, ruling that such lists constitute “confidential commercial information” and thus should not be available for public consumption.
Critics say that the agency’s unwillingness to share this information poses a clear danger to public health, particularly in cases like the current E. coli outbreak, where parents may not know if their child consumed the recalled product. According to the Centers for Disease Control and Prevention, 14 of the 16 people who have fallen ill were children.
It could also prove relevant in incidents like last year's multistate hepatitis A outbreak, which was traced to frozen strawberries imported from Egypt and sold at several Tropical Smoothie Cafes. The FDA did not specifically reveal which locations, however — a measure that some experts say would have gotten the news to ill consumers faster. That's important in the case of an illness like hepatitis A, which can be treated with a vaccine for a limited period after exposure.
“Our mantra is that a more transparent food system is a safer food system,” said Thomas Gremillion, the director of food policy at the Consumer Federation of America. “And there are lots of instances where having that distribution list would help victims of food-borne illness.”
The FDA’s current recall process has been in effect for years, though the agency did gain more recall authority under the FDA Food Safety Modernization Act of 2011. It is, for the most part, a voluntary system — which means there’s some variance in how quickly recalls happen. While most companies are highly motivated to clean up any contamination, it takes time to evaluate and respond to possible threats. And that time can be multiplied several times over if a product has moved through the hands of several distributors, manufacturers or other middlemen, an issue that the FDA was faulted for in a June 2016 alert by the Inspector General’s Office.
When a company does issue a recall, it has wide latitude over the amount of information it shares; in some cases, a recall will never be made public. Recalls that are made public typically contain a description of the product and an explanation of the problem. But companies are not required to reveal where the product was sold — whether to a store, a school, a restaurant or another manufacturer that put it in other products.
The recall for SoyNut Butter, for instance, says that “products were distributed in multiple states and may have been purchased in stores or through mail order. They were also distributed to childcare centers and schools in multiple states.” Those states include Virginia and Maryland, where two people have fallen ill. I.M. Healthy did not respond to a phone call or email requesting comment, though a statement on its website called the contamination “deeply concerning” and said that the company had immediately issued a recall. A list compiled by the site eFoodAlert claims that the product was sold at a number of major grocery chains, including Kroger, Giant and Whole Foods.
“Industry argues that they don’t want to turn over who they sell to, because competition will know and try to undercut them,” said Bill Marler, a prominent food safety lawyer who is representing the parents of one of the children sickened in the SoyNut outbreak. “That’s all well and good under normal circumstances. But those rules should not and do not apply to a product that could cause people to become ill.”
In a statement to The Washington Post, the FDA affirmed that it believes its disclosure measures are sufficient and blamed the lack of downstream recall information on federal disclosure rules. Federal regulations do limit the sort of information that can be released to the public. Under the Freedom of Information Act and Title 21 of the Code of Regulations, government agencies — and specifically, the FDA — are told to exempt trade secrets and commercial information from any of their releases.
“Examples of [confidential consumer information] include raw material supplier lists, finished product customer lists, trace back information, etc.,” said Peter Cassell, a spokesman for the FDA. “CCI is exempt from Freedom of Information Act requests, but can be shared through certain information sharing agreements (including with other Federal agencies).”
"The FDA publicizes recall notices, including pictures of affected products, and uses social media accounts to reach consumers as swiftly as possible," he later added. "In some cases, the FDA can release certain information that is otherwise exempt from disclosure if it is necessary to effectuate a recall. In many cases, it is most efficient for the company to directly notify its distributors so they can take appropriate action."
Cassell declined to make an agency lawyer available for comment or explain how the FDA had arrived at its definitions. But it’s probably worth noting that when another agency considered similar precedents, it came to different conclusions.
In the early 2000s, the Food Safety and Inspection Service — the branch of the U.S. Department of Agriculture that regulates meat, poultry and egg products — decided to revisit its own interpretation of the trade secrets rule. During a lengthy comments period, industry groups concerned with protecting their distribution lists from competitors faced off against consumer advocates. In 2008, after several years of debate, FSIS's final rule concluded that it would “not cause substantial harm to the competitive position of any business” to disclose retailer names.
“FSIS now routinely posts these lists,” said Deirdre Schlunegger, the chief executive of STOP Foodborne Illness, an advocacy group for patients that lobbied FSIS 10 years ago. “We obviously believe consumers should have as much information as possible to make safe food decisions.”
Today, when FSIS issues a Class I recall — those that seem “reasonably” likely to cause health problems — it also issues a list of all the retail locations that have, or have had, the product. During last month's massive cheese recall, for instance, FSIS published a list of every Safeway, Albertsons and Pak ’n’ Save that sold Taylor Farms salads containing Sargento pepperjack. But because FDA regulates the cheese itself, there was no such list of stores that sold the cheese outside salads.
“It does makes me wonder why the FDA can’t do the same,” said Sandra Eskin, the director of the Safe Food Project at Pew Charitable Trusts. “The fundamental issue is — is this information important to consumers during a recall? I would argue yes.”
But the man who led the effort to reform FSIS’s traded secrets rule has his own suspicions as to why the FDA hasn’t followed his lead. Richard Raymond, who was the undersecretary of agriculture for food safety under President George W. Bush, says that the fiercest opposition to the change came from the food industry. Raymond, who had been the chief medical officer in his home state of Nebraska, came to Washington, D.C., determined to change the rules on confidential information. He found himself surprised by the level of resistance.
“They were scared to death it would hurt their business,” Raymond said. “The retail stores want to protect their brand. … When you ask why FDA hasn’t done it, I suspect they don’t want that fight themselves.”
The FDA did not respond to Raymond's comment by press time. But Gremillion, of the Consumer Federation, would like to see the agency take action.
“Why do confidential business interests trump public health in some cases and not others?” he asked. “We need more transparency around this.”
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