The Halloween disclosure of a multistate E. coli outbreak linked to romaine lettuce raises another concern about the FDA and transparency — the failure to disclose where consumers purchased the tainted product. The FDA, state health authorities, retailers and restaurants know this information, but they keep it from the public. Why?
Here is another one of my pet peeves that I wrote about a year or two ago:
After 25 years doing food litigation, I am seldom surprised by the announcement of a foodborne illness outbreak. It was no different last Friday when the Indiana Department of Health announced a multi-state Salmonella outbreak linked to cut fruit – mainly melons sold at large retailers in several states. People in government or in various parts of the food industry know that an outbreak is brewing weeks before the evidence becomes too overwhelming to ignore, so on more than a few occasions, when the delay between government and industry knowledge and a public announcement becomes too slow for concerned people and I get a call, text of email.
But, it is not how the information gets out that concerns me – there will always be a difficult balance in foodborne epidemiology about when to go public. If a contaminated food product is missed by proper production and testing, we will not know of the problem until people become ill. And, the time between consumption, illness, investigation and recall can stretch for weeks or months depending on the numbers of people sick and the numbers of jurisdictions that encompass the outbreak. Foodborne illness surveillance will always have challenges and continuing to make the process faster and more accurate must always be the goal.
However, what continues to both concern and perplex me is the FDA’s failure to be more transparent with the public once we know the cause of the outbreak. In the early 2000s the USDA/FSIS had a policy that it would publicly announce who manufactured E. coli O157:H7 contaminated meat but refused to reveal the location of where the product was sold – specific retailers or restaurants. In 2002 ConAgra recalled beef in relation to an E. coli O157:H7 outbreak that sickened dozens and killed one. Most of the illnesses happened on or around the 4th of July. However, a couple of illnesses happened later that fall. When asked whether they had heard of the ConAgra outbreak and recall some of those sickened said they they had, but “we bought our meat at Safeway, not at ConAgra.”
It was not until 2008 that USDA/FSIS began to routinely disclose retail distribution lists, so retailers and consumers would know where tainted product was shipped and potentially sold. According to a recent article in the Washington Post:
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.
Not surprisingly retailers of USDA/FSIA regulated products have survived disclosure – transparency has been a benefit to consumer confidence.
Conversely, FDA has jurisdiction over 80 percent of the food supply but has remained silent and opaque leaving, retailers and consumers confused and at times angry at the lack of transparency. According the same Washington Post article:
“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.
Let me weigh in where the FDA would not. Let me also be blunt – there is no reason, especially when faced with an outbreak of foodborne illness, for the FDA to claim that the retail distribution list is a trade secret. Transparency of the food chain for products overseen by USDA/FSIS has not lead to a collapse of trade secrets. The FDA might well learn from a 10-year history of its sister food safety agency. Chicken Little, the sky did not fall.
An egregious example of FDA’s failure to not name retailers was 2017 E. coli outbreak linked to I.M. Healthy — great name for a product with a pathogen — soy nut butter that sickened dozens, some children seriously so. The outbreak began in December 2016 and reached critical mass in April 2017. A recall was publicly announced, but no retailers were named. I.M. Healthy went bankrupt and was likely uninterested or unavailable to assist in the recall. Not surprisingly, product remained available to purchase in retail settings and online several months after the outbreak and recall were announced.
Seriously, someone at the FDA needs to explain why an arguable “trade secret” trumps public health? The chain of distribution needed a good dose of transparency – both retailers and consumers were confused – not by too much information, but from too little.
Now back to last Friday when Indiana announced a multi-state Salmonella outbreak linked to cut fruit – mainly melons sold at large retailers in several states. Here, the Indiana State Department of Health – not FDA, nor the manufacturer – announced the outbreak. There was no recall yet, but Indiana did name several retailers, but not the manufacturer. The first news articles targeted retailers, not the manufacturer. Several hours later the CDC and FDA announced a 60-person Salmonella outbreak and named the manufacturer, but not the retail chain. Then the manufacturer posted a press release naming the retailer chain.
Confused? Me too.
So, my advice to the mystery FDA lawyer is simple – focus on public health and what should be disclosed and what is a trade secret will become clear. Formulations, ingredients and how products are made are trade secrets. Who supplied the tainted raw material, who made the tainted product and where the tainted product was sold are not a trade secrets – especially during an outbreak. Simplicity, transparency and consistency allows for a visible supply chain and one that consumers can have confidence in. Hiding behind “trade secrets” creates confusion and mistrust – not something that is helpful in the sale of food.