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Foodborne Illness Investigations: What Does the Public Have a Right to Know?

admin2 weeks ago (05-19)Laws and regulations27
It seems safe to assume that most consumers want to know if the restaurant they’re about to eat at o…
It seems safe to assume that most consumers want to know if the restaurant they’re about to eat at or the food they’re about to buy was recently the source of a foodborne illness outbreak. What’s less certain, however, is whether the government wants them to know this information.
CONFIDENTIAL
Deciding when to release public health information is a government responsibility fraught with competing interests. Does the agency name the source of an outbreak after it’s over at the risk of hurting a business, when no public health threat remains? Does it announce a suspected outbreak source in the midst of an investigation even if it’s not yet certain this is where the outbreak started?

First, let’s look at how an investigation unfolds.

There are two ways an outbreak is discovered, says food safety microbiologist Phyllis Entis:

1) Different patients’ cases are connected using PulseNet, a database where states report what strain of pathogen has sickened someone. In this case, the Centers for Disease Control and Prevention, which operates PulseNet, looks for patterns and clusters in the data to determine if there is an outbreak.

2) A microbe is recovered from food after testing, but before distribution, prompting CDC to utilize PulseNet to see if any illnesses are linked to that strain.

This is not necessarily a quick process. Depending on which strain (there are thousands of strains of Salmonella, for instance) causes the outbreak, the discovery and analysis period could take weeks or even months.

Once an outbreak has been identified, the U.S. Food and Drug Administration (FDA) and CDC might begin releasing information to the public. Any finger pointing that comes with the word “outbreak” attached to it carries weight. If tomatoes are implicated as the cause of a Salmonella outbreak, tomato producers and retailers, even those whose product wasn’t connected to the outbreak, may watch as their sales dry up. Information spreads at the speed of social media and the public reacts just as quickly.

On the other hand, identifying the source can help prevent illness if the outbreak is still ongoing. If the public knows that only a particular brand of salsa is contaminated, or to be on the lookout for tomatoes with a certain sticker label, the tomato industry as a whole is not hit as hard, and consumers can act as agents on the ground notifying retailers if they see the targeted product on the shelves.

As expected, there are policies in place and guidelines that must be followed when releasing outbreak reports. Guidelines from FDA’s Department of Health and Human Services can be found here.

“We typically don’t release the name when there is not a public health reason to do so,” said CDC Senior Press Officer Lola Russell in an interview with Food Safety News. “There must be something specific the public can do with the information, like check their shelves or throw something away.”

“The first priority is always to protect public health,” Russell added. “The second priority is preserving industry cooperation. We are not regulatory, even though CDC depends upon those industries to cooperate with us during those investigations.”

FDA has a similar approach.

“When the epidemiologic, laboratory, and environmental information is deemed sufficient to implicate a specific food, FDA informs the public, providing as many specifics as possible regarding the retail location, brand, packaging, lot codes, etc.,” said Patricia El-Hinnawy, press officer for FDA’s Center for Food Safety and Applied Nutrition in an interview with Food Safety News.

“Obtaining a complete and accurate understanding of the entire chain of distribution from manufacturing to retail is a challenge in outbreaks,” El-Hinnawy said. “In some situations, there can be hundreds of entities including wholesalers, brokers, distributors and retailers. In some cases, the records are not in electronic form and require extensive, time consuming, manual data collection and review.”

In other words, it’s amazing when an outbreak is discovered and traced to a specific food or company.

Of course, FDA has to consider the legal implications when identifying a company.

“In many circumstances, the relationship between commercial parties is considered confidential commercial information, and therefore we are limited in our ability to make this information public,” El-Hinnawy said. “FDA does not release confidential commercial information unless doing so is necessary to effectuate a recall.”

Confidential commercial information refers to Exemption 4 of the Freedom of Information Act (FOIA), which allows the government to refrain from releasing any “trade secrets and commercial or financial information obtained from a person and privileged or confidential.’

FDA’s use of that FOIA exemption contrasts with the U.S. Department of Agriculture’s policy on information release. USDA, which regulates meat and poultry products and whole eggs, releases a list of which retailers received a recalled product, while FDA elects not to.

An example of FDA’s withholding of retailer names is found in the 2011 Listerosis outbreak linked to cantaloupe. FDA reported that the contaminated cantaloupes had come from Jensen Farms in Colorado, but did not name any of the retail stores where the fruit was sold, despite the fact that potentially contaminated cantaloupes were likely still on store shelves.

“FDA treats retail distribution as proprietary information and leaves it up to the company, during a recall, to release that information,” Entis said. “This is one of the things that can extend the duration of an outbreak.”

While releasing “confidential commercial information” is a reason FDA would refuse to implicate a specific company during an outbreak, it is unlikely that FDA is afraid of any legal repercussions for prematurely implicating the wrong company, or inadvertently impacting the food industry at large.

Under U.S. Supreme Court precedent regarding federal administrative law (see Chrysler Corp. v. Brown, 441 U.S. 281 (1979)), FDA cannot be sued for any injury caused by the agency if its actions are within its general discretion.

As the dissemination of information to the public during an outbreak is almost certainly within that discretion, FDA has little to worry about, legally speaking.

FDA and CDC officials stand by the position that each agency only releases information to the public when it serves a public health interest. Entis, however, believes the more the public knows during an outbreak, the better.

“It’s one thing to withhold information when you are not sure,” says Entis, who maintains a blog (EFoodAlert) where she posts lists of all retailers known to be selling a recalled product. “It’s an entirely different thing to withhold information when you are.”

In 2008, as a Salmonella Saintpaul outbreak unfolded., FDA named raw red tomatoes in New Mexico and Texas as the culprit, before removing that warning, and eventually naming peppers from Mexico.

Did that outbreak leave government officials leery going forward?

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