Why are most hazardous food recalls voluntary?. Image 1.

Maggie Craig


Why are most hazardous food recalls voluntary?. Image 2.

Decue Wu



FDA product recalls seem to be almost ordinary, with fears of salmonella poisoning and undeclared allergens making regular appearances on primetime news. But up until recently, these recalls were merely suggestions made by the FDA—whether the product was actually removed from shelves was completely up to the company, putting most of the responsibility into the hands of the consumer in terms of knowing what produce was safe to buy and eat.

In January 2011, the Food Safety Modernization Act was passed, awarding the FDA the power to enforce food recalls while mandating preventative measures that will catch foodborne illness before products hit the shelves. Still, the new legislation doesn’t fully go into effect until 2016 and, due to historical and political reasons, the FDA is vastly underfunded and can’t always make sure that these new rules are being carried out. Hopes&Fears reached out to food safety experts, lawyers, and food policy activists to see why the FDA has so little authority in the market and how this affects us as consumers.



Juli Ann Putnam

FDA Public Affairs Specialist

Before the FDA Food Safety Modernization Act (FSMA) was enacted, the FDA relied on responsible parties to voluntarily recall violative food products (with the exception of statutory provisions authorizing mandatory recalls of infant formula provided under section 412 of the Federal Food, Drug, & Cosmetic Act). The FDA continues to rely on responsible parties to voluntarily recall violative food products; however, under the FSMA passed by Congress in December 2010 and signed into law in January 2011, the FDA was given the authority to issue a mandatory recall of unsafe food when a responsible party chooses not to conduct a voluntary recall and when the criteria under section 423 of the FD&C Act are met. The FDA can use its mandatory recall authority when it determines there is a reasonable probability that the food is adulterated under section 402 or misbranded under section 403(w) of the FD&C Act and that the use of or exposure to that food will cause serious adverse health consequences or death to humans or animals.

Once the violation and probable hazard level are determined, the FDA district offices work closely with the company to establish a recall strategy. In cases where a product with a serious health hazard has reached consumers, the districts will ask the company to issue a press release, which is then posted to the FDA website.

The FDA may learn about a recall from different sources

It depends on the situation. The majority of recalls are self-reported by companies to the FDA District Offices. Class I recalls are required to be reported via the Reportable Food Registry (RFR) within 24 hours of the company becoming aware of a likely Class I violation:

FDA routine inspections may uncover products which should be recalled. Some inspections include sampling of product or the food processing environment, which may result in a recall.

 State investigators may alert the FDA when they find a potential violation during their routine inspection or sampling programs.

 Consumer complaints made to the FDA’s district consumer complaint coordinators trigger FDA follow-up, which may result in a recall.

CDC and state health departments will alert the FDA when they suspect an increase in reported illnesses may be food-related.



Zak Solomon

Director, Analysis and Production at Food Sentry, LLC

Could more be done? Sure. Is the FDA doing its job? We think so, but there is certainly room for improvement. In general, the FDA/USDA are responsible for enforcing compliance with legislation and standards and monitoring the food supply for food safety issues. But consumers should be asking for more transparency in supply and value chains, and for the FDA and USDA to be developing better proactive monitoring techniques with regard to compliance. The USDA is responsible for meat, poultry, and egg products, and the FDA is responsible for everything else. With regard to preventive food safety tools, the FDA developed a predictive food safety capability focused on imports called PREDICT on which members of our team played integral roles. This system uses advanced risk modeling to determine where the FDA should focus its screening and monitoring resources. The system worked well when we were a part of the program. We are no longer involved, but as far as we know they are using this system. Food production businesses themselves are charged with complying with their own claimed food safety protocols and that is the other side of the whole story. The FDA can only do so much; industry must be responsible for themselves to a large degree, the FDA is just there to try to ensure compliance with regulations and standards and remove dangerous products from market.

The Portales, NM peanut plant incident was the first time FDA used its new mandatory recall power. In general, it takes time for the FDA to issue mandatory recalls because the process is complex. The company must be consulted, problems and their scopes must be confirmed, and finally the recall must be coordinated. These steps are important because the process is not as simple as a few people reporting illness relating to a product. There are many variables that must be accounted for in the recall process.

Sometimes the FDA will issue a recall before anyone is affected, or at least before any illnesses are reported: earlier this month Whole Foods opted to recall a certain type of cheese at locations across the nation after the FDA found listeria in a whole wheel of cheese.

Sometimes the recalls can be too little too late: in 2008 and 2009, the FDA found that the Peanut Corporation of America was the source of a salmonella outbreak that sickened thousands of people and caused at least nine deaths. Stewart Parnell, the company’s former executive, was sentenced to 28 years in prison this past September.



Marion Nestle, PhD

Paulette Goddard Professor of Nutrition, Food Studies, and Public Health at New York University

We know how to produce food safely. You look for places where hazards can occur, you take steps to prevent the hazards, you monitor to make sure the steps are taken, et cetera, et cetera. That’s been known for decades because it’s a process developed by NASA to prevent food safety problems in outer space, with astronauts. The idea that astronauts would get diarrheal diseases in outer space was pretty horrible to contemplate, so the food that accompanies them has to be safe. And for that they needed to devise procedures to do that and Pillsbury was hired to do that, and that happened decades ago. If we can do food safety in outer space we can do it on earth.

The USDA has more resources because the financing of food safety comes through House and Senate agricultural committees, and the FDA is a health agency, but for historical reasons it gets its funding from agricultural sub-committees. I think it’s a huge problem.

You have to want to produce safe food. And be really serious about it. And a lot of companies aren’t and haven’t been. It’s interesting that the problems that have been coming up now are largely FDA problems. They are foods that are regulated by FDA because the department of agriculture instituted these kind of regulations for meat and poultry in the 1990s and they have enormously reduced problems in meat and poultry.

You really have to know what you’re doing to set up a decent prevention control plan. And if you’re not serious about it then the plan can fail. And that has happened. But what this law would prevent is the kind of thing that happened with Peanut Corporation of America, where these people just knew they were producing unsafe food and sent it out anyway. And people died. People died as a result, and a lot of people got sick. And it gives the FDA some power to stop it. The problem with the recalls is that they come very late in the process. It takes a long time to figure out what is causing an outbreak of foodborne illness. It’s not obvious. It requires a lot of investigation, and so by the time everybody figures it out, and CDC does what it does and the FDA does what it does and issues a recall, usually the outbreak is over. By the time the recall is issued, there are many fewer occasions. Not always, but sometimes.”

It comes down to political will. Always. And so FSMA, the new law, gives the FDA the tools to enforce food safety regulations. What it doesn’t do is give the FDA enough money to do it, and that’s a huge problem.

While the American food supply is among the safest in the world, the federal government estimates that there are about 48 million cases of foodborne illness annually—the equivalent of sickening 1 in 6 Americans each year. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths.” - FDA.gov

In 2014, 43 out of 94 recalls were due not to foodborne illness but undeclared allergens on the labeling of the product. Milk, egg, peanut, soy, fish, crustacean shellfish, wheat and tree nuts have to be labeled.




Baylen Linnekin

Executive Director, Keep Food Legal Foundation

According to data from the federal government's Centers for Disease Control and Prevention (CDC), the leading cause of foodborne illness in the U.S. is norovirus. It's responsible for nearly three out of every five such illnesses. Because norovirus is transmitted through improper washing of hands, food contact surfaces like cutting boards, and clothing, there's little to nothing the FDA can do to prevent the 58% of foodborne illnesses caused by the virus. That is, unless you want an FDA official standing in your kitchen and making sure you wash your hands and use separate cutting boards to prepare raw vegetables and raw meats. What this means is that the task of preventing nearly sixty percent of foodborne illnesses in America—and roughly 23% of all deaths from foodborne illness in this country—comes down to local health officials who regulate and inspect restaurants and to all the people—me and you—who prepare and cook food at home.

Most of the new powers the FDA was granted under the Food Safety Modernization Act (FSMA) won't make us or our food any safer. They likely won't impact norovirus rates at all, for example. And the FDA's own optimistic estimates for how much safer the two key FSMA rules will make our food—governing produce safety and good manufacturing practices—run in the range of 3% to 5%. Worse, that's the agency's best case estimate of their combined impact. Some critics, including me, have argued that FSMA may turn out to make us and our food less safe.

That said, one important power that Congress did grant the agency was the power to issue mandatory food recalls in cases where a particular food is shown to be unsafe. I've long found it incredible that the agency lacked such authority. But it turns out the reason for the lack of recall authority is perhaps even more incredible than the lack of that power. It turns out that the FDA itself opposed having the power to order food recalls. For example, an excellent 2008 Cornell Law Review article on FDA powers, written by Professor Lars Noah, notes that "the FDA generally has resisted proposals to provide it with explicit recall authority." Incredible, right?

Our existing food system may be imperfect, but it's also probably the safest food supply the world has ever known. Some of that is no doubt thanks to federal, state, and local food safety laws. But the success of some laws is not reason enough to say we need more laws, particularly when many laws haven't made us or our food safer. So what's a consumer to do? We should demand that existing and proposed food safety laws show strong evidence they improve food safety. We should reject any that don't. By the FDA's own estimates, FSMA doesn't meet this high bar. Many small, sustainable, and organic food producers opposed the FSMA rollout because, they argued, the FDA's proposed rules wouldn't make food safer, but would impose costly new burdens on them, and could put many out of business.

So consumers need to demand our laws and regulations promote the policies behind those rules. But consumers also need to practice good preventative practices by, for example, washing their hands before and after preparing food.




Bill Marler

Managing Partner of Marler Clark, a Seattle, Washington based law firm that specializes in foodborne illness cases

The Food Safety Instruction Service, which is the USDA division that inspects meat processing plants, provides an inspector in every plant and they have rules that they are required to follow. In a FDA plant, however—and 80% of our food supply runs through the FDA—they may not go to a plant once every five to ten years. That’s the problem. Whether you need an inspector in every plant every day, I think that’s an open question. But there’s a difference between having somebody there every day and having somebody never show up. And that’s a resource problem: the FDA just doesn’t have the resources to do it.

I’m a proponent of regulation, and in my view, mandatory recall authority was never really necessary… I think people were perplexed that the FDA didn’t have recall authority but in my view, in 22 years of experience in this area, it really wasn’t an issue.

Under the Food Safety Modernization Act, the FDA now has mandatory recall authority, so they can do it. But they don’t. Basically what the FDA does is—let’s just say there’s a contamination event that would prompt a recall—they go to the company and go, "Hey, here’s the info we got. You need to do a recall." And then the company goes, "Okay," and then they do it. And then the company can put out a press release saying that they voluntarily recall. If a company refuses to do a recall, the FDA can recall it for them. So that's how it works.

The 2016 fiscal budget sees a 76.4% increase in funds going to the USDA for food safety (for meat and poultry), and a 24.5% increase in funds going to FDA food safety programs.