The new law is supposed to focus on preventing deadly outbreaks rather than just reacting to them.
WASHINGTON — Four years ago, President Obama signed into law sweeping changes designed to improve U.S. food safety and prevent outbreaks similar to the one involving Brenham, Texas-based Blue Bell, in which three people have died after eating contaminated ice cream.
The Food Safety Modernization Act, the biggest food-safety overhaul since 1938, came in response to a 46-state outbreak tied to salmonella at a Georgia peanut plant in 2008. Nine people died, and every year since, thousands have died from food-borne illnesses.
The new law is supposed to change that.
It shifts the focus from merely reacting to deadly outbreaks to preventing them.
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That is, if it can ever get implemented.
It has taken four years, more than 75,000 public comments and a federal court order to enable the Food and Drug Administration (FDA) to write the broad new rules that will govern how thousands of food manufacturers like Blue Bell will ensure their food is safe to eat.
When the rules are finalized later this year, companies will have up to three years to comply, depending on their size. But the new law still won’t require companies to test their food for bacteria, even if, as Blue Bell did in 2013, they find that potentially deadly bacteria is alive and growing in their plant.
Hundreds of changes
The new law makes hundreds of changes. But in almost all cases, it still leaves it up to companies to decide whether they need to test the food they make for bacteria before they put it on trucks and sell it.
“There is no one-size-fits-all system of preventive controls,” said Mike Taylor, the FDA’s deputy commissioner for food safety. “But also we don’t want to stymie innovation.
“We are trying to walk the line to keep the flexibility that folks need to put in place the right efficient, effective preventive control … but also create accountability for firms to do this the right way.”
The FDA has said Blue Bell knew in 2013 that at least one of its plants had tested positive for listeria. But the company chose not to tell state or federal officials or test its ice cream to learn if it was still safe.
“They just killed the listeria that they found in a small area,” said Mansour Samadpour, a former University of Washington microbiologist who is president and CEO of IEH Laboratories and Consulting Group. “They did not address the bigger question of why was it there, where did it come from?”
Companies often get bad advice and don’t bother to test food after listeria is found in their plants, he said. “If it’s in the plant,” he said, “it’s going to be in the food.”
A Blue Bell spokesman said the company’s decisions to not report the listeria found in 2013 or test its food as a result were within the law and common practice.
“Several swab tests did show the presence of listeria on nonfood surfaces in Blue Bell’s Broken Arrow plant in 2013,” spokesman Joe Robertson said in a written statement. “As is standard procedure for any such positive results, the company would immediately clean the surfaces and swab until the tests were negative.
“Under FDA and state regulations, companies in our industry were not previously required to report listeria findings,” Robertson said, adding that an agreement with Texas and Oklahoma will change that.
“We have agreed to report any findings of listeria monocytogenes in ingredients or finished products,” Robertson said. “Moreover, the government will have full access to our routine environmental sampling results for listeria.”
Williams, of the state health-services department, said the new rules are probably the most stringent ever arranged by the agency. For a year, Blue Bell will be barred from selling any products until tests of the ice cream they’re made from come back negative.
Even if the new law did require product testing to verify that safety plans were working, it wouldn’t by itself guarantee safe food, experts said.
“It’s easy to look at this and just say, ‘Let’s test everything,’ ” said Sandy Eskin, director of food-safety programs for the Pew Charitable Trust. “But then there is a real question of cost, and even of efficacy.”
George Salmas, a lawyer who defends food companies when problems arise, said it’s more important to have a system you can trust. “Even testing outgoing food product isn’t always going to identify all contamination,” he said.
Some economists and law professors argue against more regulations like the powers the FDA is assuming under the new law. Instead, let the market regulate the companies’ behavior, they say. They argue that companies will see it in their best interest to avoid the kind of nightmarish season Blue Bell is having.
Taylor, the FDA’s deputy commissioner, said, “The vast majority of firms have every reason to do the right thing. But we have to have a regulatory system that facilitates that, and when they aren’t doing the right thing, holds people accountable in a very timely way.”
“Massive undertaking”
Even so, the bill is so big, and the industry both so diverse and widely dispersed, the agency knew the law wouldn’t work without taking into account industry views, he said. The law starts with the premise that most companies want to do the right thing, and allows them to tailor their safety plans.
“It’s just an unbelievably massive undertaking,” Taylor said. “We realized from the beginning that we couldn’t possibly implement this without the active collaboration of those who actually make the food we’re trying to keep safe.”
The FDA has until Aug. 15 to finalize the rules governing hazards within plants like Blue Bell’s, with six other rules coming in quick succession.
But Taylor and many others say the bill, even after all these years, won’t be enough if Congress doesn’t provide the funding the FDA has said it needs.
“We have a workforce of about 2,000 who have been working in one way for a long time, and they have to be trained in a new way of doing things,” Taylor said. “We’re also going to be dependent on the states to help implement this. …
“We are being asked to create a whole new regime. It requires new staffing, new skills, more overseas presence and new foreign inspectors. You can’t do that for nothing.”