Where did your most recent meal come from? Whether or not it was the supermarket, a nice restaurant or nearby drive-through, its contents probably came from not just one U.S. locality but a smattering of states—and countries. Just which ones, though, neither you nor the people who sold, packaged or processed it are likely to know for sure.
If The FDA Food Safety Modernization Act recently passed by the Senate becomes law, companies and consumers would have a much better chance of tracing food back to its farm and factory origins. Such data are crucial in this age of ever more connected food supplies for helping health officials discern the source of major foodborne illness outbreaks, like the salmonella-tainted eggs that sickened more than 2,000 people this summer.
The legislation would also provide the U.S. Food and Drug Administration (FDA) with the authority to mandate food recalls, access industry records if there is reason to believe their products are adulterated, and enter foreign facilities that sell food to the U.S., among other basic authorities that the agency currently lacks.
"The whole framework for food safety law will change from this bill: from being reactive to turn[ing] it around and make it preventive, and avoid contamination before it gets onto grocery shelves," says Erik Olson, director of the Food and Consumer Product Safety Programs at the Pew Charitable Trusts. "That's a major change," he notes. Currently, "we basically have a century of reactive regulatory approach where you don't intervene until contamination is discovered."
The 1938 Federal Food, Drug, and Cosmetic Act provided the FDA with the responsibility of ensuring food safety. Various amendments and additions have passed since then, but many experts see the bulk of the current legal framework as being far out of step with the contemporary food system. In the 1930s lawmakers "just did not envision the current consolidation and global spread of the industry that we have now," Olson points out.
The bill, currently stalled due to a procedural error about approving new fees, now must be passed by the House before it can be given to President Obama to be signed into law. Neither the FDA nor the U.S. Department of Agriculture (USDA) would comment on the bill before it is ratified, but in a prepared statement Obama said, "I urge the House—which has previously passed legislation demonstrating its strong commitment to making our food supply safer—to act quickly on this critical bill."
Many experts expect the act to be pushed through with minimal changes before the end of the year. "There is very strong commitment I know from both the House and the Senate this session to get this done," Olson said.
The law would step up preventive measures such as inspecting high-risk food facilities every three years (rather than every 10 years) and establishing safe-handling standards for produce. It would also provide protection for industry whistle-blowers, because currently "there's none, stunningly," Olson says.
The 240-page bill might only explicitly mention the word "science" 11 times but, says David Plunkett, senior council for the Center for Science in the Public Interest, "the FDA thinks of itself as a white-coat agency." Also in charge of approving drugs and medical devices, it has a long history of relying on research—although it did not always have the means to do so when it came to food safety, he notes.
"This bill is going to change a lot of the things we do, and put them on a knowledge basis instead of just an intuitive basis," Plunkett says. Some food system processes are based on habit and tradition rather than science, he notes. Often food producers say, "My father did it this way, and I do it this way, and we've never had a problem," he explains. But putting science-based standards into the equation might hedge off hazardous practices and avoid the need for many recalls in the future.
Laboratory test kitchen
In suspected food contamination cases the burden of proof has largely been on the FDA to establish a case to obtain company records. And even when the situation looked to be potentially dangerous, the agency could only recommend the company issue a recall.
Although the new bill would make it easier for the FDA to obtain company records and check for contamination, the agency will not be continuously monitoring the paper trail—or the food itself. The agency would still have "to have sort of a basis to ask for" laboratory test results and records, Olson explains. But the legislation would require food companies to use either federal or accredited labs (rather than company-chosen labs as is currently allowed) to test food safety, a step that should ensure easier regulatory access if a problem does crop up.
In the 2009 peanut butter salmonella outbreak records showed that several batches had raised red flags, but the company "believed they didn't have an obligation to share those test results because they didn't actually ship those lots," Olson says.
Making companies more accountable for providing lab tests and other internal documents might discourage them from letting safety standards slide. "Instead of letting people get sick and then finding out what's wrong—where people are the guinea pig[s]—[the goal is] putting into practice some standards" to hopefully prevent food from becoming contaminated in the first place, Plunkett says.
In addition to spotting potential problems sooner, increased surveillance should help boost knowledge about the contaminants and food safety in general. "This bill will give us a very good basis for improving our knowledge," Plunkett says. "It's going to help the FDA develop a knowledge base that it needs."
As more data are collected as part of the bill's requirements, government agencies should be able to pinpoint trends in high-risk products and processes. The new information might also help in finding the origin of the millions of food poisoning cases whose sources are unknown. "The vast majority of people getting sick, we don't know the food they ate to get sick," Olson says.
Unlike manufacturing components, which are often tracked which a high degree of specificity using bar codes, RFID tags and other technology to trace them through production, keeping tabs on edible soft goods can be a tad bit trickier.
After a commercially grown tomato gets picked, it will likely find its way to a sorting facility where it is tossed in with tomatoes from a variety of farms to be sorted by size or color or quality before being sold to a processor. For now, usually "you can track it up to the door of that facility," Plunkett says. "But once it goes in it loses its identity." From that location a tomato might go on to a distributor before being sold to a grocery store or to a processing plant to make paste—and then to a manufacturer that makes spaghetti sauce or canned soup.
A 2009 report from the U.S. Department of Health and Human Services's inspector general found that 59 percent of companies were unable to provide adequate information about where their supplies were coming from and where they were going—even to comply with current law. And as the peanut butter–based salmonella outbreak earlier that year bore out, tracking those records in a timely fashion is not easy. Many records are kept on paper and companies often rely on shipping documents to trace products up or down the supply chain. In instances like the peanut butter contamination, "a rolling recall that affected literally thousands of products and hundreds of companies," Olson says, "it took months to figure out" the origin and distribution of the contaminated product.
And as more food products integrate more ingredients—obtained from more places throughout the the globe—the source of a sickness can be even harder to trace. In a January 2010 recall contamination in sausages turned out to be not from the meat but from the pepper that was used as seasoning. And in the 2007 chicken and turkey potpie recall the origin of the contamination, which was originally thought to be the turkey (thus allowing the USDA to recall the meat-based product), was unknown.
The new law will require companies to move from the so-called "one-up, one-down traceability"—that is, records of whom they receive products from and to whom they ship them—to a more comprehensive account of their supply and distribution chains. Getting to that level will likely take some work. Modernizing this massive system has "got to be one of the most difficult—and one of the areas where the most work needs to be done," Plunkett says.
Some companies have hired third-party tracking companies that will check the records of providers down the supply chain—from farm to factory. Although the outside assistance comes at a price, Plunkett says that many companies recognize that it will help them down the line. "For the consumer you get that extra measure of quality" if a product comes from a company that is tracking its products well, he notes. And for the company, "you will also have a response when the FDA comes to your door."
Upfront costs can also save big bucks down the road, Plunkett explains. Foodborne illnesses are estimated to cost some $152 billion in health care costs yearly—and recalling loads of food can mean substantial costs and income loss for companies. So, he says, "you might want to think about the science, because failure in the field is huge amounts of money."
But even with private tracking services becoming more widespread—and even more so if the bill is signed into law—the system is still far from transparent. Many tracking companies use proprietary systems, making them less likely to be shared—and because they are being implemented piecemeal, the systems often cannot talk to each other.
Safe for science
Should the bill—or a similar one—become law by the end of the year, many of the provisions will not take effect January 1. But Olson suggests that most will be implemented within a couple years. And he is just fine with delays when needed. "We've been waiting 70-plus years for this," he says, "so we are not encouraging the FDA to rush forward without the science behind them."
Most of the science is already there: "We know certain bugs make people sick; we know that certain foods are more likely to make people sick," Olson says. "Some of the most extreme problems can be identified and dealt with."
With all of the new science and knowledge will come new regulatory power for the FDA. But rather than regulate people's backyard gardens, as some critics have claimed, the law will give the FDA some basic authorities that many people assume it already had, such as mandating recalls of food shown to be contaminated. "You would think that there is recalling authority," Olson says. But "that is what comes from a law that is 72 years old."