08/05/2011 - In a perfect world, the phrase lethal spinach would be an oxymoron, but the world of food is far from perfect.
In recent years, Americans have coped with spinach that killed, eggs that sickened thousands and tomatoes that landed people in the hospital. The list goes on: serrano chilies, shredded lettuce, peanut butter and cantaloupes. All were tainted somewhere between field and fork with bacteria or viruses that had the power—once ingested—to sicken, hospitalize, cause permanent organ damage or kill, with the very old and very young especially vulnerable.
The recalls and stories about outbreaks of sickness were not mere anecdote. Statistics revealed a deeper problem: In any given year, according to the U.S. Centers for Disease Control and Prevention, an estimated 48 million Americans get sick from foodborne diseases, 128,000 are hospitalized, and 3,000 die. In mid-2010, a study by a former U.S. Food and Drug Administration (FDA) economist at Ohio State University looked at the dollar and cents of foodborne illnesses and estimated that the nation incurred more than $100 billion a year in health-related costs.
So it should come as no surprise that in late 2009, a national public opinion survey found that nearly 6 out of 10 Americans said they worried about bacterial contamination of food. The costs study and poll were funded by The Pew Charitable Trusts, which was not a coincidence. Pew was getting involved in food safety in a significant way, stepping into the middle of a battle designed to end years of federal inaction on improving the safety of the food supply. According to all parties involved, Pew went on to play a crucial role in getting a new federal food safety law through Congress.
A few months before the poll was conducted, the FDA was undertaking one of the largest food recalls in the nation’s history. Salmonella-tainted peanut products from a plant in Georgia had slipped into America’s vast food-processing network, ending up in 3,000 different items made by 200 companies. In the end, more than 20,000 people may have been sickened. At least nine people died.
One of those who became ill was Jacob Hurley, the 3-year old son of a Portland, Oregon, police officer. When Jacob came down with flu-like symptoms in early 2009, his parents took him to their pediatrician after they noticed blood in his stool. While awaiting the lab results, they fed Jacob his favorite comfort food, peanut-butter crackers. Later, they discovered that the crackers they were feeding Jacob had made him sick in the first place because they contained tainted peanut butter from the Georgia plant. Jacob recovered, but the incident made his father, Peter, an advocate for changes to the nation’s food safety laws.
Incidents such as the peanut product recall turned companies in the food industry into advocates for change as well. Recalls were hurting the bottom line. Consumers were losing faith in the safety of food.
“It doesn’t matter if it is your company or not,” explained Caroline Smith DeWaal, a longtime food activist at the Center for Science in the Public Interest. “If you are a spinach grower and there is a nationwide recall of one brand of spinach, your spinach will sit unsold. The industry wanted to have less volatility so they could be assured that the food they were producing, which is totally safe, wasn’t being subjected to these constant food crises.”
With Pew’s help, the activists and industry leaders decided to work together, which by itself was a sign of change. As one participant in the coalition put it, “These are groups that don’t normally sit in the same room together.” They agreed that something had to be done to increase safety and they knew where it had to begin—with the FDA, the agency responsible for regulating 80 percent of all food eaten by Americans. (Meat and poultry are regulated by the U.S. Department of Agriculture.)
The last major change to the food safety provisions of the Federal Food, Drug and Cosmetic Act occurred during President Franklin D. Roosevelt’s administration. That left the modern-day FDA little authority to regulate current methods of food production and to prevent outbreaks of illnesses from tainted products.
As Erik Olson, director of food programs within the Pew Health Group, explained, the world of food has changed completely in the past seven decades.
“In 1938, you may have had a little bit of canned food, but you didn’t have a huge international global market,” Olson said. “Right now, the United States is importing food from more than 150 countries. Right now, the vast majority of food that people eat is not prepared by them from fresh ingredients at home. They are eating a lot of packaged and processed food. They are not eating food that is grown or processed within a few miles of their houses.”
He continued: “We have a very horizontally and vertically integrated food system, meaning that you may have a company that produced one ingredient in California, one ingredient in India, and they are mixing them at a plant in Singapore and selling the final products around the world. The industry is completely different than it was back in the day. The regulatory system just never caught up with that.”
Olson joined the Pew Health Group in late 2008 after serving as general counsel and deputy staff director on the U.S. Senate Committee on Environment and Public Works. His experience on Capitol Hill would prove invaluable over the next two years.
He also had spent 15 years at the Natural Resources Defense Council, working on such issues as pesticides, toxic chemicals and other environmental hazards. He had experience running campaigns—coordinated efforts designed to pass legislation. “A campaign approach is figuring out everything from media strategy—short- and long-term—to polling and research; it all feeds into your political strategy that feeds into your grassroots strategy,” he said.
The understated Olson is credited by activists as being an essential “honest broker” who dealt with both industry representatives and food safety advocates. For his part, Olson said, food safety “was an area that was ripe” (then he winced at his unintentional pun) for a campaign, using the people, talent and resources Pew could bring to the endeavor.
The first thing Olson did was to convene a meeting of the consumer, health and foodborne illness victims groups that had been working to pass a food safety law. They created a coalition called Make Our Food Safe. Participants included the American Public Health Association, the Consumer Federation of America, the Center for the Science in the Public Interest and STOP Foodborne Illness, a victims group.
Some groups were concerned that Pew would try to “bigfoot” their efforts, using its resources and muscle to push other advocates aside. That turned out not to be the case.
According to other members of the coalition, Olson and Sandra Eskin, his associate in the food group, and Pew lobbyist Carolyn Brickey were sensitive to the fact that many of the coalition partners had worked for 15 to 20 years trying to improve food safety, had encyclopedic knowledge of the problems and had already worked with key legislators from both parties to develop what would become known as the FDA Food Safety Modernization Act. These partners had FDA reform bills introduced in previous sessions of Congress and had worked to develop allies. “There was a lot of work done to get it to the five-yard line,” said Scott Faber of the Grocery Manufacturers Association, “but Pew got it into the end zone.”
“Pew put together a ‘dream team’ of talent in terms of getting the legislation passed,” said Smith DeWaal. “Erik Olson, Sandy Eskin and Carolyn Brickey are well-known professionals who have worked on this issue for decades. They could harness the resources to focus on the problem and move the bill to completion.”
If so much work had been done, if the public clearly supported the change, why hadn’t the legislation advanced? One reason was inertia: It simply is hard to get anything passed in Washington. “We were talking about changing a law that was 70 years old,” said Carol Tucker-Foreman, a veteran food safety advocate with the Consumer Federation of America. “If it had been easy, it would have been changed before.”
The bill also would make a major change in the way the FDA regulated, although resistance within the agency lessened (at least publicly) with the arrival of the Obama administration, which favored the changes.
For years, FDA regulation of food was reactive: The agency responded to problems. Once an outbreak of illness was detected, the agency would trace it back to its source and seek a voluntary recall so that distribution of the tainted product was halted. “It was a react-and-respond system that needed to be reformed to focus on prevention, due to dramatic changes in how food is sourced and the dramatic changes of diet,” said Faber.
Spinach was an example. For years, spinach was produced by growers who lived near where consumers lived and consumer preference was to eat it cooked—which generally killed off any bacteria. Now, consumers prefer their spinach fresh and there is national distribution of brands. The spinach grown—and tainted—in a field in California—can end up in supermarkets in New Jersey, Minnesota, Texas or Florida. And, even if it is advertised as “pre-washed” it can still carry bacteria, such as Salmonella and E. coli.
How can spinach become contaminated? There are a number of ways, including contact with improperly processed manure; irrigation with contaminated water; farmworkers who do not wash their hands after going to the bathroom.
The food industry has learned to identify the touch points of possible contamination in their processing plants and developed procedures for minimizing them. It goes by the acronym HAACP, which stands for Hazard Analysis and Critical Control Points. The FDA Food Safety Modernization Act gives the agency the responsibility to require food processing facilities to develop prevention-based food safety plans, and directs the agency to inspect these facilities regularly to make sure they are being done right.
Before the new law, the FDA did few inspections, averaging 1 every 10 years for any given plant. In addition, the growth of imported food overwhelmed the agency.
According to the Department of Agriculture, the value of food imported into the United States went from $41 billion in 1998 to $78 billion in 2007. By volume, 15 percent of the food consumed by Americans comes from overseas, and in some categories it is much higher. Seventy-eight percent of seafood is imported; 32 percent of fruits and nuts.
China has emerged as a major food exporter. The Department of Agriculture reports that 60 percent of apple juice consumed in the United States comes from China, as does 50 percent of garlic.
As of January 2006, 367,000 facilities in 180 foreign countries had registered with the FDA to import food into the United States. Yet, as of that date, the FDA was inspecting only 1 percent of imported food at the port of entry, a situation that left the United States “essentially with an open-door policy” when it came to imports, according to Tucker-Foreman.
A root cause of the FDA’s anemic approach to food safety was a lack of money. The drug side of the FDA relies on user fees, levied on drug companies, to pay for drug reviews and enforcement. The food safety division within the FDA relies almost solely on money Congress allocates as part of the budget process.
Advocates knew that any change in FDA’s approach to food safety would require more money so it could revamp into a prevention-based agency and hire more inspectors. The Congressional Budget Office estimated that the cost of implementing the bill would be $1.4 billion over five years, though advocates believe it would be less.
The price tag is not large compared to the billions that foodborne illness costs each year in terms of loss of life, medical costs, hospital stays and lost work time. But with Congress focused on reducing the deficit and cutting federal spending, cost was certainly an obstacle to getting the bill passed.
As the members of the Make Our Food Safe coalition gathered to plan strategy in early 2009, they could be forgiven for being pessimistic. Many had been trying—and failing—to get similar legislation passed for years. Bills were introduced and went nowhere.
“On the consumer/public-health/victims side of the equation, we brought a lot of substantive knowledge about the law, but all of us combined had really de minimis resources and virtually no expertise in running a campaign,” Tucker-Foreman said.
“Pew brought an understanding of the need to have a strong substantive case, but they also knew it would require a campaign to bring the problem and the proposed solutions to the public to build widespread support and also find a way to work with elements of the industry.”
There were other factors that helped change the situation: a new administration supportive of stronger legislation, broad bipartisan support in Congress, the continuing food recalls (the peanut scare unfolded in the first half of 2009), and a clear feeling by the public that government needed to do something about rolling outbreaks of foodborne illnesses. “It was,” said Sandra Eskin of the Pew Health Group, “the appropriate, but overused, metaphor of a ‘perfect storm.’”
The Make Our Food Safe campaign was launched in March 2009. The House passed an FDA food safety bill in July of that year—warp speed by Washington standards. A separate Senate bill passed a key committee in November. An amended version of the Senate legislation would eventually become the FDA Food Safety Modernization Act, but not before it sat, stalled for months.
What happened to the momentum? At ground level, there were more complications: disagreements between the House and Senate over their differing versions of the bill, the emergence of opposition from proponents of local agriculture, and the fact that the health care debate was taking up so much oxygen.
“There was always another, higher-priority bill being considered by the Senate,” said Eskin. “First it was health care and then financial services.”
Tucker-Foreman said the bill “was tied to the rails more times than Pauline.” Smith DeWaal said that “we never got the sense that it wasn’t a priority, but we got the sense it hadn’t got to the top of the list yet. We kept hearing it was on the ‘to-do list,’ but it never got to the top.”
As the spring of 2010 turned to fall, the inertia grew. The bill wasn’t simply stalled; it was sinking beneath the surface.
In the end, a 13-year-old girl from Nevada might have saved the day. Rylee Gustafson is the victim of a foodborne illness. She became sick in 2006, at the age of 9 when she ate E. coli-contaminated spinach and almost died. The illness left her body scarred, but not her spirit. Gustafson and her mother, Kathleen Chrismer, became activists with coalition member STOP Foodborne Illness. She approached Harry Reid, the U.S. Senate majority leader and a Democrat from her home state, to plead for an update to FDA’s food-safety authorities. Joining other victims and their families as part of the coalition’s campaign, she repeatedly visited him in Washington and again when he was back in Nevada. Reid made passage of the bill a priority and sidestepped a threatened Republican filibuster. The legislation passed in the closing days of the session and President Barack Obama signed it into law on January 4, 2011.
“Harry Reid at the end was the one who had to make it happen,” said Tucker-Foreman.
But nothing is that simple in Washington. In reality, due to various technical, political and procedural glitches, variations of the bill had to pass the House three times and the Senate twice. Olson calls the bill that passed the Senate before Christmas the “final, final, final version” of the legislation.
When the bill did come up for that “final, final, final” vote, there was bipartisan support. It passed the House by a vote of 215-144 and the Senate by 73-25.
“It was really a stomach-churning process what this bill had to go through to get passed,” said Nancy Donley, president of STOP Foodborne Illness, “and it does bring to mind Otto von Bismarck’s remark.” (Bismarck observed that those who love sausages and respect the law should never watch either being made.)
For victims and survivors, passage of the law was “empowering invigorating and exhilarating.... It was cathartic in a way to be able to effect positive change,” said Donley.
In a way, the enactment of the food safety law is a textbook study in the way a successful campaign should work. There was a group of advocates willing to work together, an industry that realized it needed responsible regulation and bipartisan support in Congress for the changes. What Pew brought to the table was talent (Olson and his team are widely praised), resources (all those polls, the media work, the advertising, the shuttling of victims to and from Washington to meet with legislators cost a lot of money) and a determination to get the deed done. “Without Pew’s leadership and resources, there would be no [FDA] Food Safety Modernization Act,” said Tucker-Foreman.
But the challenge now for the Pew Health Group, for the coalition and industry, is to see that the FDA gets the money it needs to make the law work. In the political and budgetary climate of Washington in 2011, it will not be easy. “You can never call it a day,” said Donley. “You have to keep working it.”