Hungry for Change
You could fill a shopping cart with foods recently linked to outbreaks of illness caused by contamination. In June, it was cookie dough. In May, it was alfalfa sprouts. Before that, it was pistachios, peanuts, spinach, tomatoes, jalapeno peppers and, of course, hamburger.
Hardly a month goes by without Americans falling prey to another nasty pathogen lurking somewhere in the gleaming aisles, coolers and produce displays of the local supermarket.
The steady parade of well-publicized outbreaks of food-related illness has created a rare political alignment. Angry, frightened consumers and a food industry haunted by the double specter of bad publicity and lawsuits both appear ready to embrace actions by the federal government to make the U.S. food supply safer.
And the federal government has begun to take some of those steps. In March, President Barack Obama announced the formation of a Food Safety Working Group to develop proposals for upgrading federal food safety laws and improving coordination among at least a dozen federal entities that share responsibility for the safety of the nation’s food supply. Some of the working group’s recommendations already are being put into effect.
Meanwhile, legislation has been introduced in Congress that would dramatically increase the oversight power of the Food and Drug Administration over much of the food sold in the U.S., including imports.
Some lawyers and other experts see the opportunity to implement the most sweeping changes in food safety regulation in more than 70 years.
“It’s finally all coming together,” says William Marler, a Seattle lawyer who represents victims in food poisoning cases but also advises companies on how to improve food safety. “We have a Congress that’s interested, a president who’s interested and perhaps more importantly, business is interested in it as well.”
But there also is some skepticism about both the administration’s proposals and the proposed Food Safety Enhancement Act (H.R. 2749). Some suggest that the changes would be too broad, and there are concerns that the scope of the new food safety enforcement structure would overwhelm many organic farmers and other small producers.
“Pretty much all the stakeholders realize there’s a benefit to changing the rules,” says Neal D. Fortin, director of the Institute for Food Laws and Regulation at Michigan State University in East Lansing. “But there’s still disagreement about how to do that.”
While the details may not all be in place, it appears certain that the legal framework for regulating food safety in the United States is going to change, and lawyers—especially those who represent companies in the food industry—are going to have to hustle to keep up.
Litigation is likely to increase as a pumped-up FDA, an arm of the Department of Health and Human Services, identifies more outbreaks of food-borne illness and collects more evidence about their causes. Meanwhile, many companies are likely to struggle, at least initially, with stricter requirements to develop safety plans, disclose business records when outbreaks occur and improve procedures for tracing products, according to Kenneth M. Odza, a member of Stoel Rives in Seattle, who litigates food safety cases and writes a blog on the subject.
“There will be lots of regulated companies asking for advice from lots of lawyers,” says Stuart M. Pape, managing partner of Patton Boggs in Washington, D.C. Much of his practice involves advising clients on FDA and U.S. Department of Agriculture regulations.
CRISIS OF CONFIDENCE
The overall safety of the food supply in the United States is a matter of some conjecture—perhaps distorted by matters of perception.
While the U.S. food supply generally is considered to be one of the safest in the world, the national Centers for Disease Control and Prevention in Atlanta estimates that some 76 million Americans—about a quarter of the population—are stricken with some form of food-borne illness each year. Of those, more than 300,000 end up in the hospital, and some 5,000 die.
Those numbers, while not increasing in recent years, aren’t diminishing either. And while preventive efforts apparently have stalled, there are concerns on the horizon, with increasingly global sources of food supplies and an aging population more susceptible to food-borne illness.
Widespread coverage of recent outbreaks of food-related illnesses makes it seem that hardly anything in the food supply is safe. And the result is a crisis of confidence among both the food industry and regulators.
“At the end of the day, the branded companies understand that they have to have an understanding with their consumers that is based on confidence in the production of high-quality, safe products,” Pape says. “Some of the problems that have occurred have shaken that confidence. Restoring that confidence is a cornerstone of having a successful business going forward.”
The Food Safety Working Group pulls no punches in its conclusion (PDF) that the current regulatory structure is part of the problem. “Unfortunately, the nation’s food supply system is anything but flexible and coordinated,” says the group in a summary of its initial key findings. “Our system is hamstrung by outdated laws, insufficient resources, suboptimal management structures, and poor coordination across agencies and with states and localities. This approach was not rationally designed. Rather, it developed in fits and starts as the nation’s attention turned to one crisis after another.”
One reason why it’s difficult to pin down the extent of food-related illness in the United States with any certainty is that most cases of food poisoning are mild and easily misdiagnosed.
In 2006, when Elizabeth Armstrong’s 5-year-old daughter developed diarrhea, her pediatrician wrote it off as a passing stomach virus. So Armstrong wasn’t too concerned when her 2-year-old daughter, Ashley, got sick a few days later.
But unlike her older sister, Ashley didn’t get better. She got worse. Her diarrhea turned bloody, her vomit turned black, and she began to cry inconsolably. It turned out that Ashley had developed hemolytic uremic syndrome, in which toxins produced by an infection attack the body’s red blood cells, leading to anemia and kidney failure. Ashley survived, but only after undergoing six weeks of nonstop dialysis followed by another six weeks of daily dialysis. She suffered permanent kidney damage that eventually will require a transplant.
“If you’d look at her, you’d see a happy little girl, but what people don’t see is that she’s on five medications a day and one weekly injection,” says Armstrong, a marketing consultant in Indianapolis who now is a member of the board of directors for the Center for Foodborne Illness Research & Prevention. The center was founded by the mother and grandmother of a 2-year-old boy who died after eating tainted food.
Ashley’s illness was caused by a food-borne pathogen called E. coli O157:H7, a bacterium that resides harmlessly in the digestive tracts of cattle but can cause fatal disease in humans. It is linked to 80 percent of cases of HUS in the United States.
In Ashley’s case, public health authorities traced the pathogen back through the food chain from a baby-spinach salad packaged by the Dole Food Co. that the Armstrongs had eaten at dinner. The source of the contamination turned out to be an organic spinach field in California where wild pigs were suspected of bringing the pathogen to the spinach field, possibly after picking it up from cattle on the same ranch where the spinach was grown. By the time the CDC and the FDA detected the outbreak, identified the contaminated spinach and pulled it from supermarket shelves, at least 205 people had been sickened. Of those, 103 were hospitalized, 31 developed HUS and three died.
KEEPING A RELIC RUNNING
The U.S. system for regulating food safety is a relic of the early 1900s. Then, there were two main concerns: First, the dangerous and unsanitary conditions in the nation’s slaughterhouses and meatpacking plants exposed by Upton Sinclair in his muckraking classic, The Jungle; and second, the adulteration of food with toxic additives and fillers.
These concerns led to a bifurcated approach to food safety that persists today. In 1906, Congress passed the Meat Inspection Act, giving the Department of Agriculture responsibility for regulating the meat industry. (Poultry and processed eggs were later added to the USDA’s portfolio.) Also in 1906, Congress passed the Pure Food and Drugs Act, which assigned regulation of most nonmeat foods to the FDA, which was then named the Bureau of Chemistry. The only major change in the FDA’s responsibilities occurred in 1938, when Congress passed the Food, Drug and Cosmetic Act, which prohibited the interstate transport of such goods if they were adulterated or misbranded, and authorized the FDA to set food standards and inspect food-production facilities.
Over time, other federal entities got into the act.
The CDC, for instance, monitors food-borne illness, the Environmental Protection Agency regulates pesticide contamination, and the National Marine Fisheries Service inspects and sets standards for fishery products. Fifteen different federal entities now regulate various aspects of food safety.
(Most states and even many cities have added to the patchwork by adopting their own food safety rules, and creating their own inspection and enforcement agencies.)
From the beginning, the USDA was given more power and money than the FDA, and that remains the case today. While regulating about 20 percent of the food supply, the USDA is allocated twice the amount of money as the FDA, which is responsible for the other 80 percent of the food supply, according to the Government Accountability Office, the investigative arm of Congress. Further, every facility that produces or handles meat, poultry or eggs is required to have a hazards analysis and critical-control-points plan that identifies vulnerable links in the food processing chain and institutes safety measures to counteract the risk. The FDA requires such plans for dairy products and seafood, but not for produce.
This leads to some peculiar outcomes. An open-faced, packaged chicken sandwich, for instance, is considered a meat product and regulated by the USDA, which would inspect the sandwich manufacturer daily. A packaged chicken sandwich with an extra slice of bread on it would fall under the purview of the FDA, which might inspect the manufacturer of the sandwich an average of once every five years.
Up to the mid-20th century, this emphasis on meat made sense, since the vast majority of produce was grown and sold locally, creating few opportunities for pathogens to invade. This changed with the consolidation of the food industry, as small local farmers and ranchers gave way to big food conglomerates using mass-production methods.
Most livestock are now raised in confined animal-feeding operations, in which thousands of animals are kept together under extremely crowded—some say cruel—conditions until they are shipped to various central processing units for slaughtering and packing before being sold to consumers. Some food safety experts attribute the emergence of E. coli O157:H7 and some other deadly pathogens to these overcrowded conditions.
But production methods for produce have changed, too. Produce is now gathered from multiple farms and shipped to central processing facilities where it is washed and packaged for sale, or sent on for further processing. Each link in the food chain offers another opportunity for pathogens to invade the food supply—from contaminated water, contact with infected animals, mixing with tainted produce, even farm or factory workers who are ill. It has reached the point that more people get sick in outbreaks caused by contaminated produce than tainted beef, poultry or seafood, according to the Center for Science in the Public Interest, an advocacy group based in Washington, D.C.
Because of its limited resources and regulatory powers, the FDA has to play catch-up.
One barrier for the FDA is that it has restricted powers to inspect company records. When an outbreak of salmonella in early 2009 was traced back to a Georgia factory owned by the Peanut Corporation of America, the FDA had to invoke its authority under a bioterrorism law to get access to the company’s records.
Those records told a damning story. Since 2007, the PCA had repeatedly detected salmonella in its peanuts, but it continued to ship the contaminated products. More than 700 people in 46 states and Canada were sickened, and nine died. Close to 4,000 products containing the tainted peanuts were recalled. The company has since gone bankrupt. As of June, lawsuits had been filed seeking more than $200 million in damages. Meanwhile, Georgia’s peanut commissioner has estimated that the U.S. peanut industry could lose more than $1 billion due to the recall.
The PCA recall also revealed the shortcomings in the FDA’s inspection process. In the months before the outbreak, the company’s plant was inspected and passed both by state inspectors under contract with the FDA and an independent auditor. These inspectors missed or ignored the moldy walls and ceiling, leaky roof, roaches and salmonella contamination of the floors that the FDA found after the outbreak.
“The mere fact that there is an inspection isn’t enough,” says Erik Olson, director of chemical and food safety programs at the Pew Charitable Trust’s Health and Human Services Program. “You’ve got to have the inspector properly trained and inspect frequently enough to detect problems. If any of this falls short, you can have a serious problem.”
But the strains on the FDA’s inspection capabilities were apparent before the salmonella outbreak at the PCA plant. A 2007 report by the FDA’s own science board concluded that the agency was so underfunded that it “cannot ensure the safety of our food supply.” While the agency performed 35,000 domestic food inspections in 1973, it performed only 18,000 in 2007, said Peter B. Hutt II, a former chief counsel to the FDA, in testimony before Congress in 2008. Hutt now is in private practice at Covington & Burling in Washington, D.C.
If anything, says Hutt, the pressures on the FDA have steadily intensified. He notes that Congress has adopted some 120 new laws that have expanded the FDA’s responsibilities without commensurate increases in funding. Among those new responsibilities are diet supplements, food allergies, food transport and nutritional labeling. And earlier this year, Congress added the regulation of tobacco products to the FDA’s tasks.
“Piling on more and more statutes digs the FDA further into a grave,” Hutt says.
Meanwhile, the Department of Agriculture is having its own budget problems, with allocations for its Food Safety and Inspection Service increasing by only 25 percent from 1981 to 2007, while meat and poultry consumption in the United States has doubled, according to OMB Watch, a nongovernmental organization in Washington, D.C., that monitors the Office of Management and Budget.
“For a decade or more we’ve been starving the agencies,” says Michigan State’s Fortin. “If the people responsible for regulating food safety don’t have adequate funding and support, they can’t do the job.”
James T. O’Reilly, a lawyer in Cincinnati who co-chairs the Food and Drug Committee in the ABA Section of Administrative Law and Regulatory Practice, is among those who attribute the starvation diet for the FDA and the USDA to the deregulation policies of the most recent Bush administration. Further compromises have come from what O’Reilly terms “regulatory capture”—when regulators grow too close to the industry they are supposed to regulate.
But in 2006, the spinach outbreak that sickened Ashley Armstrong was followed by outbreaks of E. coli in lettuce and salmonella in tomatoes and peanut butter. Consumer confidence plummeted, and even some in the food industry were alarmed. Executives of some major food grocers fired off a letter to associations representing U.S. produce growers demanding better product safety efforts.
In September 2007, the Topps Meat Co. of Elizabeth, N.J., recalled 21.7 million pounds of ground beef for E. coli contamination, the second largest beef recall in history. Then it was salmonella in chicken pot pies, E. coli in frozen pizzas, salmonella in ground beef, tomatoes, jalapeno peppers, serrano peppers and alfalfa sprouts.
By that point, food companies were warming to the idea of tougher regulation, says Fortin. “There has been a big wake-up call for a lot of people in the food industry,” he says.
And now it appears that Congress and the new administration feel the same way.
In early July, President Obama’s Food Safety Working Group announced several initiatives by federal agencies seeking to reduce outbreaks of food-borne illness.
On July 7, the FDA approved new regulations aimed at reducing the occurrence of salmonella in eggs. The agency estimates that its measures will reduce food poisoning cases from eggs by 60 percent, or 79,000, every year. Meanwhile, the USDA’s Food Safety and Inspection Service is preparing new standards by the end of 2009 to reduce the occurrence of salmonella in turkeys and poultry.
In addition, the agency is enhancing the process by which it verifies that beef-handlers are taking appropriate steps to reduce the presence of E. coli O157:H7, and the FDA is revising industry guidelines for reducing contamination of tomatoes, melons and leafy greens.
Perhaps more importantly, the FDA and the USDA are coordinating better ways to trace food contamination when it appears.
RECIPE FOR CHANGE
Food safety issues are also getting attention on Capitol Hill. On June 17, the House Committee on Energy and Commerce unanimously reported out H.R. 2749, titled the Food Safety Enhancement Act of 2009. The full House passed the bill July 30 in a 283-142 vote.
The bill beefs up the FDA’s regulatory powers, allowing it to impose mandatory recalls—which it is not currently empowered to do—and to inspect company books without warrant. The measure also empowers the FDA to “detain” tainted food and even impose a geographically based quarantine. In addition, the bill strengthens criminal and civil penalties for food facilities that fail to comply with federal safety regulations.
In the Senate, Illinois Democrat Richard J. Durbin is sponsoring the FDA Food Safety Modernization Act (S. 510). If both measures pass, they would go to a Senate-House conference committee to reconcile any difference.
Despite the bipartisan support H.R. 2749 received in the House, the bill is not without controversy.
One provision would require all food processors—whether operating in the United States or abroad—to register every year with the FDA, and to pay an annual registration fee of $500. Processors also must institute hazard safety plans similar to those that the FDA currently requires for most processors of nonproduce food products. These provisions raise concerns for smaller food-producing operations, even small organic farms. The bill appears to exempt farm stands from the registration requirement.
The bill would also require the FDA to develop its first-ever regulations for ensuring the safe production and harvesting of fruits and vegetables deemed high risk, and it would empower the FDA to require foreign governments or qualified outside groups to certify that food imported from their countries meets U.S. safety standards.
Some are concerned about the potential for international repercussions. International standards are set in the Codex Alimentarius—developed by the World Health Organization and the U.N. Food and Agriculture Organization, and used by the World Trade Organization to settle trade disputes. U.S. efforts to set higher standards may be viewed as a trade barrier by other nations, which might consider retaliation, says Michael T. Roberts, senior counsel for international affairs at the Roll International Corp. in Los Angeles, which owns several food companies and growing operations.
But others, like Seattle food safety lawyer Marler, welcome the bill. Though he wishes the civil and criminal penalties were tougher, he is sympathetic to the concerns of small farmers and producers, who fear that the registration fees and hazard control plans would drive up costs if applied to them.
“In 16 years, I’ve never had an outbreak linked to a farmers market,” says Marler. “I think the local farmers have a point that they haven’t been linked to outbreaks, so why put an added burden on them?”
Hutt says he is concerned that an already overburdened FDA could be overwhelmed by proposed new demands, like mandatory recalls.
“Any kind of mandatory authority like that would require safeguards, such as the right to demand a hearing. That can slow down the whole process,” he says. “But if the FDA goes on Good Morning America and says that ‘Hutt’s Apple Juice’ is full of pathogens, I can guarantee that the next morning every bottle of that juice will be pulled from supermarket shelves.”
Hutt insists that the FDA already knows how to protect the public’s health if it were only given the resources to do so. He says he was “unbelievably happy” when the Obama administration boosted funding for the FDA by $511 million in its proposed 2010 budget, about half of which would go to food safety. The request is now going through the appropriations process in Congress.
Perhaps the most controversial change in the federal government’s food safety system isn’t even in the Food Safety Enhancement Act. Agriculture Secretary Tom Vilsack and others have called for a single agency that would bring all the responsibilities for food safety under one roof.
“Food safety has risen to such a level of importance that we need to have a dedicated agency overseeing all aspects of food safety,” says David W. Plunkett, senior staff attorney at the Center for Science in the Public Interest in Washington, D.C.
But Pape says that after a hundred years of regulating food under the current system, trying to shift to another would be “very expensive, very disruptive and very risky.” Besides, Hutt suggests, it might be a case of mixing, well, apples and oranges.
“Do you know what the 8,000 inspectors at the USDA do?” Hutt asks. “They are trained veterinarians who look at dead animals and decide if they are diseased. They have nothing in common with FDA inspectors, who are checking labels, reviewing good manufacturing practices and are totally differently trained, and who proceed in a completely different way. Spare us from people who think you solve serious issues of food safety by moving the deck chairs.”
Either way, O’Reilly thinks legal work in the food safety field is about to undergo a major shift. H.R. 2749 “is much stronger than anything we’ve seen before, and it will probably pass because of public revulsion about food-borne illness outbreaks,” he says. “There’s going to be a lot of work for lawyers who know what they’re doing.”
Pick Your Poison
It doesn’t take much to qualify as an outbreak of food-borne illness. Under the definition used by the Centers for Disease Control and Prevention, an outbreak occurs when two or more people have come down with the same illness after eating the same contaminated food. Applying that definition, the Center for Science in the Public Interest has counted 5,778 outbreaks of food-borne disease between 1990 and 2006, resulting in 168,898 illnesses. Just about every type of food contributed to those totals.
Here is the breakdown:
Category Outbreaks Illnesses
Beef 518 14,191
Beverages 101 3,640
Breads and Bakery 179 4,904
Dairy 221 6,364
Eggs 351 11,143
Game 28 193
Luncheon and Other Meats 196 7,108
Multi-Ingredient 1,054 30,254
Pork 233 6,954
Poultry 620 18,906
Produce 768 35,060
Seafood 1,140 11,809
Other 369 18,372
Source: Outbreak Alert! 2008: Closing the Gaps in Our Federal Food-Safety Net, published by the Center for Science in the Public Interest.