Max Levy stories from The Center for Public Integrity

Flawed state reporting leaves consumers vulnerable

2011-10-11T14:52:10-04:00

Inconsistent reporting of foodborne illnesses among states leaves large portions of the country vulnerable to the spread of potentially deadly outbreaks before health officials can identify their causes and recall contaminated foods.

Since 2006, salmonella outbreaks from products such as eggs, cantaloupe and turkey burgers have sickened at least 6,000 people, resulting in more than 700 hospitalizations and 11 deaths, according to the U.S. Centers for Disease Control and Prevention.

A News21 analysis of salmonella reporting practices found that differences across the country put residents of the worst-performing states at risk and undermine national outbreak surveillance by placing disproportionate responsibility on smaller states.

California, Texas, Florida and Illinois make up more than 30 percent of the U.S. population, but they contribute 15 percent to national salmonella outbreak surveillance. Meanwhile, Massachusetts and Missouri comprise 4 percent of the population and contribute nearly 9 percent to surveillance.

Disease reporting relies on highly variable state requirements. States like Colorado and Alabama that allow up to a week to submit a report for many illnesses, including salmonella and E. coli, may take longer to learn about an outbreak than states with more stringent requirements.

In the summer of 2008, one of the biggest and most widespread outbreaks in American history tested surveillance measures in 43 states and exposed weaknesses in the nation’s ability to identify and respond to outbreaks.

When it was over, salmonella-tainted jalapeno and serrano peppers had left two men dead in Texas, and around the country put 308 people in hospitals and made at least 1,500 others across the country sick enough to seek medical attention.

In large outbreaks, underperforming states prevent efficient responses and rely on the surveillance of other states. The same is true in smaller outbreaks; some of these elude surveillance entirely.

“There are multistate outbreaks out there that we don’t recognize and we don’t know about,” said Dr. Tim Jones, state epidemiologist for the Tennessee Department of Health. National outbreak surveillance depends on the collaboration of 2,800 state and local health departments subject to at least 50 different reporting requirements.

In some states, reports from doctors and hospitals go directly to the state health department, which handles large-scale outbreak surveillance. Reporting in bigger states is often more fragmented, with reports going to largely independent local health departments, which then report to the state.

For salmonella, E. coli and other bacterial illnesses, requirements for reporting can also include the submission of what is called an isolate to the state health department, which can be tested to identify outbreaks.

In the same way miners extract metal from certain rocks, laboratories can extract a salmonella isolate from a patient’s stool sample.

On May 22, 2008, the New Mexico Department of Health performed high-tech testing on isolates from four salmonella victims and identified the same genetic “fingerprint” on each of them: they were part of the same outbreak.

The New Mexico state laboratory uploaded the test results to a national database known as PulseNet. The next day, health officials in Texas and Colorado used the database to match fingerprints of local cases with those in New Mexico, proving they were associated with the outbreak.

Though PulseNet can identify local outbreaks, the network specializes in discovering widespread outbreaks associated with “industrial contamination events,” where the food is infected in the supply chain before reaching grocery stores and restaurants, said Dr. Ian Williams, chief of the CDC’s outbreak response and prevention branch. These outbreaks often result in a handful of reported cases in multiple states. Without PulseNet connecting the dots, epidemiologists have few leads to investigate the source of illness.

“PulseNet is the engine that finds [multistate] outbreaks,” Williams said, “and my group is the engine that investigates the outbreaks.”

Though the CDC coordinates investigations when these multistate outbreaks occur, it can only “provide guidelines and recommendations” as a non-regulatory agency, Williams said. Without a federal standard, each state has a unique set of disease-reporting requirements and practices.

For diseases that require reporting to the health department, the urgency and speed of response are at the discretion of each state.

In eight states, health departments must be notified immediately about cases of E. coli O157, which can cause kidney failure and death from eating contaminated foods, including raw milk, meats and vegetables. Seven states allow a week, the longest timeframe in the country, to submit the same report.

The breakdown between stringent and lax reporting requirements among states holds true for most illnesses, provided that requirements exist at all. CDC recommends reporting for 20 foodborne illnesses, but fewer than half of the states require reporting for all of them.

Though every state requires reporting for salmonella, 12 states and the District of Columbia do not require the submission of isolates to the state public health laboratory.

As the most populous state without the requirement, Texas received the third fewest isolates for its cases in the country before the 2008 hot pepper outbreak. Its contributions to national surveillance through PulseNet would be proportional for a state with 8 million fewer people.

By June 2, 2008, Texas reported the most cases of the hot pepper outbreak in the country. The Texas Department of State Health Services acknowledged the need to increase surveillance.

“We sent out a letter to all the clinical labs in the state and we asked them to please submit all salmonella isolates to the state lab,” said Dr. Linda Gaul, the foodborne epidemiologist for the Texas Department of State Health Services.

By simply asking, Texas received “twice as many isolates” for the rest of the outbreak, Gaul said. Over the next two months, the lab tested more than 1,200 isolates. In all of 2007, the state performed 1,835 of these tests.

By June 20, 2008, the number of cases reported in Texas doubled as a result of improved surveillance, according to CDC. Of 552 people sickened across the country, 264 were in Texas.

To begin the outbreak investigation process, epidemiologists interview victims about what they ate in the week before they got sick.

“It’s very difficult to [find the cause of an outbreak] from a single case,” said Dr. David Acheson, former associate commissioner for foods in the U.S. Food and Drug Administration. “Because you’ve got one person’s memory and they say, ‘Well, I usually buy my tomatoes at Safeway,’ but unbeknownst to them, that week they stopped at a Food Lion.”

Localized groups of related illnesses called clusters offer epidemiologists clues. By interviewing victims of clusters, investigators may learn whether they all ate at the same restaurant or bought a certain food from the same grocery store.

Clusters are difficult to investigate when too much time passes between the illness and the interview. A survey conducted by the Council for State and Territorial Epidemiologists, an organization of public health epidemiologists, found that “delayed notification from reporting sources was the most common barrier to investigation of foodborne…illness outbreaks.”

“If I line up six people and say, ‘Tell me what you ate a month ago,’ we’re going to have trouble figuring that out,” said the CDC’s Williams.

The time between getting sick, seeing a doctor, reporting the illness and testing isolates allowed two weeks to pass for more than half of the illnesses before they were identified as part of the hot pepper outbreak. From there, the speed of response and success of the investigation depend on a state’s health department.

“Minnesota is often the first out of the gate with the answer and that, in my opinion, is driven heavily by the fact that they move things through really quickly,” said Acheson. “If there were a barometer of how quick to do it, they’d be…the poster child.”

On June 23, 2008, the Minnesota Department of Health identified its first case of the hot pepper outbreak, which proved to be part of a cluster. Fifteen days later it had “unequivocally implicated jalapenos,” according to a congressional testimony by Dr. Kirk Smith, state epidemiologist in Minnesota.

Texas reported the same results earlier that week - more than a month after its first cases in late May - taking more than twice the time to reach the same conclusion. On July 9, 2008 with evidence mounting, the CDC issued a nationwide alert advising consumers to avoid jalapeno and serrano peppers, following indications that tomatoes played a role early in the outbreak.

The News21 analysis found that Texas experienced significant underreporting of salmonella isolates before the hot pepper outbreak, handicapping its ability to identify clusters and respond to outbreaks.

With nearly 8 percent of the country’s population, Texas provided 5 percent of the nation’s salmonella surveillance through PulseNet between 2001 and 2007. Over that same time, Texas reported the fourth fewest salmonella outbreaks per 100,000 people, suggesting outbreaks went unidentified or unreported more frequently in Texas than in 46 other states.

These underreporting practices characterized Texas’ salmonella surveillance before the hot pepper outbreak. As it spent the first weeks of the investigation relying on data from insufficient reporting, the outbreak continued to spread.

When it was over, the outbreak had sickened 1500 people in 43 states, Washington, D.C. and Canada, hospitalizing 308 and resulting in two deaths.

Since the outbreak, Texas has continued to request that all isolates be submitted to the state lab and increased its contribution to national outbreak surveillance to a level more proportional to population.

State health officials are discussing how to include mandatory isolate submission for salmonella in Texas’ disease reporting requirements, Gaul said.

If the requirement is added, Florida would replace Texas as the most populous state without mandatory isolate submission for salmonella.

Since 1998, the Florida Department of Health has received isolates for less than 20 percent of its cases, the lowest percentage in the country and less than half that of Nebraska – the state with the second lowest submission rate. Florida’s contribution to national salmonella outbreak surveillance accounts for less than a third of its population.

With a large population, disproportionately low participation in national outbreak surveillance and no isolate submission requirement, Florida’s salmonella surveillance mirrors Texas before the hot pepper outbreak. While Texas was able to improve its surveillance by asking for isolates, budget constraints limit Florida’s surveillance capacity, said Richard Hopkins, the state epidemiologist for the Florida Department of Health.

“If somehow, by some magic, Florida hospitals started sending the other 80 percent [of isolates] to the state public health lab, they wouldn’t have the capacity to do the [testing] that they do,” said Hopkins.

Funding issues are not limited to Florida, with health departments hurting across the country, said the CDC’s Williams. Without sufficient funding, departments have fewer resources to test isolates, conduct interviews and undertake investigations.

Foodborne outbreaks are more likely to go undetected in states lacking those surveillance and response mechanisms. While most of them will be small, localized clusters of illness, some with the scope of the hot pepper outbreak will also slip through the cracks, Tennessee’s Jones said.

“It’s just Russian roulette, waiting for enough bad things to line up,” he said, “And it’ll happen again.”

Federal agencies falling short in protecting U.S. food supply

2011-10-05T16:45:23-04:00

Federal agencies entrusted with the safety of the nation’s food supply routinely fail to prevent bacteria-infected food from reaching grocery stores and restaurants, putting millions of Americans at risk.

A months-long News21 investigation found that food safety in the U.S. depends on ineffective regulations and underfunded government agencies that lack the authority to protect consumers.

Each year one in six Americans – 48 million people – gets sick, 128,000 are hospitalized and 3,000 die from foodborne diseases, according to estimates from the Centers for Disease Control and Prevention.

Just this year, contaminated hazelnuts, cantaloupe, bologna, sprouts, papayas and two types of turkey all have caused outbreaks of E. coli and salmonella illnesses in the U.S. And late last month the CDC reported that 13 people died as a result of listeria food poisoning from eating cantaloupes produced at Jensen Farms in Granada, Colo. Altogether, 72 people in 18 states were stricken, according to the CDC.

The salmonella-contaminated cantaloupes and papayas were grown in Latin America and represent an increasing threat of foodborne illness from imported products as foreign countries provide 60 percent of all fruits and vegetables eaten in the U.S.

Altogether, food imports have quadrupled over the past decade. The U.S. Food and Drug Administration expects 24 million shipments of goods for which it is responsible to pass through the nation’s more than 300 ports of entry this year, up from 6 million a decade ago. The agency uses a risk-based system to isolate foods with high risk of contamination, but physically inspects only about 2 percent of all imported food.

Seafood poses a particularly great risk, as imports account for 80 percent of all seafood eaten in the U.S. Much of it comes from China and Thailand, where regulations often fall short of American standards.

Every year, nearly three million Americans get sick from harmful bacteria in meat and poultry, according to research from the University of Florida. Feces often contaminate these foods with salmonella and E. coli during slaughter and ends up in what people eat. According to a 2009 FDA study, one out of every five chicken breasts for sale in grocery stores is infected with salmonella.

Most of the meat and poultry Americans eat is produced in the U.S., where the U.S. Department of Agriculture is responsible for its safety. But farms where animals are raised aren’t inspected at all.

USDA inspectors are on-site at every slaughtering facility, where they eyeball carcasses for microscopic pathogens passing by at up to 35 chickens a minute. Yet the USDA had to recall nearly 9 million pounds of already-inspected, contaminated meat and poultry in 2010 alone.

Meat and poultry companies design and enforce their own safety procedures. The USDA approves the procedures and inspectors check the paperwork to make sure companies follow the rules they set for themselves.

But the system of self-regulation fails to make safety a priority, according to Timothy Pachirat, an assistant professor of politics at The New School in New York who spent five months undercover in a Nebraska slaughterhouse in 2004. His research revealed workers falsifying paperwork and lying to federal inspectors.

A new law requires facilities that pack or process produce to develop their own safety plans and submit them to the FDA for approval.

The FDA already requires similar plans for seafood and juice processors, but violators receive the agency’s most common form of enforcement: a warning letter. The News21 analysis found that between September 2009 and December 2010, the FDA failed to close out well over half the warning letters issued, which means that no one verified that the offending seafood and juice companies had actually improved their practices.

Critics of the FDA like Carol Tucker-Foreman, distinguished fellow in food policy at the Consumer Federation of America, asserts that the warning letters are not an effective enforcement tool. “The FDA,” she said, “is under the illusion that sending someone a warning letter makes a difference. If they just send them out there and don’t follow up, then no action is taken to protect public health.”

The FDA, however, views their warning letters as a strong first step in its arsenal of enforcement actions. The warning letter, said FDA spokesman Doug Kara, “is in itself an enforcement tool.” And once a company receives notice of a violation, “the vast majority of firms do take corrective action,” he said.

Equally important, the fact that a warning letter has not been closed out, said Karas, could mean that re-inspection has not taken place or that the agency has initiated a more stringent enforcement action, such as requesting an injunction or a seizure.

Despite the different perspectives, former FDA officials like David Acheson, the one-time FDA associate commissioner of foods, say that federal regulations – even without the resources to fully enforce them – are better than no regulation at all.

In January 2011, Congress gave hefty new responsibilities to the FDA when it passed the Food Safety Modernization Act. But the U.S. House of Representatives passed a budget this summer that would cut FDA funding by nearly 12 percent, jeopardizing implementation of the first major update to food safety regulation in more than 70 years.

The act gives the FDA authority to shut down companies that don’t respond to its warnings. It also increases the number of overseas inspections by the FDA 30-fold over the next six years – a goal that will be “impossible … without a substantial increase in resources or a complete overhaul in the way it operates,” according to a July 2011 FDA report.

Representative Jack Kingston, R-Ga., who chairs the House subcommittee that allots funds to the FDA and USDA, favors cutting funds for food safety enforcement. He said that the American food supply is 99.99 percent safe – a statistic based on the probability of getting sick from a single meal. Meanwhile, more than 130,000 people are sickened by a foodborne illness each day, on average.

Researchers say that keeping food safe takes hard work and that it’s expensive to ensure that nothing, or very little, goes wrong. Food companies, meanwhile, are looking for ways to deliver inexpensive products to consumers – and improve profit margins – by keeping costs low.

The News21 investigation revealed that farmers can spend two-tenths of a penny per dozen eggs on voluntary safety measures to reduce salmonella in eggs, yet many farmers choose not to do so.

Last year, the FDA made such measures mandatory for the first time, though in the year since the rules went into effect, the agency has checked up on fewer than 50 farms nationally – out of 600 farms with more than 50,000 hens – due to limited staffing, agency records show.

And small produce farms, which provide food to local farmers markets, are exempt from regulation under the Food Safety Modernization Act , despite a lack of evidence suggesting their food is safer than large growers’. Those farms are still allowed to sell nearly half of their produce to wholesalers who can distribute it nationally.

When federal regulators fail to prevent unsafe food from entering the marketplace, state and local health departments provide a last line of defense, but insufficient resources can prevent them from being effective. For example, in Rhode Island, where seven health inspectors are responsible for more than 8,000 food establishments, a bakery sickened 78 people in March 2011 with pastries stored in salmonella-tainted egg crates, hospitalizing 28 and killing two.

Different practices among state health departments put residents of the worst performing states at risk and undermine national surveillance of outbreaks, allowing some to go undetected.

In September, the FDA launched a foodborne outbreak network to work with states and streamline previously fragmented coordination within the agency.

When ineffective practices fail to detect foodborne disease outbreaks and response is slow, nobody knows why people get sick or what food to blame. Of the foodborne outbreaks the public health system does catch, more than half of the investigations go unsolved, allowing more people to be sickened and the contaminated food to remain on the market.

Mattea Kramer wrote this story while a Carnegie-Knight News21 fellow from Harvard. Max Levy wrote this story while a Carnegie-Knight News21 fellow from Arizona State. News21 is part of the Carnegie-Knight Initiative on the Future of Journalism Education. Use of content requires attribution under Creative Commons.