Romaine Riddle: Why the E. Coli Outbreak Eludes Food Investigators


A federal law enacted seven years ago was intended to prevent such outbreaks — or at least to shut them down swiftly. But rollout has been slowed by wrangling over compliance costs and details, and the challenge of training tens of thousands of farmers and facility operators. Standards may not take full effect for years.

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A worker with a tray of romaine transplants at a farm in Puyallup, Wash.

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Ted S. Warren/Associated Press

As a result, regulations developed to safeguard fresh produce delivered to schools, restaurants and grocery aisles nationwide are not yet enforced with inspections. For now, however, most farms do keep up with federal recommendations known as good agricultural practices, or GAP, submitting to voluntary audits that check whether produce is grown and packed to minimize risk.

In 2010 Congress passed the Food Safety Modernization Act, authorizing the Food and Drug Administration to work up comprehensive safety regulations. The F.D.A. largely finalized the standards in 2015, prodded by a consumer lawsuit to adhere to deadlines.

But the first inspections of the largest farms don’t begin until next year. Standards for farmers to monitor water supplies are still being fine-tuned, and are scheduled in stages through 2024.

Virulent strains of E. coli do emerge, but at least in beef, they can be neutralized by cooking. And beef products, identified by bar codes and lot numbers, are easier to trace than produce.

But leafy greens are usually eaten raw, heightening the likelihood that a dangerous strain like the latest one — Shiga toxin-producing E. coli O157:H7, which has caused kidney failure in some patients — will infect the consumer. Unlike products such as flour, lettuce’s shelf life is short: Opportunities to test the offending crop range from limited to nil. And because detailed reporting requirements to track produce from field to supermarket have not yet been hammered out, fine-tracing the source of contamination is exceedingly difficult.

Dirt Detectives

The initial alerts in this latest outbreak came from the Garden State.

On April 2, New Jersey Health Department investigators contacted officials at the Centers for Disease Control and Prevention. They were seeing a cluster of patients with E. coli infections.

“The first step in any of these large outbreaks is to understand we have a problem,” said Matthew Wise, deputy chief for outbreak response in the C.D.C.’s division of foodborne, waterborne and environmental diseases.

Within days, more states called in, having identified a common DNA fingerprint of the bacteria among their patients. The states uploaded their DNA reports to the C.D.C.’s database. On April 4, the C.D.C. contacted the F.D.A., which searches for contaminated products.

By April 5, the database indicated a multistate outbreak and by the next day, C.D.C. researchers were working up a uniform questionnaire for state health workers to interview patients. They quickly zeroed in on leafy greens.

“Leafy green outbreaks are difficult to solve,” said Dr. Wise, an epidemiologist. “A lot of times people don’t even know what type of lettuce they’ve eaten.” Realizing it had been mostly eaten in restaurants was a significant clue, he added. “Maybe it was coming in big bags of prechopped lettuce.”

Between the two agencies and state partners, a battalion of several hundred investigators threw themselves into the hunt.

Ultimately, the full measure of the outbreak will not be known. Usually only the sickest patients seek medical help. The C.D.C. estimates that for every case reported to the authorities, 20 to 30 more people fall ill from the same strain; about 128,000 Americans are hospitalized and 3,000 die each year from foodborne illnesses. In a nationwide outreach to clinicians, C.D.C. officials have emphasized that Shiga toxin illnesses should not be treated with antibiotics.

By April 13, the C.D.C. announced that 35 people from 11 states had become ill from the same strain of E. coli, now linked to romaine lettuce from the Yuma region of Arizona. F.D.A. investigators traced the sickness among a cluster of eight inmates at an Alaska prison back to whole-head romaine that had been harvested from Harrison Farms, in the Yuma area. But they could not link other cases to the same farm.

Harrison Farms is a member of the Arizona Leafy Greens Marketing Agreement, an organization of producers whose practices meet or exceed requirements established through the Food Safety Modernization Act, said Teressa Lopez, a spokeswoman for the group.

But it turns out that romaine is not romaine is not romaine.

It can be processed and distributed in many ways — chopped, cored, sold as hearts or even mixed with other greens in salad bags. The more processes, the more convoluted the trail. The scores of patients who became ill after eating romaine at restaurants had not consumed the whole-head product.

Dr. Stephen Ostroff, deputy commissioner for foods and veterinary medicine at the F.D.A., compared so-called traceback efforts to finding common points of intersection among flight paths on an airline magazine’s map. Step by step, investigators work backward from each known point of contact for a patient, sifting through menu items, individual recollections, bills of lading, distribution sites, chopping and bagging facilities, locations where lettuce is cooled, trucks and fields. It is rarely linear. Finding a needle in a haystack is a no-brainer compared with finding the source of the Shiga toxin-producing E. coli making its way around the country.

Officials say the bacteria almost certainly originated in the fecal material of an animal. But was it tilled into the soil? Found in farm animals? Did deer nibble and excrete their way at night through fields?

Or was the bacteria spread by any of the many ways water connects with fresh produce, including human hygiene practices?

Trevor V. Suslow, a postharvest quality expert at the University of California, Davis, who trains educators in the new compliance regulations, explained how the same water-involved practice used by two farmers could pose very different risks. Both might use crop protection sprays, he said. But one would fill farm tanks from a disinfected municipal water source, while another might draw from a pond or canal. “Same practice but very different risk profiles and potential for negative food safety consequences,” he said. Standardized training under the new act has been designed to highlight such risks.

The continuing investigation is focusing on the Yuma area, Dr. Ostroff said. The contamination, he added, “may be at several dozen farms. But we don’t know which farms. And it may not be that simple. The contamination may not have occurred at a farm but at a processor.”

The Yuma growing region includes some 230,000 acres of agricultural land, 23 cooling plants and nine facilities that produce bagged lettuce and salad mixes.

“We have to take into consideration every possibility,” Dr. Ostroff said.

Working Backward

The idea driving the new regulations, Dr. Ostroff said, is “to move the system from one that reacts when problems occur to working to prevent them in the first place.”

Because farmers are still receiving produce-safety training to prepare for when inspections of the largest farms begin next January, no one can say how effective these standards will be. The F.D.A. requirements include regular testing of water and manure used as fertilizer; the industry has discretion over how the testing is carried out.

Consumer groups say that rules streamlining record-keeping are as crucial to the program’s success as the hygiene and monitoring requirements.

“This outbreak highlights the important role that product-tracing has in an outbreak investigation,” said Sandra B. Eskin, director of the Safe Food Project at the Pew Charitable Trusts. “One of the reasons this investigation continues is that it’s been very challenging to trace lettuce back to a farm without an effective recording system.”

But that system does not seem to be imminent. “We will be engaging discussion with industry to identify ways to do better labeling and traceability of products,” Dr. Ostroff said. “It’s a work in progress.”

Correction: May 7, 2018

A caption with an earlier version of this article incorrectly described the photo. It shows romaine being transplanted to a field, not being harvested.

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C.D.C. Director’s $375,000 Salary Will Be Cut


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Dr. Robert R. Redfield’s salary is being reduced following reports that he was being paid more than the Health and Human Services secretary, the head of the Food and Drug Administration and the director of the National Institutes of Health.

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Tracey Brown/University of Maryland School of Medicine, via Associated Press

The government will lower the $375,000 salary of the new director of the Centers for Disease Control and Prevention, Dr. Robert R. Redfield, after reports that he was being paid considerably more than previous directors, the Department of Health and Human Services confirmed on Monday, though it declined to say what his new pay will be.

Dr. Redfield, who became the C.D.C. director in March, had been given the higher salary under a provision called Title 42. It was created by Congress to allow federal agencies to offer compensation that is competitive with the private sector in order to attract top-notch scientists with expertise that the departments would not otherwise have. News reports of his earnings sparked complaints from Senate Democrats and watchdog groups.

“Dr. Redfield has expressed to Secretary Azar that he does not wish to have his compensation become a distraction for the important work of the C.D.C.,” an H.H.S. spokeswoman, who declined to be named, wrote in an emailed response to questions from The New York Times. “Therefore, consistent with Dr. Redfield’s request to the Secretary, Dr. Redfield’s compensation will be adjusted accordingly.”

Title 42 was not used for Dr. Redfield’s predecessor, Dr. Brenda Fitzgerald, an obstetrician-gynecologist, who was paid $197,300 a year until she resigned in January, or for her predecessor, Dr. Thomas R. Frieden, an infectious disease specialist and the former health commissioner of New York City, whose salary was $219,700.

Dr. Redfield, an H.I.V./AIDS researcher at the University of Maryland School of Medicine and co-founder of its Institute of Human Virology, was also being paid more than his boss, Alex M. Azar II, the H.H.S. secretary; Dr. Scott Gottlieb, head of the Food and Drug Administration; and Dr. Francis Collins, director of the National Institutes of Health.

Each of those political appointees is paid less than $200,000 a year, and Dr. Gottlieb and Mr. Azar took much larger pay cuts in their government jobs than did Dr. Redfield, who reported $757,100 in salary and bonuses from the University of Maryland Department of Medicine for 2017 through mid-March of 2018.

“The recruitment of Dr. Robert Redfield was a rare opportunity to hire one of the world’s leading virologists,” Caitlin Oakley, an H.H.S. spokeswoman, said in an emailed statement. “Dr. Redfield has over 30 years of experience as a groundbreaking scientist, academic researcher, and clinician who has been a global leader in the fight against one of the most devastating infectious diseases of our time — HIV/AIDS. The selection of Dr. Redfield was the right choice at the right time for the right purpose. Dr. Redfield is someone who understands this work from all of these perspectives and has firsthand knowledge of what researchers and practitioners need to keep the American people safe at home and abroad.”

After Dr. Redfield’s salary was reported by news organizations, Senator Patty Murray, Democrat of Washington state, wrote to Mr. Azar questioning Dr. Redfield’s salary and the use of the Title 42 provision to compensate him so highly. She asked whether the agency made an “extensive and exhaustive” effort to find a director before deciding to pay Dr. Redfield under the special exemption. And she also asked for documentation of those search and recruitment efforts, including the descriptions of the job as a “scientific position.”

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More Than 200 Million Eggs Recalled Over Salmonella Fears


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Eggs that may have been contaminated with salmonella were distributed to nine states, the federal Food and Drug Administration said on Friday.

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Matt York/Associated Press

A company has recalled more than 200 million eggs after an outbreak of salmonella was traced to one of its farms in North Carolina.

The federal Food and Drug Administration reported Friday that eggs from the affected farm were distributed to nine states — Colorado, Florida, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Virginia and West Virginia — and were likely connected to 22 reported cases of salmonella infections.

The agency learned about a cluster of salmonella outbreaks in multiple states last month, and investigators worked with the Centers for Disease Control and Prevention and state authorities to trace the source of the illness, the F.D.A. said. That led them to an egg farm in Hyde County, N.C., owned by Rose Acre Farms of Seymour, Ind.

The affected farm has paused its egg distribution and the company has voluntarily recalled more than 206 million eggs. The F.D.A. urged consumers to check their purchases and avoid eating eggs that might be contaminated.

Eggs from the North Carolina farm were sold to restaurants and in supermarkets under multiple brand names, including Coburn Farms, Country Daybreak, Food Lion, Glenview, Great Value, Nelms and Sunshine Farms.

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E. Coli Linked to Chopped Romaine Lettuce Infects People in 11 States


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A romaine lettuce field near San Luis, Ariz. Tainted lettuce has been linked to the Yuma region.

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Caitlin O’Hara for The New York Times

Nearly three dozen people have been infected in an E. coli outbreak linked to chopped romaine lettuce from the Yuma, Ariz., region, the Centers for Disease Control and Prevention said on Friday.

The agency said that it had not yet identified a grower, supplier, distributor or brand common to the 35 cases of infection across 11 states, so it urged consumers to avoid any chopped romaine lettuce from the Yuma area.

“If you cannot confirm the source of the lettuce, do not buy or eat it,” the C.D.C. said in a statement. The agency also recommended that restaurants and retailers not serve chopped romaine lettuce from the region.

The people infected so far range in age from 12 to 84 years old. Of the 22 people hospitalized in the outbreak, three had developed a type of kidney failure, according to the C.D.C. No deaths have been reported. Because of an average reporting delay of two to three weeks, illnesses that may have occurred after March 27 have not yet been counted.

The C.D.C. said that 26 of 28 infected individuals surveyed reported eating a salad at a restaurant, with romaine lettuce being the only common ingredient. The restaurants reported using bagged, chopped romaine lettuce.

The agency said it is still working to pinpoint the source of the outbreak.

The infections are somewhat spread out, geographically. Nine people were infected in Pennsylvania, more than any other state. Eight people were infected in Idaho and seven in New Jersey.

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Vocations: Fighting Disease Is a Battle Often Won With Spreadsheets


Had you originally thought you’d work in a hospital or private practice?

Yes. My father was a gastroenterologist, so between his practice and my medical training, I was only familiar with physicians who worked in clinical practice, did research or trained other physicians.

But during my residency at what is now NYU Langone Health, I started to have doubts. The high volume of patients was exhausting, and the fellowship offered an opportunity to think about whether being a clinician was the right fit.

The officers I’d shadowed during medical school went out into the field to the site of an outbreak, such as a cruise ship, and did what we called shoe leather epidemiology, pounding the pavement.

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Dr. Christina Tan meets with colleagues at the New Jersey Department of Health in Trenton.

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Bryan Anselm for The New York Times

What else attracted you to this role?

My predecessor was my supervisor during my fellowship.

One minute he was serving as a health expert, and the next he was communicating health risks. Following that, he was responding to a public health emergency or figuring out how to get resources for programs. He had to work with a variety of groups and make decisions really quickly, often with little information.

It was a cool thing to watch and confirmed my interest in this area.

What lessons are there from flu season?

Fortunately, the season has peaked, but we’re still seeing widespread flu activity that will most likely last through May.

The flu is unpredictable, which is why public health departments monitor it all year round.

For example, we saw the emergence of the 2009 H1N1 pandemic in the late spring, after seasonal flu ended that year.

We’ve learned that we need to ensure that public health and health care partners maintain vigilance in monitoring for flu and other emerging infections. We also need to maintain flexibility in our preparedness and response plans so we can adapt what we do, based on what the disease trends tell us.

Do you get out in the field these days?

Yes, but my team mainly plugs away at spreadsheets, looking at data. Most outbreak investigations are not glamorous or hyper-dramatic, like in the movie Contagion.

I’m also the assistant commissioner of the state Epidemiology, Environmental and Occupational Health division.

We often work with local health departments and health care facilities that are in the field interviewing patients and collecting specimens, including blood, sputum and stool, for lab testing, to confirm the presence of certain microorganisms.

Occasionally — particularly with some of the rarer diseases like imported Lassa fever — we’ll work in the field to further monitor hospital staff members that have been exposed, or to interview additional patients.

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Medicare Is Cracking Down on Opioids. Doctors Fear Pain Patients Will Suffer.


“The decision to taper opioids should be based on whether the benefits for pain and function outweigh the harm for that patient,” said Dr. Joanna L. Starrels, an opioid researcher and associate professor at Albert Einstein College of Medicine. “That takes a lot of clinical judgment. It’s individualized and nuanced. We can’t codify it with an arbitrary threshold.”

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Mr. Zobrosky’s medication regimen is strictly monitored at home. He submits to random urine tests and brings his pills to his doctor to be counted.

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Eamon Queeney for The New York Times

Underlying the debate is a fundamental dilemma: how to curb access to the addictive drugs while ensuring that patients who need them can continue treatment.

The rule means Medicare would deny coverage for more than seven days of prescriptions equivalent to 90 milligrams or more of morphine daily, except for patients with cancer or in hospice. (Morphine equivalent is a standard way of measuring opioid potency.)

According to Demetrios Kouzoukas, the principal deputy administrator for Medicare, it aims to further reduce the risk of participants “becoming addicted to or overdosing on opioids while still maintaining their access to important treatment options.”

The Centers for Medicare and Medicaid Services estimates that about 1.6 million patients currently have prescriptions at or above those levels. The rule, if approved as expected at the end of a required comment and review period, would take effect on Jan. 1, 2019.

Dr. Stefan G. Kertesz, who teaches addiction medicine at the University of Alabama at Birmingham, submitted a letter in opposition, signed by 220 professors in academic medicine, experts in addiction treatment and pain management, and patient advocacy groups.

His patients include formerly homeless veterans, many of whom have a constellation of physical and mental health challenges, and struggle with opioid dependence. For them, he said, tapering opioids does not equate with health improvement; on the contrary, he said, some patients contemplate suicide at the prospect of suddenly being plunged into withdrawal.

“A lot of the opioid dose escalation between 2006 and 2011 was terribly ill advised,” Dr. Kertesz said. “But every week I’m trying to mitigate the trauma that results when patients are taken off opioids by clinicians who feel scared. There are superb doctors who taper as part of a consensual process that involves setting up a true care plan. But this isn’t it.”

Some two dozen states and a host of private insurers have already put limits on opioids, and Medicare has been under pressure to do something, too. Last July, a report by the inspector general at the Department of Health and Human Services raised concerns about “extreme use and questionable prescribing” of opioids to Medicare recipients. In November, a report from the Government Accountability Office took Medicare to task, urging greater oversight of opioid prescriptions.

If the rule takes effect, Mark Zobrosky’s experience could be a harbinger for many patients. Mr. Zobrosky, 63, who lives in the North Carolina Piedmont, takes opioids for back pain, which persists despite five surgeries and innumerable alternative treatments. He has an implanted spinal cord stimulator that sandpapers the edge off agony, and has broken four molars from grinding because of pain, he said. He receives Medicare as a result of his disability, including a private plan that pays for his drugs.

He submits to random urine tests and brings his opioids to his doctor to be counted every month. To prepare for mandatory reductions, his doctor has tapered him down to a daily dose equivalent of about 200 milligrams of morphine. (Mr. Zobrosky has a large frame; doctors say that opioid tolerance depends on many factors — one person’s 30 milligrams is another person’s 90.)

In February, Mr. Zobrosky’s pharmacist told him that his insurance would no longer cover oxymorphone. His out-of-pocket cost for a month’s supply jumped to $1,000 from $225, medical records show. “I can’t afford this for very long and I’m nervous,” he said.

A Medicare official who would speak only on background said that the limit for monthly high doses was intended not only to catch doctors who overprescribe, but also to monitor patients who, wittingly or not, accumulate opioid prescriptions from several doctors. When the dose is flagged, the pharmacist or patient alerts the doctor.

But it falls to pharmacists to be the bad-news messengers. James DeMicco, a pharmacist in Hackensack, N.J. who specializes in pain medications, said that negotiating opioid insurance rejections for patients was already “beyond frustrating.” He spends hours shuttling between doctors and insurers. “My heart goes out to patients because they feel stigmatized,” he said.

Dr. Anna Lembke, an addiction medicine expert at Stanford, sees merit in the intent of the proposed rule, if not its design.

“The C.D.C. declared a drug epidemic in 2011, which they unequivocally and rightly attributed to overprescribing,” she said. “Without external limits, I do not believe that prescribers will be able to limit their prescribing to the extent necessary to address this public health crisis.”

But, she added, Medicare also needed to establish a reasonable grace period to allow patients on high doses to taper down safely.

According to a draft of the rule, when a high-dose prescription is rejected, a doctor can appeal, asserting medical necessity — although there is no guarantee that the secondary insurer covering the drugs under Medicare would relent. A pharmacist may fill a one-time, emergency seven-day supply.

Opponents of the new limit say that doctors are already overwhelmed with time-consuming paperwork and that many will simply throw up their hands and stop prescribing the drugs altogether.

A delay or denial would put chronic pain patients — or those with inflammatory joint diseases, complex shrapnel injuries or sickle cell disease — at risk of precipitous withdrawal and resurgence of pain, doctors said.

The Medicare proposal relies on guidelines from the Centers for Disease Control and Prevention that say doctors should not increase an opioid to a dose that is the equivalent of 90 milligrams of morphine.

But experts say that Medicare misread the recommendations — that the C.D.C.’s 90-milligram red flag is for patients in acute pain who are just starting opioid therapy, not patients with chronic pain who have been taking opioids long-term. The acute pain patient, the guidelines say, should first be offered treatments like acetaminophen or ibuprofen. A short course of a low-dose opioid should be a last resort.

“We didn’t take a specific position on people who were already on high doses,” said Dr. Lewis S. Nelson, the chairman of emergency medicine at Rutgers New Jersey Medical School and University Hospital, who worked on the guidelines.

“We did say that established, high-dose patients might consider dosage reduction to be anxiety-provoking, but that these patients should be offered counseling to re-evaluate,” he added. “There is a difference between a C.D.C. guideline for doctors and a C.M.S. hard stop for insurers and pharmacists.”

Dr. Erin E. Krebs recently released a comprehensive study showing that patients with severe knee pain and back pain who took opioid alternatives did just as well, if not better, than those who took opioids. Nonetheless, she and seven others who worked on the C.D.C. guidelines signed the letter opposing the Medicare rule.

“My concern is that our results could be used to justify aggressive tapering or immediate discontinuation in patients, and that could harm people — even if opioids have no benefit for their pain,” said Dr. Krebs, an associate professor of medicine at the University of Minnesota.

“Even if we walk away from using opioids for back and knee pain, we can’t walk away from patients who have been treated with opioids for years or even decades now,” she added. “We have created a double tragedy for these people.”

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