Florida’s Del Monte Fresh Produce Fights Salmonella Claims With Unusual Litigation September 30, 2011 Until recently, cantaloupe from Productos Agricolas de Oriente, S.A., was to be detained at U.S. ports of entry because, according to the FDA import alert, prior shipments appeared to be harvested and packaged under "insanitary conditions." (Photo by Brandon Quester/News21.) By Brandon Quester and Tarryn Mento News21 GUATEMALA CITY — When an Albany, Ore., church group gathered for a dinner in February 2011, three people ate salmonella-tainted cantaloupe and fell ill. They were the first confirmed victims of an outbreak involving a rare strain of salmonella that eventually reached 10 states — from California and Nevada to Pennsylvania and Maryland — and was linked to 20 illnesses this spring. About This Story This story — part of a project called “How Safe Is Your Food?” — was done for the News21 program based at the Walter Cronkite School of Journalism and Mass Communication at Arizona State University. The program is supported by the Carnegie Corporation of New York and the John S. and James L. Knight Foundation of Miami to encourage excellence and innovation in college journalism. The Washington Post published a version of this story on Sept. 25. The entire project — stories, photos, videos, graphics, documents, is available at the “How Safe Is Your Food?” project website. The Florida Center for Investigative Reporting also will publish select stories from the project in early October. This is FCIR’s second collaboration with ASU student journalists. FCIR published the first, “Stateless in the Dominican Republic,” from Aug. 22 to Sept. 12. Federal and state officials traced the outbreak to a farm in Guatemala 2,800 miles away that grows cantaloupe for Del Monte Fresh Produce N.A. Inc. The U.S. Food and Drug Administration urged a recall of nearly 60,000 cantaloupes imported into the U.S. from the farm in Asunción Mita, located about four hours from here and issued an alert banning any further imports from the farm. Del Monte Fresh Produce responded with an unusual challenge to the decisions and conclusions of the FDA, the Oregon Public Health department and its senior epidemiologist, raising questions about how foodborne illness outbreaks are investigated and the steps authorities take to stop them from spreading. In court actions against the FDA and Oregon, Del Monte Fresh Produce contended its cantaloupes never tested positive for salmonella and, as a result, federal and state investigators did not have proof of the contamination. The company said the FDA did not exhaust other possibilities of contamination, including when the product was in the hands of retailers or during transit. Then on Sept. 27, the company dropped its suit against the FDA. On that same day, the FDA lifted its import ban. Neither the FDA nor Del Monte Fresh Produce would comment on the timing of the actions. In the world of epidemiology, the science of tracing and identifying diseases in a population, it’s rare for scientists to test the exact food suspected of carrying pathogens, said Dr. Kirk Smith, epidemiology supervisor for the Minnesota Department of Health. By the time symptoms occur and a foodborne illness is reported and confirmed, the product in question has likely been consumed or has exceeded its shelf-life and been thrown away. Instead, scientists, like detectives, interview victims, collect data, analyze patterns and match food “fingerprints” to determine the likely source of an outbreak. “The majority of outbreaks, we don’t have the food to test,” Smith said. “Laboratory confirmation of the food should never be a requisite to implicating a food item as the vehicle of an outbreak. Epidemiology is actually a much faster and more powerful tool than is laboratory confirmation.” David Acheson, former FDA associate commissioner of foods, said Del Monte Fresh Produce’s challenge underscores how important it is for the agency “to do everything in its power to make sure it’s right” when putting pressure on a company to recall a product. “It would be unfortunate if the impact of this was that the power of epidemiology to protect public health is diluted,” he said. “In a way, epidemiology is on trial.” News21, a national university student reporting project, has traced the cantaloupe outbreak since March, reviewing nearly a thousand pages of documents, including government reports and emails between investigators and the company, and conducting dozens of interviews. Reporters also visited the farm in Guatemala, nestled amid winding dirt roads in a fertile valley near the El Salvador border where the problem allegedly began. Anatomy of the Outbreak When people started getting sick in Oregon from the rare strain of salmonella known as Salmonella Panama, epidemiologists there began comparing the strain to reported cases in other states. When the case matches were confirmed, multiple state health departments began coordinating with investigators from the FDA and the U.S. Centers for Disease Control and Prevention to track down the origin of the outbreak. Through a series of patient interviews and questionnaires, epidemiologists identified a common theme: Victims reported purchasing and eating food from Costco, a national warehouse store. Stands of fresh fruits and produce fill the lower level of El Mercado Central, or Central Market, in the heart of Guatemala City. The two-floor market is filled with arts and crafts on the first floor, with produce stands on the lower level. Although much of the food is grown around Guatemala, some of the food is imported from surrounding countries and even the United States. (Photo by Brandon Quester/News21.) Using Costco customer purchase receipts and shipping records, investigators quickly zeroed in on cantaloupe grown at the Productos Agricolas de Oriente, S.A.’s Asunción Mita farm and distributed through Del Monte Fresh Produce N.A. Inc. Both are indirect subsidiaries of the global food giant Fresh Del Monte Produce Inc. Under pressure from the FDA, Del Monte Fresh Produce issued a limited, voluntary recall of the cantaloupe on March 22. The recall included 4,992 crates of cantaloupes that were shipped to Costco retailers in seven states. The cantaloupe was “grown in and shipped from Del Monte Fresh’s farm in Asuncion Mita” and has the “potential to be contaminated with (salmonella),” according to the recall issued by the company. “The language in the release was suggested and approved by the FDA,” Del Monte Fresh Produce said in an email statement to News21. Since the March recall, eight additional illnesses have been confirmed from the tainted cantaloupe, according to a June 23 update from the CDC. But because state health department reporting practices vary and victims can test positive for salmonella months after being infected, it is unclear when the victims consumed the cantaloupe — thus leaving it an open question whether the limited recall left contaminated cantaloupe on U.S. store shelves. On July 15, several months after the outbreak, the FDA issued an import alert, effectively banning future melon imports from Asunción Mita. An import alert is an FDA action that prohibits imported goods from entering U.S. commerce and mandates that they be detained at U.S. ports of entry without physical examination. Unusual Litigation In an Aug. 22 complaint filed in U.S. District Court for the District of Maryland, Del Monte Fresh Produce contested the recall and alert, saying the FDA has no evidence that the cantaloupe from Asunción Mita was the source of the salmonella outbreak. The company said the government actions were based on “erroneous speculation, unsupported by scientific evidence.” In another unusual move, Del Monte Fresh Produce filed notice to sue the Oregon Health Authority’s Public Health Division as well as its senior epidemiologist, Dr. William E. Keene, for “misleading allegations regarding Del Monte Fresh’s imported cantaloupe.” In court documents, Del Monte Fresh Produce said the FDA demanded that it either go along with the recall “or suffer the consequences of an FDA consumer advisory questioning the wholesomeness of Del Monte cantaloupes.” The suit said that with the winter cantaloupe season approaching, the company will face “irreparable harm” if the alert is not immediately lifted. Del Monte Fresh Produce, the largest importer of cantaloupe to the U.S., gets 27 percent of its cantaloupe from the farm in Asunción Mita, according to the August court filings. Food safety experts and state health department epidemiologists say they are concerned that the company’s threat of legal action could have a dramatic chilling effect on how future public health advisories are issued. “The lawsuit against the epidemiologist in Oregon is very troubling to me because they seem to be singling out an individual official,” said Tony Corbo, a senior lobbyist on food-related legislation for Food & Water Watch, a food safety advocacy group. “This lawsuit could have a chilling effect on public health agencies recommending that recalls be taken based on epidemiological information.” Tim Jones, an epidemiologist for the Tennessee Department of Health, said if public health officials like him are constantly worried about lawsuits “it would have a terrible effect — slowing them down and hesitating to do things.” In its statement to News21, Del Monte Fresh Produce said that’s not the intent of the litigation. “Although Dr. Keene is mentioned in our filings, our intent was not to single out any particular state official,” Del Monte Fresh Produce said. “Rather, we reluctantly took these actions to draw attention to weaknesses in the current system that appear to have influenced this recall.” On Sept. 27, Del Monte Fresh Produce unexpectedly announced that it had decided to drop the suit against the FDA. In a prepared statement, the company said only that it had reached an “amicable resolution” with the FDA. The company’s public relations firm, Weber Shandwick Worldwide, would not comment on why the company suddenly dropped the suit. The firm said legal action against Oregon and its senior epidemiologist is still under consideration but that discussions are ongoing. Keene said he could not comment publicly on the case because of the threatened litigation. The FDA decided to lift the import alert because Del Monte Fresh Produce had provided evidence “reflecting and verifying the farm’s compliance with good agricultural practices,” said FDA agency spokesperson Stephanie Yao in an email to News21. Yao said she was not authorized to comment further. Imports Growing The cantaloupe recall has drawn attention to the high-risk fruit, involved in multiple U.S. outbreaks or recalls in the last 20 years, and to a government regulatory system strained by soaring food imports. The Del Monte Fresh Produce recall is one of 31 U.S. outbreaks and recalls from contaminated cantaloupe that have killed three and sickened more than 1,200 people since 1990, according to a News21 analysis of data from the FDA and the CDC. U.S.-grown cantaloupes can be the source of problems. Most recently, 17 people died as a result of listeria food poisoning from eating cantaloupes produced at Jensen Farms in Granada, Colo., according to the CDC. Altogether, more than 80 people in 19 states have been stricken. But much of the cantaloupe consumed in the U.S. comes from other countries — countries that often don’t have the same safety standards as in the U.S. The U.S. imports more cantaloupe than any other country in the world. Nearly a third of all melon exports end up in the U.S., and in recent years nearly half of those have come from Guatemala, according to the U.S. Department of Agriculture’s Economic Service. Overall, imports account for 15 percent of the U.S. food supply, including nearly two-thirds of all fresh fruits and vegetables. The FDA, which is responsible for the safety of 80 percent of the nation’s food supply, cannot effectively regulate all this imported food, former FDA associate commissioner Acheson said. The FDA “simply does not have the resources,” he said. “It doesn’t have the people, and it certainly doesn’t have the dollars to even begin to (regulate) this well.” The FDA “pays no attention to whether a product leaves its country of origin or its exporting country with the right certification,” Acheson said, adding that the agency physically inspects less than 1 percent of food imports. Banned Cantaloupe The farm at Asunción Mita is located in a modest, mostly rural area dotted with small homes, chicken coops and fields of corn and mango trees. A water-soaked road leads to a gated entrance. When two News21 reporters visited in June, Del Monte Fresh Produce executives would not permit them access to the facility and declined to let employees be interviewed. Two guards, handguns strapped to their hips, stood behind the chain link fence, checking anyone who sought entry. On July 15, nearly four months after Del Monte Fresh Produce voluntarily recalled nearly 60,000 cantaloupes, the U.S. Food and Drug Administration issued an import alert for the Guatemalan farm, effectively banning cantaloupe imports from Asunción Mita. The company challenged this alert and filed a lawsuit against the FDA -- but recently dropped the claim. (Photo by Brandon Quester/News21.) Until the FDA import altert was lifted in late September, Del Monte Fresh Produce was unable to import any cantaloupes from the farm here. Any of its melons exported to the U.S. would have been detained at U.S. ports of entry because prior shipments appeared to be harvested and packaged under “insanitary conditions,” according to the FDA alert. For an alert to be lifted, a company is supposed to provide evidence that its imports are negative for salmonella and other pathogens. One week before Del Monte Fresh Produce filed suit against the FDA, the company submitted a 84-page document to the FDA that contained the results of a third-party audit conducted at the Asunción Mita facility, previous FDA inspection records of another Productos Agricolas de Oriente farm in 2010, and a history of FDA and independent testing of fruit from the Asunción Mita facility that tested negative for salmonella. According to the audit performed in April by a company hired by Del Monte Fresh Produce, the facility scored 97 out of 100 possible points, losing three points in the sanitary programs category. The inspection firm recommended covering an exposed sewage ditch, incorporating daily cleansing and sanitation of the dump tank — a basin of water in which fruit is cleaned before packing — and the use of squeegees instead of brooms to push water into drains. The farm in Guatemala has not been a source of problems for Del Monte Fresh Produce in the past. However, the company has had its cantaloupes pulled from U.S. stores. In fact, the March recall was the third associated with Del Monte Fresh Produce cantaloupe in three years. The other recalls involved melons shipped to California and Nevada in 2009, recalled by a California retailer that sold the cantaloupes, and a 2010 recall by Del Monte Fresh Produce of cantaloupes distributed in Michigan that were grown in and shipped from Arizona. In the 2009 and 2010 instances, the Del Monte Fresh Produce-branded cantaloupes were randomly tested by state health agencies, who determined that they had the potential to be contaminated with salmonella. Del Monte Fresh Produce said in an email statement that the company worked with state and federal agencies during the two previous cantaloupe incidents and that each case was resolved when the FDA determined no additional actions were necessary. No illnesses were reported in either case. Pinpointing Blame The emails News21 obtained through public records requests provide an inside look at discussions between state health officials and Del Monte Fresh Produce representatives leading up to the March recall. Keene, Oregon’s lead epidemiologist, said he alerted Dr. Thomas Young, Del Monte Fresh Produce’s vice president of research and agricultural services, of the outbreak’s link to the company’s cantaloupe on March 15. Two days later, Young sent an email response detailing Del Monte’s safety practices in Guatemala. “In summary, I cannot imagine how (salmonella) could be coming from our Mita operation, but I am available to assist you in your investigation,” he wrote. Evidence of Del Monte’s cantaloupe as the source of contamination was “overwhelming,” Keene wrote on March 19. “I think we need to move ahead with the common understanding that your cantaloupes caused this outbreak,” he added, noting that he was speaking for Oregon and not the FDA or other regulatory agencies. Keene included in the email an epidemiological analysis of cantaloupe consumption in the U.S. and how it relates to the share of Asunción Mita cantaloupe in the U.S. market. He used this analysis to explain the high probability that the contaminated cantaloupe originated from Asucnión Mita. “In our world, these numbers are considered pretty good evidence, however circumstantial,” he wrote to Young in the same March 19 email. Young argued that none of Del Monte Fresh Produce cantaloupes tested positive for Salmonella Panama. Keene responded that a positive test “is a pretty tough standard to meet,” given the fact that the implicated cantaloupe had already been consumed and whatever remained had likely been thrown away. The emails between multiple state health departments and Costco also reveal that Costco customer receipts confirmed 11 out of the first 13 victims purchased Asunción Mita cantaloupe. In court documents, Del Monte Fresh Produce contended that the contamination could have occurred when the cantaloupes were in the hands of retailers. The company also contends that the FDA never tested cantaloupe from the site and that its own tests showed the cantaloupe were safe. In its import alert, the agency said it is extremely unlikely that the salmonella outbreak could have been due to an isolated event in the field or in a packing house. The source of the contamination, according to the alert, was likely irrigation of fields with water contaminated with sewage, processing produce with Salmonella-contaminated water, poor hygienic practices on the part of workers, animals in close proximity to the cantaloupe or water sources, and/or unsanitary equipment at the Asunción Mita farm. Out of the Loop Guatemala’s food safety director for the Ministry of Agriculture, Dr. Antonio Ferrate, said he and his agency have been left out of the FDA’s dealings with Del Monte Fresh Produce. The FDA, he said, rarely talks to Guatemalan officials. In March, when the ministry was notified of the outbreak, the melons already had been harvested, so the government was unable to conduct tests to see if the fruit was safe, Ferrate said. Herbert Pezzarossi, director of produce with the Guatemalan Ministry of Agriculture, Ranching and Health, said it has been difficult to work with the U.S. Food and Drug Administration because of poor communication when dealing with recalls and inspections. (Photo by Brandon Quester/News21.) Herbert Pezzarossi, director of produce for the Guatemalan ministry, said Del Monte Fresh Produce conducted its own tests, but the ministry never received the results. “We asked for (test results),” he said. But the company argued “that this was a transnational issue that the U.S. was taking care of.” In an interview with News21, Pezzarossi and Ferrate questioned whether the cantaloupe should have been shipped out of Guatemala at all. Pezzarossi called the shipments “irregular” and Ferrate called them “illegal,” saying the company did not have the proper licensing, including a sanitary operating license, to ship the cantaloupe. Del Monte Fresh said in an email response to News21 that “any inference that Del Monte is importing any illegal shipments from Guatemala is completely false.” Ferrate said his government does not intend to punish the company but will instead work with it to ensure that it meets export requirements in the future. Cindy Martinez of Plaza Pública, an investigative online news site, assisted with reporting in Guatemala.