Everyone seems to hate government now days. From being afraid the FDA “food police” will try to steal your seeds, to trying to privatize Social Security, government is perceived as both overbearing and incompetent (at the same time). Some want to gut the EPA and abolish the Department of Education. Some see the “private sector” as a panacea for all our ills — that somehow an unregulated, or nearly so, economy will magically produce good wage jobs, a clean environment and smart, well-mannered children. Be that as it may, I have not seen anyone yet suggest that we privatize the office of the Attorney General, in full or in part. Might I be so bold as to suggest at least a small subcontract to “Marler Clark, Food Safety Prosecutors?” I would be willing to put people in jail for poisoning people, and I would do it on the cheap – perhaps for the fun of it. Here is how it would work.
In 1938 Congress passed the Federal Food, Drug, and Cosmetic Act in reaction to growing public safety demands. The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce. Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health. The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.
Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:
Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce. Any person who commits a prohibited act violates the FDCA. A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by not more than three years or fined not more than $10,000 or both.
A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct. Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation. Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $1,000, or both.
Similar laws deal with the meat side of the equation over at USDA/FSIS.
So, in the near two decades of being involved in every major foodborne illness outbreak in the United States, I have seen more than a few outbreaks that, if I had the authority, I would have prosecuted, some as felonies and some as misdemeanors. Either way, I would have sought fines and jail time for the executives responsible for food safety. Here is a “sample platter” by “bug:”
Castleberry – In July of 2007, the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and public health officials in Texas and Indiana joined to investigate a botulism outbreak. Four outbreak victims — siblings from Texas and a married couple from Indiana — had been hospitalized with botulism after eating Castleberry’s hot dog chili sauce.
On July 18, FDA issued a consumer advisory regarding the presence of botulinum toxin in Castleberry’s brand chili products and Castleberry’s Food Company issued a voluntary recall that included a limited number of production dates of Castleberry’s Hot Dog Chili Sauce Original, Castleberry’s Austex Hot Dog Chili Sauce Original, and Kroger Hot Dog Chili Sauce. The recall was expanded on July 21 to include all production dates for 91 types of canned chili sauce, chili, other meat products, chicken products, and dog food that were manufactured in the same set of cookers, or “retorts” as the hot dog chili sauce at the Castleberry’s facility in Augusta, Georgia.
By August 24, eight cases of botulism had been reported to the CDC. In addition to the Indiana couple, the mother of the children in Texas had developed symptoms of botulism, which brought the total number of Castleberry-associated cases in Texas to three. There were also three unrelated residents of Ohio who had developed botulism after consuming Castleberry’s hot dog chili sauce. Botulinum toxin was identified in leftover chili sauce collected from the refrigerator belonging to one of the Ohio cases.
On July 18 and 19, a team of FDA investigators was sent to the firm’s warehouse to collect samples of Castleberry’s products for testing. Of 17 swollen cans obtained from the Castleberry’s facility, 16 tested positive for Clostridium botulinum (C. botulinum) toxin. Several other tests revealed C. botulinum toxin in additional cans of Castleberry’s chili products.
FDA inspectors conducted testing at the Castleberry plant and observed several food safety violations. After its inspection, FDA cited Castleberry’s for “failure to maintain fixtures in repair sufficient to prevent food from becoming adulterated.”
Raw Milk – In the summer of 2008, an outbreak of Campylobacter jejuni in Del Norte County, California (near the Oregon border) that sickened 16 people and left one paralyzed was traced to Alexandre EcoDairy Farm raw milk. Fifteen of the people who were infected with Campylobacter consumed the milk; the 16th was an employee of the dairy. The consumers were part of an illegal “cow-leasing” program that gave them access to the milk.
Odwalla – On October 31, 1996, the Food and Drug Administration (FDA) announced that Odwalla was recalling all of the company’s juice products that contained unpasteurized apple juice. The recall was initiated in response to 13 reported cases of E. coli O157:H7 illness that had been linked to the company’s unpasteurized apple juice by the Seattle-King County Department of Public Health.
During the course of the public health investigation into the outbreak, a genetically indistinguishable strain of E. coli O157:H7 that had been isolated from case patients was found in a bottle of unpasteurized Odwalla apple juice. Investigators from FDA found numerous violations of health and safety codes at the Odwalla manufacturing plant, including lack of proper sanitizing procedures and poor employee hygiene. The FDA also found that the plant accepted decayed fruit from suppliers.
When the outbreak was over, one child was dead from complications arising from her E. coli O157:H7 infection, and more than 65 individuals were confirmed infected with the bacteria in the western U.S. and British Columbia. Of these reported cases, more than a dozen developed hemolytic uremic syndrome (HUS), a life-threatening condition that causes the body’s major organs – particularly the kidneys – to fail.
In 1998, Odwalla was indicted and held criminally liable for the 1996 E. coli outbreak. The company plead guilty to 16 federal criminal charges and agreed to pay a $1.5 million fine.
Jack in the Box – On January 13, 1993, the Washington Department of Health (WDOH) was notified that a cluster of children suffering hemolytic uremic syndrome (HUS) secondary to E. coli infection was being treated in a Seattle-area hospital and that there had been an increase in emergency room visits from patien
ts with bloody diarrhea. &nb
sp;In response to the apparent outbreak, WDOH began interviewing case-patients for an epidemiologic investigation and learned that nearly all patients had consumed hamburgers purchased from Jack in the Box restaurants in the days before becoming ill.
Since the ground beef identified as the source of the outbreak had been distributed to Jack in the Box restaurants in Washington, Idaho, California, and Nevada, all states investigated cases of bloody diarrhea that had been reported since November 15, 1992 to determine whether patients had eaten hamburgers from Jack in the Box in the days before becoming ill. By the end of February 1993, the states had reported the following:
• Washington reported 602 patients with bloody diarrhea or HUS. 477 Washingtonians were culture-confirmed with E. coli infections, with illness onset peaking between January 17 and January 20, 1993. 144 people were hospitalized; 30 developed HUS, and three died.
• Idaho reported 14 culture-confirmed E. coli O157:H7 cases with illness onset dates between December 11, 1992 and February 16, 1993. Four people were hospitalized; one developed HUS
• California reported six culture-confirmed cases, with 34 patients meeting the outbreak-case definition with illness onset dates between November 15 1992 and January 31, 1993. Fourteen people were hospitalized; seven developed HUS, and one child died.
• Nevada reported only one culture-confirmed case, with 58 other patients meeting the outbreak-case definition with illness onset dates between December 1, 1992 and February 7, 1993. Nine people were hospitalized; three developed HUS.
Over the course of the outbreak investigation and the litigation that followed, documents from Foodmaker, the San Diego-based parent company of Jack in the Box, revealed that the company had been warned by local health departments and by their own employees that they were undercooking their hamburgers prior to the outbreak, but the company had decided that cooking beef to 155 degrees, the standard set by WDOH, made the meat too tough.
Cargill – On October 6, 2007, Cargill Meat Solutions Corporation announced that it was recalling approximately 845,000 pounds of frozen ground beef patties for possible E. coli O157:H7 contamination. The recall was initiated after three people in Minnesota tested positive for E. coli and a joint investigation by the Minnesota Department of Health and Minnesota Department of Agriculture identified the Cargill hamburger patties as the source of the illnesses. Forty-seven people would be part of the outbreak.
The Cargill products were sold at retail establishments and to restaurants and other institutions. Sam’s Club announced that it was pulling the potentially E. coli-contaminated ground beef patties produced by Cargill from its store shelves nationwide on October 5.
The most grievously sickened victim was Stephanie Smith, who developed HUS and spent months in a medically induced coma. The former dance instructor was paralyzed from the waist down, and both her kidney function and cognitive abilities were impaired.
Dole – In late September of 2005, the Minnesota Department of Health (MDH) received several reports of E. coli O157:H7 illness among Minnesota residents and began conducting laboratory testing to determine whether the cases were related. Through pulsed field gel electrophoresis (PFGE) testing, commonly called DNA “fingerprinting” of the E. coli bacteria isolated from patients, public health investigators identified a single strain of E. coli O157:H7 that was causing illness and recognized that an E. coli O157:H7 outbreak was underway in Minnesota. MDH ultimately counted 23 laboratory-confirmed cases of E. coli O157:H7 and seven epidemiologically linked cases. Two cases developed hemolytic uremic syndrome (HUS). Oregon and Wisconsin reported one case each. The manufacturer of the lettuce was Dole.
Dole – On September 14, 2006, the Food and Drug Administration (FDA) announced that a nationwide E. coli outbreak had been associated with the consumption of bagged baby spinach. For fear of E. coli contamination, all bagged spinach was recalled nationwide, and on September 19, 2006, the FDA announced that all spinach implicated in the outbreak had been traced back to Natural Selection Foods, a company located in California’s Salinas Valley that was marketed under the Dole brand.
FDA and the Centers for Disease Control and Prevention (CDC) confirmed 205 E. coli illnesses associated with the spinach E. coli outbreak, including thirty-one cases of hemolytic uremic syndrome, 104 hospitalizations, and four deaths. Victims of the E. coli outbreak were identified in 26 states: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Michigan, Minnesota, Nebraska, Nevada, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. Wisconsin was the state hardest-hit in the outbreak, with 49 confirmed cases of E. coli. Canada reported one confirmed case.
A joint trace-back by FDA and the State of California revealed that four spinach fields were the possible source of the E. coli contamination. The outbreak strain of E. coli was isolated from cattle fields nearby the implicated spinach fields, as well as from a wild boar that was killed in one of the fields.
Nebraska Beef – In late July and early August of 2006, the Minnesota Department of Health (MDH) received notification that three people, all residents of or visitors to Longville, Minnesota, had tested positive for E. coli O157:H7. At the same time, MDH learned that many members of the Salem Lutheran Church in Longville had become ill with a gastrointestinal illness after eating meals served at the church on July 10 and 19.
MDH conducted epidemiologic and environmental health investigations into the confirmed illnesses and the church outbreak to determine whether they were related. MDH’s epidemiologic investigation revealed seventeen illnesses that met the case definition. Three people developed hemolytic uremic syndrome (HUS) and one person died. Attendance at the church’s July 19 dinner was significantly associated with illness.
MDA conducted a traceback of the ground beef purchased at the Supervalu and learned that Interstate Meat distributed the ground beef in question to Supervalu. Further traceback of the meat revealed that the “most possible” source of the meat delivered to the Supervalu store was the Nebraska Beef processing plant. In addition to this, the USDA reported that a sample of beef trimmings collected on June 14, 2006 at a processing plant cultured positive for a genetically indistinguishable strain of E. coli O157:H7 as the outbreak strain.
Nebraska Beef – In late June of 2008, public health officials in Michigan and Ohio began investigating several cases of E. coli O157:H7. An epidemiological investigation by officials at the Michigan and Ohio departments of agriculture determined that the source of the E. coli outbreak was ground beef purchased at Kroger stores.
Kroger stores recalled an undetermined amount of ground beef, which was ultimately linked to 42 illnesses of E. coli O157:H7– 21 in Michigan and 20 in Ohio. In its recall announcement, Kroger identified stores that had sold the contaminated meat, including Fred Meyer, QFC, Kroger, Fry’s, Ralph’s, Smith’s, Baker’s, King Soopers, City Market, Hilander, Owen’s, Pay Less, Scott’s, Dillons, and Gerbes.
Nebraska Beef also issued a massive recall of ground beef, which was eventually expanded to include a total of 5.3 million pounds of meat intended for use in ground beef production.
On July 18, 2008 the CDC announced that 49 confirmed E. coli O157:H7 cases had been linked both epidemiologically and by molecular fingerprinting to the consumption of ground beef products produced with Nebraska Beef meat. States with confirmed cases included Georgia, Indiana, Kentucky, Michigan, New York, Ohio, and Utah. Twenty-seven people were hospitalized, and one patient was known to have developed a type of kidney failure called hemolytic uremic syndrome (HUS). No deaths were reported.
Later that year, in August of 2008, Nebraska Beef recalled an additional 1.2 million pounds of meat for potential E. coli contamination after a cluster of Boston illnesses was traced to Whole Foods, whose processor, Coleman Natural Meats, purchased the meat from Nebraska Beef. As many as 30 E. coli cases were reported in California, Colorado, Connecticut, Idaho, Illinois, Massachusetts, New Jersey, New Mexico, Pennsylvania, Virginia, and Canada in association with the August recall. On August 14, Nebraska Beef expanded its recall to include 160,000 pounds of meat, bringing the total meat recalled in August to 1.36 million more pounds.
Chi-Chi’s – In late October of 2003, Pennsylvania health officials learned of a potential hepatitis A outbreak from emergency room doctors treating patients in Beaver County. The Beaver County Health Department (BCHD) and Pennsylvania Department of Health (PDOH) began investigating the apparent outbreak, and learned through interviews that all case patients had eaten at the Chi Chi’s restaurant at the Beaver Valley Mall in the weeks before becoming ill.
On November 3, PDOH issued a hepatitis A advisory, encouraging anyone who had eaten at the Beaver Valley Mall Chi-Chi’s restaurant within the past 14 days to receive an Immune globulin (Ig) shot to prevent becoming ill with the hepatitis A virus. Ig is only effective in preventing infection with hepatitis A if it is administered within 14 days of exposure to the virus. PDOH scheduled Ig immunization clinics at several locations over the following days.
By November 7, PDOH had identified 130 people who had contracted hepatitis A as part of the outbreak. The number had grown to 240 cases by November 11, and kept climbing. By November 14, three people had died due to liver failure caused by hepatitis A, and the number of ill people had risen to 500.
PDOH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), conducted an epidemiological study of the outbreak, and determined that green onions imported from Mexico were the source of the outbreak. The FDA issued a statement dated December 9, 2003, affirming that this outbreak was associated with eating raw or undercooked green onions.
Ultimately, over 650 confirmed cases of hepatitis A, both primary and secondary, were linked to consumption of green onions at the Beaver Valley Mall Chi-Chi’s. The victims included at least 13 employees of the restaurant, and numerous residents of six other states. Four people died as a consequence of their hepatitis A illness. In addition, more than 9,000 people who had eaten at the restaurant during the period of potential exposure, or who had been exposed to ill Chi-Chi’s customers, obtained immune globulin shots to prevent hepatitis A infection.
Wright County Egg – In August 2010, Wright County Egg of Galt, Iowa recalled 380 million shell eggs due to contamination with Salmonella. The recalled eggs were distributed nationwide under many different brand names, in 6, 12, and 18 pack cartons, as well as 15-carton cases. Hillandale, another Iowa egg producer, recalled 170 million eggs bringing the total to 550 million nationwide. The CDC has now reported over 2,000 cases of Salmonella Enteritidis (SE) tied to the contaminated eggs.
On August 31, the FDA issued a report of their investigation at the two egg farms, revealing massive violations. At Congressional hearings into Wright County Egg and Hillandale Farms on September 22, 2010, it was revealed that the egg producers had long-term Salmonella problems as well as a history of making people sick.
Peanut Corporation of America – At least 714 people in 46 states were confirmed ill with Salmonella Typhimurium infection after consuming peanut and peanut butter products produced by Peanut Corporation of America (PCA) in 2008 and 2009. The Minnesota health department first listed a product advisory on January 9, 2009, when the presence of Salmonella was detected in King Nut peanut butter.
The outbreak strain of Salmonella was then traced to the Peanut Corporation of America’s Blakely, GA processing facility. Recalls began with commercially distributed peanut butter, but the list of recalled products quickly grew to include over 3600 products made with peanut butter and peanut paste produced by PCA in the Blakely, GA and Plainview, TX facilities since January 1, 2007. Congressional hearing revealed that the owner of PCA was aware that peanut product was testing positive for Salmonella before shipment.
Con Agra – Public health officials from several states collaborated to determine the source of the Salmonella I 4,5,12:i:-* outbreak, and the Centers for Disease Control and Prevention (CDC) officially announced that a Salmonella outbreak had been traced to the consumption of ConAgra pot pies on October 9th. At the time, ConAgra did not initiate a recall.
The CDC issued an investigation update regarding the Salmonella outbreak on October 10, 2007. In that update, the CDC announced that at least 152 people had been confirmed as suffering from Salmonella infections that had been linked epidemiologically and through laboratory testing to the consumption of contaminated potpies between January 1, 2007 and October 9, 2007.
Cargill – The Centers for Disease Control and Prevention (CDC) has been investigating a 31 state Salmonella outbreak Heidelberg outbreak that has sickened 107, hospitalized 10, and killed one. In mid July, 2011 the U.S. Department of Agriculture issued a Public Health Alert for ground turkey when it discovered that 77 people had become ill with Salmonella, however did not disclose the brand responsible for the outbreak until July 29, 2011 when it was announced that Cargill-made ground turkey was responsible for the outbreak and the company recalled 36 million pounds of ground turkey that was sold to retailers and restaurants around the U.S.
Subway – 103 people were officially counted in the outbreak of Salmonella Hvittingfoss linked to Subway restaurants in Illinois. 26 of those sickened had to be hospitalized.
No single vehicle of infection was identified, and Illinois Subway restaurants voluntarily withdrew lettuce, green peppers, red onions and tomatoes and replaced them with new produce. The outbreak strain was Salmonella Hvittingfoss, a fairly rare serotype of Salmonella that usually only presents in one or two cases a year in Illinois.
Gate Gourmet – In September of 2004, health agencies from many U.S. state and international health agencies began receiving reports that travelers who had recently traveled by air from Honolulu, Hawaii in late August of 2004 had tested positive for Shigella sonnei infections. An epidemiologic investigation commenced, and investigators soon determined that food served on several flights from the Honolulu airport was the source of the travelers’ illness.
Further investigation revealed that food produced by Gate Gourmet, an
airline caterer, and served on several different airlines’ flights was the source of the outbreak. As a result, in February of 2005, the Food and Drug Administration (FDA) inspected the Gate Gourmet, Inc., facility located at 324 Rodgers Boulevard, Honolulu, Hawaii, which provides food and beverage service to various airlines at Honolulu Airport.
In a letter to Gate Gourmet headquarters, FDA noted: “The observations made during the inspection revealed that your facility is in violation of the Public Health Service Act and the Interstate Conveyance Sanitation regulations.” During the inspection, Gate Gourmet was cited for holding foods at improper temperatures, pest and vermin violations, equipment maintenance and cleanliness violations, and bare-hand contact with ready-to-serve items.
Senor Felix – On January 5, 2000, Public Health – Seattle & King County issued a notice to Washington residents that three people had been confirmed ill with Shigella infections after eating five-layer dip manufactured by Senor Felix Gourmet Mexican Foods and sold under several brand names. Two other cases were pending confirmation in Washington, and more illnesses had been reported in California and Oregon.
The Food and Drug Administration (FDA) issued a nationwide warning regarding the contaminated dip on January 27, 2000, and announced that 49 cases of Shigellosis associated with the consumption of Senor Felix dips had been reported in California, Oregon, and Washington; five patients had been hospitalized.
Senor Felix recalled its entire inventory of bean dip, which had been sold under four brand names: Senor Felix’s Five Layered Party Dip, Delicioso 5 Layer Dip, Trader Joe’s Five Layered Fiesta Dip, and The Carryout Café Mexican Fiesta Party Dip 5 Layer.
Health officials ultimately identified 406 people with Shigella infections who had eaten the dip in the week prior to illness. Cases were reported in 10 states. An environmental investigation of the processing facility revealed numerous problems with manufacturing practices and quality control at the Senor Felix facility.
Some of the above causes of the above outbreaks could well have been considered for felony prosecution. All, however, could have been prosecuted as misdemeanors. Under either scenario a CEO may well have faced both a fine and jail time. Consider for a moment how a CEO might well think twice about pushing food safety to the side ahead of increased sales and profits. My bet is that if I had prosecuted some of the above cases, as the crimes they were, many of the others would never have happened. CEOs now might risk poisoning people because an insurance company will pick up the tab, but they would not risk personal fines and jail time. I think it is time to give it a shot. Attorney General Holder, my number is 1-206-346-1890.