The Food and Drug Administration has identified the source of most or all of the E. coli O157:H7 contamination that has sickened dozens and caused at least one death: Natural Selection Foods, otherwise known as Earthbound Farm, a California producer of organic fruits and vegetables.
The Darwinian name of the company does not appear to have been intended as ironic.
E. COLI O157:H7: A NASTY BUG
Escherichia coli O1567:H7 is an especially dangerous strain of the common E. coli bacterium. A Centers of Disease Control website has information on the bug. CDC estimates 73,000 cases of infection in the US per year, 2-7% (approximately 1,500 to 5,000) lead to hemolytic uremic syndrome and kidney failure, and about 61 cases lead to death. CDC’s otherwise informative website emphasizes undercooked beef and cross-contamination as disease vectors, and mentions in passing “sprouts, lettuce, salami, unpasteurized milk and juice.”
CDC advises consumers to “[w]ash fruits and vegetables thoroughly, especially those that will not be cooked.” Other health authorities say washing is ineffective because the bacteria is inside the spinach leaves rather than on the outside:
“If you have bought pre-packaged fresh spinach, don’t eat it,” said Dr. Antonia C. Novello, New York’s state health commissioner, in a press release. “If it is in your refrigerator throw it out. Rinsing the spinach will not make it safe to eat.”
DOWNPLAYING THE CONNECTION BETWEEN ORGANIC PRODUCTION PRACTICES AND PATHOGENIC CONTAMINATION
CDC does not mention that the only case of unpasteurized juice known to have caused an outbreak was organic. The FDA announcement, reproduced below, also is silent about the organic connection. FDA identifies Natural Selection Foods by name but does not mention that it is a major producer of organic foods under the trade name Earthbound Farm.
Despite a reputation for being “backyard farmers,” Earthbound Farm is a large company with revenues of $200 million in 2004. Before the spinach recall, revenues were expected to grow to $450 million in 2006 — a 125% increase in one year. The company’s owners describe themselves as “city kids from Manhattan” who started the company 22 years ago after graduating from UC Santa Cruz and Berkeley. In her May 2006 feature article about owners Drew and Myra Goodman, San Francisco Chronicle reporter Carol Ness noted the contrast between the mom-and-pop, back-to-nature image of organic farming with Earthbound Farm’s reality:
The company is so big, and depends on so many fuel-burning trucks to move its produce, that it’s criticized as industrial, as not really organic. The Goodmans come right back with proof of their pure heart: 400,000 trees planted to consume carbon dioxide, 4,200 tons of chemical fertilizers and 135 tons of pesticides kept out of the environment every year.
Much of what distinguishes organic from conventional agriculture is self-defined good intentions. According to its website, “Earthbound Farm’s mission is to bring the benefits of organic food to as many people as possible and serve as a catalyst for positive change.”
EARTHBOUND FARMS AND THE FAILURE OF ITS QUALITY ASSURANCE PROGRAM
Earthbound Farm’s home page says nothing about the spinach recall, but information is available on the “Press Kit” page:
Spinach Update: In keeping with the Federal Drug Administration’s (FDA) advice to consumers in regard to spinach, effective today, September 15, 2006, Earthbound Farm has removed all spinach ingredients in every salad that we manufacture. If you have any additional questions, please call (888) 736-2840 or refer to our online statement.
Calling the telephone number yields a recorded message, not a company representative. The online statement (first of several on the list) says its recall is “proactive” and “voluntary,” meaning that it did not force FDA to exercise its statutory authority to compel the recall:
After consulting with the US Food and Drug Administration (FDA) and the California Department of Food and Agriculture (CDFA), we have voluntarily initiated this recall. This is a proactive step, taken as a precaution, to protect the health and safety of our customers. While neither the FDA nor the CDFA have yet determined the source of the e coli problem, we believe that recalling all spinach product packed in our facilities is the right thing to do. The FDA has said that they are looking at the entire industry and we will continue to do our part in their investigation.
The statement implies that Earthbound Farm is taking a leadership role among spinach producers, not that it has been identified as the primary (and possibly sole) source of E. coli O157:H7 contamination.
The statement also does not mention the possible role organic agricultural practices might have had in the E. coli outbreak, specifically its reliance on animal manure for fertilizer. Earthbound Farm advertises its facility sanitation program and “training in Good Manufacturing Practices,” and elsewhere says that it complies with applicable FDA regulations for GMP.
Earthbound Farm also promotes its participation in a voluntary USDA-sponsored quality assurance program: that utilizes the Hazard Analysis Critical Control Point (HACCP) model:
A Quality Assurance Supervisor oversees every shift; he or she continually monitors chlorine levels of our water, the temperatures of our packing plant, and the quality of our products and water. Our processing plants participate in the USDA’s Qualified Through Verification (QTV) program. As a part of the QTV program, USDA auditors review records, observe and interview employees, conduct pre-operation sanitation inspections, and follow a specialized Systems Audit Checklist to confirm that the company is following its QTV plan. As an added safeguard, our products and equipment are tested for bacteria by an independent certified lab.
USDA’s Agricultural Marketing Service (AMS) certifies QTV programs and charges user fees to implement them.
Under QTV, the USDA reviews and assesses a firm’s documented Hazard-Analysis-Critical Control-Point (HACCP) based food safety plan (HACCP). USDA makes on-site audits to determine the effectiveness of a firm’s implementation of its plan. USDA auditors review records, observe and interview employees, conduct pre-operation sanitation inspections, and follow a specialized Systems Audit Checklist to confirm that the company is following its QTV plan. Only companies that are able to meet existing good manufacturing and sanitation practices and that demonstrate that they are following their QTV plan, including adherence to the required HACCP-based techniques, are qualified to be in the program. As an added safeguard, our products and equipment are tested for bacteria by an independent certified lab.
According to the company, its HACCP program has achieved a “Level One rating,” which only 24% of all participating companies achieve. This raises questions about whether the HACCP program is actually targeted on preventing human health risk. HACCP can be an effective tool for achieving safety, but the evidence available strongly suggests that Earthbound Farms’ HACCP program failed. It is possible that slavish adherence to complex paperwork requirements became a substitute for ensuring actual product safety. It’s also possible that the plan itself was fatally flawed.
The effectiveness of any HACCP-based system at reducing human health risk depends on performing a thorough hazard analysis, identifying critical control points that address identified hazards, and monitoring production to ensure that the procedures applied at these control points are effective. In this case, for example, one would expect the HACCP plan to have the following elements:
- A recognition that pathogenic contamination from animal manure is a human health hazard.
- The identification of one or more critical control points in the production process from farm to delivery truck where pathogenic contamination could occur.
- Implemented specific procedures for preventing or eliminating pathogenic contamination.
- Establishing a statistically valid testing regime that ensures, with a quantifiable level of certainty, that organic spinach leaving its manufacturing plant is free of pathogens.
Earthbound Farms does not disclose its HACCP plan on its website so we are unable to determine whether it failed to follow its own plan or failed to design it properly. Meanwhile, the company touts its products as “healthful” because they are free of “chemical pesticides or synthetic fertilizers,” and “never genetically engineered of modified.” Says the company, “Organic farming encourages an abundance of species living in balanced, harmonious ecosystems.” Apparently E. coli O157:H7 is one of those species.
A strong implication found across the organic foods industry is the implication is that pesticide residues, synthetic fertilizers, and genetic modification are “unhealthful.” Evidence supporting such statements is hard to locate. When USDA’s Agricultural Marketing Service established the National Organic Program in 2000 to help organic producers market their products, it specifically avoided any suggestion that organic foods were healthier than foods produced under conventional agriculture. Rather, USDA touted only benefits to producers:
The benefits of implementing national uniform standards of production and certification include: (1) providing a common set of definitions on organic attributes and standardizing the manner in which the product information is presented, which may reduce the cost associated with enforcement actions in consumer fraud cases; (2) reduced administrative costs; and (3) improved access to organic markets (pp. 485-486).
AMS was well aware of the human health risks posed by pathogens in animal manure used as fertilizer. Nevertheless, it refrained from establishing any standards that would protect public health on the ground that it was incompetent to do so:
Although public health officials and others have identified the use of raw manure as a potential food safety concern, at the present time, there is no science-based, agreed-upon standard for regulating the use of raw manure in crop production. The standard in this rule is not a public health standard. The determination of food safety demands a complex risk assessment methodology, involving extensive research, peer review, and field testing for validation of results… The NOP does not have a comparable capacity with which to undertake a comprehensive risk assessment of the safety of applying raw manure to human food crops.
At the same time, AMS declined to delegate this responsibility to third parties that would certify adherence to the top program it was then establishing:
To delegate the authority to determine what constitutes safe application of raw manure to certifying agents would be even more problematic. A certifying agent cannot be responsible for establishing a Federal food safety standard. Therefore, the standard in this rule is a reflection of AMS’ view and of the public comments that this standard is reasonable and consistent with current organic industry practices and [National Organic Standards Board] recommendations for organic food crop production (emphasis added; pp. 75-76)
The National Organic Standards Board (NOSB) is a advisory group controlled by organic agriculture and its allies. All have clear financial interests in expanding the market for organic foods. As a practical matter, NOSB writes the rules and USDA ratifies them.
Although AMS avoided making any health claims for organic foods, producers of organic foods have not been so shy. Earthbound Farm’s trademarked motto is “Food to live by,” a slogan that darkly implies that conventionally produced foods are risky. Its website links approvingly to an essay by Dr. Andrew Weill (“Important Reasons to Choose Organic”), who objects to pesticides:
As a class of chemicals, the pesticides in use on conventional crops are suspect. The bottom line is simple: they can’t be good for us. The only question is, “How bad are they?” I’m afraid the answer might be “pretty bad.”
Weill speculates that “degenerative neurological conditions whose causes are not known will turn out to be the result of toxic injury” from pesticides. He specifically mentions Parkinson’s disease and Lou Gehrig’s disease.
Earthbound Farm promotes the opinions of Dr. Alan Greene (“Why Organic Is the Healthiest Choice for Kids”), who says organic foods are the “healthiest foods possible” because they are the “purest and most nutritious available.” Greene specifically claims that organic foods are safer than foods produced using conventional agriculture:
Has organic been proved safer?
Some people challenge that organic foods have not been proved healthier than conventional ones. I believe exactly the opposite to be true. Organic farmers have grown safe, nutritious food for hundreds of years; conventional farming has been the norm for a small fraction of that time, and its safety is still in the experimental stage.
Determining the safety of a conventional pesticide may take 30 years or more. We know now, for example, that some of the older pesticides, such as DDT, caused serious health problems in children. But this didn’t become evident until 30 years after the substance was banned for environmental reasons. We may not see the full effects of the new, subtler poisons we’re putting on crops for a long, long time.
Also on Earthbound Farm’s website, Dr. Phil Landrigan echoes the opinions of Weill and Greene about pesticides:
Many of the chemicals used for standard crop production are toxic to the nervous system, can cause cancer, can damage endocrine and reproductive organs, and can be toxic to the immune system. Organic farming systems do not use toxic chemical pesticides or fertilizers. Organic foods are minimally processed without artificial ingredients, preservatives or irradiation.
None of the essayists discusses the possibility that organic foods pose greater risk from foodborne pathogens.
The Organic Trade Association promotes organic agriculture as environmentally superior and better for public health and nutrition. In 2002, it established a nonprofit arm called The Organic Center “to support scientific research about the benefits of organic agriculture and its products to human health.” Although described as independent, Weill and Greene are board members, along with OTA executive director Katherine DiMatteo. The information posted on its science pages has an advocacy rather than scientific flavor.
OTA has a FAQ sheet on animal manure which correctly states that under USDA rules organic farms cannot use raw manure to fertilize crops:
Certified organic farmers are prohibited from using raw manure less than 120 days prior to harvesting crops whose edible portion has direct contact with soil or soil surface, or less than 90 days prior to harvesting crops whose edible portion does not have direct contact with soil or the soil surface.
Scientific evidence supporting the safety of the 120- and 90-day time periods is hard to locate; none was provided by USDA in its regulations implementing the National Organic Program. In its response to comments on the proposed rule, USDA acknowledged that it had selected 120- and 90-days because they were recommended by the industry’s advisory board:
The NOSB has strongly supported the proposed 90- and 120-day intervals, and the vast majority of commenters indicated that these provisions would be feasible for virtually all organic cropping systems (p. 76).
Combined with USDA’s refusal to base its rule on scientific risk assessment, which we noted earlier, it is clear that there is no connection between safety and the NOP’s limited restrictions on the timing of harvesting after the application of raw manure.
Still, OTA denies that organic foods are more likely to b contaminated by E. coli O157:H7.
Are organic products more likely to be contaminated by E. coli?
No, there is no reputable scientific evidence to indicate this. All food—whether conventional or organic—is susceptible to E. coli. In fact, CDC has issued the following statement: “The Centers for Disease Control and Prevention…has not conducted any study that compares or quantitates the specific risk for infection with Escherichia coli O157:H7 and eating either conventionally grown or organic/natural foods. CDC recommends that growers practice safe and hygienic methods for producing food products, and that consumers, likewise, practice food safety within their homes (e.g., thoroughly washing fruits and vegetables).”
In the case of pesticides, organic agriculture says the absence of proof of safety is evidence of risk. In the case of manure, it says that the absence of proof of harm is evidence of safety.
As of September 15, lawsuits had been filed alleging personal injury in Oregon, the San Francisco Bay area, and Milwaukee. All plaintiffs are represented by the Seattle law firm of Marler Clark, which describes itself as “the nation’s foremost law firm with a practice dedicated to representing victims of food poisoning.” The firm’s web page highlights five cases, including the 1993 Jack-in-the-Box case and the 1996 Odwalla apple juice case.
Four of the five cases involve undercooked ground beef or cross-contamination errors committed by commercial food service workers. In these cases, it’s not obvious that the producer or retailer was responsible for resulting illness. Proper food preparation and sanitary conditions would have prevented illness, and the public does not expect raw ground beef to be safe to eat.
The Odwalla case is unique because the product was sold directly to consumers. Contamination occurred at manufacture and there were no reasonable steps a retailer or consumer could perform to avoid it. News accounts characterized the risk as resulting from Oswalla’s failure to pasteurize, but unpasteurized fruit juice had been sold for decades without appreciable risk of illness. What distinguished Odwalla’s products is that they were organic.
INJURY TO CORPORATE REPUTATION
Earthbound Farm manufacturers bagged spinach under more than two dozen different labels (see the FDA statement below). Many of these labels belong to innocent parties such as food distribution companies and retailers who could not have had anything to do with the outbreak. Presumably, their contracts with Earthbound Farm provide for indemnification of losses, certainly loss of product and possibly loss of sales or damage to reputation. Future contracts with Earthbound Farm can be expected to be more demanding.
INJURY TO THIRD PARTIES
Los Angeles Times reporter Jerry Hirsch describes a different group adversely affected: spinach farmers not affiliated with Earthbound Farm but unable to sell their product because of the outbreak.
.”We have hundreds of thousands of dollars of spinach out in the fields right now,” said Dale Huss, vice president of production for Ocean Mist Farms Inc. in Castroville. “Our customers are pulling the product off of shelves. This is a panic.”
Huss said the sudden collapse of the spinach market was especially frustrating for him because his farm passed an FDA inspection last week.
“We’re the ones paying the price,” said Bob Martin, general manager of Rio Farms in King City.
FDA Statement on Foodborne E.coli O157:H7 Outbreak in Spinach
As part of the agency’s continued commitment to keep the public informed of food safety issues, the Food and Drug Administration (FDA) is providing this update on the outbreak involving spinach.
The U.S. Food and Drug Administration (FDA) is continuing to alert consumers about an outbreak of E. coli O157:H7 in multiple states that may be associated with the consumption of fresh spinach and fresh spinach containing-products.
Based on current information, FDA advises that people not eat fresh spinach or fresh spinach containing-products that are consumed raw. Individuals who believe they may have experienced symptoms of illness after consuming pre-packaged spinach are urged to contact their health care provider.
At this time, Natural Selection Foods, LLC, of San Juan Bautista, California, is recalling all of its products that contain spinach in all the brands they pack with “Best if Used by Dates” of August 17, 2006 through October 1, 2006.
FDA continues to investigate whether other companies and brands are involved.
Natural Selection Foods, LLC brands include: Natural Selection Foods, Pride of San Juan, Earthbound Farm, Bellissima, Dole, Rave Spinach, Emeril, Sysco, O Organic, Fresh Point, River Ranch, Superior, Nature’s Basket, Pro-Mark, Compliments, Trader Joe’s, Ready Pac, Jansal Valley, Cheney Brothers, Coastline, D’Arrigo Brothers, Green Harvest, Mann, Mills Family Farm, Pro*Act, Premium Fresh, Snoboy, The Farmer’s Market, Tanimura & Antle, President’s Choice, Cross Valley, and Riverside Farms. These products include spinach and any salad with spinach in a blend, both retail and food service products. Products that do not contain spinach are not part of this recall.
E. coli O157:H7 causes diarrhea, often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death. To date, 94 cases of illness have been reported to the Centers for Disease Control and Prevention (CDC), including 14 cases of HUS and one death.
At this time, the investigation is ongoing and states that have reported illnesses to date include: California, Connecticut, Idaho, Indiana, Kentucky, Maine, Michigan, Minnesota, Nevada, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Utah, Virginia, Washington, Wisconsin, and Wyoming. The affected products were also distributed to Canada and Mexico.
FDA continues to work closely with the U.S. Centers for Disease Control and Prevention (CDC) and state and local agencies to determine the cause and scope of the problem. As part of our investigation, we will test packages of spinach from confirmed cases of E. coli infection.
FDA will provide daily updates on its investigation. Please check this site for updated information.