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September 16, 2006; Updated October 20, 2006
(Questions & Answers are also available in Spanish)
FDA and the State of California announced October 12 that the test results for certain samples collected during the field investigation of the outbreak of E. coli O157:H7 in spinach are positive for E. coli O157:H7. Specifically, samples of cattle feces on one of the implicated ranches tested positive based on matching genetic fingerprints for the same strain of E. coli O157:H7 that sickened 204 people.
The trace back investigation has narrowed to four implicated fields on four ranches. The outbreak strain of E. coli O157:H7 from cattle feces was identified on one of these four ranches. At this time, testing of other environmental samples from all four ranches that supplied the implicated lot of contaminated spinach are in progress. The positive test result is a significant finding, but is just one aspect of this investigation. More information may come forward as the investigation continues. These four fields, located in Monterey and San Benito counties, are not currently being used to grow any fresh produce. While the focus of this outbreak has narrowed to these four fields, the history of E. coli O157:H7 outbreaks linked to leafy greens indicates an ongoing problem. As FDA stated in its letter to the lettuce industry in November of 2005, FDA continues to be concerned due to the history of outbreaks and the on-going risk for product contamination of leafy greens.
FDA announced on September 29, 2006 that all spinach implicated in the current outbreak has traced back to Natural Selection Foods LLC of San Juan Bautista, California. This determination is based on epidemiological and laboratory evidence obtained by multiple states and coordinated by the Centers for Disease Control and Prevention (CDC). Natural Selection Foods issued a recall of all implicated products on September 15, 2006. More specifically, Natural Selection Foods has recalled all spinach products under multiple brand names with a date code of October 1 or earlier. Five other companies have issued secondary recalls because they received the recalled product from Natural Selections. See below for a complete list of brand names that are subject to the recalls. In order to protect consumers, retailers and food service operators should not sell raw spinach or blends that may contain raw spinach that are subject to these recalls. These recalls include raw spinach and blends that may contain raw spinach with date codes of October 1 or earlier. Processed spinach (e.g., frozen and canned spinach) is not implicated in this outbreak.
FDA, the State of California, the CDC and the United States Department of Agriculture (USDA) continue to investigate the cause of the outbreak.
To date, 204 cases of illness due to E. coli O157:H7 infection have been reported to the CDC including 31 cases involving a type of kidney failure called Hemolytic Uremic Syndrome (HUS), 104 hospitalizations, and three deaths. The first death was an elderly woman in Wisconsin; the second death, a two-year-old in Idaho; and the third death, an elderly woman in Nebraska.
The 26 affected states are: Arizona (8), California (2), Colorado (1), Connecticut (3), Idaho (8), Illinois (2), Indiana (10), Kentucky (8), Maine (3), Maryland (5), Michigan (4), Minnesota (2), Nebraska (11), Nevada (2), New Mexico (5), New York (11), Ohio (26), Oregon (6), Pennsylvania (10), Tennessee (1), Utah (19), Virginia (2), Washington (3), West Virginia (1), Wisconsin (50), and Wyoming (1). In addition, Canada has one confirmed case in the Province of Ontario.
There has been a long history of E. coli O157:H7 outbreaks involving leafy greens from the central California region. Spinach processed by other manufacturers has not been implicated in this outbreak, however, based on discussions with the industry, and given the past E. coli O157:H7 outbreaks, FDA and the State of California expect the industry to develop a comprehensive plan which is designed to minimize the risk of another outbreak due to E. coli O157:H7 in spinach grown in central California. While this plan is under development, FDA and the State of California reiterate our previous concerns and advise firms to review their current operations utilizing the FDA's guidance for minimizing microbial food safety hazards.
FDA and the State of California have previously expressed serious concern with the continuing outbreaks of foodborne illness associated with the consumption of fresh and fresh-cut lettuce and other leafy greens. After discussions with industry, FDA and the State of California, as part of a longer term strategy, now expect industry to develop a plan to minimize the risk of another outbreak due to E. coli O157:H7 in all leafy greens, including lettuce.
The Grower Shipper Association of Central California, the Produce Marketing Association, the United Fresh Produce Association, and the Western Growers Association, said today, "We are committed to working together as one industry to learn everything we can from this tragedy, and will redouble our efforts to do everything in our power to reduce the potential risk of foodborne illness. As we have in the past, we will work aggressively with the Food and Drug Administration and state regulatory authorities to ensure the industry's growing and processing practices continue to be based on the very best scientific information available, and that we are doing everything possible to provide the nation with safe and healthy produce."
Implementation of these plans will be voluntary, but FDA and the State of California are not excluding the possibility of regulatory requirements in the future.
FDA will be holding a public meeting to address the larger issue of food borne illness linked to leafy greens later in the year once the current investigation is complete.
Additional information regarding the safe handling of raw produce and fresh-squeezed fruit and vegetable juices can be found at Safe Handling of Raw Produce and Fresh-Squeezed Fruit and Vegetables on the FDA/CFSAN web site.
Additional general food safety tips, can be found on the Fight BAC! web site.
E. coli O157:H7 is a bacterium that causes diarrhea that is often bloody; the diarrhea can be accompanied by abdominal cramps. Fever may be absent or mild. Symptoms usually occur within 2-3 days following exposure, but may occur as soon as 1 day following exposure or up to one week following exposure. Healthy adults can typically recover completely from E. coli O157:H7 exposure within a week. However, some people, especially young children and the elderly, can develop Hemolytic Uremic Syndrome (HUS) as a result of exposure to E. coli O157:H7, a condition that can lead to serious kidney damage and even death.
Spinach implicated in the current outbreak has traced back to Natural Selection Foods LLC of San Juan Bautista, California. Natural Selection Foods LLC has recalled all spinach products under multiple brand names with a date code of October 1, 2006 or earlier. Five other companies have issued secondary recalls because they received the recalled product from Natural Selection Foods LLC. See below for a complete list of brand names and associated date codes that are subject to these recalls. FDA continues to advise consumers not to eat raw spinach or blends that may contain spinach that were subject to any of the aforementioned recalls. These recalls are applicable to the brands listed in the recall notifications and include raw spinach and blends that may contain raw spinach with date codes of October 1 or earlier. Processed spinach (e.g. frozen and canned) has not been implicated in this outbreak.
Consumers are further advised that proper storage of fresh produce can affect both quality and safety. To maintain the quality of fresh produce, store perishable fresh fruits and vegetables (like strawberries, lettuce, herbs, and mushrooms) in a clean refrigerator at a temperature of 40° F or below. All produce that is purchased pre-cut or peeled should be refrigerated to maintain both quality and safety.
Many precut, bagged produce items like lettuce are pre-washed. If so, it will be stated on the packaging. This pre-washed, bagged produce can be used without further washing.
Cooking fresh spinach at 160 degrees Fahrenheit for 15 seconds will kill any E. coli O157:H7 present.
FDA does have a petition under review to permit the irradiation of multi-ingredient foods, including prepackaged (bagged) fresh produce, for the purpose of controlling microbial contamination. This petition, if approved, would permit the irradiation of prepackaged fresh spinach at specified doses. FDA is reviewing this petition. Note, however, that the suitability and efficacy of the irradiation of foods for microbial control must be examined by industry on a product-by-product basis.
In order to protect consumers, retailers and food service operators should not sell raw spinach or blends that may contain raw spinach that is subject to the Natural Selection Foods LLC recall or one of the five associated secondary voluntary recalls. These recalls specifically include spinach and blends that may contain spinach with date codes of October 1 or earlier.
Any other type of leafy green (lettuce, collard greens, kale) is NOT implicated in this outbeak.
An outbreak is defined by the CDC as two (2) or more cases of the same disease related to a common exposure.
The first illness associated with this outbreak occurred on August 2, 2006, although most illnesses reported to date cluster with onsets from August 26 - September 12, 2006.
FDA first became aware of the current outbreak on September 13, 2006. FDA will continue to release additional information as it becomes available.
Yes. A previous outbreak involving fresh spinach occurred in California in October of 2003. Sixteen (16) cases of illness were reported and two (2) people died. The causative agent was E. coli O157:H7.
In the current spinach E. coli O157:H7 outbreak, the fact that illnesses are so dispersed (over 26 states to date) suggests that the contamination likely happened early in the distribution chain. The investigation into the possible source and cause of contamination is ongoing, including on the farm and in processing plants.
FDA's 1998 Guide to Minimize Microbial Contamination of Fresh Fruits and Vegetables (also referred to as the Good Agricultural Practices (GAPs) guide) describes potential sources of microbial contamination in the field and packing house environments and makes broad scope recommendations for how to reduce or minimize opportunities for contamination.
According to the GAPs guide, areas that should be considered to minimize the potential for the microbial contamination of produce include: agricultural water (e.g., for irrigation or crop protection sprays); wild and domestic animals; worker health and hygiene; the production environment (use of manure, previous land use, and use of adjacent land); post harvest water quality (water used to wash or cool produce) and sanitation of facilities and equipment. Our experience in outbreak investigations since 1998 points to the importance of these areas as being significant to avoid contamination of fresh produce at the farm or packinghouse. We also know that there is still a substantial need for additional produce safety research.
FDA focused on the farm and packing facilities because of a need to raise awareness about food safety at these stages of the supply chain. FDA's 2004 Produce Safety Action Plan, however, recognizes that contamination can happen at any point in the supply chain.
To date, 6 firms have initiated recalls:
Based on recall audits conducted by FDA, the agency recently determined that on September 15, 2006, Kenter Canyon Farms, Inc., of Sun Valley, California initiated a voluntary recall of re-packaged spinach. The recalled spinach was part of the nationwide recall of Natural Selection Foods. The product was packaged in 5 oz. clam shell plastic containers. The products recalled were: Kenter Canyon Farms Baby Spinach, Kenter Canyon Farms Mesclun, and Kenter Canyon Farms Spicy Mix. The recalled products were distributed only in Southern California. The "expiration date" located on the back of the package is September 20, 2006.
On 9/22/06, Pacific Coast Fruit Company of Portland, Oregon initiated a voluntary recall of its spinach salad products and pizza that may include spinach supplied by Natural Selections Foods, a California grower and processor. These products may be contaminated with E. coli O157:H7. Products recalled were distributed through various retail outlets in Alaska, Oregon, Washington and Idaho and include: Baby Spring Mix Salad Kit (4.6 lbs), Chef on the Run- Bacon Spinach Salad (9oz plus 2fl oz dressing), Chef on the Run-Spring Greens Salad (5oz plus 2fl oz dressing), Trader Joe's-Baby Spinach and Greens with Bleu Cheese, Candied Pecans and Cranberries with Raspberry Vinaigrette Dressing (10oz), Trader Joe's-Baby Greens and Spinach Salad with Wild Maine Blueberry Dressing (10oz), Mediterranean Veggie Blend Kit- 15lbs and My Brotheres Pizza Spinach and Garlic- 15oz and 36oz. Salad products were distributed on "clam shells" and will have a "USE BY DATE" of on or before September 20, 2006. Pizza products were distributed on "round cardboard bottoms with a plastic over wrap" and will have a "USE BY DATE" of on or before September 23, 2006. Pacific Coast Fruit Company discontinued making all products with spinach supplied from California on September 14, 2006.
On 9/22/06 Triple B Corporation, doing business as, S.T. Produce of Seattle, Washington initiated a northwest states voluntary recall of certain salad products that may contain spinach with a "Use By" date of 8/22/2006 thru 9/20/2006. Spinach used in these products may have been supplied from Natural Selections Foods, a California grower and processor, to S.T. Produce. This recall was initiated subsequent to an announcement by Natural Selections Foods of a nation-wide recall of all their products that contain spinach because they may be contaminated with E. coli 0157:H7. The recalled products were distributed in Washington, Oregon, Idaho and Montana to retail stores and delis. The salad products were sold in a hard plastic clamshell container with the "Use By" date located on the bottom of the container. The products being recalled include: NWG Spinach Salad (5 oz.), Spinach Salad, QFC (5 oz.), Charlie's Spinach Salad (5 oz.), Charlie's Tabouli & Goat Cheese Salad (10 oz.), NWG Tabouli & Goat Cheese Salad (10 oz.), Tabouli & Goat Cheese Salad, QFC (10 oz.), T/H Spring Mix Salad (5.5 oz.), T/H Mozzarella Spring Mix Salad (5.5 oz.), T/H Baby Spinach Salad (5.5 oz.), Walnut and Blue Cheese Salad w/ Grilled Chicken Breast (6.5 oz.), Larry's Market Tabouli & Goat Cheese Salad (10 oz.), Charlie's Seasonal Greens Salad (2.5 oz.), Charlie's Seasonal Greens Salad (4 oz.), Charlie's Baby Spinach Salad (6 oz.), Charlie's Baby Spinach Salad (5oz), and Caesar Bowtie Noodle Salad Kit with Grilled Chicken Breast (6.9lbs).
On 9/17/06, River Ranch, of California, announced a voluntary recall of spring mix containing spinach. River Ranch obtains bulk spring mix containing fresh spinach from Natural Selections for processing and packaging. The following brand names are included in the River Ranch recall: Fresh N' Easy Spring Mix and Hy-Vee Spring mix containing baby spinach, distributed to retailers in Texas, Iowa, New Mexico, Georgia and Ohio. The River Ranch product included in the recall is packed in 5 oz. bags and 5 oz. plastic trays.
On 9/19/06 RLB Food Distributors of West Caldwell, New Jersey, announced a voluntary recall that may contain spinach from Natural Selection Foods. All the products recalled by RLB have an "Enjoy Thru date of 9/20/06 or before." The products are: Balducci's Mesclun Mix, Balducci's Organic Baby Spinach, Balducci's Mixed Greens, FreshPro Mesclun Mix, FreshPro Organic Baby Spinach, FreshPro Mixed Greens, FreshPro Salad Mix with Italian Dressing, and FreshPro Salad Mix with Ranch Dressing. The recalled products were distributed in Connecticut, New York, New Jersey, Pennsylvania, Maryland, Delaware, Virginia and Washington DC.
On 9/15/06, Natural Selection Foods, LLC, of San Juan Bautista, California announced a voluntary recall of all products that contain fresh spinach with "Best if Used by Dates" of August 17, 2006 through October 1, 2006. (See additional information about brands associated with Natural Selection Foods below). Other companies and brands of fresh spinach and fresh spinach containing products may also be involved in this outbreak; FDA and CDC continue to investigate this possibility.
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, Compliments, Trader Joe's, Ready Pac, Jansal Valley, Cheney Brothers, D'Arrigo Brothers, Green Harvest, Mann, Mills Family Farm, Premium Fresh, Pro-Mark, Snoboy, The Farmer's Market, Tanimura & Antle, President's Choice, Cross Valley, and Riverside Farms.
Yes. The federal (principally CDC and the FDA) and state governments are working together to analyze samples from ill persons and product samples in an attempt to quickly identify the source(s) of the outbreak.
The outbreak strain of E. coli O157:H7 from ill persons is being "fingerprinted" at public health laboratories around the country, as part of PulseNet (the network of public health laboratories that sub-type bacteria). All E. coli O157:H7 strains associated with this outbreak have the same "fingerprint" (DNA pattern).
Farm investigations are in progress, focusing on fields associated with the production lots/brands implicated in illnesses as identified from available epidemiological data. Numerous samples have been collected to date including water, soil, sediment and other materials of environmental interest. These samples are being analyzed by FDA and state laboratories.
Spinach Sample Results
There are now a total of 13 confirmed product samples that contain the E. coli O157:H7 outbreak strain.
The Colorado Department of Public Health and Environment has confirmed the presence of the outbreak strain of E. coli O157:H7 in a sample of Dole spinach with a lot code of P227A02, and a "best if used by" date of August 30, 2006.
The Ohio Department of Health confirmed the isolation of E. coli O157:H7, matching the outbreak strain, from a package of bagged spinach.
The Wisconsin Department of Health and Family Services has confirmed that E. coli O157:H7, the same strain as that associated with the outbreak, has been found in 2 bags of Dole Baby Spinach with lot codes of P227A.
The Nevada Department of Health and Human Services has reported a confirmed finding of E. coli O157:H7 in bagged spinach, matching the outbreak strain. The Nevada sample was analyzed by FDA Pacific Regional Lab NW.
The Pennsylvania Department of Health has confirmed that E. coli O157:H7, the same strain as that associated with the outbreak, has been found in 2 individual bags of Dole spinach purchased in Pennsylvania with a "best if used by" date of August 30, 2006, and a lot code of P227A01.
The Utah Department of Health (UDOH) and the Salt Lake Valley Health Department (SLVHD) have confirmed that E. coli O157:H7, the same strain as that associated with the outbreak, has been found in a bag of Dole Baby Spinach purchased in Utah, with a lot code of P227A01. Laboratory tests were conducted by the Utah Public Health Laboratory (UPHL).
The New Mexico Department of Health announced on September 20, 2006, that it had linked a sample from a package of spinach with the outbreak strain of E. coli O157:H7. DNA fingerprinting tests determined that the strain from the spinach matches the strain from patients in the outbreak. The package of spinach that tested positive was Dole Baby Spinach, with a lot code of P227A03.
The Illinois Department of Public Health has confirmed that E. coli O157:H7, matching the outbreak strain, has been found in a package of Dole Fresh Spinach with a lot code of P227A02, and a "best if used by" date of August 30.
The Arizona Department of Health Services reported a confirmed finding of E. coli O157:H7 in Dole bagged spinach, with a lot code of P227A03, and a "best if used by" date of August 30, 2006, matching the outbreak strain.
The Nebraska Health and Human Services System reported a confirmed finding of E. coli O157:H7 in Dole bagged baby spinach, with a lot code of P227A01, and a “best if used by” date of August 30, 2006, matching the outbreak strain.
The Utah Department of Health reported a confirmed finding of E. coli O157:H7 in Dole bagged baby spinach, with a lot code of P227A01, matching the outbreak strain.
The FDA developed the Lettuce Safety Initiative in response to recurring outbreaks of E. coli O157:H7 in lettuce. The primary goals of the initiative are to reduce public health risks by focusing on the product, agents and areas of greatest concern and to alert consumers early and respond rapidly in the event of an outbreak. On August 24, 2006, the State of California Department of Health Services and Department of Food and Agriculture and the FDA met with industry and academia to further clarify the goals, objectives and the next steps for the Lettuce Safety Initiative. This meeting was facilitated by the Western Institute for Food Safety and Security. This initiative is based on the 2004 Produce Safety Action Plan, intended to minimize the incidence of food borne illness associated with the consumption of fresh produce.
Since 1995, there have been 19 outbreaks of foodborne illness caused by E. coli O157:H7 for which lettuce or leafy greens were implicated as the outbreak vehicle. Although tracebacks to growers were not conducted (or "not conclusive") in all of the outbreak investigations, a majority of the outbreaks, including the recent outbreak in September of 2005, traced product back to California, many of which were from the Salinas Valley, though not exclusively.
FDA regularly issues assignments to sample both domestic and foreign fresh produce items. Reports of those assignments are posted on FDA's website.
FDA has the lead for foreign GAPs education/outreach and has been working with a number of food safety partners in other countries, and in the U.S., on a variety of programs targeted at the safety of fresh produce. FDA's produce safety action plan, instituted in 2004 and ongoing, contains four main objectives and many specific milestones to address produce safety, including outreach and education activities. Additionally, FDA has been distributing information materials in English and Spanish on the safe handling of raw produce and fruit and vegetable juices to health educators and state and local health agencies. FDA in conjunction with the Produce Marketing Association and the Partnership for Food Safety Education developed a multi-faceted national produce handling education campaign. Launched two years ago, this education program utilizes the media, food safety advocates and Partnership members to communicate safe handling recommendations about produce to consumers.
