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FDA Investigates Multistate Outbreak of Cyclosporiasis

What is the Problem and What is Being Done About It?

The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating a multi-state outbreak of Cyclospora infections. We are moving quickly to learn as much as possible and prevent additional people from becoming ill. We recognize that people will be concerned about this outbreak, and we will continue to provide updates and advice.

The FDA, CDC, and state and local officials are investigating a multi-state outbreak of Cyclospora illnesses.

According to reports from the CDC, multiple state health departments have reported Cyclospora infections. As of August 19, 2013, CDC has been notified of 593 cases of Cyclospora infection from 20 states: Arkansas, California, Connecticut, Florida, Georgia, Illinois, Iowa, Kansas, Louisiana, Minnesota, Missouri, Nebraska, New Jersey, New Hampshire, New York (including New York City), Ohio, Tennessee, Texas, Virginia, and Wisconsin. It is not yet clear whether the cases reported are all part of the same outbreak. The FDA is continuing its investigation and has not ruled out any possibilities.

On July 30, 2013, the states of Iowa and Nebraska announced that their analysis indicated that the outbreak in those states was linked to a salad mix.

The FDA traceback investigation has confirmed that the salad mix identified by Iowa and Nebraska as being linked to the outbreak of cyclosporiasis in those states was supplied to restaurants in those states by Taylor Farms de Mexico, S. de R.L. de C.V., a processor of foodservice salads. The FDA traceback investigation found that illness clusters at restaurants were traced to a common supplier, Taylor Farms de Mexico, S. de R.L. de C.V. The restaurants in Iowa and Nebraska include Olive Garden and Red Lobster, both of which are owned by Darden Restaurants. FDA's investigation has not implicated consumer packages sold in grocery stores.

On August 12, 2013 Taylor Farms de Mexico officially informed the FDA that, as of August 9, 2013, the company voluntarily suspended production and shipment of any salad mix, leafy green, or salad mix components from its operations in Mexico to the United States. The firm has committed to not resume production and shipping of these products from its operations in Mexico without FDA's approval. To date only the salad mix has been implicated in the outbreak of cyclosporiasis in Iowa and Nebraska. This voluntary action goes beyond the implicated salad mix and includes iceberg lettuce, romaine lettuce, green leaf lettuce, red cabbage, green cabbage and carrots. The action of Taylor Farms de Mexico exemplifies the company's cooperation with federal and state officials throughout this ongoing, complicated investigation.

Taylor Farms de Mexico, S. de R.L. de C.V. has been cooperating with all FDA requests during the investigation. The Mexican government's food regulatory authorities, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) and the National Agro-Alimentary Health, Safety and Quality Service (SENASICA), have also been collaborating with FDA in the investigation of this outbreak.

The FDA and the firm will conduct an environmental assessment of the firms processing facility in Mexico, to try to learn the probable cause of the outbreak and identify preventive controls to put in place to try and prevent a recurrence. The most recent inspection, in 2011, of the processing facility of Taylor Farms de Mexico, S. de R.L. de C.V. conducted by FDA found no notable issues. Additionally, as a result of this investigation FDA is increasing its surveillance efforts on green leafy products exported to the U.S. from Mexico.

The Iowa Department of Inspections and Appeals (DIA) and the Nebraska Department of Health and Human Services have announced that they believe the contaminated salad is no longer in the food supply in those states. The last date that someone reportedly became ill with cycloporiasis in Iowa was on July 1, and in Nebraska on July 2. The typical shelf life for a salad mix is up to 14 days.

FDA will continue to work with its federal, state and local partners in the investigation. The goal will be to combine information collected from other affected states with that provided by the state health authorities in Iowa and Nebraska to identify a specific food item linked to the illnesses. Should a specific food item be identified, the FDA, CDC, state and local partners will work to track it to its source, determine why the outbreak occurred, and if contamination is still a risk, implement preventive action, which will help to keep an outbreak like this from happening again.

FDA is following the strongest leads provided by the states and has prioritized the ingredients of the salad mix identified by Iowa and Nebraska for the traceback investigation, but is following other leads as well. In the traceback process, the traceback team identifies clusters of people made ill in separate geographic areas and works to trace the path of food eaten by those made ill to a common source. This is labor intensive and painstaking work, requiring the collection, review and analysis of hundreds and at times thousands of invoices and shipping documents.

FDA has dedicated a 21-person team at the headquarters level to solving this outbreak, and will augment this team as needed. Additionally, there are FDA specialists across the country in 10 field offices working on the outbreak.

In an effort to leverage all sources of information that could be available on this outbreak, FDA has asked its field offices to review and send information forward from consumer complaints that could be Cyclospora related. FDA will evaluate these consumer complaints to determine whether they provide information to supplement the epidemiology provided by the CDC and the states. FDA will also evaluate this information to determine if there might be opportunities to collect product samples.

What is Cyclospora?

Cyclospora cayetanensis is a parasite composed of one cell, too small to be seen without a microscope. This parasite causes an intestinal infection called cyclosporiasis.

Cyclospora is acquired by people ingesting something - such as food or water - that was contaminated with the parasite. Cyclospora needs time (days to weeks) after being passed in a bowel movement to become infectious for another person. Therefore, it is unlikely that Cyclospora is passed directly from one person to another. For more information on Cyclospora, see: http://www.cdc.gov/parasites/cyclosporiasis.

Who is at Risk?

People can become infected with Cyclospora by consuming food or water contaminated with the parasite. People living or travelling in countries where cyclosporiasis is endemic, including certain tropical or subtropical regions of the world may be at increased risk for infection.

What are the Symptoms?

The time between becoming infected and becoming sick is usually about 1 week. Cyclospora infects the small intestine (bowel) and usually causes watery diarrhea, with frequent, sometimes explosive, bowel movements. Other common symptoms include loss of appetite, weight loss, stomach cramps/pain, bloating, increased gas, nausea, and fatigue. Vomiting, body aches, headache, fever, and other flu-like symptoms may be noted. Some people who are infected with Cyclospora do not have any symptoms. If not treated, the illness may last from a few days to a month or longer. Symptoms may seem to go away and then return one or more times (relapse). It's common to feel very tired.

What do Consumers Need to Do?

Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling food. Fresh produce should be thoroughly washed before it is eaten.

If more specific information becomes available, FDA and CDC will share it with the public, along with any steps consumers can take to prevent illnesses.

Who should be Contacted?

Contact your healthcare provider if you have diarrhea that lasts for more than 3 days.

The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD or consult the fda.gov website: www.fda.gov .

SOURCE:

FDA

August 20, 2013



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