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FDA Update on Recent Hepatitis A Outbreaks Associated With Green Onions From Mexico



December 9, 2003

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The Food and Drug Administration is reaffirming that several recent Hepatitis A virus outbreaks have been associated with eating raw or undercooked green onions (scallions). Investigations by state and local health departments, the Centers for Disease Control and FDA have determined that the outbreaks were caused by green onions traced to Mexico for the three outbreaks with completed traceback investigations. It is important to remember that Hepatitis A Virus is transmitted by fecal-oral route. Produce can become contaminated when a person who has Hepatitis A or whose hands are contaminated with Hepatitis A virus comes into contact with the product or by exposure of the product to water contaminated with Hepatitis A virus.

Hepatitis A outbreaks associated with raw or undercooked green onions served in restaurants occurred in Tennessee, North Carolina and Georgia in September and in Pennsylvania in late October through early November. The source of the green onions in the outbreaks has been traced to Mexico for the Tennessee, Georgia and Pennsylvania outbreaks. The source of the onions in the North Carolina outbreak is still being determined. The exact source of the contamination has not been established in any of these outbreaks. FDA is continuing to investigate in both the U.S. and Mexico and has been in consultation with Mexican authorities to obtain their assistance in assessing the situation.

A team of investigators from FDA and CDC spent the first week of December in Mexico working with Mexican officials to visit the four firms and associated facilities identified in the FDA traceback investigations. Preliminary findings from the FDA team include the following points:

* The onions would have been harvested in July or early August for the Tennessee and Georgia outbreaks and September for the Pennsylvania outbreak.

* At the point of the inspections in December 2003, none of the farms or packing sheds inspected were harvesting or handling green onions, or had field workers or packing shed workers present.

* No one firm’s onions are common to all of the outbreaks under investigation.

* FDA, CDC and the states to date have found no evidence of contamination of implicated green onions occurring at firms operating in the U.S., but investigations relating to the source of green onions in the North Carolina outbreak are continuing.

* There are no reliable methods currently available to find Hepatitis A virus in samples collected in the field, so FDA did not collect environmental or green onion samples for Hepatitis A analysis.

* The investigation team identified issues of concern from interviews and observations at all four firms visited including items such as poor sanitation, inadequate hand washing facilities, questions about worker health and hygiene, the quality of water used in the fields, packing sheds, and the making of ice, any of which can have a role in the spread of infectious diseases such as Hepatitis A

* FDA was pleased to see that some of the farms visited were making or had just completed improvements to their water systems and other physical facilities.

As FDA investigates the sources of products implicated in foodborne outbreaks, FDA is always concerned with the monitoring of worker health, water quality, and sanitary conditions.

FDA and the Mexican government are working together on an ongoing basis with regard to technical issues arising from the process of investigating all possible sources of implicated products in foodborne outbreaks. The FDA and Mexican health and agriculture authorities are engaged in a joint effort to ensure the safety of Mexican produce entering the United States and improving the health of citizens on both sides of the border.

FDA is pleased to know, as Dr. Javier Trujillo, Undersecretary of Food Safety and Quality indicated, that the Government of Mexico is already well along in implementing a program of inspecting growers on a regular proactive basis by region so that problems can be prevented before they arise.

Hepatitis A is a liver disease that develops within 2-6 weeks after exposure. Hepatitis A is usually mild and characterized by jaundice (yellow discoloration of the skin), fatigue, abdominal pain, loss of appetite, nausea, diarrhea, and fever. It can occasionally be severe, especially in people with liver disease. Persons infected with Hepatitis A virus, in particular children, may have no symptoms or very mild symptoms.

Hepatitis A virus sequences from persons who became ill in the outbreaks in Tennessee, Georgia, North Carolina and Pennsylvania were identical or very similar to sequences observed among persons with Hepatitis A living along the United States-Mexico border and travelers returning from Mexico, consistent with a source in Mexico.

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