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Public Health Focus

Archived Updates on the FDA Investigation in Honduras

 

May 6, 2008: Honduran firm Agropecuaria Montelíbano continues to work to improve its FOOD-safety controls over its growing and packing operations to minimize the potential for contamination of cantaloupes. The firm has provided the Food and Drug Administration (FDA) within the U.S. Department of Health And Human Services (HHS) with documentation of its corrective actions made through April 2008.   However, after review of the documentation submitted, the measures implemented to date do not appear to adequately prevent the risk of contamination.  HHS/FDA continues to work with the firm by providing a detailed review of the corrective measures, including specific comment on the areas that still need improvement. 

On March 21, 2008, HHS/FDA issued an Import Alert on Agropecuaria Montelíbano after epidemiological and trace-back investigations linked cantaloupes from that company to a Salmonellosis outbreak in the United States, with 51 illnesses confirmed in 16 States.

A multidisciplinary team, which consisted of experts from both HHS/FDA and the HHS Centers for Disease Control and Prevention, conducted an on-site evaluation of Agropecuaria Montelíbano in Honduras.

Agropecuaria U.S. Customs officials and HHS/FDA will continue to detain Agropecuaria Montelíbano's product, without physical examination, when offered for entry into the United States, until HHS/FDA lifts the Import Alert.  For HHS/FDA to remove Agropecuaria Montelíbano from the Import Alert, HHS/FDA needs to verify that the firm has taken the corrective measures necessary to ensure that it is growing, processing and transporting cantaloupes in a way that does not cause the melons to appear to be adulterated, that its product meets U.S. standards for food safety, and that, specifically, its cantaloupes do not contain Salmonella.

April 18, 2008: The U.S. Food and Drug Administration expects to shortly complete its investigation of the Honduran cantaloupe grower and packer, Agropecuaria Montelibano. The FDA is working expeditiously to review documents and analyze data related to the investigation.

On March 21, the FDA issued an import alert on Agropecuaria Montelibano after epidemiological and trace-back investigations linked cantaloupes from that company to a salmonellosis outbreak in the United States, with 51 illnesses confirmed in 16 states.

A multidisciplinary team, which consisted of experts from both the FDA and the Centers for Disease Control and Prevention, recently completed an on-site evaluation of Agropecuaria Montelibano in Honduras.

The team worked with Honduran government officials to evaluate the company's melon growing fields and packing facilities. Preliminary information from the investigation team reveals that there might be systemic problems at Agropecuaria Montelibano that could have contributed to the outbreak.

FDA's investigation process is very thorough. It includes the on-site visit to the firm in Honduras, the analysis of laboratory samples, and a review of the firm's documentation of policies and procedures. Next steps could include an on-site verification of the implementation of corrective actions by the firm. 

Agropecuaria Montelibano's product will continue to be refused at the United States borders until the FDA's lifts the import alert.  For the FDA to remove Agropecuaria Montelibano from the import alert, the FDA needs to verify that the firm has taken the corrective measures necessary to ensure that it is growing, processing and transporting cantaloupes in a way that does not cause the melons to be adulterated, that its product meets U.S. standards for food safety, and that specifically its cantaloupes do not contain Salmonella.

April 7, 2008: The U.S. Department of Health and Human Services (HHS) has completed the on site component of the investigation of cantaloupes in The Republic of Honduras.

HHS dispatched a multidisciplinary team, which consisted of experts from both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) from within the department, to Honduras for about a week to investigate a Honduran packer and grower of cantaloupes, Agropecuaria Montelíbano.

Epidemiological and trace-back investigations performed in the United States between February and March of this year indicated that the current salmonellosis outbreak, in which 51 illnesses were reported in 16 states since January, was associated with the consumption of cantaloupes exported by Agropecuaria Montelíbano.

The HHS team worked with Honduran government officials to evaluate the company's growing fields and packing houses, and collected environmental samples during the course of the investigation. The samples are currently undergoing analysis at an FDA lab in the United States, and the agency is currently evaluating all of the evidence associated with this investigation.

Results of the investigation should assist Agropecuaria Montelibano in identifying and implementing additional pathogen-control measures needed to ensure that its produce meets U.S. standards for food safety.

April 2, 2008: As FDA’s scientific investigation team continues its work in Honduras to determine the source or sources of the Salmonella contamination linked to cantaloupes from the company Agropecuaria Montelibano, the Centers for Disease Control and Prevention has announced another confirmed case of Salmonella Litchfield linked to the current outbreak. This brings the total number of illnesses reported in the U.S., as part of this outbreak, to 51 since January.  

Separate from the investigation taking place in Honduras, a recently completed FDA test of cantaloupe imported from Agropecuaria Montelibano before the March 21st import alert was put in place, revealed the melons to be contaminated with a strain of Salmonella identified as Salmonella Freetown.  While this is a different strain of Salmonella than is associated with the outbreak, the possibility that cantaloupe from this company may be contaminated with other types of Salmonella reaffirms the value of the public health action FDA is taking to keep potentially unsafe products from reaching the U.S. consumer.

This investigation is a collaborative effort between FDA, CDC, the firm and the Honduran government.

FDA will continue to provide updates on the investigation.  Please check back for the latest information.

April 1, 2008: FDA’s scientific investigation team is in Honduras to meet with officials from the Honduran government and from the cantaloupe grower and packer, Agropecuaria Montelibano.

The team has started collecting information in an effort to determine the source or sources of recent Salmonella contamination of certain shipments of fresh cantaloupes from Honduras. The expert team aims to identify which growing fields and packing houses originated and processed the produce responsible for the outbreak.

The results of FDA’s evaluation may help determine the source or sources of the Salmonella contamination and what additional control measures Agropecuaria Montelibano may need to implement in order to ensure that produce shipped to the United States meets U.S. standards for food safety.

FDA will continue to provide updates from our investigation on the ground in Honduras.  Please check back for the latest information.