The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Maryland Department of Health (MDH) and other state and local agencies continue to investigate the  outbreak of Salmonella Kiambu illnesses, which has sickened 47 people and has already claimed one life.

Based on sampling and analysis reported by MDH, the outbreak appears to be linked to consumption of Maradol papayas, imported from Mexico. On July 26, 2017, Grande Produce (San Juan, TX) recalled Caribeña brand Maradol papayas that were shipped to an unnamed Maryland distributor center between July 10 and July 19.

The introduction of Salmonella-contaminated papayas into the US retail market occurred despite the issuance in August 2011 of Import Alert 21-17, COUNTRYWIDE DETENTION WITHOUT PHYSICAL EXAMINATION OF PAPAYA FROM MEXICO.

What is an Import Alert?

An Import Alert informs “…FDA field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations.” It can be very narrow (apply to a single company or importer) or extremely broad, as in the case of Import Alert 21-17. The purpose of the Import Alert is to place the burden of proving product safety on the shoulders of the producer or importer. The first Import Alert was issued in 1974.

History of Import Alert 21-17

Mexican papayas were the source of a Salmonella Agona outbreak that sickened 106 people in 25 US states between January 1 and August 25, 2011. The outbreak was traced to several brands of papayas distributed in the USA and Canada by Agromod Produce, Inc.

During the investigation into the source of the outbreak, FDA analyzed 211 samples of Mexican papayas, finding Salmonella in 33 (15.6 percent) of them. The positive samples came from 28 different firms and nearly all the major papaya-growing regions of Mexico. In response to the extent of the contamination, FDA issued Import Alert 21-17 on August 25, 2011.

Are there any exceptions to the Import Alert?

FDA policy allows for exemptions to an Import Alert, if a company can provide evidence that their products are likely to remain in compliance with FDA laws and regulations. In the case of Import Alert 21-17, FDA considers Salmonella-negative test results from five consecutive shipments over a period of time to be evidence of probable compliance. Entities able to meet these criteria may apply for an exemption. If accepted, they are added to  the Green List appended to the Import Alert.

How does the Green List Work?

At last count, FDA has granted 98 exemptions in the nearly six years during which the Import Alert has been in force. Once granted, exemptions remain in effect unless FDA receives evidence of lack of compliance, such as a result of a consumer complaint, a Salmonella-positive routine retail surveillance sample. There is no requirement for inspection of the exempt entity’s operations, for routine or periodic submission of lab test results, or for any other form or recertification. A Green-listed entity under Import Alert 21-17 has carte-blanche to ship papayas from Mexico into the USA.

What Happens to Detained Shipments under Import Alert 21-17?

Entities whose products are detained without physical examination may apply to have those products released by submitting evidence from a third-party laboratory that the product is not contaminated with Salmonella. Otherwise, the product either will be refused entry into the USA, or will be destroyed.

The action taken last week by Grande Produce represents the second time in recent years that Caribeña brand Mexican papayas have been recalled due to Salmonella contamination. The first recall took place in May 2012 after routine testing by Caribe Produce, LTD CO discovered Salmonella contamination.

A recent search of Texas Secretary of State corporate filings revealed Raul Cano to be both the registered agent for Caribe Produce and a Managing Member/Director of Grande Produce. Both companies currently share the same street address. According to a May 2017 article published in Texas Border Business, Grande Produce is owned jointly by Raul Cano and his brother, Juan Cano.

While the identity of the Mexican grower who supplied the recalled papayas has not been determined, Chiapas-based Finca Monte Verde identifies its US distributor to be Grande Produce and identifies Caribe Produce as its contact point in the USA. Finca Monte Verde is on the Import Alert 21-17 Green List and, therefore, is exempt from automatic detention.

There is no information on either the Finca Monte Verde or the Grande Produce websites to indicate whether or not Finca Monte Verde is the sole supplier of papayas to Grande Produce. While FDA is conducting a traceback investigation of the recalled Caribeña papayas, its investigators also are working with CDC and state agencies to determine whether other brands of papayas may be implicated in the Salmonella outbreak.

Although the investigating state and federal agencies have not yet determined the origin of the contaminated papayas, or the point in the tree-to-table distribution chain at which they may have become contaminated, one thing is certain. Either the papayas entered the USA under the aegis of a Green-Listed entity or the produce was admitted as a result of a third-party lab analysis certifying a Salmonella-negative result.

As food safety advocate Bill Marler pointed out in his recent opinion piece, ‘Why the US imports tainted food that can kill you,’ FDA’s ability to carry out proactive inspections of foreign growers and packers is severely limited by budget constraints, forcing the agency to rely on the good faith and probity of these entities and of their third-party testing laboratories to deliver a safe product to US consumers.

In this case, it seems the outcome was a large gap in the food safety border wall—maybe large  enough to drive a refrigerated 18-wheeler through.

This article first appeared on Food Safety News and is reposted here with permission. Attorney Bill Marler is the publisher of Food Safety News.