Salmonella Outbreak Exposes Flaw in FDA ‘Import Alert’ System

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.

The CDC posted this photo with the outbreak notice, describing maradol papayas as large, oval fruits that weigh 3 or more pounds, with green skins that turn yellow when the fruit is ripe. The flesh inside the fruit is salmon-colored.” Photo courtesy of CDC

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.

Evanger’s proposes donating recalled pet food. FDA says ‘no’

The United States Food and Drug Administration (FDA) has vetoed a proposal by Evanger’s Dog and Cat Food Co. to donate recalled pet food to animal shelters after conducting random spot-checks for pentobarbital.

The proposal was revealed in a June 29, 2017 Warning Letter issued by FDA, and released on its website Tuesday morning (July 4, 2017) under the agency’s standing policy to post recent Warning Letters on a weekly basis.

The letter addressed to Holly N. Sher and Joel A. Sher, President and Vice President, respectively, notifies them that FDA found “…serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations” during an investigation that included supplier traceback, facility inspection, and analysis of samples collected by FDA.

In its response to the Evanger’s proposal to donate recalled pet food, FDA said that finding the contents of individual cans of food from recalled lots to be negative for pentobarbital would not provide “…sufficient assurance that the remaining units are not adulterated.”

After stating that FDA’s own testing confirmed the pentobarbital contamination not to be homogeneous throughout an entire lot, the agency declined Evanger’s proposal and recommended destruction of all remaining recalled product.

The Warning Letter is the most recent development in an investigation of Evanger’s that began in early January with the reported illness of five dogs in a single household and the death of one of the dogs. Lab tests conducted on the gastric contents of the dead dog and on the remains of Evanger’s Hunk of Beef au Jus canned dog food that had been fed to all five of the animals, revealed the presence of a ‘large quantity’ of pentobarbital in both samples.

FDA opened its investigation immediately upon becoming aware of the incident. A team of inspectors began an on-site inspection of Evanger’s manufacturing facility in Wheeling, Illinois on January 10, 2017.

On February 14, 2017, the inspection team furnished Evanger’s management with a Form 483, listing a series of Inspectional Observations, including:

• Pentobarbital found in a sample of Evanger’s Hand Packed Hunk of Beef au Jus, 12 oz. can (Lot #1816E06HB13)
• Pentobarbital found in a sample of Against the Grain brand Grain Free Pulled Beef with Gravy Dinner for Dogs, 12 oz. can (Lot #2415E01ATB12; BEST DEC 2019)
• Condensate dripping throughout the facility, including into open cans in-process and onto totes of raw meat
• Pitted, cracked and damaged floors
• Peeling paint, mold throughout the facility and a live ‘fly-like insect’ in the hand-packing area during processing
• Inadequate temperature controls

In addition to the two pentobarbital-positive samples cited in the February 14th Form 483, FDA has found pentobarbital in the following five production lots of Evanger’s dog food:

• Braised Beef Chunks, lot code 2016E08BBW11 Best Aug 2020.
• Hunk of Beef Au Jus, lot code 1816E14HBC18 Best June 2020.
• Hunk of Beef Au Jus, lot code 1816E02HB12 Best June 2020.
• Hunk of Beef Au Jus, lot code 1316E23HB09 Best Jan 2020.
• Hunk of Beef Au Jus, lot code 1816E03HB17 Best June 2020.

On March 3, 2017, Evanger’s voluntarily recalled all cans of Evanger’s Braised Beef Chuncks, Evanger’s Hunk of Beef Au Jus and Against the Grain Pulled Beef with Gravy manufactured between December 2015 and January 2017.

In correspondence dated 2/4/2017, 2/21/2017, 4/4/2017, 5/18/2017 and 5/23/2017, Evanger’s addressed FDA’s Inspectional Observations, and proposed a series of corrective actions. In addition to the proposed donation of recalled product, the following actions, listed in the Warning Letter, are those FDA found to be inadequate or unacceptable.

Evanger’s discontinued doing business with the meat supplier alleged by the company to be the source of the adulterated meat.

Evanger’s was unable to supply any documentation or evidence that the indicated supplier was the only one who supplied the contaminated raw materials. Therefore, FDA was unable to evaluate whether or not this was an adequate response.

Evanger’s suggested that if pentobarbital were to be present in any of its ground loaf products, it would be “…well within the range that FDA had previously deemed not to be a health or safety concern in pet foods.”

FDA disagrees that grinding would dilute any pentobarbital to safe levels, and points out that there is zero tolerance for pentobarbital in pet food.

Evanger’s proposed random pentobarbital tests of finished products prior to shipment as a way to ensure that raw materials are not adulterated.

FDA considers this to be an inadequate and unreliable way to ensure the safety of the finished product. FDA’s own testing has demonstrated pentobarbital contamination is not uniformly distributed throughout all cans in a production lot. Also, the agency disagrees that finished product testing can mitigate the risk of pentobarbital in the raw material.

Evanger’s now requires new and current suppliers to provide letters of guarantee for their products.

FDA points out that a letter of guarantee may not provide adequate assurance of product safety, and recommends conducting site audits and/or reviews of supplier procedures in addition to the letter of guarantee.

As is customary, the Warning Letter concludes with a requirement that Evanger’s must furnish a written reply within fifteen working days, spelling out the steps it has taken or will take to correct the violations and prevent them from occurring again.

The complete text of the Warning Letter can be found on the FDA website.

This article first appeared in Food Safety News and is reposted here with permission.

Death by a Thousand Cuts

Donald Trump has declared war. Not on North Korea; not on ISIS or Iran. Certainly not on Russia.

Donald Trump has declared war on the Food Safety Modernization Act.

Trump has not asked Congress to repeal the act or to void its regulations. He knows that would not happen. Instead, he has launched a stealth attack via the budgetary process. An attack on the underpinnings of the country’s food safety enforcement system.

Last week, the Trump White House submitted its budget proposal to Congress. Buried within a single line of the more than one thousand-page budget was the following information:

Foods Program
2016 Actual spending: $1,002,000,000
2017 Estimated spending: $985,000,000
2018 Proposed spending: $910,000,000

That’s correct. Spending on food safety activities under Trump is already on the decline and, if he has his way, will continue to decrease year by year until the Food Safety Modernization Act is nothing but an empty shell. Emasculated due to lack of funding.

How does this compare with the previous administration’s funding? Since the 2011 enactment of the Food Safety Modernization Act, funding for the Foods Program has increased year over year at least in line with inflation, except for 2013 (the year of the infamous budget sequester – the 10% across-the-board cut to all discretionary spending programs).

Actual Spending on Foods Program
(Inflation-adjusted value of 2011 spending in brackets for comparison)
2011: $836,244,000
2012: $866,920,000 ($853,550,000)
2013: $796,638,000 ($866,052,000)
2014: $882,814,000 ($880,101,000)
2015: $903,340,000 ($881,146,000)
2016: $1,002,000,000 ($892,262,000)
2017 (est’d): $985,000,000 ($909,054,000)

We were already nearly four months into the fiscal year by the time Trump’s occupation of the Oval Office began, mitigating his impact on the Foods Program spending for 2017. However, his budget proposal for 2018 will reduce spending on the FDA’s Foods Program to less than the actual dollars spent in 2011, when adjusted for inflation.

The Animal Drugs and Feed Program, which encompasses approval of veterinary drugs and enforcement of pet food safety, fares even worse.

Animal Drugs and Feed Program
2016 Actual spending: $159,000,000
2017 Estimated spending: $158,000,000
2018 Proposed spending: $108,000,000

The Animal Drugs and Feed Program has been the runt of the FDA litter for many years, its year-over-year funding having failed to keep up with inflation more often than not. Yet, in an age when pet food safety is more important to more people than ever before, Trump has proposed to cut the budget for this program by 32% in real dollars and by 38% in inflation-adjusted dollars (based on 2011 dollars).

Spending on the Animal Drugs and Feed Program has not been this feeble since 2008.

Actual Spending on Animal Drugs and Feed Program
(Inflation-adjusted value of 2011 spending in brackets for comparison)
2011: $158,771,000
2012: $156,909,000 ($162,057,000)
2013: $147,774,000 ($164,430,000)
2014: $164,313,000 ($167,098,000)
2015: $175,024,000 ($167,296,000)
2016: $159,000,000 ($169,407,000)
2017 (est’d): $158,000,000 ($172,595,000)

Other federal departments and agencies are not immune to the disease of deregulation by financial starvation. The Centers for Disease Control and Prevention, the Environmental Protection Agency, and others too numerous to list here also are affected. Trump’s war on government regulation is unrestricted. And he is using the budget process as his primary weapon.

It is not a coincidence that I revived eFoodAlert when Trump took office. In the absence of robust and well-funded FDA enforcement programs, it is up to each one of us to provide the necessary vigilance. To recognize and report food safety issues. And to raise our voices in support of the regulatory and enforcement activities that are the essential underpinning of the Food Safety Modernization Act.

Remember Peanut Corporation of America. Remember De Coster Egg Farms. Remember the illnesses and deaths that resulted from the cavalier attitudes of the principals in both companies. Lack of enforcement breeds lack of compliance.

Trump has declared war on clean water, clean air, and food safety. It is time to fight back.