Last autumn, the New York State Department of Agriculture and Markets found Listeria monocytogenes in a sample of Saladini brand Alfalfa Sprouts produced by Lushlife Gardens (Milford, NJ). The state reported its finding to FDA.
FDA inspectors visited the sprout processing facility and carried out an inspection and environmental sampling that lasted for several days – November 15th to 21st, to be precise. Two of the 40 environmental swab samples yielded Listeria monocytogenes, demonstrating the continued presence of the human pathogen in the processing facility. In addition, inspectors documented insanitary conditions in the sprouting facility, including condensate dripping from dirty fabric onto seeds and sprouts.
In spite of a confirmed finding of Listeria monocytogenes – a potentially deadly microbe – in a sample of the company’s alfalfa sprouts, in spite of the confirmed presence of the same strain of Listeria monocytogenes in the processing environment, and in spite of documented insanitary conditions, the contaminated Saladini Alfalfa Sprouts were never recalled.
As is typical, FDA gave Lushlife Gardens a deadline for taking necessary corrective actions to clean up its processing facility and procedures; however, the company’s January 2, 2012 response letter was found by FDA to be inadequate, as it did not provide documentation of the corrective actions that the company claimed to have taken. So FDA issued a Warning Letter to Lushlife Gardens on January 18th, which gave the company 15 working days to notify the agency of the steps taken to correct the violations. The Warning Letter included the following:
“During the inspection, the FDA investigators collected sample number 689489 consisting of 40 environmental swabs. Analysis of two swabs (one on the floor just inside the green house entrance and another on the floor underneath row (b)(4) of (b)(4) yielded L. monocytogenes. One of the isolates was indistinguishable from the strain that was isolated by the NYAG as analyzed with pulse gel electrophoresis (PFGE). We have attached a copy of the analysis which demonstrates that the isolates match for two different kinds of PFGE tests. These observations suggest that the L. monocytogenes isolated from your product by NYAG likely came from the facility.
Our investigators also observed condensate dripping onto seed and sprouts from black fabric, rope and string. The black fabric was not adequately cleaned and sanitized as evidenced by apparent mold growing on the fabric. These conditions are reasonably likely to result in contamination of your product with L. monocytogenes.”
I have to wonder why FDA remained silent in the face of these observations. I realize that the batch of sprouts documented by New York State to be contaminated probably had expired, but it’s clear from the FDA Warning Letter that the risk of contamination was ongoing. While the agency may not have been in a strong position to press for a recall of other production lots, it could have – and, in my opinion, should have– issued a warning to the public. After all, as the Warning Letter said,
“The conditions observed during the inspection and the finding of L. monocytogenes in your facility cause the sprouts processed at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S. C.§342(a)(4)], in that your sprouts have been prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.”
It has now been more than one year since Congress passed, and the President signed, the Food Safety Modernization Act. This law, among other tools, gave FDA mandatory recall authority for the first time in its history. Does FDA have the backbone to use its new authority for the protection of the public?
Or is it “business as usual” at the agency on which US consumers depend to keep our food supply safe?