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?
eFoodAlert 
Thomas, I am confused why you ask me to send you the draft paper as it is posted on my blog and comes up when I click http://truthontruthiness.blogspot.com/ – it also has a ‘disclaimer’ that allows unlimited copying and distribution. I would also note that you are trying to change or control the discussion – my point is not that the food supply is safer today than in the past; but that safe is an absolute and therfore we should couch our descriptions in terms of minimizing risk! I believe that the statement the “food supply is safe” is an implied warranty and would/should lead to potential liability. At least it should reduce the credibility of officials who also write about the actual risks associated with food. For example, in Canada the official statistics for foodborne microbial disease have gone from 400,000 to 12million per year between 1974 to now; however, population has only gone from 25million to under 35million (BTW – I am aware of USA foodborne statistics). Let’s face it as long as there are recalls the system is operating in failure mode.
LikeLike
Simply amazing!
LikeLike
…….and bring his/her operation up to acceptable standards. For anyone to think that Uncle Sam just flew in the window to save us, with burdonsome issues like FSMA………well that’s foder for an SNL skit. We have always scrutinized imported products into our plants in the US. It’s a task which is not taken lightly, and requires a high level of awareness. I look forward to your paper, and in doing so assure you, we are out here, and these issues are serious and forefront.
LikeLike
As a former colleague of the foodbuglady I think she is absolutely right! I think it is time we stop saying that the food supply is safe – the food supply has not been safe in the past, is not safe now and probably won’t be safe in the future. If the food supply was safe then we could fire most of the folks working for food regulatory agencies who live off the avails of unsafe food. It is HIGH time that regulatory agencies start to express their goals in realistic terms like ‘minimizing risk due to unsafe food’. I would like to invite Dr. Thomas Lopez to read my draft document:
On Truthiness and Safe – how safe is safe if safe isn’t really safe? http://truthontruthiness.blogspot.com/ .
Additionally, there is no sense blaming the Chinese for our problems. It is the responsibility of the importer to ensure that the products meet our regulations – if the importer can’t do that s/he should look for another source.
LikeLike
Bill, please forward your draft to me at lopez1054@comcast.net. I have to disagree with you. The food across the world today is safer than it has ever been in history as we know it today. The science based approach to food safety is light years advanced from what Pastuer accomplished. I do agree, leaving our food safety to any Regulatory agency is silly. Food Safety sits squarely on our shoulders, Industry. In saying that, why beat up the FDA, petition the Sprout Producer to do the right thing……….
LikeLike
It is very hard to arm chair Quarterback the actions of the FDA without a complete timeline and full disclosure of all of the sampling/product locations, with results. In my 30 year history within the private sector of Food manufacturing, if there is the slightest doubt, the FDA strongly recommended a voluntary recall. With the above stated scenerio, no recall, no lethality reported, I might have come to the same conclusion had I the data. It’s evident they made the right decision, did not alarm the public, which ultimately results in upseting commerce
LikeLike
Thomas, I appreciate your comments and your position. I am a microbiologist by training and a food safety advocate by inclination. I spent several years in the 1970s working for what was then known as Health Protection Branch – Canada’s FDA.
I find it hard to justify the complete lack of public notice on a batch of alfalfa sprouts that were documented by New York State’s Department of Agriculture and Markets as being contaminated with Listeria monocytogenes – especially when this contaminant was a genetic match to a strain of L. monocytogenes recovered from the processing facility. There were two (2) L. monocytogenes-positive environmental swabs. One was taken under a “row” (presumably of developing sprouts).
I believe that some level of public warning was called for in this instance. Or would you have waited for a related human isolate to be found?
Phyllis
LikeLike
Hi Phyllis, I too am a seasoned Microbiologist specifically pathogenic organisms and epidemiology. I very much respect your position on this, and value your expected Federal response. Without all of the data, I am at a loss for a defense of their actions. The term “Warn” also has it’s pitfalls and has to be seriously thought out as to the approach one takes. Through default, without data your position is definately the one with the most margin of security. A solid NO on the human isolate.
LikeLike
I am writing for a friend who does not have access to a computer. She thought she would treat her dog, a Hungarian Vizla, to something healthy and bought Uncle Sam’s duck treats. Within the next 12 hrs. her dog had violent diarrhea with blood in it. The dog continued to be sick the next day not wanting to eat and throwing up. I don’t understand why American companies keep using China to produce their treats?? (Chicken Strips and Duck Strips) I guess money is always the bottom line rather than the safety of our pets. So sad that we can’t even trust our own country to do the right thing. I will also report this to the FDA along with all the other recall lists I subscribe to. Uncle Sam’s Duck treats are made by Segeants’ Pet Care Products in CHINA and sold in Publix supermarkets in Florida.
LikeLike
Hi Barbara,
Did you find out what was the cause of the pet’s issue. Was it a bacteriological or chemical insult. Did the dog fully recover? To wrap all of China’s exports in one unsafe package might be slightly too restraining. I am interested in the outcome, as I am sure many other pet owners are also.
Thanks, Tom…Pathogenic Microbiologist
LikeLike