Statement from Nancy -- The issue about the wooden shelving is somewhat confusing -- as I understand it, the FDA is saying that they are only banning the use of wood when it is not properly cleaned (i.e., for my company FLFCC); and that they are willing to work with artisans on this issue. I had, however, asked in writing for the ability to demonstrate by testing that my boards were safe prior to being shut down in October. I was cited, fairly, because the FDA found a pathogenic (illness-causing) bacteria, listeria monocytogenes, present in 12 of 47 samples at my plant in April 2013. Some of those positive samples were on the wood shelving (also drains, and the underside of a stainless steel table, a cart slated for washing, a stainless steel shelf rack, the rim of one brine vat). What became confusing to me was what was required of me in order to make a satisfactory response to the positive sampling, which I sincerely thought that I did. With a few helpers, we did extra intensive cleaning in the plant on all surfaces (inside the air ducts, ceilings,boards, etc etc) and this was detailed to inspectors. I should have done my own post-cleaning environmental testing to confirm that the cleaning was effective, but this is expensive (approx. $30-40/sample) and it is a step that we were not previously required to do (but will be going forward). Everything in inventory currently was made after July 13, when I thought I was in the clear to restart production. I was, and am, willing to make adjustments as necessary to meet regulatory requirements -- but those steps need to be clear. I am also considered a repeat violator because there were samples taken by the FDA in June 2012 that also were positive for listeria. However, we also did a thorough cleaning response in 2012 -- but again did not do follow up environmental sampling to assure that the cleaning was effective (again, expensive, and never had been a requirement before). We know what cleaners and concentrations work. I believe that there is a very reasonable possibility, given the nature of listeria and how ubiquitous it is in the environment, that the plant was recontaminated. And, while I recognize the need to maintain the plant in good condition at all times, I believe it is also worth noting that both employees that I had in 2012 were gone by the 2013 sampling, so there had been a 100% turnover in staff and I as owner had been out with knee surgery during that window of time. I did not produce any cheese between Dec. 2012 and May 2013, and only 13 batches prior to August 2013. I am very interested in being cooperative with the regulatory process so that food safety guidelines are met, but also in a way that does not overwhelm the financial and manpower resources of small businesses like my own. I think there are exciting new sanitizing and testing technologies available to help even small producers meet the need to assure that the products leaving the plant are clean; but this is going to add a whole layer of cost to the food system. I think it is worth asking, probably through research, whether this extra layer of protection is worth the cost. I think it is also fair to question whether the FDA is going to allow room for a business like mine to grow into the new regulations; as a producer, it is very frustrating to find myself being cast as an unhygienic operation, when I do not believe that is the case. Had I been antagonistic, or uncooperative, I would better understand the severity of the actions the FDA took against me, which effectively caused me to lose approximately one year of business activity, and siphoned off funds that would have better been used to make adaptations to the new regulations. As a food producer trying to make an honest living at a small-scale, farm-based business, I cannot afford to add a full-time Regulatory Compliance Officer to my staff, as many of the large plants have done. I am also grateful for the opportunity to give voice to my concerns through this medium; otherwise the regulatory system is not a very democratic process: The FDA issued press releases about my business, but I had no real opportunity to offer my response to the information.
Posted on: Thu, 12 Jun 2014 13:43:41 +0000
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