So began the letter to Sunland Inc. on November 26, 2012. Many groups have written about this topic already, however, I wanted to provide some thoughts on what this means to the rest of the food industry under FDA’s jurisdiction.
It began as a voluntary suspension of operations during the height of the recall, but when the facility decided to reopen its doors, FDA invoked its new FSMA authorities to keep them closed.
FDA’s first use of its new authority in the forced suspension of operations at the peanut-product manufacturing plant of Sunland Inc. is bringing to fruition the words that have been repeated for the last two years: Be prepared, and Don’t Wait. And now, despite the number of pending, unissued rules … the time has come. FDA is enforcing this impactful part of the Food Safety Modernization Act.
What food facilities should take critical note of is that, not only were FSMA provisions invoked to enforce the suspension itself (under Section 102), but several of the 483 Inspectional Observations and cited infractions related to various new FSMA requirements were noted in order to substantiate the suspension.
Some of these observations focused on several requirements under Section 103 Preventive Controls, including:
A lack of records to document the cleaning of the production and packaging lines after Salmonella was detected in peanut and nut butters between 2009 and 2012. We could give Sunland benefit of the doubt, and say the company may have done the required cleaning but just didn’t document it – or maybe it didn’t do it at all. Either way, in the eyes of the agency, if it isn’t documented, it didn’t happen. FSMA will require heightened record-keeping requirements which Sunland clearly did not keep. (Section 103)
Distribution of certain lots of peanut butter and nut butters that were positive for Salmonella per Sunland’s internal testing. One must question whether Sunland had, or used, a test-and-hold program. This citation would lead one to believe that no such practice was in place, because if it were, the contaminated products would have still been in Sunland’s control when the test results were in. If, on the other hand, Sunland really shipped product that they knew was positive for Salmonella and did not institute a recall, it will only be a matter of time before we hear about activity from the Office of Criminal Investigation at FDA and then possibly the Department of Justice.
Distribution of products in which Sunland tests detected allergens but did not label them as containing the peanut, almond, and soy. Again, perhaps the company had already distributed the products prior to receiving the test results … but if that’s the case, the company should have recalled those products due to undeclared allergens.
A lack of preventive food safety for employees, including inadequate hygiene and lack of hand-washing sinks in the production or packaging areas. This one is hard to extend any benefit of the doubt when employees were observed working bare-handed, where no hand-washing sinks were available.
A similar lack of preventive pest control practices was observed, with effective measures not being taken to exclude pests from the processing areas.
Storage of raw ingredients was not adequately controlled, allowing for birds to land on open bed trailers of exposed peanuts and for exposure to rain, providing an enhanced growth opportunity for Salmonella.
Finally, FDA concluded that there was reasonable probability that Sunland products “are contaminated with Salmonella, or are at risk for such, based on the conditions in your facility.”
If we stop and think about timing, I have speculated in the past that the first time FDA uses the
“Suspension of Registration,” authority it will be with a big bang. I think this situation proves me correct. However, I do wonder why FDA waited until the company was just about to re-open. That alone is indicative of the “Big Bang Theory” from the regulators.
The next very important lesson is that, according to the letter from FDA, Sunland did put a corrective action plan together, but the FDA did not like what they saw and thus suspended the facility’s registration. The critical lesson here is to work very closely with the regulators in response to situations like this. However closely the company and its consultants may think they worked with FDA, the response that the corrective plan was not adequate tells me that that they did not work closely enough.
With its history of recorded contamination, Sunland provides a strong example of the value of FDA’s new authority. Records showed that the company had placed contaminated product in the market since 2009. Prior to FSMA, however, FDA did not have authority to mandate a recall or suspend/revoke facility registration. In the past, it was the game of voluntary recall followed by FDA requested recall along with some ugly press, and finally the complex process of seizing products. But if FDA had had these authorities back in 2009, would the plant have been shut down long before – preventing the distribution of a great deal of contaminated product, and an unknown number of illnesses between then and now? It can be expected that the answer is probably yes – if the FDA had done the inspections on a regular basis. But that is something that requires the one thing FDA does not have, which is resources. This case demonstrates the importance of FSMA and the additional enforcement powers granted under it to FDA in order to better protect consumer health and safety.
Some may read the letter from the FDA Commissioner and the 483 and conclude that testing product gets you in trouble – so don’t test. I hope that FDA is vocal about this and points out that is not testing that gets you in trouble, it is testing and not reacting appropriately to the results that gets you in trouble.
I hate to say I told you so, but … If you haven’t been preparing for the record-keeping and preventive controls rules of FSMA over the last two years, be ready for the consequences if FDA shows up at your door. The specifics of the provisions have not been released, but it certainly appears that FDA is stepping up the consequences of being out of compliance. They have now stepped off first base with a suspension of registration and have achieved the big bang.
There are lessons in this for all of us to avoid getting a letter from the FDA Commissioner that starts with “The U.S. Food and Drug Administration (FDA) hereby suspends the registration for your food facility.” So let’s make the best of those lessons as we interpret the FDA actions, and, at the same time, urge FDA to be vocal about the expectations that they have, so we all benefit from these unfortunate situations.
Did you know…
In a November newsletter, we made a call to industry to pick up its role to educate consumers, citing the French GMO study that linked genetically modified corn to cancer was, at first, highly cited by the media, and then began being declaimed as fraud. Last week the European Union’s food safety agency (EFSA), definitively rejected the report, stating that it did not meet “acceptable scientific standards.” The agency’s assessment listed weaknesses of the study as “unclear study objectives, the low number of rates used in each treatment group, a lack of detail on the feed and treatment formulation, key information missing on the statistical methods employed.”
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The U.S. Food and Drug Administration (FDA) hereby suspends the registration for your food facility… by David W. K. Acheson is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License.