There is so much focus right now on the seven proposed rules under comment and pending final rule making that it’s easy to lose sight that some powerful provisions of the Food Safety Modernization Act (FSMA) are alive and kicking well before the proposed rules become final. For example, you may want to consider the food facility registration suspension of Roos Foods – and pause for a moment to think twice about what you believe to be your “legal rights” in an FDA inspection and suspension process.
Prior to the January 2011 signing of FSMA, FDA had to get an injunction to suspend production and/or distribution at a food facility. It is a process that could take weeks before it went into effect. But, with the authorities that FDA was given with the signing of the Act, such injunctions are no longer needed. Rather, FDA now has the enforcement authority to bypass the courts and order the suspension – as it did for Roos Food on March 11, when it issued an order to suspend the registration of the food facility. Suspension of a facility’s registration means that the facility is prohibited from introducing food into U.S. commerce by any means, including all food still under the facility’s control that was produced before or after the Order was received. So, while technically a company can still produce product, it can’t ship it.
The order was issued based on FDA’s determination that the food produced in the facility “has a reasonable probability of causing serious adverse health consequences or death to humans, and that [the] facility created, caused, or was otherwise responsible for such reasonable probability” (which is synonymous with a Class 1 recall). This is the second time that FDA has used its new authority, with the first being the November 2012 suspension of operations at Sunland Inc. after the peanut butter outbreak, a company that is now up for auction.
So what did Roos Foods do that was so egregious that it warranted this suspension? It’s typically not one thing that goes wrong that leads to a problem of this magnitude, it’s multiple factors that contribute to a problem of this size. And this holds true in this case. Roos Foods’ cheese products were linked to a national outbreak strain of Listeria monocytogenes as found through an FDA investigation and whole-genome sequencing. Although the company voluntarily recalled the products, the suspension was invoked after findings of unsanitary conditions at the company’s facility during the FDA inspection.
It gets worse–when it rains it pours—literally in this case. As noted in the FDA report, “Water was raining from the facility’s roof into the facility, including onto the cheese processing equipment and storage tank. … Water was dripping from the ceiling onto 50 pound paper bags of salt, cheese product packaging materials, and labels … rust-colored water droplets were falling from the metal ceiling, the metal support beams, pipes, and other infrastructure above the cheese vats and onto food processing equipment … The water was pooling on food contact and non-food contact surfaces.”
Whether you feel FDA’s new authority is appropriate, or you see it as an abuse of authority for the Agency to bypass the courts and the need for injunctions, it’s difficult to argue that FDA shouldn’t exercise the option for immediate action when food-contact surfaces are being subjected to a ‘rain storm’ of potential contamination. Given this, you can hardly say that FDA is running wild, wielding its enforcement authority in an unchecked manner. No one in the food industry who truly takes food safety seriously could possibly see this type of problem at Roos as being acceptable. Conversely, it is just such cases for which FSMA’s authority is intended – to give FDA the equivalent of an injunction so the agency can move fast to protect public health without the need to go through a court process that can last for weeks or months. But this also means that any food processor that has a Class 1 recall needs to be aware that FDA could use the registration suspension authority in order to put a halt to a public health risk within hours rather than months.
So is industry left without a system of checks and balances? No. The FSMA provision does also allow for the facility to request an informal hearing on facility reinstatement, however it also makes clear that this must be based on “genuine and substantial issue of fact,” not “mere allegations or denials.” Additionally, once an order is issued, no food may be distributed from any building of the named facility, including any food still under the company’s control that was produced before and after the order was received. The suspension remains in effect until the order is vacated and the facility’s registration is reinstated.
This is, however, something that every processor needs to think about, and have a plan for – should a significant recall occur. If you have a recall, your odds of being inspected skyrocket. You then better ensure that all your food safety programs including your environmental monitoring, cleaning and sanitation practices are in top-notch shape, and you identified the root cause of the recall and eradicated it. Otherwise, you risk inspectors citing you for insanitary condition violations – which are on the rise.
FDA has just begun to get its FSMA authorities. With seven rules pending, and becoming final in the next two years, we can’t say it often enough – Know how the rules will impact you, and, if you haven’t already, start preparing now for compliance. FDA is taking its authorities seriously, which can result in major repercussions for those who don’t.
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Extended Comment Periods. FDA has extended the comment period for the proposed rule on Intentional Adulteration to June 30, 2014, and that for High Risk Food Methodology until May 22, 2014. The comment period for the proposed Preventive Controls for Animal Food rule will remain at March 31, 2014, because the agency has indicated it will be re-releasing portions of this rule (as well as the preventive controls for human food) this summer.