With this post, we’d like to say that we're not trying to make a political statement for or against anyone. We're simply trying to assess the new dynamics unfolding in Washington and how that might affect the companies we serve. We consistently see a lot of interaction from various government agencies with TraceGains content, and we appreciate the work that you've done and continue to do to implement FSMA. It's important work and we know your jobs aren't easy. With that said, we invited Marc Sanchez, FDA and regulatory attorney, to help us sort out the likely and unlikely.
With FSMA, we’re now at a stage where we’re not talking about rules that are coming out anymore, but rather discussing implementation instead, and particularly at this stage, discussing what is at risk with the change up in D.C.
A lot of news being published lately tends to go back and forth with the Republican Congress and the Republican president in regards to FSMA rules specifically, so for the food and beverage industry, it's good to get clarity on what parts of FSMA may be at risk—what we like to call “FSMA soft spots.”
This is a relevant and really pressing topic, as we now have single party control in Congress and within the executive branch, which has not happened in quite some time. And one thing we can all agree on is the fact that these first couple of weeks into a Trump presidency has been, admittedly, a wild and unpredictable time, even unorthodox in the approach. This leads us to wonder how much can be done and how much is feasible to do with regards to FSMA. There hasn’t been much discussion regarding the FDA so far, so the goal of this post is to get into what seems likely/unlikely, and to provide tips on how you can plan for your 2017 and FSMA implementation.
So far within this administration there have been a number of executive orders and staff changes quickly being executed. What we know for sure, in terms of what changes are coming to the FDA, is that there will be a new FDA commissioner. There have been at least two potential nominees discussed by the transition team that are yet to be put forward, but this is a change that is inevitable, and with new commissioners we get new ideas and changes regarding how an agency is run.
Starting immediately—the day of the inauguration—the Trump administration took the steps necessary to delay and reconsider/undo numerous regulations/policies as they issued a “regulatory freeze pending review” memo from the Chief of Staff. This really looked at regulations that were either in consideration, pending finalization, or were under review.
Additionally, there have been some general statements indicating a goal of deregulation, with ad hoc numbers alluding to a reduction of 80% in the total number of regulations put forward. We’re still trying to figure out exactly what that means, but there is a clear intent to stop regulation at this current stage and to deregulate some of the areas that have active regulation.
How Much of FSMA Is Regulation?
What does it mean when politicians talk about regulation? It can be an ambiguous term that they use to talk about anything an executive agency does. It's kind of getting back to basics to remember what exactly politicians mean when they throw around the term “regulation.”
Because FSMA, like so much of regulation, is a hybrid of statute and rulemaking (FSMA, as a body of law, was passed by Congress and signed into law by President Obama), it was not a complete package. Some items were effective immediately without FDA rulemaking—items like the FDA's mandatory recall authority—and other parts needed the FDA to expound upon through the rulemaking process.
So, FSMA might have said something like, "We need a rule on produce safety," but did not detail the 175-page produce safety rule with all of its detail. Instead, it was simply a request for the agency to make that rule. So, FSMA is a statute. The rulemaking comes from the FDA which goes through the notice and comment period. We all remember the past two years we spent going through the seven core rules of FSMA, attending meetings and webinars with the FDA, combing through the comments that were published, sifting through revised rules, and finally getting to the finalization point with all these rules.
It's key to understand what came from Congress and what came from the FDA in terms of what's at risk for this deregulation topic that we keep hearing from the new administration.
What about guidance documents?
One thing to note, guidance documents are not regulations. They're the least authoritative, the least formal type of “regulation” (if we want to call it that), and they don't impose new rules, they don't oppose new requirements. They're simply the FDA providing a discussion on either an application process or qualifications for certain programs or interpretations of certain rules to attempt to help industry comply with rules. They are recommendations only.
On the extreme side of things, we’ve heard some chatter regarding the possibility of the total elimination of an agency. Is there a possibility that parts of an agency be either budget-wise or administratively removed? For example, could we potentially see the Center for Food Safety and Applied Nutrition be abandoned and thrown away? The short answer is likely, no.
The elimination of an agency cannot be done unilaterally through executive order. Any sort of agency change or agency reconfiguration has to go through Congress. This isn’t to say that Congress may not have the appetite to change the FDA, but it would be a real surprise to see the FDA reconfigured through a congressional action.
What is more likely to happen are a couple of things:
1. Personnel Changes
The new FDA commissioner will most likely be named in the next couple of weeks and confirmed shortly after. This person typically has more of a drug and device background versus a food background, but will still have some enforcement priorities or other priorities for the Center for Food Safety and Applied Nutrition, which could include new personnel in director positions, as well as various other personnel changes. All of this is likely.
2. Cut the Budget
We also have Congress' ability to dramatically reduce the FDA budget, which can in effect starve off portions of programs or portions like the Center for Food Safety and Applied Nutrition. The question then becomes, "How much does this new Congress want to do, and how quickly?"
For example, it appears their number one priority is to repeal the Affordable Care Act, which can in turn push FDA budget items down the pipeline of priorities. But this is something that can happen and there are remedies for it.
The ability to repeal any of the core seven rules of FSMA is unlikely. The seven core rules are not subject to the regulatory freeze memo mentioned above because they are final rules. Repealing a final rule is very, very difficult to do administratively. For example, the Trump administration could start a process to vacate and reissue a rule. What they must do at this point is get a court order to start the process. Additionally, they must have a scientific justification for why the first rule was wrong and why the new rule is right. This is very hard to do in the case of the FSMA rules because the FDA was very robust in their scientific rationales and very detailed in why the rules were needed.
But if there are scientific reasons, they would then have to go through the notice and comment period, just like the original rules did. This intense process makes it seems very unlikely that this sort of initiative would be successful.
It is possible, however, that FSMA as a statute could be repealed. It's a highly political move. There are a lot of people within the industry that understand the benefits of FSMA. It is onerous and a pain to put into implementation, but that's regulation in general.
What Does 2017 Look Like?
The main takeaway for our readers is to state that FSMA is still good law. We're going to hear a lot about deregulation, changes in priorities, etc. It's been amazing to see the amount of news generated from this administration and its new Congress in just a couple of weeks. So, within that shuffle, don't lose sight that you do have compliance and implementation deadlines, and you do have FSMA obligations—these haven't changed.
As we are in the implementation phase, there are a good amount of questions regarding how to apply the broad requirements within some of these seven core rules to specific products or specific operations. With such diversity within the industry, the FSMA Technical Assistance Network is going to continue to receive lots of questions and provide clarity on how to comply with these implementation parts of FSMA.
What can be anticipated for this coming year are FDA inspections. These are going to continue to go on, and are going to continue to be FSMA-geared inspections looking for compliance with the FSMA requirements. So, in 2017, expect more FSMA warning letters and perhaps more FSMA-related recalls.
It's going to be a very busy year with lots of FSMA things to do! As an industry, we have enough to focus on without necessarily thinking that any of this can change. We really encourage you to continue to look for draft guidances, continue to reach out to the Technical Assistance Network, and to continue your implementation program.
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