By Dr. David Acheson
Within an eight-month period (September 2015 to May 2016), FDA published six of the seven major rules of FSMA, which I said at the time “will literally impact hundreds of thousands of entities globally when one considers all seven new rules due out in the coming months and in the early part of 2016.” Although this was considered to be a good thing by most – and has turned out to be quite accurate, one journalist, Jim Prevor, saw it as anything but good in his 2015 column, republished earlier this month in memoriam.
As Prevor stated, “This is almost certainly a sign of trouble because it is impossible for any human being, or even any team, to have carefully considered the unintended consequences when so many entities are directly impacted.” The thought behind this was that, particularly related to produce, there was no testing prior to the passage of FSMA that determined it would have any impact on the frequency of food safety outbreaks. He was doubtful that it would actually improve public health outcomes, felt that holding producers criminally responsible for food safety issues would discourage production, and thought “those who make these policies just want the opportunity to declare they did something.” Thus, he stated, “What they actually did may be completely counterproductive.”
He was not the only one with such views. In a TAG article we wrote at the time, we cited a report on the economic viability of FSMA by Richard A. Williams, who contended that the four “most burdensome regulations” of FSMA fail to demonstrate that the benefits of the rules will outweigh their costs, thus, he believed Congress should repeal its statute.
As I stated then in relation to the report, and now reiterate for both authors, “In brief – it’s out of line.”
I’m not saying that FSMA is perfect by any means, nor that FDA didn’t have an onerous task to try to set rules to the Congressional Act – particularly with the charge to “essentially write a one-size-fits-all set of rules, and the food industry is anything but one size,” as I stated for Prevor’s column. But, having been on both the public and private sides of the industry, I believed at the time, and still do now, that we need the rules because we need consistent food safety standards. Many quality companies already fulfilled, or exceeded, the components of FSMA, but we need to have these rules for companies such as the PCAs of the world, who not only are not up to standards, but flagrantly flout them.
I also saw (and see) benefits resulting from the rules – with the caveat that I expected it would “take 5 to 10 years for us to really be able to look at FSMA’s impact objectively and be able to show benefits outweighing costs.” We are now teetering on that 10-year mark from rule publication and at least five years from the compliance dates for nearly all.
So, what are my thoughts today?
One of the important precursors for FSMA was the FDA Food Protection Plan which was published in 2007 and called for a shift in focus on food safety for FDA from a reactive regulatory approach to a preventive approach. Following the final signing of FSMA in 2011 and then the development of the actual regulations one can focus back on one of the areas I saw in 2015 as essential to FSMA’s success, my hope was that as FDA developed the rules, they really would focus on a preventive regulatory strategy with risk-based inspections and taking action in a risk-based way. Without these, I stated, the rules would be both costly and disruptive to the industry. But FDA literally wrote those words right in the title of the key human and animal foods rules: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls. And that truly is the basis of the rules, with the phrase “risk-based” appearing 247 times in the PCHF rule, and you’d be hard-pressed to find an FDA FSMA document today without the words appearing somewhere.
Unfortunately, when Congress passed along the charge to FDA to modernize the rules of food safety, it neglected to pass along the resources and funding for the agency to fully implement all the rules of FSMA as mandated. That has been an issue since its passage and remains so today.
FDA’s implementation has had its pitfalls along the way and will continue to do so. But I do believe FSMA has had significant positive impact on food safety for both the food industry and consumers. FSMA has been a mind shift to a focus on risk and prevention which allows industry to put the money where the risks are. FDA does not always see it that way and, in my opinion, we are still overburdened with technical violations that have minimal or no public health impact. In 2015, I said, “I look forward to traveling the new road of FSMA with you!” It truly has been my pleasure to work with and assist so many of you in the industry, while building a support team of experienced TAG experts; and I look forward to our continued travels through FSMA together, along with whatever else the future of the food industry may bring.
Give us a call, we’d love to aid in your travels!
