The FDA Perspective: A Look Back at FSMA’s Origin

Even before the Food Safety Modernization Act (FSMA) was signed into law on Jan. 4, 2011, the Food and Drug Administration (FDA) was preparing. In fact, when Michael Taylor was appointed as FDA’s senior advisor to the commissioner in 2009 (then deputy commissioner for foods and veterinary medicine in 2010), he accepted the position with the expectation that FSMA would be passed “sooner rather than later,” and it would become the central mission of FDA’s food program. “So a lot was going on to prepare well before the law was enacted,” said Taylor, who now co-chairs the board of directors of STOP Foodborne Illness.

FSMA called for a mindset shift, one that required a fundamental change in FDA’s approach to food safety, he said. It shifted the traditional system of inspect/enforce/react to a system based on the central aspiration to prevent foodborne illness. This not only meant a different set of rules, but also a different way of looking at the mission to protect public health, he said.

Additionally, Taylor said, the spinach E. coli outbreak of 2006, which had been instrumental in catalyzing the politics of getting FSMA enacted, had shifted some elements of the produce industry from resistance to regulation into a mode of wanting regulation. “So when I came in, the agency was already thinking about how to regulate produce safety even without FSMA. So FDA started developing a produce safety rule even before FSMA was enacted.”

Once FSMA was enacted, FDA prioritized the top seven rules it felt to be most important to finish quickly. The goal was to meet the dozens of statutory deadlines as fully as possible, but, Taylor said, “we were really quite explicit at the time that meeting all the deadlines was not doable. That was just not remotely possible, but we wanted to move as quickly as we could on the major rules.”

So FDA set up working groups for each rule with representatives from different areas of FDA. “It took the rulemaking completely out of the normal sequential drafting and review process that typically occurs at FDA — and helps make rulemaking a lengthy process — and brought all the elements that go into rulemaking into one integrated set of committees,” he said. “It was a daunting task with an incredible list of deliverables. And that work still goes on.”

Produce Safety Rule.

There was a strong consensus from the manufactured foods sector at the time FSMA was enacted that the new preventive controls framework was the right way to go. In the produce sector, there was less clarity and unity around both the need for and manner of regulation, Taylor said. Trying to move a sector that had no federal regulation for food safety (other than for pesticide residues) to being under a comprehensive preventive regime generated a lot of questions and concerns. Not only were (and are) there vast regional differences on farms in terms of food safety problems, agricultural systems and scale of production, but there was, he said, “a politically powerful sustainable ag community that initially just wanted to be left alone.”

So Taylor invested a great deal of time in outreach, visiting farms and meeting with farmers in more than half the states, hearing from a wide range of people in different settings. From the visits, he made the decision to repropose the produce safety rule, despite the time pressure FDA was under. Realizing there were ways to improve the rule, he said, “that decision helped make the rule better. It also showed we were listening and trying to get it as right as we could.”

Even with all the work that was done, Taylor said, “when I look back, I realize we didn’t know as much as we needed to know on produce safety. So, while the produce rule has some very sound elements, we didn’t come up with all of the right regulatory strategies to be successful.”

For example, FSMA identifies, and the rule addresses, key vectors of contamination (such as animals, water, worker hygiene and soil amendments), but, due to the great diversity of produce operations across the country, the rule necessarily leaves the risk assessment and intervention decisions in particular situations largely to the grower. This framework can work in a lot of settings, but is not working for leafy greens, he said, as this sector often involves very large-scale production in the vicinity of animal agriculture, which has contributed to numerous illness outbreaks, despite FSMA’s prevention mandate. “The proximity of dairy and cattle operations to leafy green fields is an unsolved food safety problem that requires business and policy decisions that are probably beyond the reach of the Produce Safety Rule to compel in its current form,” Taylor said.

“FSMA creates a very solid, very appropriate prevention framework for most of the food system, and it is having a tremendously positive impact in manufacturing,” he said. “But the produce sector illustrates that we’re not there yet in terms of the food system as a whole and having the right set of policies and strategies for food safety.”

“When I look back, I realize we didn’t know as much as we needed to know on produce safety.”Michael Taylor, Former Deputy Commissioner for Foods and Veterinary Medicine

Traceability.

One rule that Taylor chose not to prioritize — and was publicly open about — was traceability (Section 204). As written by Congress, the section specifically precludes FDA mandating true real-time full-value chain tracing. It is more about restricting what FDA can do for traceability then about empowering FDA to act. “That remains a critical issue today,” Taylor said. FDA did the best it could in its recently proposed rule, he said, “but the fundamental conceptual flaw is that FSMA continues to treat traceback as an investigation that FDA does rather than making it an obligation of the industry to provide timely and accurate traceback information.”

So, once the Centers for Disease Control and Prevention identifies the food vehicle it believes associated with an outbreak, FDA will still have to do its “persistent shoe-leather investigation” up the chain, searching for the documents and disparate records that can lead it to the source, and only then hope to contain the outbreak and discover the cause. “It is a step-by-step, time-consuming investigation,” Taylor said.

Because of the statutory limitations in Section 204 of FSMA, Taylor saw it as less important to prioritize the traceability rulemaking as he felt it would not make as much contribution to public health as other required rules. “I think traceability remains an open issue, particularly for sectors like fresh produce items grown outdoors that are inherently high risk,” Taylor added. “We still haven’t solved traceability. And FDA alone can’t solve it under current law.” If there were a clear business commitment in industry to solve it, the proposed rule might help, he said. “But for reasons that I continue not to understand, there has not been sufficient will across the produce value chain to fix the traceability problem.”

Funding.

Another barrier to FSMA’s success that continues today is lack of adequate funding. Despite the amount of time Taylor and others spent working with the budget process within the administration and with Congress, FSMA implementation remains funded at about half of what the Congressional Budget Office estimated would be needed. “We were creating entirely new produce safety regulatory programs, entirely new importer regulatory programs, brand new inspection frequency mandates, including a massive foreign inspection mandate — and you can’t just do that out of thin air,” he said. “Congress and the administration have fallen far short of funding FSMA to the level that is needed to implement the law successfully. That’s a huge remaining issue.”

Developing and implementing the rules of FSMA was a tremendous learning experience and took a lot of effort by a lot of people at FDA and across the food industry. But the most memorable part of it all for Taylor were the farm visits, the farmer discussions and the many interactions with a wide range of other food system stakeholders. “That was the most educational and gratifying part of the experience for me,” he said.