A conversation with Michael Taylor, deputy commissioner for foods at the U.S. Food and Drug Administration, on putting the ambitious, one-year-old Food Safety Modernization Act into action.

q-a-michael-taylor406.jpgQ: While FDA seems to be making progress on FSMA, there have been a couple key missed deadlines: the produce safety rule, foreign supplier verification… What can we expect to see in the next couple of months?

A: We’ve prioritized our work. There are five major foundational rules that we’re giving first priority to and working hard to get out as soon as possible, as close to the statutory deadline as possible. There are a lot of moving parts here and we’re going to miss some deadlines, but we take the deadlines seriously and want to meet them as much as we can.

Let me just focus on these five foundational rules… two of them are the basic preventive control rules. We have two separate rules, one for human food facilities and the second for animal feed facilities, and obviously these are central to the law. The third one is the produce rule, which, for the first time, would set standards for growing practices on the farm. The fourth is the foreign supplier verification proposed rule.  This would establish a program of importer accountability, to ensure that foods offered for import are being produced under the same standards, or with the same level of protection, as our new preventative control of produce standards. The fifth in this sort of top five list is the accredited third party certification.

The first four of these rules are under review under the normal [Office of Management and Budget, Office of Information and Regulatory Affairs] review process.

Q: You don’t have a sense that they’re getting stalled there – or are things proceeding as expected?

A: No. There’s a high level of interest in getting these out as soon as we can and we’re getting a high level of attention. It’s just working through the process. There’s a lot of interest across the administration in getting the rules out as soon as we can.

It’s just the logistical challenge of getting this volume of rulemaking done and out the door at the same time. There are only so many economists, so many lawyers, so many [regulation] writers, so we’ve had to to some prioritizing, but the initial four would be a huge leap forward for implementation, and then the accredited third party certification will follow shortly behind.

There are some other important rules to come, that I think you’ll be seeing action on in 2012, including the safe food transport provision of the law, the intentional adulteration provision… there are several other pieces that we’re working on.

Q: We just saw a pretty historic and high-profile cantaloupe outbreak. Could you share some insight on how FDA reacted to this – we saw the agency’s reports – but internally, what was the reaction? Was this a Jack in the Box moment?

A: Well, this is the most deadly foodborne outbreak we’ve had in memory. It was taken for the serious public health tragedy and problem that it was. Our focus was mobilizing — working with CDC, with the states — to trace the problem back to its source and contain it as rapidly as we could. I think, actually, the system worked well to do that as expeditiously as possible, given all the challenges and constraints on traceback and the inherent challenge of these epidemiological investigations.

It was urgent, from our standpoint, to get to the source, to contain this outbreak, and to give people as much information as possible, as rapidly as possible, so they could protect themselves.

One of our themes going forward is to treat outbreaks not just as public health problems that need to be contained — to protect people, to minimize the destruction to the food supply — but as a learning experience. We’re going to do more environmental assessments, or route cause investigations, to follow up on outbreaks so that we can inform future prevention efforts.

It’s different from Jack in the Box because Jack in the Box catalyzed a big public policy shift that had not been made at the time that outbreak happened –  [towards preventive controls and accountability for pathogens]. As far as produce, the public policy shift has already happened, as demonstrated by FSMA. We know that we need to prevent and to use our modern understanding of where hazards come from and how they can be minimized to reduce the risk of illness.

The cantaloupe outbreak underscored how imperative it is to implement that policy shift — to get the rules in place, to provide that oversight, to ensure that the right practices are being observed as broadly as possible. It really underscored the huge stakes involved when prevention fails.

Q: The FSMA progress report notes that there were 20,000 inspections conducted in FY 2011, with the states as partners. The HHS Inspector General recently highlighted some issues FDA’s had with contracting with the states. For example, 10 percent of the contracted inspections were incomplete. What is the agency doing to ensure that things aren’t falling through the cracks?

A: Specifically with respect to the findings in the IG report, as reflected in the report itself, we agree with the conclusions and recommendations, there are clearly some areas where we need to strengthen the audit efforts and how we oversee the state work. There’s been a lot of progress in that area. I think it’s important to appreciate the extent to which strengthening that federal-state partnership, enhancing both the capacity and the accountability of the states to perform inspection at a level that meets a consistent national standard, is a very central priority for our implementation of the law.

It raises a broader issue when we talk about FSMA, which is very important to underscore and for people to understand: getting the regulation done is a big part of implementation, but really just the first step. The food gets safer based on the implementation of those rules and our ability to, working with the states, provide oversight and verify that those standards are actually being met in practice.  A lot of our focus is on how we can strengthen the oversight system, which includes working with states to get more of them participating in the regulatory standards, so states can meet these to harmonize.

It’s a continuing process to get states up to this level, but can pay big dividends as far as public health bang for the buck, but we have to invest in it.

Q: So how often do you run up against the fact that states are, as far as I know, not adding inspectors or expanding their workforce to meet these growing demands? They’re pretty strapped for resources.

A: We’ve run into that increasingly often. That’s a big problem. This is where, I think, there are some big decisions that have to be made. How do we maintain the state level workforce that can, very efficiently, provide oversight for the national food safety objectives? One of the important features of FSMA is that it recognized these institutional issues and how important they are. It recognized our need to define and support state capacity so we could leverage state resources. We are specifically mandated to leverage state resources. We’ve got to figure this out. How do we make the investment in the states that strengthens the national food safety effort in an efficient way?

Q: The Congressional Budget Office estimated it would cost $1.4 billion over 5 years to implement FSMA. Congress gave FDA a $50 million boost for this year. How are you feel
ing about your ability to fulfill the new mandate, not just this fiscal year but also the next? Is that something that keeps you up at night?

A: Yes. This keeps me up at night. How do we get the resources to do the several new jobs that Congress has given us in FSMA? We see doing it with a combination of redeploying and making the best use possible of current resources but also working with Congress and our stakeholders to get additional resources and that’s going to be an ongoing challenge, for sure.

See Food Safety News tomorrow for Part II of our conversation with Taylor, on carbendazim in orange juice, antibiotics, and a single food safety agency.