Part II of a conversation with Michael Taylor, deputy commissioner for foods at the U.S. Food and Drug Administration, on a variety of issues facing the agency. 

Q: The agency’s getting a lot of heat, both from public health advocates and the media, over antibiotics in animal agriculture. This issue doesn’t seem to be going anywhere, even with the cephalosporin announcement. Why isn’t FDA taking bolder action here and what additional science, if any, would you need to back up the action that these groups want you to take?

A: The FDA really considers this an important public health issue. We need to implement the strategy we laid out in the draft guidance we published in 2010, which is a strategy for phasing out the growth promotion, or feed efficiency, uses of medically-significant antibiotics, ones that are important for human medicine. We’ve got to phase these so-called production uses out and we need to bring the remaining uses of medically-important antibiotics under veterinary control.

We think this is a strategy that protects both human and animal health. We’ve been reaching out to constituencies – the animal drug industry, the veterinary community, the animal production community – to craft a strategy. We do believe we can make serious progress, rapidly, through this voluntary phase-out strategy.

We are committed to that, we expect to be moving forward on that in the coming months. And, again, we haven’t taken the regulatory options off the table. We can go label by label, product by product…but what we know is that going that route, based on past experience, is a very legalistic, drawn out process and we think we can make progress more rapidly with the strategy we’re pursuing.

Q: Is that what you’d have to do, legally, you’d have to go through and formally withdraw each product individually?

A: Yeah. These are products that were approved by FDA, that first came in 50 years ago and they were approved for these uses. In order to remove them through a regulatory, legal process it requires having hearings for each approved use. You’d have to marshal the evidence, have a formal hearing before an administrative judge with lots of lawyers and lots of legal back and forth. And it costs millions of dollars and takes years to do each one.

There’s been real progress in the community on this issue. There’s a whole market phenomenon….Major retailers wont buy product that’s been treated for these purposes. There’s an international recognition – major areas of the world won’t accept product that’s been produced in this way.

I think what we’re seeing in the industry in this country is that it’s time to solve this problem. We’re optimistic. We’ve had good dialogue with the drug companies who make these products.

I know people need to see the concrete steps, and I’m confident they will and until then people are more than entitled to push us and to ask us the questions. Will this strategy bear fruit? We believe it will.

Q: You have found that both the meat industry and the drug companies have been very receptive to reducing usage? The last antimicrobial drug sales numbers didn’t show a reduction…

A: It’s a complex community out there, particularly in animal production. There’s some big operators in animal production who don’t use antibiotics for these purposes, there’s some who still do. There’s a diversity of practices out there. We regulate, primarily, the manufacturers of the drugs and we’ve had a positive dialogue with them. We’re also working closely with the American Veterinary Medical Association (AVMA).

We want to bring the remaining uses, the legitimate prevention and treatment uses, under veterinary supervision. So AVMA is working very positively with us. We have a lot of reasons to be confident this strategy can work.

Q: Would Rep. Slaughter’s bill help FDA on this front?

A: It’s way too complicated to get into discussing the specifics of the bill. But the motivation to reduce non-judicious uses and bring judicious use on veterinary control, that’s where we need to go and that’s the track we’re on.

Q: So in 10 years, would you be able to buy medically important antibiotics for animals without a prescription?

A: Under our strategy, no.

Q: Arsenic in apple juice, carbendazim in orance juice – these are issues that have gotten high profile press coverage and a lot of consumers seem very concerned. FDA says these are things we probably don’t need to be worried about, but people remain concerned. How is FDA communicating risk and safety issues to the public?

A: These incidents just remind us that for all of the very appropriate focus on microbial pathogens and resulting illnesses, which has been the focus of a lot of our attention… with all of that focus on microbiological hazards, we cannot lose our focus on chemical hazards. FDA has an ongoing program. The two cases you mention both involve chemical hazards, but they are, as you know, very different.

One involves enforcing the tolerance system for approved pesticides and, when there’s not an approval, enforcing the law that says if there’s an illegal residue it should not be in commerce. The arsenic issue, here’s an environmental contaminant, how do you minimize exposure and be sure that exposures are at a level that don’t pose a threat to public health? I think we need to be vigilant on both fronts.

We’re focusing a lot of effort to ensure we’re focusing attention on future Brazilian imports of orange juice. With respect to arsenic in apple juice, we’re looking hard at whether we need a different, more stringent number to guide our action in regard to arsenic in juice. We need to be vigilant on these issues and I think we’re making the right efforts to do that.

Q: It seems like this whole controversy could have been avoided if we just had a residue limit for carbendazim for orange juice, why don’t we? We allow this chemical on lots of imported products…

A: As you know, EPA is responsible for evaluating the safety of pesticide residues in food and setting tolerances under a statute that controls what they do. That’s a complicated, challenging task, but there’s the ones that would make that decision. At the present time, there is no tolerance for carbendazim in orange juice. FDA enforces pesticide tolerances and so where there is no tolerance, the agency enforces the law, which says those are illegal residues.

Q: So you’re still drinking orange juice?

A: Absolutely.

Q: We’ve heard that reorganizing food safety into a single agency might be on the list of priorities for the Obama administration. You’ve served at both FDA and USDA – do you ever envision this happening, do you think that it could work?

A: My perspective is that I’m totally focused on implementing FSMA and managing the change that we’re making here at FDA and I have my hands more than full with that task.

Q: Have you heard that that is something the administration is attending to do?

A: Well, I heard it from you.

Q: Sorry, I have to ask you: what do you eat? For example, there are some food safety folks who say they will not eat sprouts… Do you have any food rules?

A: I’m married to a PhD nutritionist, so I eat lots of fruits and vegetables. But, no, I’m pretty omnivorous. I observe the practices that we recommend, in terms of paying attention to where and how food is handled and prepared. Clean, separate, coo
k and chill — I believe in that. And I try not to eat too much.

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See Part I of this interview, which focuses on implementing the ambitious Food Safety Modernization Act into action, from yesterday.