Part II of Food Safety News’ conversation with Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine at the U.S. Food and Drug Administration, covers sequestration, pet food, antibiotics and whether he plans to retire anytime soon.
A: A loss of resource is obviously going in the wrong direction in terms of our ability to move forward on FSMA. We’ve said that we can continue with the rulemaking process with current resources – though a loss of resources can slow that down and delay things – but there are impacts we’ve outlined in terms of loss of inspections. It all remains to be seen how it will play out. There’s a huge amount of contingency planning and preparation going into how to figure out how to do this. It’s a pretty complicated picture.
Q: We keep having problems with pet treats and pet food. How will the rule on preventative controls for animal feed help on this front? What does FDA hope to achieve as far as preventing these problems?
A: The animal preventive control rule is under the same authority as the human rule, so it’s based upon the same premise: that if you’re making pet food, you’re obligated to understand what hazards are reasonably likely to occur and to put in place controls to prevent those. One reason we have a separate rule for animal feed and pet food is that there are special considerations, particularly for pet food, where a product is basically the sole diet. With that, the composition, or getting the right nutrients in there, is part of safety.
With this chicken jerky treat issue – with all this imported product, and all these reports of problems, illnesses and deaths – we’re investigating to try to understand what the hazard is, to figure out what’s going on here, but these situations where you don’t know what the hazard is have to be addressed differently.
I don’t think the preventive controls rule is going to be the magic wand for the jerky treat problem that we’ve got, which we’re actively investigating. We’re putting a lot of effort toward trying to figure out the problem so we can do something about it. There was a recent report of antibiotic residues in some product. As you know we have established ways of enforcing our tolerances, or, when there’s not a tolerance set for a particular drug residue, taking action there. In a particular operation, if antibiotic residues are reasonably likely to occur, it could be part of a preventive control plan. It gets a little complicated depending on the nature of the food safety issue.
Q: I guess it’s just hard to imagine why one of these major pet food companies wouldn’t already be managing their supply chain with a preventive control system in place…
A: Without commenting on those companies, or what they’re doing specifically, I think our sense is that a lot of companies are managing their supply chains with what are understood to be best practices and a lot of companies aren’t. There’s not a uniform picture. That’s one reason why FSMA is so important.
Q: I don’t know if you saw that Reps. Waxman and Slaughter introduced a bill, the DATA Act, this week that would basically require FDA to collect more information on antibiotics used in animal agriculture – it would also require the [Government Accountability Office] to study’s FDA data collection and how well the current voluntary strategy is working. How do you think your current approach is working?
A: So we’re clear on the process: Last year we issued three documents. One was final guidance 209, which is the basic strategy, or policy we’re pursuing to work toward voluntary removal of production uses and non-judicious uses, and remaining uses going under veterinary supervision. We published draft guidance 213 to lay out the pathway for getting those uses off the label, but also getting legitimate, safe prevention uses on the label, and then we put out a draft of the veterinary feed directive to sort of streamline the rule to facilitate veterinary oversight.
We’re very committed to this initiative. We’re getting close to completing our work on the final guidance 213 and a proposed veterinary feed directive rule to amend the current rule. What we put out is a draft of codified language, and we’ve gotten a lot of comments on the draft, so we think we’ll have a full-blown proposal, with a preamble and economic analysis ready to go soon and then put into the clearance process.
Q: So that will have to through the Office of Management and Budget as well, yes?
Q: Once we actually have a regulation, how will other stakeholders know how many drug companies have voluntarily changed their labels?
A: Once guidance 213 is final, what we’re asking is that within 90 days companies let us know their intentions about proceeding down this pathway to voluntarily removing production uses from the label. We’ve proposed three years to get all the existing production uses off the label. So we’ll see. We’re very optimistic based on the dialogue we’ve been having with companies – that they will come in and we will be able to move down this pathway in a very significant manner.
The Animal Health Institute, which represents the drug industry, has been supportive of the initiative, and so we think this is the way to make significant progress. To the extent companies don’t come in, we will certainly be engaging them. We need to implement the policy direction of guidance 209 and we’ll be very actively engaged with companies to see that that happens.
Q: So you’ll look at all of the companies that have approved antibiotics with growth promotion uses on their labels and go through your checklist, on who has notified you and who hasn’t?
A: Oh yes.
Q: And then will there be some sort of progress report on how that’s going?
A: I think we want to find a way to keep be transparent and keep people posted. We want to be as transparent as we can be. There are aspects of how we interact with companies – proprietary information, for example – that put some limits on how we communicate, but we know there is great interest in how this is going. We will be as forthcoming as we possibly can within our legal limits.
Q: I don’t know if you’ve looked at the details of the DATA act, but it calls for a lot more specific information – like animal class, dosage, duration of use, etc. I know FDA has generally said it needs more data here, but does the agency need that level of detail to better understand the link between use and antimicrobial resistance?
A: We all want to have better usage data to help us gauge what progress we’re making on antimicrobial resistance – to inform the community, to inform veterinarians. More use data is good. What we’re interested in is having the dialogue on what the most useful information is and what are practical ways to get it.
I think there are complexities in how you collect this information. We published an advanced notice of rulemaking last year inviting comments on that. We’re working with other agencies, including in the NARMS context. There’s a lot going on. I haven’t looked at the specific bill introduced, but we’re open to dialogue on all fronts to figure out how we can get good, useful information to help us be successful.
Q: Are you going to retire before all the elements of FSMA are implemented, or will you see this out until the last provision has been rolled out?
A: [Laughter] I haven’t gotten that question yet. No, I’m here for the long haul. I am very committed to seeing this through. I have no plans to retire, to answer your question. I am very committed to seeing this through.
See Part I of the interview, covering the next FSMA rules and imports.
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