Sunday, June 26, 2011
Taylor Talks FSMA Implementation, Funding
Food and Drug Administration "food safety czar" Michael Taylor expressed cautious optimism Monday that FDA can resolve what has become a primary concern: a huge new regulatory mandate coupled with the threat of no resources for implementation.
Taylor told an audience of state and local food and drug officials that while the funding to implement the newly enacted FDA Food Safety Modernization Act -- a sweeping new responsibility for FDA -- remains uncertain, the agency remains optimistic that "at the end of the day, it won't be so dire."
As he has several times in outreach speeches to the food policy community, Taylor pointed out that FDA has a "a huge workload." And even though public health officials are working hard, the agency will likely not meet all of its deadlines. On top of the back log, FDA has no idea what its budget will be for fiscal year 2012. An agriculture appropriations bill that cleared the House last week would cut food safety programs $87 million below fiscal year 2011.
Under FSMA, the agency has to craft standards for produce safety and preventive controls, establish a risk-based inspection program, conduct a traceability pilot, and the list goes on.
"This is part of the empathy-inducing aspect of the law, because it is, in fact, a huge work load. But one that we readily embrace," said Taylor in his remarks at the opening session of Association of Food and Drug Officials conference in Plano, Texas.
"There's a lot of work going on. People are energized," added Taylor, emphasizing, again, that it is "impossible to meet all the deadlines."
"The reality of our resources and the processes of getting rules cleared...it's physically impossible to do all of them," he said. The FDA is working to prioritize these issues and push through "the most essential building blocks" first.
All of these initiatives, of course, depend on resources.
"[The resource challenge] is a serious one," said Taylor. "We have been given really a whole new job...been given a mandate to build a whole new system of food safety oversight."
"While we build on a strong foundation and we have a base of resources that we can do a lot with, you can't build a new house without new financing," he said. "You can't pretend that all the new programs and systems that this law calls for can be achieved without new resources."
Without more funding, FDA can still create regulations, though rulemaking could be delayed, according to Taylor, but it remains to be seen whether the agency will be able to build the capacity to enforce them.
"I think we all know that words on the page don't make food safer," said Taylor. "What do you do to make those come to life? What investments do we have to make to make those regulations come to life so they can have the effect we want them to have on strengthening food safety?"
Taylor pointed to the need for real investments in science and research as well as state and local capacity as critical elements of the new system.
"Again, you can't do this without the resources. The current budget situation does paint a challenging picture," said Taylor, noting that a patchwork of continuing resolutions to keep the government funded -- as we saw in 2011 -- makes it nearly impossible to plan ahead.
"When Congress gives us our budget over half way through the fiscal year it's very difficult to use that money in as orderly a way as possible. You cant use that money to hire the experts you need because the hiring process is such that you wont get them hired until the end of the fiscal year." All of this compounds the resource issue.
"We just have to work together to figure this out," said Taylor. "We can make good, efficient use of whatever we've got, but figuring out a way to get a more predictable flow of resources is crucial for all of us."