FDA will ask Congress to increase funding for implementing food safety reform, with particular interest in expanding the fees imposed on industry, Deputy Commissioner for Foods Mike Taylor says.

"We know we'll need additional resources to fully implement this law," Taylor said Jan. 27 at a Food and Drug Law Institute conference in Washington.

"Make no mistake, resources … will be a continuing issue as we work to build the new food safety system contemplated by the new law," he added.

But budget concerns and opposition by members of Congress to imposing additional fees on industry likely make FDA's request a long shot.

While Congress passed the law with fees required only from firms with facilities that fail initial inspections and must be re-inspected, the House food safety reform bill, which followed the Obama administration's recommendation, would have imposed additional fees.

"We'll be working with Congress on both the appropriation side, and we'd like to revisit the fee issue that was addressed in the House bill but didn't make it in the Senate bill," Taylor said.

Not only did broader fee requirements not make it in the law, but key backers said Senate approval depended on imposing only the targeted re-inspection fees.

The House bill called for industry to pay annual registration fees in addition to fees for FDA's inspections of firms' facilities and for re-inspections when necessary (Also see "Final Item On Congress' Food Safety Menu: Passing Enforcement Reform" - Pink Sheet, 3 January, 2011.).

Indeed, the administration's FDA budget proposed for fiscal 2011 included $182.8 million in broadly applied food registration and inspection fees and $6.5 million in more targeted re-inspection fees. The $1.04 billion for food programs would be a 32.9% increase from fiscal 2010 (Also see "FDA Budget Request Shows Optimism For Broad Food Safety User Fees" - Pink Sheet, 8 February, 2010.).

Congress passed the food safety law with a Senate-authored provision explicitly exempting dietary supplement manufacturers from the hazard analysis and critical control point rules now imposed on all food product manufacturers. Food safety reform leaders in the Senate said HACCP provisions would be duplicative for supplement firms because of the supplement good manufacturing practices FDA published in 2007.

Priorities Among Many Provisions

Taylor observed that with more than 50 regulations, guidances, programs and reports to Congress required by the law, "we do have to set priorities."

"We'd like to revisit the fee issue that was addressed in the House bill but didn’t make it in the Senate bill." – FDA food programs chief Taylor

He said FDA is prioritizing "the key building blocks for prevention" by focusing on rulemakings for food safety standards, prevention controls at food facilities and an oversight system for food product imports.

Further, the agency will be "ready to use new administrative enforcement tools within the timeframe in the law," Taylor added.

Rare Use Of Mandatory Recall

But for one of those tools – mandatory recall authority – the threat of use appears to have as much enforcement power as its actual application.

Taylor, an advocate for a preventive approach to food safety enforcement appointed to head all FDA food programs in January 2010, emphasized the agency does not expect to make mandatory recall orders on a regular basis.

He pointed out "there are plenty of examples of companies who are slower, not as responsive and whose behavior needs to be changed by the knowledge that FDA has that power."

"We don't expect to exercise it much because … that power is backed up by civil penalties and by the fact that companies are required to pay the costs of our overseeing the mandatory recalls," Taylor added.

"When FDA requests a recall, and has a safety concern as the basis for it, and is prepared to go public with that information, there are very few companies that want to commit the suicide that one commits by defying FDA on safety issues."

Food and drug attorneys at the FDLI conference also predicted rare use of the mandatory recall authority.

Stuart Pape, a partner at Patton Boggs, said firms previously could wield some advantage when FDA requested a recall.

"FDA now can say, 'If you don't agree, we are prepared to issue a mandatory recall,'" Pape said, adding that "it makes no sense whatsoever" to disagree with FDA on recall issues.

"You'd have to be the most stubborn person on the face of the earth to get yourself to a position where you are subject to a mandatory recall," he said.

More than mandatory recalls, FDA's new authority to suspend a firm's registration, required annually under the law, could have impact.

After FDA suspects a problem with a food product from a certain firm and finds conditions at a facility "that are broadly violative with substantial correction needed, it becomes a form of administrative injunction because the effect of suspending the registration is to make it unlawful to have product from that facility move in interstate commerce," Pape said.

While the threshold for suspending a registration is the class I recall standard – a food presents a reasonable probability of causing serious adverse health consequences – FDA is not likely to use this enforcement for all class I food recalls.

However, registration suspension allows FDA to move quickly in order to prevent problems such as the unprecedented recall of food products linked to the Peanut Corp. of America's distribution of salmonella-tainted peanut ingredients. PCA-linked recalls started in early 2009 and extended through 2010 by hundreds of companies along the supply chain that sourced ingredients or finished products from the firm (Also see "Attention To Details Helps Firms Conduct "Short And Sharp" Recalls - Experts" - Pink Sheet, 8 March, 2010.).

"A soon as FDA people hit that facility and saw what it looked like, if this provision were law that would have given rise to their ability to suspend the registration immediately, make it illegal to ship any product out of that facility, not have to rely on state officials to do that, not have to go to court – this is all administrative, there is no court involved," Pape explained.

FDA Has Momentum, Will Need Money

Taylor said the agency began working on implementing provisions of the law before Congress passed it.

FDA has "considerable momentum" on establishing the authority added in the law, he said.

"There is a lot FDA can and will do to put the new law into action, to building the foundation of the new system within our current resources. But completing the system … will require new resources and new investment over a period of years."

The Congressional Budget Office's estimate of $1.4 billion for FDA's food safety enforcement costs in the next five years does not match agency expectations, Taylor said.

"That's a whole new system of oversight to enforce. We cannot possibly create that whole cloth without resources. It's going to be a big issue for the next few years," he said.

Funding for all federal agencies will be a big issue with President Obama suggesting a five-year freeze on agency budgets during his State of the Union address Jan. 25.

FDA and other federal agencies are operating on a continuing funding resolution that expires March 4. The CR held appropriations at fiscal 2010 levels, and increases for the rest of fiscal 2011 as well as for fiscal 2012 are unlikely as the Republican-majority House likely will propose substantial budget cuts.

The White House proposed an overall FDA budget of $4.03 billion for fiscal 2011, a 22.8% increase over the 2010 appropriation. The total includes direct or appropriated funding of $2.51 billion, a 6.2% increase, with the remainder from fees.

By Malcolm Spicer

FDA's Food Safety Reform Needs More Funding – Mike Taylor

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