U.S. Food and Drug Administration Commissioner Margaret Hamburg Thursday warned of more outbreaks and import problems if food safety is not properly funded and defended a proposal to collect registration fees to help pay for oversight.

During a House appropriations hearing on the FDA’s budget, which is increasingly supplemented by fees aimed at drug makers, lawmakers questioned Hamburg about whether her agency would have enough resources to implement the sweeping Food Safety Modernization Act.

Rep. Sam Farr (D-CA), who represents Salinas, known as “America’s salad bowl” for it’s extensive fruit and vegetable production, asked the commissioner what would happen if FDA fails to get increased funding for food safety.

“It’s an enormous concern,” said Hamburg. “If we don’t get the money, we will see more foodborne outbreaks, we will not be able to work with companies to put in place the kind of systems we know make a difference.”

“We know that we’ll have increasing problems with food imports that don’t meet our standards and can’t be adequately screened. We know that more problems are going to happen. We have an opportunity to get in front of the problems and address them.”

“We are not, as a nation, putting the resources into food safety as we should be,” added Hamburg. “If you look at the budget…  if you look at how much every American is paying for the FDA, around food safety, it’s about three and a half dollars per year. If you look at the benefits we provide, I think it’s worth more than that.”

The most heated exchange of the hearing was over an Obama administration plan that proposed raising $220 million for food safety funding with food facility registration fees.  Appropriators pointed out that similar proposals had failed in the past, which raises concerns about whether FDA will see a real increase in resources for fiscal year 2013.

Rep. Tom Latham (R-IA) sharply questioned Hamburg on the proposal, arguing that it was simply a food tax that will fall on consumers.

“Is this food safety fee really needed? I would argue, emphatically, yes,” said Hamburg. “Food safety is of upmost importance to both consumers and to the food industry. We know that although we have one of the safest food supplies in the world but we still have some real vulnerabilities.”

Hamburg pointed to foodborne illness statistics and “a pretty dramatic” lack of consumer confidence in food safety. “It’s a wise investment that will pay off dividends down the road that will be dramatic,” she said.

“This is not a user fee, this is an existence fee,” said Latham, noting that FSMA did not explicitly authorize registration fees. “I just don’t understand what vehicle you’re going to use to authorize this fee.

“Why don’t you just ask for money rather than do something you know is not going to happen?” Latham asked.

“Well, if you want to give us the appropriations we’d be glad to have that,” said Hamburg, adding that she believed the registration fees were “an appropriate cost of doing business” and pointed out that drug companies also pay registration fees.

Using the same points raised by the 33 food industry groups who recently wrote to the subcommittee, Latham continued to press the issue: “You understand this has been rejected twice by Congress?”

“I am concerned about that,” said Hamburg. The exchange continued for several minutes.

Later in the hearing, Rep. Rosa DeLauro (D-CT), former chair of the subcommittee, ardently made the case for granting FDA regular appropriations.

“We could increase the budget authority!” she exclaimed, incredulously. “Quite frankly. I’m appalled with what the budget provides for food safety… I believe this is an abdication of our Congressional responsibility.”

“Those fees are not going to be approved. Without that where do you go?”

If FDA were able to pursue a registration fee, Hamburg did give some hint as to what the fee might look like.

“It would most likely be a fee that would very much reflect a number of important factors, including size of the company, levels of production, etc,” said Hamburg. “What we would hope to be doing is what we’ve done successfully with drugs and devices where we sit at the table with industry and the different components of the food system…and identify what are our goals? Where are the gaps? How can we best address them?”

  • Well I don’t see why they need such a huge money. Although, I understand their concern that they need it to make preventive measures on implementing FSMA. I hope they don’t plan to put this on the customers.

  • don gordon

    More funding? FDA’s first priority should be becoming more efficient. FDA conducts about 12,000 high risk food inspections/year. There are approximately 250 work days. This yields 48 inspections /day. There are 18 Districts which results in about 2-3 inspections per day per FDA District Office. This could easily be doubled if FDA reduced or virtually eliminated inspection reports. The current CSO spends as much or more time writing reports than conducting the actual inspection.

  • It would be useful for FDA to bolster their caser that more money means greater food safety. The FDA has in recent years initiated mandatory HACCP for juices and seafood. These required a lot of resources for program development, implementation and inspection. What were the results of these in terms of food safety incidence?
    Also how does FDA attempt to “get in front of import problems” By doing more testing? By placing more inspectors abroad? By more cooperation with foreign governments? These things are already done to some extent. How effective are they?

  • Ken Appel

    With millions of increased shipments every year due to globalization combined with the FDA’s inability to inspect them (I think it is less than 2% of all food imports) there can’t be any doubt that the incidence for pathogens in the food supply will rise. The question remains how to deal with it.
    Getting the food industry to where drug manufacturing is may be a long haul. For the most part, pharmaceutical companies are self regulating when it comes to compliance but this did not happen overnight. Deadly problems, followed by many regulations with industry’s financial support (willing and forced) led to where we are today.
    The trouble with arguments between the FDA and Congress is the inability to quantify the problem. General statements are met with skepticism because there is nothing below the surface to sink your teeth into.
    The resources for an FDA upgrade to become more efficient – new computer systems, track and trace reporting, revamped SOPs, and yes, more headcount – may be so great that these band aide measures will do very little to decrease the threats. There is nothing like a human tragedy (e.g. listeria outbreak in cantaloupe kills 30 people) to drive policy.

  • James Meehan

    The role of the FDA in food safety cannot be argued. However, when cuts are being made to social and health services, I think an effort should first be made to increasing agency productivity. I do not understand the recent increase in middlemen (between CFSAN and White Oak) when increasing the number of investigators/investigations and just applying already available methods and criteria can make a big difference.