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Sweeping Food Safety Rules Raise More Concerns About FDA Funding

Administration looks at fees to fund FSMA implementation

As stakeholders review the landmark draft food safety rules the U.S. Food and Drug Administration released Friday – which may take a while, given that the two rules come to more than 1,000 pages with another couple hundred pages of supporting documents – there are renewed concerns about the agency’s ability to actually enforce the sweeping measures.

While the initial response from consumer advocates, industry groups, and lawmakers was positive, especially after such a lengthy delay, agency officials were repeatedly pressed  during a Friday phone briefing with reporters on whether there will be adequate resources to implement the forthcoming rules.

“Resources remain an ongoing concern,” said FDA Commissioner Margaret Hamburg, who was quick to point out that the new law was projected to save more than it would cost by preventing illnesses and outbreaks. “We hope to be able to work very closely with Congress as they shape the 2013 and 2014 budgets.”

But in the current budget landscape, the agency has little to no chance of getting funding increases at levels deemed necessary by the Congressional Budget Office. According to CBO, the Food Safety Modernization Act would likely cost around $1.4 billion over five years to implement. In the last budget, FDA received a $50 million increase, and many considered the boost miraculous in the face of rampant cuts.

In an interview with Food Safety News, Michael Taylor, Deputy Commissioner for Food and Veterinary Medicine, said that FDA absolutely needed additional resources to invest in technical assistance and education, research, and to better partner with the states: “We’ve said from the beginning we’ll need additional resources to fully implement this.”

“With produce, in particular, the state agriculture departments want to work with us to reach out and educate farmers so they’re moving toward compliance,” said Taylor. Working with state agriculture departments to ensure growers understand the new, complex produce requirements will be a feat in and of itself.

Taylor also told reporters Friday that, due to budget constraints, FDA would be relying upon state regulators to help enforce the new rules, once they are finalized. The agency is trying to build up the capacity of the states to do this type of work and better integrate it into a coordinated system, but state governments have been facing their own budget cuts, and FDA will likely be limited in how much it can help the states.

With only modest funding increases from Congress, FDA is increasingly looking at charging the food industry fees, much like it charges drug manufacturers to pay for drug regulation.  The Obama administration’s fiscal year 2013 budget proposal sought a $253 million increase, but $222 million of that was to come from food facility registration fees, which the entire food industry, from farm to factory is roundly opposed to.

“As consumers continue to cope with a period of prolonged economic turbulence and food makers struggle with record high commodity prices, the creation of new food taxes or regulatory fees would mean higher costs for food makers and lead to higher food prices for consumers,” a diverse group of food industry associations wrote to the FDA last year. “As such, we believe imposing new fees on food makers is the wrong option for funding food safety programs.”

Taylor recognizes that fees are somewhat of an uphill battle, but believes such a funding mechanism is necessary if Congress doesn’t appropriate the funding necessary to overhaul the food safety system from reactive to preventive.

“We’re not there yet in terms of a consensus around fees. We’ll continue that dialogue,” said Taylor. “It’s not for us, ultimately, to say where the resources come from. We can identify resource needs and then work with Congress, work with the industry to figure out how to meet them. Whether it’s fees or appropriations or some combination, the important thing is to get the resources into the program.”

One of the big problems with transforming the food safety system is that inspections, including domestic, but especially abroad, are extremely resource intensive. Under FSMA, the FDA is supposed to double the number of inspections it conducts for the next few years. So far, the agency has been able to meet that mandate, but it will become increasingly difficult to meet those benchmarks, according to Taylor.

The new law gives FDA an inspection frequency mandate for food facilities, based on risk, but there isn’t one for farms or produce packinghouses  (farms and on-farm packinghouses do not have to register with the agency, so FDA won’t have a database of these companies). This all might mean that there will be very limited on-farm inspection once the rules roll out.

“From a resource standpoint, there will be a limit to the frequency of produce inspections,” said Taylor. “They will be very targeted.”

Just how will FDA target these inspections? There will be multiple factors, according to Taylor, who said the agency plans to be transparent about how it designates high-risk produce products. Past outbreaks and data on contamination rates will be part of the equation.

© Food Safety News