Congress may deny funding in looming budget battles

By MATEUSZ PERKOWSKI

Capital Press

A new food safety law has theoretically increased the Food and Drug Administration's power, but questions remain about the agency's ability to use that new regulatory muscle.

The Food Safety Modernization Act would increase inspections of foreign and domestic food facilities, establish a food-tracing system and expand the FDA's access to food-handler records, among other provisions.

The bill was signed into law by President Obama in early January, but its implementation will depend on appropriations from the new Congress.

Concerns about the federal deficit will likely prevent full funding of the law, said John Bode, a food and drug law attorney in Washington, D.C., and a former USDA official.

"There will be big budget pressures," Bode said at the recent Northwest Food Processors Association trade show in Portland.

The new law gives the FDA broad discretion in regulating the causes of foodborne illness, but monetary constraints will probably limit the agency's actual enforcement, he said.

"Nobody is more cognizant of the FDA's scarce resources than the agency itself," Bode said.

The Congressional Budget Office has estimated the bill would require more than $1.6 billion in federal spending between 2011 and 2015.

New fees charged to domestic and foreign food companies are expected to generate about $240 million, partially offsetting the cost to FDA, according to CBO. However, that would still leave more than $1 billion in new FDA activities not covered by fees.

In addition, other federal agencies -- like the Environmental Protection Agency and Centers for Disease Control -- would have to spend $335 million on new programs, bringing the federal government's net cost to roughly $1.4 billion, according to the CBO.

Aside from funding, complying with the logistical and managerial aspects of the new law will be no simple feat.

"There's a tremendous amount of work to come," Bode said.

Increased inspections alone will be a handful for the FDA.

Last year, for example, the agency inspected roughly 100 foreign food facilities, Bode said. The new law calls for that number to rise to 600 facilities in 2011 and then to double annually for five years.

The CBO projected that roughly 50,000 domestic and foreign facilities would need to be inspected annually by 2015, up from about 7,400 in 2009.

Expanding inspections at that rate will be very challenging to do in a competent manner, Bode said.

The FDA must also embark on a massive rule-making effort to pound out the details of the new law, often on an ambitious schedule, he said.

Within a year, the agency must propose new rules for the "safe production and harvest" of certain raw fruits and vegetables.

In that same time frame, the FDA must develop a system for importers to verify the food safety procedures of their foreign suppliers.

The law requires food facilities to analyze their safety vulnerabilities and then develop preventative controls. The agency must develop regulations for these plans within 18 months.

Every two years, the FDA will have to review the most relevant scientific data on public health to "determine the most significant foodborne contaminants."

Based on these studies, the agency will issue "action levels" for such substances, which are basically thresholds that -- if exceeded -- will prompt the agency to pull food products from the market.

"What we're seeing is a system where the FDA will develop new action levels," potentially for substances that aren't currently considered contaminants, Bode said.

Although the new law's provisions give food manufacturers a general sense of the future regulatory landscape, the full impact won't be known until details emerge, said Mark Hooper, supply director at the Pinnacle Foods processing company and former chairman of NWFPA.

"Those are big questions. What are the rules actually going to say? And what's going to get funded?" Hooper said. "It's coming. It's big, but we don't know how big."

Pinnacle has about 1,400 food suppliers, many of them overseas, so import rules will be of major importance to the company, he said.

Heightened scrutiny of foreign suppliers may convince some food manufacturers to return to buying ingredients from U.S. growers, but in many cases domestic sourcing still won't be practical, Hooper said.

"There are commodities that are only available offshore," he said.