CongressNow: "Democratic Food Safety Bill Faces Questions From All Sides"

Democratic Food Safety Bill Faces Questions From All Sides

By: Stephen Langel

CongressNow Staff

Thursday, April 24, 2008 2:30 PM

During the first hearing on a Democratic draft food, drug and medical device safety legislation today it became clear that the bill faces obstacles on all sides — lawmakers from both parties, the administration and industry among them.

At issue is the Food and Drug Administration Globalization Act, which builds upon earlier legislation to address worries about tainted food and drugs coming into the United States.

While all the parties at today’s hearing of the House Energy and Commerce Subcommittee on Health agreed that changes were necessary if the Food and Drug Administration is to improve its handling of imported food, they also shared many of the same concerns, including the likelihood that new fees would increase food costs and the possibility that port-of-entry restrictions would hurt certain states’ economies. The FDA added that the bill should take a more focused “risk-based” approach to inspecting facilities.

Rep. John Dingell (D-Mich.), chairman of the House Energy and Commerce Committee; Rep. Frank Pallone (D-N.J.), chairman of the Subcommittee on Health; and Rep. Bart Stupak (D-Mich.), who chairs the panel’s Subcommittee on Oversight and Investigations, introduced draft legislation last week addressing the safety of imported food and drugs. Today’s hearing addressed the food portions, with discussion of the drug and medical-device provisions on tap for next week.

On food safety, the bill would give the FDA authority to issue mandatory recalls of tainted food. The legislation would also create a food registry for all food facilities within the U.S. and require that these companies pay $2,000 per year as part of registration. This fee would provide the FDA with an estimated $600 million annually for food safety.

Also, all foreign and domestic food facilities would be required to have safety plans in place that would be subject to a mandatory FDA inspection every four years. Furthermore, importers would have to get their products certified by FDA-accredited food safety agents or be restricted to only those ports that have federal testing laboratories. Importers would also have the option of meeting security requirements in order to secure fast-track importation into the U.S. market.

Among those questioning the new fees were Rep. Joe Barton (R-Texas), the ranking member of the full committee; Rep. Nathan Deal (R-Ga.), the Subcommittee on Health’s ranking member; and Calvin Dooley, president and CEO of the Grocery Manufacturers Association.

They said they worry that the new fees will lead to higher food prices for the public, which they said is especially problematic during uncertain economic times. Rep. Darlene Hooley (D-Ore.) agreed that the fees were a concern, suggesting that they should be assessed on a sliding scale based on a company’s size and should not be assessed at all on smaller firms.

A mix of Republicans and Democrats also criticized a provision in the draft language that would limit the ports of entry that products could pass through if an importer does not get its products certified as safe by FDA-accredited food safety agents. Companies that do not get certified could only import their products through ports that have an FDA laboratory on site, but most states do not have this, the lawmakers said.

There are only 13 ports nationally that have such laboratories, a reality that would penalize states such as Texas that lack the facilities, Barton and Gene Green (D-Texas) said. “I don’t think we should pick winners and losers based on decisions [to add FDA laboratories] that were made decades ago,” Green said.

Dingell responded that the bill was only a draft and that he was open to negotiating with members to address their concerns. But changes are necessary, he emphasized. “We are in a public health crisis,” he said, with a 78 percent drop in food inspections over the past 35 years and the FDA only able to inspect food manufacturers once every decade.

Meanwhile, the FDA and GMA both urged a risk-based inspection system. “We believe the proposed legislation should be more closely targeted and prioritized according to risk,” Stephen Sundlof, director of FDA’s Center for Food Safety and Applied Nutrition, told Senators today. “Several of the legislative sections are not primarily focused on high-risk products. Some of these requirements would require such substantial resources that they would not be feasible.”

But Dingell was skeptical of a risk-based program, arguing that recent studies show that the FDA lacks the technology to do proper risk-based analysis.

GMA also called on Congress to provide the FDA with the power to establish safety standards for fruits and vegetables, require food companies to have a food safety plan, require every food importer to police its foreign suppliers, build the capacity of foreign governments and enlist the private sector in ensuring safety, and give the agency the authority to recall contaminated products.