Salmonella Problem Stirs Food Safety Bills, Hearing From Energy & Commerce

At an upcoming hearing, House Energy and Commerce Committee leaders will question executives from labs that tested ingredients at the peanut processing facility linked to widespread recalls due to salmonella contamination.

"I am extremely troubled by reports that the plant tested positive for salmonella numerous times but nothing was done to ensure that the product did not go on to the market," Energy and Commerce Chairman Henry Waxman, D-Calif., said Jan. 29.

Waxman and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., have scheduled a hearing Feb. 11 to investigate the contamination at the Peanut Corporation of America's facility in Blakely, Ga.

Meanwhile, multiple lawmakers are seeking support for bills that would make sweeping changes in food safety laws as FDA continues to issue reports of recalls related to the outbreak.

The contamination was linked to illness in more than 500 people and eight reported deaths.

Witnesses scheduled to testify at the hearing include representatives from labs that tested peanut butter ingredients processed by PCA, committee staffers say.

One of the witnesses, Darlene Cowart, is president of J. Leek Associates of Brownsfield, Texas. The second lab executive called to testify is Charles Deibel, president of Chicago-based Deibel Laboratories.

FDA says the contamination of products recalled by firms around the country was linked to peanut butter products manufactured at the PCA facility (¹ (Also see "Peanut Product Recalls Renew Questions On FDA’s Food Safety Capability" - Pink Sheet, 26 Jan, 2009.), p. 11).

Although PCA discovered salmonella on 12 occasions in internal testing since 2007, outside labs reported negative results on some occasions and the firm released the ingredients into the supply chain (see ² (Also see "Peanut Butter Firm’s GMP “Deviation” Offers Lessons For Manufacturers" - Pink Sheet, 2 Feb, 2009.)).

Stupak said the committee has requested documents from PCA.

"There are still far too many questions surrounding FDA's role in allowing the Peanut Corporation of America to distribute contaminated products," he said.

Also scheduled to testify at the hearing are acting FDA Commissioner Frank Torti, PCA owner and President Stewart Parnell and the commissioner of Georgia's Department of Agriculture, Thomas T. Irvin.

Outbreak Sparks Congressional Response

Several lawmakers say the latest outbreak reaffirms the need for swift food safety reform, and are using the report to draw attention to their bills.

Rep. John Dingell said Jan. 28 he is reviving his proposal for sweeping food and import safety reforms that he and Stupak floated in draft legislation in 2008 (³ (Also see "FDA Failures During Heparin Crisis Drive Congress’ Stronger Drug Safety Push" - Pink Sheet, 5 May, 2008.), p. 8).

Stupak and Health Subcommittee Chairman Frank Pallone, D-N.J., a key ally for the dietary supplement industry, joined Dingell as initial co-sponsors of the FDA Globalization Act of 2009.

Pallone noted PCA's "outrageous actions" indicate "food manufacturers cannot be trusted to self-regulate." He added he will schedule subcommittee hearings to discuss FDA inadequacies in detail.

"Antiquated authorities and years of starving FDA of resources has put the public health at risk. Every few months brings another crisis - E. coli in spinach, contaminated heparin, tainted peppers and now salmonella in peanut butter," Dingell said.

"The time to act is now," the Michigan Democrat and longtime FDA critic added.

Some experts have speculated food safety would take a backseat in the 111th Congress as lawmakers focus on economic and health care issues, but the bill's introduction suggests otherwise.

"The fact that Dingell, Stupak and Pallone are all on the bill means that this is a top priority," John Manthei, a food and drug attorney at Latham & Watkins and former Energy and Commerce majority counsel, said in an e-mail.

Manthei also noted the introduction of the bill would have been cleared with Waxman, who angled Dingell out of the chairmanship following the November elections (⁴ (Also see "Waxman Takes Legislative Driver’s Seat With Energy & Commerce Move" - Pink Sheet, 24 Nov, 2008.), p. 8).

Bill Calls For Firms' Food Safety Plans

The bill proposes providing FDA with appropriate funding and authorities for regulating food, drugs, devices and cosmetics in a global economy.

The authorities would include mandatory recall power over "unsafe" drug products, similar to its authorities to order medical device recalls. The agency also already has authority to retract approvals for prescription drugs.

While that provision was part of Dingell's 2008 draft legislation, in the wake of domestic food contamination problems the 2009 bill more comprehensively addresses overall food safety concerns.

The bill's three co-sponsors say it would provide FDA with the funding it needs to increase inspections of food facilities, and require food manufacturers to have "preventive safety plans in place" and subject "the plans to FDA inspection."

The bill also would close "loopholes in FDA's ability to trace the source of contaminated products, and imposes stiff penalties on companies that violate safety standards," the lawmakers say. They add that the bill requires "parity between foreign and domestic drug and device facility inspections."

Durbin, DeLauro Plan Bills For Introduction

Sen. Dick Durbin, assistant majority leader in the Senate, plans to reintroduce his FDA Food Safety Modernization Act in February, a staffer said.

The Illinois Democrat's bill, introduced in the last Congress, would give FDA mandatory recall authority for food, establish third-party inspection accreditation systems and increase the agency's resources.

The planned re-introduction is due in part to the latest outbreak, according to the Durbin spokesman, who also noted the bill was written with Republican input.

While President Obama has not had time to focus on FDA food safety reform since his swearing in, Durbin's bill includes provisions similar to those in legislation Obama introduced as the junior senator from Illinois, the staffer said in an e-mail.

Durbin is widely believed to have the president's ear concerning congressional priorities.

Rep. Rosa DeLauro, D-Conn., chairwoman of the House Appropriations subcommittee with FDA oversight, said she plans to reintroduce a bill she filed in 2007 that proposed creating a separate food safety agency (⁵ , p. 9).

The Food Safety Modernization Act would remove food safety from FDA oversight and establish a new agency for food within the Department of Health and Human Services. Under the legislation, FDA would retain authority over drugs and devices but be renamed.

While the Durbin staffer said the senator's priority is passing the FDA Food Safety Modernization Act, he retains a long-term goal of establishing a "single food safety agency."

Economic Focus No Problem

Food and drug attorney A. Wes Siegner believes some form of food safety legislation is likely to pass in the 111th Congress.

"I'd be surprised, even with the economy, that something didn't get passed," said Siegner, of Hyman, Phelps and McNamara.

However, he doubts that a bill to create a separate food agency will be the vehicle for food safety reform. Siegner pointed out that the interests of both the Department of Agriculture and FDA in retaining their current authorities are impediments to creating a new agency.

On the other hand, giving FDA mandatory recall authority for food products is likely to pass as part of food safety legislation, he added.

- Katie Stevenson ([email protected])