FDA would have been able to act earlier to limit the impact of contaminated peanut products if food firms were required to report all positive tests for contaminants, according to an agency executive.

"It would have alerted us sooner that there was a problem," Stephen Sundlof, director of FDA's Center for Food Safety and Applied Nutrition, said during a Feb. 11 hearing on Capitol Hill.

Under current law, food and supplement firms are not required to submit to FDA results of tests showing the presence of contaminants if a product has not been released into the market.

Sundlof discussed contaminants and other food safety issues during a House Energy and Commerce Oversight and Investigations Subcommittee hearing on FDA's response to the salmonella outbreak linked to peanut products processed at the Peanut Corporation of America's Blakely, Ga., plant.

PCA declared Chapter 7 bankruptcy Feb. 13, amid law suits, continued recalls and ongoing investigations. This filing begins the process of liquidation, and the firm is unlikely to re-emerge.

When FDA inspected the Georgia facility after tracing the contamination to PCA, the company provided records the agency requested but did not offer additional records on its previous salmonella findings.

Ben England, a food and drug lawyer who served as counsel in FDA's Office of Regulatory Affairs, said requiring all positive contaminant findings would not prevent bad actors from withholding the information.

"The only companies that would report anything would be the companies that would not have distributed the product in the first place," he said in an interview.

England also noted the burden with compliance would fall on "companies that are not in a category with this one, which is apparently in the practice of knowing their product is contaminated and shipping it anyway."

According to FDA, PCA made 12 findings of salmonella in peanut ingredients processed at the Georgia facility since 2007, but did not report the information. On some occasions, PCA shipped product to customers after outside labs showed negative results for materials the company's tests indicated were contaminated.

During the hearing, Charles T. Deibel, an executive with a lab PCA hired, said it is "not unusual" for a firm to receive a positive test on a product and then submit the material for a retest.

"What is virtually unheard of is for an entity to disregard those results and place potentially contaminated products into the stream of commerce," said Deibel, president of Chicago-based Deibel Laboratories.

FDA has noted PCA deviated from good manufacturing practices. The agency and the Department of Justice are investigating.

The Department of Agriculture Feb. 5 suspended PCA for a year from doing business with the federal government, including as a subcontractor. USDA also proposed debarring Lynchburg, Va.-based PCA for three years due to the salmonella outbreak.

Both actions are likely moot, given the firm's bankruptcy.

"The actions of PCA indicate that the company lacks business integrity," making it unfit as a federal contractor, says David Shipman, acting administrator of USDA's Agricultural Marketing Service.

At the hearing, PCA President and CEO Stewart Parnell and the Blakely plant manager, Sam Lightsey, refused to answer members' questions, invoking their Fifth Amendment right against self-incrimination.

The subcommittee released e-mails written by Parnell and Lightsey indicating their knowledge of previous salmonella contaminations while assuring company employees that no contaminations had occurred. In one, Parnell indicated he discounted a warning of contamination from a PCA plant worker.

A message from Parnell instructed Lightsey to release product that received a negative test result from an outside lab after its initial positive result.

Testimony and responses to subcommittee questions from PCA's outside laboratories were also made part of the record. In a written statement, J. Leek Associates microbiology lab manager Michelle Pronto said PCA stopped using JLA's services after the firm received too many positive tests from the Brownsville, Texas-based lab.

"A Number Of Shortcomings"

Sundlof told the subcommittee the outbreak "highlights a number of shortcomings with our nation's food safety systems, and underscores the need for greater federal oversight, more effective industry practices and stronger safeguards."

"Food safety is a priority for the new administration," he added.

During questioning from committee members, Sundlof said making peanut butter a high-risk food could be necessary.

A CFSAN spokesman Feb. 12 noted the agency has identified two areas "for enhanced focus during routine food safety inspections."

The areas involve "requesting information for review on the firm's internal environmental and incoming/in-process/finished product testing programs for pathogens and other contaminants" and "enhanced environmental sampling by FDA during its inspections."

Further, the spokesman noted FDA does not need additional authority to boost environmental sampling, which the agency recognized "about a year ago" as "a need to address moving forward."

Under the Bioterrorism Act enacted in 2002, FDA can request records, but firms are not required to provide them unless the agency has "reasonable belief that an article of food is adulterated" and could potentially cause harm, the spokesman said in an e-mail.

Additionally, the FDA spokesman said resources for increased environmental sampling were set aside in fiscal 2009 and a course was developed for investigators. The course is set to be offered to investigators in March, he said.

Sundlof noted FDA has been identified as lacking in authority to issue preventive controls for high-risk foods, enhance access to records during inspections and ensure that inspectors have access to all information, and to require food facilities to renew their registrations every two years.

FDA Could Use Mandatory Recall - Sundlof

Sundlof said mandatory recall authority over food "would be a useful tool" for FDA that, "in some circumstances, could result in faster removal of implicated products from commerce."

However, he said, he does not recall an occasion when a firm has not cooperated, noting FDA already has tools, such as seizures, to pressure firms to recall products.

England said if FDA gains the authority, the food industry will need training on compliance. The agency should develop a "mandatory recordkeeping program to make everyone competent to recall," he said.

The first salmonella recall linked to PCA's ingredients came Jan. 10 with King Nut's recall of peanut butter provided to hospitals, schools and other institutions. However, PCA itself did not recall any of its products until Jan. 13. The firm has since expanded its recalls to include more products.

The Centers for Disease Control and Prevention say the outbreak has sickened 600 people, and possibly contributed to eight deaths. FDA's Web site listed more than 2,000 recalled peanut products from more than 200 firms through Feb. 13.

The salmonella outbreak has fueled calls for immediate food safety reform from members of Congress, including proposals to give FDA mandatory recall authority(see chart: " ¹ Menu Of Food Legislation Grows ").

"I cannot think of a case that better demonstrates that the FDA and the USDA should have mandatory recall authority than this case," Rep. Diana DeGette, D-Colo., said during the hearing. She has introduced legislation, H.R. 815, to give FDA mandatory recall authority for food.

Oversight and Investigations Chairman Bart Stupak, D-Mich., Rep. John Dingell, D-Mich., and Rep. Frank Pallone, D-N.J., recently introduced the FDA Globalization Act of 2009, H.R. 759. The bill would impose wide-reaching supply chain safety improvements, including giving FDA recall authority for food. It also addresses drugs, devices and cosmetics (² Also see "Salmonella Problem Stirs Food Safety Bills, Hearing From Energy & Commerce" - Pink Sheet, 2 February, 2009., p. 6).

In a Feb. 12 release, Stupak says the PCA problem is "one more reason to move our FDA Globalization Act sooner rather than later."

- Katie Stevenson (k.stevenson@elsevier.com)

Calls For Reporting Requirements, Recall Authority Remain As PCA Crumbles

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