FDA's response to an outbreak of salmonella bacteria in peanut butter shows little evidence that the agency is capable of keeping the complex food supply safe, according to a former FDA executive.

Despite conducting what FDA calls "a very active and dynamic investigation" into how contaminated peanut butter has sickened around 500 people and may have killed six, FDA is "hamstrung" by food-borne outbreaks, said William Hubbard, a former associate commissioner for policy.

"It seems to me like every one of the outbreaks is about the same," he said in an interview Jan. 22. "They take too long and the companies have inadequate information and a lot of people get sick before the source is ever found."

FDA is working with food manufacturers to recall all food products containing peanut butter and peanut paste made in the Blakely, Ga., plant of the Peanut Corporation of America since July 1, 2008.

Since Jan. 10, companies working in conjunction with FDA have recalled more than 300 products over concern that Salmonella Typhimurium bacteria might contaminate their cookies, candies, ice creams, cereals and energy bars.

Stephen Sundlof, director of FDA's Center for Food Safety and Applied Nutrition, said in a conference call with reporters Jan. 21 that tracking the distribution of PCA peanut butter has revealed "a fairly complex web" of secondary and even tertiary food products that the agency and the Centers for Disease Control and Prevention are still identifying.

The bacterial contamination was initially found in jars of King Nut peanut butter used for institutional purposes and manufactured in PCA's Blakely plant, which has since ceased production of peanut products. FDA maintains no major national brands of peanut butter in jars are believed to be affected.

Sundlof said FDA had not previously inspected the PCA facility while it was producing peanut products. He added that Georgia state inspectors visited the plant in June 2008 at the request of FDA, and had found some violations that were corrected during the inspection.

Hubbard blamed the salmonella outbreak on "a reactive system" in which FDA's food protection function is hobbled by antiquated labs, a lack of inspectors and no authority to compel firms to keep detailed records of manufacturing practices.

The peanut butter recalls are the latest in a recent series of food crises, including the discovery of melamine in chocolates and infant formula; E. coli contamination of spinach; and salmonella found on peppers (¹ Also see "As Melamine Turns Up In Sweets, Advocates Turn Up Heat On FDA" - Pink Sheet, 15 December, 2008., p. 4).

Some trade and advocacy groups are calling for radical structural change at the agency, while others say food safety oversight can be improved using the existing regulatory system.

Fixing Food Protection

Brian Kennedy, director of communications for the Grocery Manufacturers Association, said the salmonella crisis creates additional evidence supporting the trade group's call for FDA reform.

Congress should give the agency authority to require "every food company selling food in the U.S. to conduct a food safety risk analysis that identifies potential sources of contamination" and to propose suitable food safety controls, he said in a statement.

GMA also recommends requiring that each food firm develop and use a safety plan for its entire ingredient supply chain (² Also see "Supplements Shielded From Spread Of Peanut Butter-Like Problems – Trades" - Pink Sheet, 26 January, 2009.).

The Center for Science in the Public Interest Jan. 22 issued a harsh reprimand of FDA's handling of the salmonella outbreak, calling the agency "woefully inadequate to the task of protecting American consumers from unsafe food."

With their long shelf lives, tainted peanut butter products have the potential to continue to sicken and kill consumers, said CSPI Food Safety Director Caroline Smith DeWaal.

FDA has "minimal" ability to protect the public from such a threat, due to its lack of mandatory recall authority and decentralized food oversight responsibilities, she added.

The Government Accountability Office has touted the deterrent power that the threat of mandatory recall could have on firms (³ Also see "Threat Of Mandatory Recall A Deterrent, GAO Says In Food Safety Study" - Pink Sheet, 21 July, 2008., p. 14).

CSPI also advises Congress and the Obama administration to take on the "shovel ready" task of restructuring food safety by acting on legislation to separate food from drug and device regulation.

Rep. Rosa DeLauro, chairwoman of the House Appropriations subcommittee with FDA oversight, said Jan. 17 the salmonella outbreak further proves the need for the Food Safety Modernization Act, which she plans to introduce soon.

Much like the Safe Food Act the Connecticut Democrat introduced with Sen. Richard Durbin, D-Ill., in February 2007, the bill would seek to establish an independent food safety agency outside of FDA, increase the frequency of inspections and grant the new agency mandatory recall authority (⁴ Also see "Safe Food Act Would Combine CFSAN, USDA Food Duties Under New Agency" - Pink Sheet, 19 February, 2007., p. 15).

Desperately Seeking Science

Not everyone sees a food safety agency as practical or even necessary, despite the outcry for FDA overhaul.

Food safety scientist Ken Lee emphasized that the salmonella outbreak was first and foremost a failure of industry's mission to produce safe foods, but called the recall responses by firms "exemplary."

Lee, director of the Food Safety Center at the Ohio State University, also expressed confidence that "we can work with the existing system" of food oversight, especially since the Department of Agriculture is forming the science-based National Institute for Food and Agriculture.

The institute, created by the 2008 federal farm subsidy programs reauthorization, is intended to be a cross-agency body enhancing the status and accessibility of food and agricultural science. It is slated to begin operations in October 2009.

Hubbard acknowledged the prevalent opinion that FDA's food safety apparatus is weak, saying "you've got to do something almost drastic to really make a difference."

However, he said he remains unconvinced that an independent food safety agency would prove any more prepared than FDA to prevent the next outbreak of contaminated food.

"I worry that it would take so much time and effort to reorganize that you wouldn't get anything done while you're reorganizing," he said.

- Dan Schiff (d.schiff@elsevier.com)

Peanut Product Recalls Renew Questions On FDA’s Food Safety Capability

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