P.C.A. expands recall, denies allegations

by Keith Nunes
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LYNCHBURG, VA. — The recall of products manufactured by the Peanut Corporation of America (P.C.A.) at its Blakely, Ga., facility went from bad to worse Jan. 28 when the company announced it was recalling all products manufactured at the plant from Jan. 1, 2007, to the present. In a separate statement, the company also denied Food and Drug Administration allegations that it did not manufacture its products at the Blakely plant using good manufacturing practices.

The expanded recall includes all peanuts, dry and oil roasted, granulated peanuts, peanut meal, peanut butter and peanut paste. It is unclear how much actual product is still in the supply chain, but F.D.A. officials said it may be one of the largest food product recalls the agency has had to address.

"We have been devastated by this, and we have been working around the clock with the F.D.A. to ensure any potentially unsafe products are removed from the market immediately," said Stewart Parnell, president of the P.C.A., a privately-held company that has been in business since 1976. "Additionally, we are working alongside state and federal food safety experts in every way we can to help them protect consumers, both now and in the future."

Earlier on Jan. 28, the F.D.A. releaseda report based on its investigation of the Blakely facility after the recall had been traced to the plant. In the report, the inspectors pinpointed 12 instances where independent laboratory tests detected the presence of various Salmonella strains in P.C.A. products, but the company had the products retested, found them to be negative and shipped them to customers.

The inspection report also noted that the P.C.A.’s peanut paste line was not cleaned after Salmonella Typhimurium, the strain associated with the food-borne illness outbreak, was isolated from the peanut paste manufactured on Sept. 26, 2008.

"The firm continued to manufacture peanut paste in this system from 9/26/08 to the beginning of this inspection on 1/09/09," stated the report.

Other observations in the report include:

• Failure to perform mechanical manufacturing steps so as to protect food against contamination;

• Failure to store finished food under conditions that would protect against microbial contamination;

• The design of equipment and utensils failed to preclude the adulteration of food with contaminants; and

• Proper precautions to protect food and food-contact surfaces from contamination with microorganisms could be taken because of deficiencies in plant construction and design.

In a statement, the P.C.A. denied any allegations that it sought favorable results from any laboratory in order to ship its products.

"P.C.A. uses only two highly reputable labs for product testing and they are widely used by the industry and employ good laboratory practices," the company said.

The company also noted the inspection report released by the F.D.A. on Jan. 28 does not represent the final agency determination regarding compliance.

"P.C.A. does not agree with all the observations noted, and there are some inaccuracies," the company said.

Michael Rogers, director of field investigations in the F.D.A.’s Office of Regulatory Affairs, said, the "deficiencies (in the report) are related to cleaning programs and procedures, as well as failure to implement steps required by the F.D.A. to mitigate Salmonella contamination in the facility."

Questions have arisen about the laboratories that did the testing work for the P.C.A. and how they may have come to differing conclusions regarding the presence of Salmonella. Mr. Rogers said Salmonella may exist in small pockets in a product such as peanut butter and it is possible to draw both a negative and a positive sample from the same product lot.

He did note, however, that "obtaining a positive sample at a place in the facility related to a product where it shouldn’t be there and then subsequently obtaining a negative result, absence of any study or steps to mitigate those two conflicting results is not a common industry practice and it’s something we take very seriously."

The F.D.A. is currently declining to name the laboratories used to test P.C.A products.

"We have no information to suggest there are any problems with those laboratories or the results that were reported and documented by the inspection team," Mr. Rogers said.

Criminal investigation called for

Despite its denials, the P.C.A. has come under fire from industry, state and federal officials.

"Although we support P.C.A.’s precautionary move to recall additional products, since the health and safety of the consumer is our highest priority, one thing is certain — willful neglect of public health and safety cannot be tolerated under any circumstance," said Patrick Archer, president of the American Peanut Council, Alexandria, Va. "This is a clear and unconscionable act by one manufacturer. This act is not by any means representative of the excellent food safety practices and procedures of the U.S. peanut industry."

In an interview with the Associated Press, Georgia Agriculture Commissioner Tommy Irvin said, "They tried to hide it so they could sell it. Now they’ve caused a mammoth problem that could destroy their company — and it could destroy the peanut industry."

Representative Rosa L. DeLauro of Connecticut also weighed in on the situation on Jan. 28 and noted, "The actions by the Peanut Corporation of America can only be described as reprehensible and criminal. Not only did this company knowingly sell tainted products, it shopped for a laboratory that would provide the acceptable results they were seeking. This behavior represents the worst of our current food safety regulatory system.

"Because our regulatory system is broken in this area, I will be contacting the Department of Justice to request an investigation into the behavior by the Peanut Corporation of America to determine whether their actions warrant criminal prosecution. We must pursue a zero-tolerance policy when dealing with businesses that intentionally sell tainted products."

In a media teleconference held Jan. 27, F.D.A. officials sidestepped the issue of criminal activity.

"Whether or not there was any criminal activity involved is a different issue," said Dr. Stephen Sundlof, director of the Center for Food Safety and Applied Nutrition at the F.D.A. "This is a matter of producing food in accordance with the Food, Drug and Cosmetic Act and where there are violations of those laws and regulations that apply to those laws then that is technically a violation of the law."

In a subsequent statement, Mr. Rogers said a discussion of what charges might be filed against the P.C.A. is premature.

"We need to follow our normal process and that involves allowing the firm to respond and implement appropriate corrective actions," he said.

What about previous inspections?

Previous inspections of the P.C.A.’s Blakely facility were conducted by the Georgia Department of Agriculture under contract with the F.D.A. Given the extent of breaches in good manufacturing practices observed during the F.D.A.’s January investigation, questions have arisen regarding how potential problems were not noticed earlier.

"Let’s recognize that all inspections are a snapshot in time," Mr. Rogers said. "And it only reflects what the firm is currently doing and the conditions at that particular time."

Mr. Sundlof cited the ceiling leaks observed at the Blakely plant by the F.D.A. investigators during the January inspection.

"My understanding is that since the Georgia inspection that the company had replaced its roof," he said. "…that resulted in some actual openings in the roof where rainwater and other debris could get in."

F.D.A. actions ensnare food companies not a part of recall

WASHINGTON — On Sunday, Jan. 18, the Food and Drug Administration announced consumers should avoid consuming peanut butter or peanut butter containing products, because they may be linked to the Salmonella Typhimurium outbreak that has sickened hundreds of consumers. By the next day, the F.D.A. had amended its statement and was encouraging consumers to visit its web site and search its database of recalled products if they had concerns. Unfortunately, by that time the damage had been done as media outlets warned consumers to avoid peanut butter.

Media outlets such as MSNBC posted headlines that stated "Stop eating foods containing peanut butter, F.D.A. says." The confusion created by the F.D.A.’s Jan. 18 declaration prompted several food companies to try and cut through the confusion by issuing press releases noting their products are not a part of the nationwide recall.

Companies that have issued statements indicating that they are not a part of the recall include:

• Chattanooga Bakery, Inc., Chattanooga, Tenn.

• ConAgra Foods, Inc., Omaha, Neb.

• Dreyer’s Grand Ice Cream, Oakland, Calif.

• The Hershey Co., Hershey, Pa.

• The J.M. Smucker Co., Orrville, Ohio

• Kraft Foods Inc., Northfield, Ill.

• Lance, Inc., Charlotte, N.C.

• Mars Snackfood US, Hackettstown, N.J.

• Nestle USA, Solon, Ohio

• Sara Lee Corp., Chicago

• Smart Balance, Inc., Paramus, N.J.

For a complete list of companies and products involved in the Peanut Corporation of America recall, visit www.fda.gov.

This article can also be found in the digital edition of Food Business News, January 20, 2009, starting on Page 1. Click here to search that archive.

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